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    05 July 2026, Volume 29 Issue 19
    Guidelines·Consensus
    Expert Consensus on Medication Therapy for Acid-related Diseases
    China Pharmacological Society Committee on Drug-induced Diseases
    2026, 29(19):  2593-2607.  DOI: 10.12114/j.issn.1007-9572.2026.0063
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    Acid-related diseases are characterized by high incidence rates and significant disease burden. Excessive gastric acid secretion or heightened gastric acid sensitivity represents the common pathogenesis of these conditions, leading to the widespread application of the principle of "treating different diseases with the same therapy" in medication management. With growing concerns regarding the risks associated with inappropriate use of acid-suppressing drugs such as proton pump inhibitors, there is an urgent need to deepen the systematic understanding of medication therapy for acid-related diseases and to promote rational drug use. This consensus was developed by a multidisciplinary panel of experts in clinical medicine, pharmacy, and methodology. Based on evidence-based medicine, it provides a systematic elaboration on the classification of acid-related diseases, therapeutic drugs, diagnostic methods, and pharmaceutical care services. Additionally, it offers consensus recommendations and management strategies for key clinical issues encountered in practice. The release of this consensus is of great significance for establishing a medication therapy management system and promoting rational drug use for acid-related diseases.

    General Practice/Community Health Service
    Research on the Localization of the Patient-centered Medical Home Model in China: Adaptation Mechanisms, Challenges, and Pathway Analysis
    ZHAO Xinxin, SUN Xiaoting, LUO Xinhao, SUN Jin, PENG Derong, ZHENG Jialin
    2026, 29(19):  2608-2613.  DOI: 10.12114/j.issn.1007-9572.2025.0520
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    Under the background of the global transformation of primary health care (PHC) systems, the patient-centered medical home (PCMH) model, with its core philosophy of "people-centered, integrated, continuous, and team-based care", has emerged as a significant paradigm for enhancing PHC service quality. In China, community health services are undergoing a critical transition from a disease-treatment focus towards health management. The deepening implementation of systems such as contracted family doctor services and hierarchical diagnosis and treatment provides fertile ground for adopting and integrating PCMH concepts. This paper systematically reviews the core elements of PCMH and international practical experiences. By comparing these with the current state of China's community health service system, it identifies structural discrepancies and transformational challenges across six key dimensions: payment incentives, information technology, human resources, service culture, organizational management, and systemic collaboration. Corresponding synergistic reform strategies are proposed. Building on this analysis, the study constructs a progressive, four-stage implementation pathway comprising "organizational preparation, process re-engineering, comprehensive scaling, and continuous improvement". The aim is to provide a reference that combines theoretical systematicity and practical operability, thereby to promote the high-quality development of China's contracted family doctor services with the emphasis shifting from "quantity of contracts" to "quality of service", and from "fragmented" to "integrated" care.

    Study on the Prevention and Treatment of Hypertension and Diabetes Mellitus in Community Hospital
    ZHANG Xiaojuan, LIU Yang, PENG Bo, YE Yuan, ZHU Kun
    2026, 29(19):  2614-2620.  DOI: 10.12114/j.issn.1007-9572.2024.0250
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    Background

    Primary health institutions serve as the frontline defense against hypertension and diabetes. Their capabilities are critical to China's ability to effectively prevent and control these two chronic conditions.

    Objective

    To analyze the current situation of health management and treatment services provided by community hospitals in China for patients with hypertension and diabetes to identify problems and make suggestions.

    Methods

    The "Quality Service Grassroots Activities Application System" collected information on hypertension and diabetes prevention and treatment capacity and service provision in 3 718 community hospitals. Descriptive statistical analysis and multiple linear regression analysis were carried out based on Stata15.0.

    Results

    There were statistically significant differences in the allocation of electrocardiogram machines and peripheral blood glucose meters among primary health institutions across different regions (P<0.001). Similarly, significant regional disparities were observed in the availability of essential antihypertensive and hypoglycemic medications (P<0.001). The annual number of hypertension and diabetes diagnoses and treatments per institution also varied significantly by region (P<0.001). Additionally, significant differences were found in the renewal rates of hypertensive and diabetic patients across regions(P<0.001). Furthermore, significant variations were observed among regions in the standardized management rates of hypertensive and diabetic patients, as well as in blood pressure and blood glucose control rates (P<0.001). Multiple linear regression analysis revealed that factors such as region, institution type, the number of essential antihypertensive drugs available, the number of registered general practitioners, the proportion of medical income to total income, the proportion of medical insurance income to medical income, and the contract renewal rate significantly influenced the annual number of diagnosed and treated hypertensive patients (P<0.05). Similarly, region, institution type, the number of practicing (assistant) physicians, the proportion of medical income to total income, and the renewal rate were found to affect the standardized management rate of hypertensive patients (P<0.05). Moreover, region, institution type, the number of electrocardiogram machines, the number of practicing (assistant) physicians, and the proportion of medical income to total income had statistically significant effects on blood pressure control.

    Conclusion

    The hardware conditions of community hospitals in the western region are better, but the medical service capacity is not as good as that in the east, and the soft power still needs to be improved. The ECG machine is the best, but the peripheral blood glucose meter, drug equipment, diagnosis and treatment times and other indicators that reflect the ability of medical services are not as good as those in the east. The integration of medical prevention of hypertension and diabetes still needs to be implemented, and public health indicators such as standardized management rate and blood pressure and blood glucose control rate are "decoupled" from the medical service capacity of community hospitals, and the indicators related to medical services and public health services are "inverted", with the former being high in the east and the latter in the west, and the quality and service connotation of public health data need to be improved.

    The Residents' Perception of Health Education Needs in Different Community Types
    YI Minzhe, GAO Qingtao, YANG Xianxiao, CHEN Weiwei
    2026, 29(19):  2621-2630.  DOI: 10.12114/j.issn.1007-9572.2024.0513
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    Background

    Community health education is widely recognized as an effective health promotion strategy with low costs and high benefits. Nevertheless, existing research on health education needs lacks an analytical framework based on various community types, making it difficult to fully explain the differentiated and diverse health education needs under the complex population composition of urban communities.

    Objective

    To investigate the health education needs of residents in different types of communities and whether there are significant differences, thereby providing support for community health medical science popularization efforts.

    Methods

    This study was conducted in Hangzhou from April to June 2024, employing a mixed-methods research approach. The qualitative research phase involved purposive sampling to select open-ended interviews from heterogeneous, transformed, homogeneous and system-based community types, aiming to understand residents' perceptions of health education needs. A total of 14 residents were included, along with 21 policy texts to understand the knowledge system residents should possess in health education. Nvivo 12.0 software was utilized to perform a three-level coding of the text data, categorizing health education content needs based on resident perspectives and policy document analysis. Based on the identified themes, a questionnaire was designed. In the quantitative research phase, residents from four community types were selected as survey subjects, and the Likert 5-point scale was used to quantify the needs for health education content. Then, descriptive statistics, nonparametric tests, and multivariate Logistic regression models were employed to investigate the degree of these needs and differences in health education content among different community types.

    Results

    The qualitative research synthesized eight primary themes of health education: major disease prevention and control, healthy lifestyles, maternal and child health, mental health, environmental health, medication health, emergency and safety, and sex education, encompassing 23 specific educational topics. A total of 299 valid questionnaires were collected in the quantitative research, with a response rate of 94.03%. The results highlighted that the highest need is first aid knowledge [5 (4, 5)], followed by cancer prevention and treatment [4 (4, 5)]. Kruskal-Wallis H test results indicated that residents' educational level, income level, and different types of communities had a significant impact on the health education needs (P<0.05). Further multivariate Logistic regression analysis showed that different educational levels significantly influenced the needs for diabetes prevention (P<0.05) and life safety education, different income levels significantly affected the needs for cardiovascular and cerebrovascular disease prevention and infectious disease prevention (P<0.05), and different types of communities had significant differences in the needs for natural environmental pollution prevention, infectious disease prevention, diabetes prevention, cardiovascular and cerebrovascular disease prevention, first aid knowledge, and life safety education (P<0.05).

    Conclusion

    Residents' perceptions of community health education needs are diverse, influenced by multiple factors such as educational level, income level, and community health resources. Different types of communities should closely align with residents' perceptions of health education needs for precise targeting, while ensuring the effectiveness and equity of educational resources.

    Study on Traditional Chinese Medicine Service Capacity and Delivery Efficiency of Village Clinic in a District of Beijing
    WANG Cheng, SHI Xuefeng, YANG Yong, BAI Qian
    2026, 29(19):  2631-2637.  DOI: 10.12114/j.issn.1007-9572.2023.0853
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    Background

    As a unique medical resource in China, traditional Chinese medicine (TCM) has palyed an essential role in maintaining population health. However, facing the growing health demands, some problems of TCM at the grassroots become prominent, such as the unbalanced and inadequate development of TCM and the weak service capacity of TCM. Therefore, it is crutial to improve the rural TCM service system for rural revitalization and the construction of a healthy China.

    Objective

    To evaluate the medical service capacity and efficiency of village clinics in a district of Beijing, analyze the existing problems in the development of TCM, and provide reasonable suggestions for further promoting the development of TCM in village clinics.

    Methods

    A total of 394 village health centres in a district of Beijing were selected for the study from January to March in 2021. First, descriptive statistical analysis was used to analyze the TCM provision capacity of the village clinic in 2019, including TCM related human, material and financial resources and services. Then, data envelopment analysis was employed to calculate the overall efficiency, pure technical efficiency and scale efficiency of the villiage clinic. The human resources and hardware construction were regarded as input indicators, and capital return and service volume as output indicators. The comprehensive efficiency, technical efficiency and scale efficiency of the village clinic were calculated.

    Results

    Overall, 394 village clinics in this district provided TCM services in 2019. There were 45 rural doctors mainly practicing TCM, 471 sets of TCM diagnosis and treatment equipment. The income of Chinese herbal medicine and Chinese patent medicine was 1.224 5 million yuan and 34.161 9 million yuan, respectively. The number of TCM treatments was 64 716 times. Based on data envelopment analysis, 264 village clinics were in a state of increasing return to scale, 13 village clinics were in a state of decreasing return to scale, and only 7 village clinics were in a state of effective allocation of TCM resources. Besides, there were regional differences in the efficiency of TCM service among townships, towns and streets.

    Conclusion

    The village clinics in this district have some problems, including inadequate TCM rural doctors, insufficient TCM related equipment, evident disparities in medical income, and low efficiency of TCM service provision. Among them, the problem of scale efficiency is particularly prominent, which has become a key factor restricting the improvement of TCM service efficiency, resulting in the slow development of TCM in the region. These problems might be solved by a series of measures, such as enlarging TCM talents, optimizing the allocation of TCM relaed equipment, improving the health compensation mechanism, and strengthening the distinctive advantages of TCM, and then TCM in village clinics could devlelop with high-quality in the new era.

    Original Research
    Impact of Acute Respiratory Distress Syndrome Etiology on the Prognostic Value of Driving Pressure: a Prospective Cohort Study
    LIU Yang, ZHOU Guoping, LI Xiaoshi, LI Ping, ZHANG Xin
    2026, 29(19):  2638-2647.  DOI: 10.12114/j.issn.1007-9572.2025.0365
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    Background

    Airway driving pressure (DP) is a recognized independent predictor of mortality in mechanically ventilated patients with acute respiratory distress syndrome (ARDS). Although pathophysiological differences between pulmonary and extrapulmonary ARDS are well-established, it remains unclear whether the prognostic value of DP varies by ARDS etiology.

    Objective

    This prospective cohort study evaluated whether ARDS etiology modifies the association between DP and 90-day all-cause mortality.

    Methods

    We enrolled 172 mechanically ventilated ARDS patients aged>18 years who met the Berlin definition at Nanjing Gaochun People's Hospital from December 2021 to October 2023. Patients were classified as having pulmonary ARDS (n=82) or extrapulmonary ARDS (n=90) based on clinical features. We collected data on Day 1, including Sequential Organ Failure Assessment (SOFA) score, Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score, the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and respiratory mechanics including DP, plateau pressures (Pplat), and respiratory system compliance (Crs). The primary outcome was 90-day all-cause mortality. Cox proportional hazards regression models were employed to assess the interaction between DP and ARDS etiology (pulmonary versus extrapulmonary) on 90-day mortality. Sensitivity analyses using inverse probability of treatment weighting (IPTW) based on propensity scores were conducted to account for potential confounders.

    Results

    Among the 172 ARDS patients mean age (57±18) years, 63 (36.3%)died during follow-up. Non-survivors had higher SOFA scores, APACHE Ⅱ scores, DP, Pplat, and lower PaO2/FiO2 ratios and Crs than survivors (all P<0.05). The association between DP and 90-day mortality (HR=1.134, 95%CI =1.067-1.206, P<0.001) varied by ARDS etiology (P=0.04 for interaction) after adjustment for age, PaO2/FiO2 ratio, and SOFA score. In pulmonary ARDS (n=82), both PaO2/FiO2 (HR=0.990, 95%CI=0.980-1.000, P=0.04) and DP (HR=1.253, 95%CI =1.146-1.370, P<0.01) were associated with 90-day mortality. Conversely, in extrapulmonary ARDS (n=90), DP (HR=1.083, 95%CI=0.957-1.227, P=0.21) was not associated with mortality, while only the SOFA score remained an independent risk factor(HR=1.277, 95%CI=1.067-1.528, P<0.01). These findings were consistent in the IPTW analysis (P=0.009 for interaction between ARDS etiology and DP on mortality).

    Conclusion

    While DP is a strong predictor of mortality in ARDS overall, its prognostic significance differs by etiology. Specifically, in extrapulmonary ARDS, elevated DP is not significantly associated with poor prognosis, suggesting that ventilation strategies should be aligned with the underlying ARDS etiology.

    Clinical Characteristics and Risk Factors for Recurrence of Cryptogenic Organizing Pneumonia
    ZHAO Huili, LU Lina, ZHUO Ya, WANG Xin
    2026, 29(19):  2648-2655.  DOI: 10.12114/j.issn.1007-9572.2024.0510
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    Background

    Cryptogenic organizing pneumonia (COP) is a form of non-specific lung injury characterized by the formation of alveolar granulomas. While it typically responds well to glucocorticoid therapy, the condition is prone to relapse upon dose reduction or discontinuation of treatment. Recurrence of COP is associated with a poor prognosis and significantly impacts patients' quality of life. Consequently, analyzing the clinical characteristics and identifying risk factors for recurrence are crucial for early recognition and minimizing the likelihood of relapse.

    Objective

    By analyzing the clinical data of patients with COP, we aim to identify potential risk factors associated with disease recurrence. This research will enhance the understanding of COP recurrence mechanisms and provide valuable insights for clinical doctors to develop more effective prevention strategies.

    Methods

    We retrospectively collected data from 95 patients who were diagnosed with COP through a combination of clinical, radiological, and pathological assessments at the Affiliated Central Hospital of Shandong First Medical University from 2014 to 2023. All patients were followed up at 1, 3, and 6 months after discharge, with the results interpreted jointly by specialized pulmonologists and radiologists. Patients were divided into two groups based on recurrence status: the recurrence group and the non-recurrence group. We analyzed the general information, clinical manifestations, laboratory tests, and imaging findings of the two groups. Univariate analysis was performed, and significant indicators were further subjected to multivariate Logistic regression analysis to identify independent risk factors for COP recurrence.

    Results

    A total of 95 patients with COP were included in this study, comprising 49 males and 46 females, with ages ranging from 18 to 85 years. The main clinical manifestations were dry cough, chest tightness, dyspnea, and respiratory distress. Chest imaging primarily showed multifocal or large areas of consolidation in both lungs. Laboratory tests showed no significant specificity, but some patients had elevated inflammatory markers, including white blood cell count, neutrophil count, C-reactive protein, and erythrocyte sedimentation rate. Pathological findings included granulation tissue formation in the alveolar ducts and alveolar spaces, often accompanied by massive accumulation of foamy macrophages, inflammatory cell infiltration, alveolar epithelial proliferation, fibrous tissue proliferation, and widened alveolar septa. Among the 95 patients, 24 experienced recurrence. Univariate analysis revealed that white blood cell count, neutrophil count, C-reactive protein, alanine aminotransferase, lactate dehydrogenase, γ-glutamyl transferase (γ-GT) , erythrocyte sedimentation rate, arterial oxygen partial pressure, time from onset to diagnosis, and fever were associated with COP recurrence. Multivariate Logistic regression analysis identified higher lactate dehydrogenase (OR=1.003, 95%CI=1.003-1.037, P=0.024) , higher erythrocyte sedimentation rate (OR=1.084, 95%CI=1.037-1.132, P=0.002) , lower arterial oxygen partial pressure (OR=0.882, 95%CI=0.817-0.952, P=0.001) , and longer time from onset to diagnosis (OR=1.017, 95%CI=1.003-1.031, P=0.016) as independent risk factors for COP recurrence.

    Conclusion

    Higher lactate dehydrogenase, higher erythrocyte sedimentation rate, lower arterial oxygen pressure, and longer time from onset to diagnosis are independent risk factors for COP recurrence.

    Comparative Study of Cardiac Structure and Function in Obstructive Sleep Apnea Patients Based on the Classification of Hypopnea/Apnea Ratio
    QIN Han, YANG Mei, LIU Yingcun, LIU Yazhen, XIE Junhao, CHEN Xiaojie, LIU Juan
    2026, 29(19):  2656-2663.  DOI: 10.12114/j.issn.1007-9572.2025.0404
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    Background

    Obstructive sleep apnea (OSA) is associated with cardiac structural remodeling and functional impairment. Most studies have focused on the overall OSA population, with limited attention given to the impact of different distributions of hypopnea and apnea events on cardiac structure and function.

    Objective

    To compare the impact of different hypopnea/ apnea ratio (HAR) classifications on cardiac structure and function in patients with OSA.

    Methods

    A retrospective analysis was conducted on 193 hospitalized patients with OSA and 44 control subjects at the Department of General Practice, Daping Hospital, Army Medical University from January 2023 to February 2025. All participants underwent comprehensive echocardiography during the same period. Based on the HAR, OSA patients were classified into apnea-dominant (n=66) and hypopnea-dominant (n=127) groups. They were also divided into mild (n=68), moderate (n=73), and severe (n=52) OSA groups according to the apnea hypopnea index (AHI). General demographics, comorbidities, sleep monitor parameters, and echocardiography data were collected to analyze the impact of different HAR classifications on cardiac structure and function in patients with OSA.

    Results

    Left atrial systolic diameter (LADs), left ventricular diastolic diameter (LVDd), right atrial systolic diameter (RADs), aortic sinus diameter (AOAs), main pulmonary artery systolic diameter (MPAs), interventricular septum diastolic thickness (IVSTd), and left ventricular posterior wall diastolic thickness (LVPWd) were significantly higher in apnea-dominant OSA patients than those in hypopnea-dominant patients (P<0.05). Spearman correlation analysis revealed that in patients with OSA, LADs, LVDd, RADs, AOAs, MPAs, IVSTd, and LVPWd were positively correlated with AHI, and oxygen desaturation index (ODI), while negatively correlated with HAR. The lowest SpO2 (LSpO2) was negatively correlated with MPAs. The percentage of total sleep time with SpO2 <90% (T90) was positively correlated with LADs, LVDd, RADs, AOAs, and MPAs (P<0.05). Multiple linear regression analysis revealed that after adjusting for the effects of gender, age, BMI, and AHI, there were no significant differences in cardiac structural indicators between the two types of OSA. Gender, age, and BMI were significant predictors of multiple cardiac structural parameters (P<0.05), while AHI was identified as an independent predictor of MPAs (P<0.05).

    Conclusion

    The distribution patterns of hypopnea and apnea events show no difference in their impact on cardiac structure and function in OSA patients. Gender, age, BMI, and AHI may have more significant impacts on cardiac remodeling.

    Comparison of the Effectiveness of Fried's Frailty Phenotype and the FRAIL Scale in Assessing Pre-frailty among Community-dwelling Older Adults Undergoing Health Examinations
    PANG Shu, SUN ying, JIANG Chunyan
    2026, 29(19):  2664-2670.  DOI: 10.12114/j.issn.1007-9572.2025.0405
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    Background

    Pre-frailty represents a transitional risk status between health and frailty. Early identification and intervention during this stage can delay or even reverse the frailty development. However, there is a lack of standardized pre-frailty assessment tool tailored for community-dwelling older adults.

    Objective

    To compare the effectiveness of Fried's Frailty Phenotype (FP) and FRAIL Scale in assessing pre-frailty among community-dwelling older adults undergoing health examinations, thereby providing evidence for the selection of appropriate assessment tools.

    Methods

    A cross-sectional study was conducted using convenience sampling to recruit older adults aged 60 years and above undergoing health examinations at five community health centres in Beijing from December 1, 2024, to March 20, 2025. Demographic data were collected, and frailty status was assessed using the FP and the FRAIL scale. Activities of daily living (ADL) were evaluated using the Modified Barthel Index (MBI), and quality of life was assessed using the 36-Item Short Form Survey (SF-36). Spearman rank correlation and Kappa statistics were used to analyze the consistency and correlation between the two scales. Using MBI and SF-36 scores as validity criteria, the validity of both tools was evaluated via Spearman rank correlation, receiver operating characteristic (ROC) curve analysis, and Bayes discriminant analysis.

    Results

    The prevalence of pre-frailty detected by the FP was higher than that by the FRAIL scale (36.3% vs. 25.3%). The two scales showed a moderate positive correlation (rs=0.713, P<0.001) and moderate agreement (Kappa=0.606, P<0.001), with consistent classification in 81.2% of participants. Frailty severity assessed by both scales was positively correlated with ADL decline and negatively correlated with SF-36 total, Physical Component Summary (PCS), and Mental Component Summary (MCS) scores. Both scales demonstrated associations with ADL decline, with ROC curve areas under the curve (AUC) of 0.736 and 0.735, respectively (P<0.001). Bayes discriminant analysis indicated that the cross-validation accuracy for ADL decline was higher for the FP (86.3%) than the FRAIL scale (85.1%). ROC analysis revealed that the FP had higher sensitivity (74.0% vs. 64.4%), while the FRAIL scale had superior specificity (80.1% vs. 65.8%) for predicting ADL decline. The optimal cutoff value for both scales in predicting ADL decline was 0.5.

    Conclusion

    The FP and FRAIL scale demonstrate moderate correlation and consistency, and both are negatively associated with quality of life. Both tools possess moderate validity in verifying ADL decline and are suitable for assessing pre-frailty in community-dwelling older adults. The FP, with its higher sensitivity and inclusion of objective indicators, is more suitable for pre-frailty screening in health examination settings aiming for "early detection and intervention". Conversely, the FRAIL scale, due to its simplicity and high specificity, serves as a viable alternative for rapidly identifying high-risk individuals in resource-limited settings. These findings suggest practical value in integrating frailty screening into routine community health examinations and initiating interventions based on a 0.5 cutoff value.

    Predictive Model for Breakthrough Influenza Cases in the Elderly Population: a Nested Case-control Study
    BAO Ruolin, LU Chao, FENG Xin, YE Chunmei, LAI Fenhua, NI Zuowei, YANG Dongbo, ZHENG Yongtao
    2026, 29(19):  2671-2677.  DOI: 10.12114/j.issn.1007-9572.2024.0223
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    Background

    Influenza is a common respiratory infectious disease that poses a serious threat to the health of the elderly population. Vaccination against influenza is an important measure to prevent infection and reduce disease burden among the elderly. However, individuals who have been vaccinated against influenza may still contract the disease, resulting in breakthrough cases, and there is currently limited research on breakthrough cases of influenza vaccination among the elderly.

    Objective

    To investigate risk factors for breakthrough influenza cases among individuals aged 70 years and older, construct a predictive model to facilitate early identification and prevention of influenza infection among the elderly.

    Methods

    A nested case-control study was conducted among individuals aged 70 years and older in Xiaoshan and Linping Districts of Hangzhou who received influenza vaccination between September 1, 2023, and March 31, 2024. The survey includes demographic information (gender, age, living arrangements, and residential area) , information on influenza vaccination in the past year, a history of chronic illnesses (such as hypertension, diabetes, hyperlipidaemia, stroke, coronary heart disease, chronic obstructive pulmonary disease, asthma, etc.) , and details of personal lifestyle (average sleep duration in the past week, and engagement in moderate or higher intensity physical activity) . Individuals who developed influenza infection during the 2023-2024 influenza season were classified as breakthrough cases, while those who remained uninfected served as controls. Multivariate Logistic regression analysis with backward stepwise was used to identify significant risk factors. A nomogram-based risk predictive model was constructed using these factors, the model was evaluated using the Hosmer-Lemeshow goodness-of-fit test, receiver operating characteristic (ROC) curve analysis, Calibration curve.

    Results

    Among 99 735 vaccinated individuals aged 70 years and older, 4 689 breakthrough cases were identified during the follow-up period, yielding a breakthrough infection rate of 4.70%. A stratified random sample of 4 853 individuals was selected as the control group. Statistically significant differences (P<0.05) between cases and controls were observed in age, sex, living arrangement, residential area, history of hypertension, diabetes, stroke, coronary heart disease, chronic obstructive pulmonary disease (COPD) , asthma, prior-season influenza vaccination, and engagement in moderate or vigorous physical activity. Multivariate Logistic regression analysis identified all these variables as independent influence factors (P<0.05) . The predictive model incorporating these variables demonstrated good fit (Hosmer-Lemeshow P=0.762) , strong discrimination (AUC=0.806, 95%CI=0.786-0.834) , and good calibration, indicating close agreement between predicted and observed outcomes.

    Conclusion

    Breakthrough influenza infections can still occur in older adults aged 70 years and older after influenza vaccination, and their occurrence is associated with age, gender, living arrangement, residential area, multiple chronic conditions, influenza vaccination status in the previous year, and moderate-to-vigorous physical activity. The risk prediction model developed in this study demonstrates good predictive performance and can provide a reference for identifying older adults at high risk of breakthrough influenza infections.

    Analysis of the Temporal and Spatial Evolution of TCM Syndromes in Idiopathic Pulmonary Fibrosis in the Past 30 Years
    MAO Ruixiao, FENG Zhenzhen, LIU Wenrui, WANG Jiajia, LI Jiansheng
    2026, 29(19):  2678-2687.  DOI: 10.12114/j.issn.1007-9572.2025.0479
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    Background

    Idiopathic pulmonary fibrosis (IPF) is characterized by increasing incidence and mortality in the context of global population aging, with poor prognosis and substantial economic burden. In traditional Chinese medicine (TCM), accurate syndrome differentiation is essential for effective treatment. However, the heterogeneity of IPF syndromes, shaped by both temporal evolution and regional differences, has not been systematically investigated from a long-term, macroscopic perspective.

    Objective

    To investigate the spatiotemporal evolution of TCM syndromes and syndrome elements in IPF from 1997 to 2025 based on a comprehensive literature analysis.

    Methods

    Relevant studies on TCM interventions for IPF were retrieved from CNKI, VIP, WanFang Data, CBM, and PubMed. The search timeframe was from database inception to April 2025. After screening according to predefined criteria, data including TCM syndromes, syndrome elements, publication year, region, and author affiliations were extracted. The studies were categorized into four periods (1997-2003, 2004-2010, 2011-2017, and 2018-2025) and seven geographical regions in China. Statistical analyses, including association rule mining, hierarchical clustering, and descriptive statistics.

    Results

    A total of 172 studies involving 11 680 patients were included. Publications were most frequent in North China, with Beijing University of Chinese Medicine contributing the largest number. Fifty TCM syndromes were identified, among which qi-yin deficiency, phlegm-blood stasis congealing, qi deficiency with blood stasis, and lung-kidney qi deficiency were the most prevalent. Seventeen syndrome elements were extracted, with qi deficiency, blood stasis, yin deficiency, and phlegm turbidity being the most common pathological elements, while the lung and kidney were the predominant disease-location elements. Temporal analysis showed that qi-yin deficiency and phlegm-blood stasis congealing consistently predominated across all periods. The proportions of qi-yin deficiency and lung-kidney qi deficiency increased from 1997 to 2017 but declined thereafter, whereas qi deficiency with blood stasis exhibited a continuous upward trend. Syndrome element analysis indicated that qi deficiency, yin deficiency, blood stasis, and phlegm turbidity persisted throughout the disease course, with phlegm turbidity showing a decreasing trend in recent years. Regional analysis revealed that qi-yin deficiency predominated in most regions, whereas phlegm-blood stasis congealing was more common in Northeast China, and lung-kidney qi deficiency in Southwest China. Association rule and clustering analyses consistently identified core combinations of qi deficiency, yin deficiency, blood stasis, and phlegm turbidity.

    Conclusion

    The core TCM syndromes of IPF are characterized by qi-yin deficiency and phlegm-blood stasis congealing, with qi deficiency, yin deficiency, blood stasis, and phlegm turbidity forming the fundamental pathological basis throughout disease progression. These findings, revealing the core pathological basis and its spatiotemporal evolution, support the implementation of region-specific, dynamic, and individualized treatment strategies based on syndrome patterns, providing evidence for precision TCM diagnosis and management.

    Assessment and Optimization of Community Health Behaviors Guided by the Behaviour Change Wheel Theory
    LI Wanyu, JIN Hua, YANG Sen, FU Qiangqiang, YU Dehua
    2026, 29(19):  2688-2694.  DOI: 10.12114/j.issn.1007-9572.2024.0157
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    Background

    With the increasing burden of chronic diseases, promoting health behaviors among residents has become a key public health priority. Although health literacy and awareness of health management have gradually improved, a significant gap remains between knowledge and actual behavioral change. The Behavior Change Wheel (BCW) theory, as a systematic framework for identifying behavioral determinants and designing targeted interventions, has been widely applied internationally. However, empirical research applying this model to the health behaviors of community residents in China remains limited.

    Objective

    To assess the current status of health behaviors among community residents in Shanghai, identify their influencing factors, and propose optimization strategies to improve health behaviors based on the BCW framework.

    Methods

    From February to May 2023, a stratified sampling method was employed. Based on the permanent population and the number of community health service centers (CHSCs) in each administrative district of Shanghai, 1 to 4 CHSCs were randomly selected from each district, resulting in a total of 28 centers. At each site, 50 community residents attending outpatient services were invited to complete a structured questionnaire assessing their health behaviors. The questionnaire was developed based on the BCW framework. Health literacy was assessed using the Health Literacy Management Scale (HeLMS) , while health management behaviors, health management beliefs, and participation in health management programs were evaluated using self-designed items. To control for confounding, propensity score matching (PSM) based on general individual characteristics was applied to balance baseline variables, and key influencing factors of health behaviors were subsequently analyzed.

    Results

    A total of 1 436 community residents were included in the study. Among the four dimensions evaluated, the highest score rate was observed in health management beliefs (mean score: 2.58±0.63; score rate: 86.0%) , followed by health literacy (mean score: 95.40±16.28; score rate: 79.5%) . In contrast, health management behaviors showed a lower score (mean score: 4.24±1.73; score rate: 60.6%), and participation in health management programs was the lowest (mean score: 4.00±2.67; score rate: 33.3%) . Based on health management behavior scores, residents scoring ≥5 were categorized as the good behavior group (n=412) , and those scoring ≤4 as the poor behavior group (n=1 024) . PCM (1∶1) was applied to control for potential confounding variables including gender, age, education level, residential area, source of medical payment, monthly income, and marital/childbearing status. After matching, significant differences remained between the two groups in health literacy and health management belief scores (P<0.05) . Targeted optimization strategies were subsequently proposed based on the BCW framework: improving residents' health literacy and health management beliefs.

    Conclusion

    Community residents in Shanghai demonstrated relatively strong health management beliefs and health literacy. However, the execution of health-related behaviors and participation in health management programs remain suboptimal. Guided by the BCW framework, this study proposed a set of multi-dimensional intervention strategies encompassing health education, capacity building, incentive mechanisms, and environmental support. These strategies target core behavioral determinants such as capability and motivation, aiming to enhance residents' health behavior performance and provide theoretical and practical guidance for systematic community health management interventions.

    Characterisation of the Prevalence of Overweight/Obesity among Residents Aged 18-44 Years in Hebei Province in 2013 and 2020
    TANG Lijuan, QI Qi, ZHANG Fan, GAO Yifu, CAO Yajing, YUE Fujuan, GAO Jinchai, LIU Xiaoli
    2026, 29(19):  2695-2704.  DOI: 10.12114/j.issn.1007-9572.2025.0112
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    Background

    The problem of overweight and obesity has become increasingly prominent in recent years and has become a major global public health problem. China has also launched the "Weight Management Year" campaign, hoping to prevent and control chronic diseases related to overweight and obesity from the source. However, due to differences in economic and geographical conditions, the prevalence of overweight and obesity varies in different regions. What is the trend of overweight and obesity prevalence in Hebei Province in recent years, and where are the key points for prevention and control? This problem urgently needs to be solved.

    Objective

    To grasp the trend and change of overweight and obesity prevalence among residents aged 18-44 in Hebei Province between 2013 (from May to September) and 2020 (from April to December). Dynamically analyse the influencing factors and provide an objective basis for prevention and treatment strategies and measures for healthy Hebei and weight management.

    Methods

    We collected data from the 2013 Hebei Provincial Cardiovascular Disease Epidemiological Survey and the 2020 Hebei Provincial Residents' Cardiovascular Disease and Risk Factor Surveillance Project cross-sectional survey, and used different obesity indicators to comprehensively measure the prevalence of overweight and obesity among residents aged 18-44 years. The influencing factors and the interaction between each factor of overweight and obesity were explored by using the multifactorial Logistic regression model, and the changing situation was analyzed.

    Results

    In 2020, the detection rates of standardised overweight, obesity, body fat percentage obesity, abdominal obesity and high waist-to-height ratio (WHtR) of Hebei residents aged 18-44 years will be higher than those in 2013 (the number of individuals detected with overweight, obesity, high body fat percentage, abdominal obesity and high waist-to-height ratio after standardization based on the 2010 national census population / the standard population count of individuals aged 18-44 from the 2010 national census), which were 32.24%, 11.49%, 24.86%, 27.03% and 45.01%, respectively; and in 2020, 32.85%, 25.75%, 57.93%, 40.77% and 59.73%, respectively. Multivariate Logistic regression analyses of the factors affecting different types of obesity in the adult population of China showed that men, older age groups (compared with the 18-20 groups), married and hypertensive individuals had a higher risk of various types of obesity. In addition to the above factors, insufficient physical activity, educational level of junior high school and below, occupation as self-employed and agricultural workers, high-fat diet, intake of fish and eggs >1 000 g/week, and sleep <6 h/d also increased the risk of different types of obesity. The results of the multiplicative interaction analysis showed that the risk of obesity, body fat percentage obesity, and high waist-to-hip ratio in married hypertensive patients was 1.551 (95%CI=1.400-1.758, P<0.05), 1.418 (95%CI=1.170-1.720, P<0.05), and 1.652 (95%CI=1.454-1.935, P<0.05) times that of the reference group, respectively; the risk of abdominal obesity was higher in people with short sleep duration and a high-fat diet (OR=1.428, 95%CI=1.075-1.897, P<0.05); the risk of high waist-to-hip ratio in self-employed or agricultural workers with hypertension was 3.248 (95%CI=1.418-7.44, P<0.05) and 3.100 (95%CI=1.606-5.984, P<0.05) times that of the reference group, respectively. Compared to 2013, in 2020, among the common influencing factors of various obesity types, the proportion of males in the overweight and body fat percentage obesity groups slightly decreased, while in other obesity types, the proportion increased; the proportion of people in different obesity types in the age groups of 31-35 and 36-40 reached over 20%; the proportion of married individuals in the two types of generalized obesity groups slightly decreased, while in the two types of central obesity groups, the proportion slightly increased; the proportion of hypertensive patients in various obesity types significantly increased, more than doubling compared to 2013.

    Conclusion

    In 2020, the detection rate of all types of obesity among residents aged 18-44 years in Hebei Province will be significantly higher than that in 2013, and attention should be paid to the dynamic trends of risk factors related to overweight/obesity in young and middle-aged populations in Hebei Province, so as to take targeted preventive measures, enhance the health awareness of the residents, and do a good job of weight management.

    Original Research·Special Topic: Integration of Curative and Preventive Medicines
    Construction of Evaluation Indicator System for Primary Care Doctors' Service Capability in Integration of Medical and Preventive Care
    CHEN Cunchuan, ZHANG Huifang, FAN Boyang, SUN Wenning, WANG Yingjie, ZHANG Ao, ZHAO Yang, WANG Haipeng
    2026, 29(19):  2705-2710.  DOI: 10.12114/j.issn.1007-9572.2024.0492
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    Background

    The integration of medical and preventive care has emerged as an essential strategy to address the increasing healthcare demands of the population and effectively enhance public health outcomes. Primary care doctors play a pivotal role in implementing the integration of medical and preventive services, making the assessment of their competencies essential for advancing this integration. However, the indicators for evaluating the primary care doctors' service capabilities in the integration of medical and preventive care have not yet been comprehensively explored and established.

    Objective

    This study aims to develop an indicator system for assessing the service capability of primary care doctors in the integration of medical and preventive care, providing a reference framework for evaluating and improving their competencies.

    Methods

    From June to August 2023, purposive sampling was employed to select consulting experts specializing in theoretical research, practical implementation, and administrative management related to the integration of medical and preventive services. A two-round Delphi method was conducted following informed consent, with questionnaires distributed via WeChat or email. The proposed competency evaluation framework was discussed, refined, and finalized. Analytic hierarchy process (AHP) was subsequently utilized to determine the weight of each indicator.

    Results

    The response rates for the first and second rounds of consultation were 96.7% and 100.0%, respectively. The expert authority coefficient was 0.885. Kendall's coefficients of concordance for the two rounds were 0.181 (P<0.001) and 0.371 (P<0.001) , indicating significant consensus among experts. The finalized framework comprises three primary indicators, nine secondary indicators, and 26 tertiary indicators.

    Conclusion

    The constructed indicator system is scientifically rigorous and reliable, identifying the core elements required to assess the service capabilities of primary care doctors in the integration of medical and preventive care. This framework provides a valuable reference for accurately evaluating and enhancing the capacity of primary care doctors to integrate medical and preventive services.

    Study on the Service Capability of Primary Care Doctors to Integrate Medical and Preventive Services and Its Influencing Factors in Shandong Province
    ZHANG Huifang, CHEN Cunchuan, FAN Boyang, SUN Wenning, WANG Yingjie, ZHANG Ao, ZHAO Yang, WANG Haipeng
    2026, 29(19):  2711-2716.  DOI: 10.12114/j.issn.1007-9572.2024.0491
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    Background

    Primary care doctors are the main providers of medical and preventive services. Understanding their current service capacity is crucial for guiding and optimizing relevant practices. However, systematic evaluations and comprehensive analyses of primary care doctors' capabilities to integrate medicine and prevention services remain limited.

    Objective

    This study aimed to assess the current capacity of primary care doctors in Shandong Province for delivering integrated medical and preventive services and to analyze the factors influencing this capacity, providing a reference for improvement strategies.

    Methods

    In August 2023, a multi-stage stratified random sampling method was used to conduct a questionnaire survey of 477 rural and community physicians in Shandong Province. The questionnaire included demographic characteristics and an evaluation of integrated service capacity. Scores for overall and dimension-specific capacities were categorized into high (≥80%) , medium (≥60% and <80%) , and low (<60%) groups. Ordinal Logistic regression was used to identify factors influencing integrated service capacity.

    Results

    Among the respondents, 273 doctors (57.2%) demonstrated high overall capacity for integrated services. The number of doctors in the low-score group for professional knowledge and skills and for comprehensive service ability were 67 (14.0%) and 40 (8.4%) , respectively. Higher capacity was associated with having a bachelor's degree or above (OR=3.470, 95%CI=1.802-6.680) , awareness of policies on medical and preventive integration (OR=4.211, 95%CI=2.742-6.468) , perceived organizational emphasis on integration services (OR=2.36, 95%CI=1.347-4.138), and participation in at least two training sessions on integration (OR=2.557, 95%CI=1.228-5.324) (P<0.05) .

    Conclusion

    The overall capacity of primary care physicians in Shandong Province to deliver integrated medical and preventive services is satisfactory. However, there is a need to strengthen professional knowledge, skills, and comprehensive service abilities. Efforts should focus on raising awareness of medical-preventive integration, implementing targeted training programs, and establishing innovative assessment and incentive mechanisms to further enhance the capacity of primary care doctors in this area.

    Original Research·Special Topic: Digital and Intelligent Healthcare
    Diagnostic Performance of a Hand-held Single-lead ECG Device in Detecting Atrial Fibrillation and Its Potential in Atrial Fibrillation Screening in Community
    CHEN Xinyi, HUANG Ziqian, CHEN Yufeng, HUANG Jun, WENG Fan, LAI Zhisheng, XUE Yumei, CAO Xi
    2026, 29(19):  2717-2723.  DOI: 10.12114/j.issn.1007-9572.2025.0375
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    Background

    Early detection of atrial fibrillation is important for timely initiation of anticoagulation. Hand-held single-lead electrocardiogram devices are recommended for atrial fibrillation screening, but limited evidence is available for its use in Chinese population.

    Objective

    To investigate the diagnostic performance of a hand-held single-lead ECG device (MyDiagnostick) in atrial fibrillation screening and its potential in the opportunistic screening of atrial fibrillation in the community.

    Methods

    Diagnostic performance of the MyDiagnostick was examined among 296 hospitalized patients with atrial fibrillation, using 12-lead electrocardiograms as the gold standard. Sensitivity, specificity, and kappa value were calculated. A single-time point opportunistic screening for atrial fibrillation was conducted using the MyDiagnostick in 1 577 community dwellings. Detection rate of atrial fibrillation was calculated.

    Results

    The sensitivity and specificity of the MyDiagnostick for diagnosing atrial fibrillation were 0.945 and 0.947, respectively. The Kappa value was 0.892. Among 1 577 community dwellings, 60 cases of atrial fibrillation were detected (3.80%), among which 33 cases were new-onset atrial fibrillation (2.13%). Male gender (OR=2.553, 95%CI=1.504-4.333) and a history of stroke/transient ischemic attack/thrombosis (OR=2.840, 95%CI=1.330-6.064) were risk factors for atrial fibrillation in the community population.

    Conclusion

    The handheld single-lead electrocardiogram device of MyDiagnostick has a high accuracy in atrial fibrillation diagnosis and shows the potential to be used in atrial fibrillation screening in the community.

    The Current Situation and Influencing Factors of Smart Health Management Services and Devices Utilization among Chinese Adults: a Mixed Methods Study
    ZHAO Xinran, WU Yibo, ZHANG Xuxi, CHEN Ping, SUN Xinying
    2026, 29(19):  2724-2734.  DOI: 10.12114/j.issn.1007-9572.2025.0376
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    Background

    In China, the structural contradiction between surging health management demands and an insufficient high-quality supply has driven the need for smart health management services. By leveraging information and communication technology (ICT) alongside artificial intelligence (AI), these services integrate the entire process of health monitoring, assessment, and intervention, emerging as a critical new area of demand.

    Objective

    To systematically analyze the current usage, demands, and influencing factors of smart health management services and devices among adult residents in China, thereby providing an evidence base and strategic recommendations for their sustainable development.

    Methods

    An explanatory sequential mixed-methods design was employed. Quantitative data were collected from September to December 2023 using a stratified cluster random sampling method. Adults aged 18 and above were surveyed via the Wenjuanxing platform. The questionnaire captured demographic characteristics and utilized standardized scales alongside self-developed items to measure eHealth literacy, media motivation, attitude toward the behavior, subjective norms, perceived behavioral control, as well as the demands, behavioral intentions, and actual usage behaviors regarding smart health management services. Structural equation modeling (SEM) was applied to analyze the influencing factors. Qualitative data were gathered from May 2024 to March 2025 through one-on-one, semi-structured interviews. The interviews explored participants' basic profiles, personalized demands, usage experiences with smart health management monitoring devices, service model preferences, and feedback. Finally, an explanatory sequential mixed-methods framework was utilized to integrate and interpret the quantitative and qualitative results.

    Results

    A total of 2 900 questionnaires were distributed, yielding 2 786 valid responses (effective recovery rate: 96.1%). Thirteen individuals participated in the qualitative interviews. Findings revealed: (1) The usage rate of smart health management monitoring devices among adult residents in China was 37.7% (1 051/2 786), demonstrating a declining trend with age, with significantly lower usage among the elderly. (2) User demands exhibited multi-level and age-stratified characteristics. Overall demands were concentrated on basic functions such as health monitoring and answering health queries; qualitative research further revealed a progressive demand model ranging from basic life management to empowered self-actualization. Younger groups preferred basic prevention and lifestyle optimization, whereas older groups focused more on practical functions like disease management. (3) The intention to use was at a moderately high level (62.68±20.65). SEM results indicated that attitude toward the behavior (β=0.568, P<0.001) was the strongest predictor of intention, while subjective norms (β=0.103, P<0.001), and media motivation (β=0.089, P<0.001) also had significant positive effects. eHealth literacy indirectly influenced both intention (β=0.045, P<0.001) and usage behavior (β=0.051, P<0.001) through media motivation. Perceived behavioral control indirectly affected intention (β=0.014, P<0.001) and usage behavior (β=0.016, P<0.001). Urban residence independently and positively affected intention (β=0.056, P<0.001) and usage behavior (β=0.125, P<0.001), and having medical insurance significantly promoted intention (β=0.039, P=0.008). Qualitative findings identified that usage barriers included objective factors (e.g., high costs, product quality issues) and perceived obstacles (e.g., discomfort in wearing, privacy concerns). User attitudes were significantly polarized; positive or negative evaluations stemmed directly from usage experience, perceived benefits, and product intelligence, whereas individuals with neutral attitudes were prone to abandonment due to a lack of clear perceived value. Furthermore, personal beliefs and cultural backgrounds profoundly influenced technological decision-making.

    Conclusion

    This study reveals that smart health management services among Chinese adults are characterized by high intention but low usage, with age-stratified differences in current usage and demand structures. Regarding influencing mechanisms, attitude toward behavior and subjective norms are the core drivers of intention. eHealth literacy and media motivation exert a significant serial mediating effect, while perceived barriers constitute the primary resistance to behavioral transformation. Future promotion of smart health services should emphasize age-friendly design and precision implementation, while leveraging the synergistic role of primary healthcare to bridge the intention-behavior gap. This approach will enhance adults' proactive health management capabilities and facilitate the goal of healthy aging.

    Evidence-based Medicine
    The Risk of Pre-COPD Populations Progressing to COPD under Different Criteria: a Meta-analysis
    ZHANG Wenbo, WANG Junlong, ZHANG Yuping, JIANG Shuai, WANG Huaqi
    2026, 29(19):  2735-2743.  DOI: 10.12114/j.issn.1007-9572.2025.0553
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    Background

    Chronic obstructive pulmonary disease (COPD) is one of the three leading causes of death worldwide. Early prevention is particularly important for reducing the global healthcare burden. To enhance clinicians' awareness of high-risk populations for COPD and thereby enable early identification of such individuals, the GOLD guidelines have explicitly introduced the pre-COPD. Compared with the general population, individuals in the pre-COPD stage have a higher incidence of COPD; however, few studies have conducted a quantitative analysis of the relative validity of the various indicators.

    Objective

    Clarify the progression of patients with pre-COPD to COPD under different screening indicators, quantify their risk of developing COPD, and compare the clinical value of different screening indicators.

    Methods

    Cohort studies on the progression of pre-COPD to COPD published from the establishment of databases to November 30, 2025, were retrieved from CNKI, Wanfang Data, VIP Chinese Journal Service Platform, PubMed, Embase, and Web of Science. Two researchers independently conducted retrieval, literature eligibility screening, data extraction, and quality assessment. Meta-analysis was then performed using R 4.4.1. For the difference in COPD incidence between high-risk populations defined by different screening criteria and normal populations, Hazard Ratio (HR), Relative Risk (RR), and Odds Ratio (OR) were collected or calculated for aggregation and comparison to assess the risk.

    Results

    A total of 23 studies were included, covering 6 grouping criteria: NOCB, PRISm, FEV1/FVC<75%, DLCO, FEV3/FEV6<lower limit of normal (LLN), and variable airflow limitation. Among them, FEV1/FVC<75% had the strongest correlation with COPD incidence (RR=11.98, 95%CI=3.91-36.72). The correlation strength of other indicators in descending order was as follows: variable airflow limitation (RR=4.51, 95%CI=2.37-8.57), low DLCO (RR=4.05, 95%CI=1.49-11.05), PRISm (RR=2.33, 95%CI=1.72-3.14), FEV3/FEV6<LLN (RR=2.11, 95%CI=1.48-3.03), and NOCB (RR=1.36, 95%CI=1.02-1.81).

    Conclusion

    Populations with NOCB, PRISm, low DLCO, variable airflow limitation, FEV3/FEV6<LLN, or FEV1/FVC<75% have a higher risk of developing COPD than normal populations, among which the population with FEV1/FVC < 75% has the highest risk.

    Systematic Review and Meta-analysis of the Efficacy and Safety of mRNA and Recombinant Protein Subunit Vaccines Against Respiratory Syncytial Virus
    LI Yutong, ZHAO Danting, JIANG Feng, WANG Yanna, LIU Yizong, LIANG Wenjuan, LU Jiahai
    2026, 29(19):  2744-2752.  DOI: 10.12114/j.issn.1007-9572.2025.0354
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    Background

    Respiratory syncytial virus (RSV), an important pathogen causing lower respiratory tract infections in the elderly, has been the subject of continuous research and development for the production of effective and safe vaccines, both domestically and internationally. To date, three RSV vaccines have been approved for use globally, two recombinant protein subunit vaccines and an mRNA vaccine. As vaccines with different functional mechanisms, their efficacy and safety have yet to undergo systematic comparison and evaluation.

    Objective

    In this study, we sought to compare differences in the efficacy and safety of these RSV mRNA and recombinant protein subunit vaccines.

    Methods

    Computerized searches of the Web of Science, PubMed, Cochrane Library, Embase, and Scopus databases were conducted for randomized controlled trials (RCT) on the implementation of RSV vaccines in the population, with the search period extending from the date of database establishment to May 2025. The trial group consisted of individuals who received an injection of the RSV vaccine, whereas the control group received injection of a control vaccine. Two researchers independently screened the literature, extracted the data, and evaluated the risk of bias in the studies. Data analysis was conducted using R 4.5.0 and RevMan 5.4.1 software, and the evidence level of outcome measures was evaluated using the GRADE standard.

    Results

    In terms of vaccine efficacy, mRESVIA was found to have highest protective effect based on Bayesian network meta-analysis [OR (95%CI) =0.17(0.09-0.31)], followed by Arexvy [OR (95%CI) =0.21(0.16-0.29)]. However, among the three vaccines, the protective efficacy of Abrysvo was relatively lower [OR (95%CI) =0.42(0.32-0.56)]. From the perspective of the level of immunogenicity, an independent sample t-test was conducted on the geometric mean ratio of antibody titers (GMFR) induced by the Arexvy vaccine and mRESVIA with the results indicating that in the RSV-B subgroup, the GMFR of Arexvy was significantly higher than that of mRESVIA, and the difference was statistically significant (t=-2.550, P=0.019). From the perspective of safety, a comparison of risk differences (RD) in the reporting rate of local (injection site) pain occurrence revealed that there was no statistically significant difference among the vaccines (P>0.05); a comparison of relative risks in the reported rates of serious adverse reactions/death events also showed that there was no statistically significant difference among the vaccines (P>0.05). Furthermore, the GRADE classification results revealed that the rates of lower respiratory tract infections, geometric mean fold rise, geometric mean ratio, and reporting of local (injection site) pain were of high-quality evidence, whereas in contrast, the reporting of severe/death events was of low-quality evidence.

    Conclusion

    Compared with traditional recombinant protein subunit vaccines, mRESVIA, an emerging mRNA vaccine, was found to have superior protective efficacy, which can be attributed to its unique advantages. We accordingly believe that this vaccine has considerable potential for future development and market expansion, although its long-term efficacy and protective effects for specific populations necessitate further verification.