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    Comparative Study of the Efficacy and Safety of Sacubitril/Valsartan and Dapagliflozin in the Treatment of Dilated Cardiomyopathy with Low Blood Pressure
    ZHANG Yong, CAI Xiang, NING Feifei, LIANG Xiao, GUO Ning
    Chinese General Practice    2023, 26 (23): 2912-2917.   DOI: 10.12114/j.issn.1007-9572.2023.0050
    Abstract649)   HTML7)    PDF(pc) (1681KB)(232)       Save
    Background

    Dilated cardiomyopathy has an extremely poor prognosis, sacubitril/valsartan and dapagliflozin are important drugs to improve the prognosis. However, patients with dilated cardiomyopathy tend to have low blood pressure, which would make it unable to use both drugs at the same time. There is no comparative study of the efficacy and safety of sacubitril/valsartan and dapagliflozin in the treatment of dilated cardiomyopathy with low blood pressure.

    Objective

    To investigate the efficacy and safety of sacubitril/valsartan and dapagliflozin in dilated cardiomyopathy patients with low blood pressure.

    Methods

    A total of 124 patients with dilated cardiomyopathy admitted to the First Affiliated Hospital of Xi'an Jiaotong University from March 2021 to May 2022 were selected as the study subjects. All patients were diagnosed with dilated cardiomyopathy for the first time, and the systolic blood pressure (SBP) was 95-110 mmHg before medication. Patients were prescribed with sacubitril/valsartan (50 mg/time, twice a day) or dapagliflozin tablets (10 mg/time, once a day) before or at discharge and divided into the sacubitril/valsartan group (71 cases) and dapagliflozin group (53 cases) according to clinical drug use. The outpatient follow-up was performed 6 months after discharge until November 2022. General information of the two groups such as age and gender were collected through the hospital electronic medical record system, baseline and 6-month follow-up SBP, diastolic blood pressure (DBP) , and BMI of the two groups were recorded. Baseline and 6-month biochemical indicators〔N-terminal pro-B-type natriuretic peptide (NT-proBNP) , glycated hemoglobin (HbA1c) , fasting blood glucose (FBG) , estimated glomerular filtration rate (eGFR) , blood potassium〕, cardiac function indicators〔left ventricular ejection fraction (LVEF) , left ventricular end-diastolic diameter (LVEDD) , left ventricular end-systolic diameter (LVESD) , left atrial diameter (LAD) 〕, 6 min walking test (6MWT) and clinical events were collected. The biochemical indicators, cardiac function indicators and incidence of clinical events before and after treatment were compared between the two groups.

    Results

    Compared with the pre-treatment period, the levels of blood potassium, LVEF and 6MWT were increased in the sacubitril/valsartan group and dapagliflozin group after 6 months of treatment (P<0.05) , and the elevations of 6MWT level in the dapagliflozin group was higher than that in the sacubitril/valsartan group (t=2.444, P=0.016) . Compared with the pre-treatment period, the levels of SBP, DBP, BMI, NT-proBNP, HbA1c, FBG, LVEDD, LVESD, LAD were decreased in the sacubitril/valsartan group and dapagliflozin group after 6 months of treatment (P<0.05) , the reductions of SBP (Z=5.217, P<0.001) , DBP (t=3.070, P=0.003) , eGFR (Z=2.495, P=0.013) levels in the sacubitril/valsartan group and BMI (Z=4.410, P<0.001) , HbA1c (Z=4.493, P<0.001) , FBG (t=4.832, P<0.001) , LAD (Z=2.830, P=0.005) levels in the dapagliflozin group were higher. There were no deaths or hypoglycemic discontinuation events in the two groups during 6 months of follow-up, and there were no statistical differences in the incidence of hypotension discontinuation, hyperkalemia discontinuation, renal insufficiency discontinuation, urinary system infection discontinuation and heart failure re-hospitalization between the two groups (P>0.05) .

    Conclusion

    Both sacubitril/valsartan and dapagliflozin were effective in improving cardiac function in dilated cardiomyopathy patients with low blood pressure. The safety of the two groups is similar. However, the use of sacubitril/valsartan should be noted for the risk of hypotension and renal insufficiency.

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    Effect of Sodium Valproate, Oxcarbazepine and Levetiracetam on the Development of Different Functional Areas in Children with Epilepsy by Griffiths Development Scales-Chinese Edition
    BAI Yanmin, DU Kaixian, CHEN Hao, JIA Tianming, GONG Huan, YU Shengyuan, LI Lin, GUAN Jing, ZHU Yingying
    Chinese General Practice    2023, 26 (23): 2918-2922.   DOI: 10.12114/j.issn.1007-9572.2023.0102
    Abstract373)   HTML12)    PDF(pc) (1464KB)(162)       Save
    Background

    Epilepsy is a chronic episodic brain disorder with a high incidence and can seriously affect the quality of life of the patients. Therefore, timely treatment to control seizures is particularly important. Numerous studies have shown the effect of antiepileptic drugs on cognition, but there are few studies on the effects of different functional areas in children.

    Objective

    To explore the effects of sodium valproate (VPA) , oxcarbazepine (OXC) and levetiracetam (LEV) on the development of different functional areas in children with focal epilepsy by Griffiths Development Scales-Chinese Edition (GDS-C) .

    Methods

    A total of 83 children with focal epilepsy who attended in outpatient and ward of the Department of Pediatric Neurology of the Third Affiliated Hospital of Zhengzhou University for the first time from January 2021 to April 2022 were selected, and randomly divided into VPA group (n=27) , OXC group (n=28) and LEV group (n=28) according to the random number table method, 30 healthy children who were examined during the same period were selected as the control group. The changes of EEG interictal epileptiform activity (IEA) before and after 6 months of treatment were recorded and the clinical effect was evaluated according to seizure frequency, the GDS-C was used to evaluate the development quotient of each functional area in the children.

    Results

    The total clinical effective rates of VPA group, OXC group and LEV group were 92.6%, 89.3% and 92.9%, with no significant difference among the three groups (χ2=0.418, P=1.000) . The total EEG IEA effective rate of the VPA group, OXC group and LEV group were 88.9%, 57.1% and 89.3%, with significant differences among the three groups (χ2=11.152, P=0.004) ; the total effective rate of EEG IEA in OXC group was lower than that in VPA group and LEV group (P<0.05) . Before treatment, there were statistically significant differences in the the development quotient of each dimension among four groups (P<0.05) ; the development quotient of each dimension in three groups were lower than that in the control group (P<0.05) . After treatment, there were significant differences in the the development quotients of hand-eye coordination and performance dimensions among three groups (P<0.05) ; the development quotients of sports and personal-social dimensions in LEV group were higher than VPA group (P<0.05) , the development quotients of personal-social, hand-eye coordination and performance dimensions in LEV group were higher than OXC group (P<0.05) . Compared to the pre-treatment period, the development quotients of personal-social and practical reasoning dimensions significantly decreased in VPA group (P<0.05) , the development quotients of personal-social, language, hand-eye coordination, performance and practical reasoning dimensions significantly increased (P<0.05) .

    Conclusion

    VPA, OXC and LEV are all effective in the treatment of focal epilepsy in children, and all three have quivalent efficacy; In terms of improving EEG IEA, OXC is inferior to VPA and LEV; VPA may have a negative effect on personal-social and practical reasoning dimensions, OXC has little effect, and LEV may have improvement on personal-social, language, hand-eye coordination, performance, practical reasoning dimensions.

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    Retrospective Analysis of 2 992 Times of Therapeutic Drug Monitoring of Valproic Acid from 2019 to 2021
    DING Jing, MENG Zhuocheng, ZHANG Yan, CUI Xiaohua, LIU Jiarui, HE Jiao, ZHANG Yang, LI Yajuan, YANG Liu
    Chinese General Practice    2023, 26 (23): 2923-2929.   DOI: 10.12114/j.issn.1007-9572.2023.0016
    Abstract346)   HTML5)    PDF(pc) (1738KB)(192)       Save
    Background

    Valproic acid, as a mood stabilizer, has been extensively used for the treatment of bipolar disorder and other psychiatric conditions. Although therapeutic drug monitoring (TDM) of valproic acid has been carried out at home and abroad for many years, controversies persist regarding the influence of age, sex and other factors on its plasma concentration.

    Objective

    To analyze the TDM results of valproic acid, providing a reference for rationalized individualized treatment of bipolar disorders or other psychiatric conditions.

    Methods

    Through the laboratory information system of Ruimei Medical Laboratory, information on TDM of valproic acid in outpatients and inpatients (including the patient's age, sex, TDM raw data, monitoring samples, and monitoring frequency) was obtained from Xi'an Mental Health Center from 2019 to 2021. The plasma concentration of valproic acid was classified into three categories (<50 mg/L, 50-100 mg/L and >100 mg/L) according to the therapeutic window range recommended in the Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology (hereinafter referred to as AGNP Consensus) , and the percent of each category was calculated. And subsequent data analysis was performed using MedCalc 5.2.

    Results

    A total of 2 431 patients were monitored 2 992 times for understanding valproic acid treatment status, of which 1 637 were for men, and 1 355 for women. The frequencies of TDM of valproic acid increased by 54.93% in 2020 and 44.00% in 2021 compared to those reported in 2019. The proportion of patients who received only once was about 74.41%. Compared with inpatients, outpatients had higher prevalence of receiving one TDM of valproic acid (χ2=95.15, P<0.001) , and lower prevalence of receiving two, or at least three TDM of valproic acid (χ2=49.41, 34.24, P<0.001) . The plasma valproic acid concentration in inpatients was higher than that in outpatients (Z=-11.60, P<0.001) . Meanwhile, higher plasma valproic acid concentration was observed in female patients than in male patients (Z=-4.39, P<0.001) . However, there was no significant difference between the age groups (Z=0.75, P>0.05) . For each study year 2019-2021, the proportion of plasma concentration of valproic acid within the therapeutic window was 57.72%, which was significantly higher than that of the proportion of below and above the therapeutic window (χ2=155.38, 1 216.68, P<0.001) . The proportion of the plasma valproic acid concentration (<50 mg/L, 50-100 mg/L, or >100 mg/L) had statistically significant differences between different age and gender groups, and over the years (P<0.05) . The plasma valproic acid concentration ranged between 40-80 mg/L for males, females, or total participants, which was slightly lower than the therapeutic range (50-100 mg/L) recommended by the AGNP Consensus.

    Conclusion

    The individual treatment program in patients should be determined clinically according to age and sex to increase the proportion of plasma valproic acid concentration in the therapeutic window. Additionally, TDM of valproic acid should be emphasized in inpatients and outpatients to ensure safe and effective medication administration in clinical practice.

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    Ideas for the Diagnosis and Treatment of Multisystem Immune-related Adverse Events Caused by Immune Checkpoint Inhibitors
    ZHANG Yanjing, SONG Xiaokun
    Chinese General Practice    2023, 26 (23): 2930-2935.   DOI: 10.12114/j.issn.1007-9572.2022.0585
    Abstract556)   HTML5)    PDF(pc) (1592KB)(256)       Save

    As a new type of anti-cancer therapy, immune checkpoint inhibitors (ICIs) have transformed the treatment of various cancers. However, ICIs are associated with many potential complications, namely immune-related adverse events (irAEs) , possibly involving the nervous, cardiac, pulmonary, cutaneous, renal, gastrointestinal, hepatic, and hematologic systems. Although a series of guidelines for the management of irAEs have been issued, early identification, diagnosis and treatment of irAEs in clinical practice are still not standardized enough due to different levels of awareness and attention regarding the disease across clinicians. We analyzed the clinical data of a patient with severe multisystem irAEs developed after treatment with cindilimab, and reviewed relevant literature, then summarized the benefits and limitations of treatments for irAEs, providing ideas for better managing multisystem irAEs clinically.

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