Page 110 - 2022-23-中国全科医学

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【Abstract】 Background Community-acquired pneumonia（CAP）is one of the common infectious diseases
with high morbidity and heavy disease burden. Despite the continuous advancement of diagnostic technology and the launch
of new antimicrobial drugs，the morbidity and mortality of CAP are still high. The clinical research of Shufeng Jiedu capsules
in the adjuvant treatment of CAP is increasing，but there is still a lack of systematic review and meta-analysis. Objective
To systematically evaluate the efficacy and safety of Shufeng Jiedu capsules in the treatment of CAP. Methods Randomized
controlled trials（RCTs）about Shufeng Jiedu capsules in the treatment of CAP was retrieved in CNKI，Wanfang Data，VIP，
SinoMed，PubMed，Cochrane Library and EMBase from inception to November 2021 by computer. The control group was treated
with routine western medicine，and the experimental group was treated with Shufeng Jiedu capsules orally on the basis of the
control group. The retrieval time was from the establishment of the database to November 2021. RevMan 5.3 software was used for
data analysis，and GRADE criteria were used to evaluate the level of evidence for the outcome indicators. Results A total of 13
studies with 1 355 patients were included. The results of meta-analysis showed that the cure rate of the test group〔RR=1.49，
95%CI（1.28，1.74），P<0.000 01〕，the total effective rate〔RR=1.18，95%CI（1.13，1.24），P<0.000 01〕，imaging
complete absorption rate〔RR=1.57，95%CI （1.13，1.89），P<0.000 01〕 were higher than the control group，antibiotic use
time〔MD=-1.25，95%CI （-1.90，-0.61），P=0.000 1〕，time of fever disappearance〔MD=-1.15，95%CI（-1.93，-0.37），
P=0.004〕，time of cough disappearance〔MD=-0.96，95%CI（-1.13，-0.80），P<0.000 01〕，time of expectoration
disappearance〔MD=-1.44，95%CI（-2.40，-0.48），P=0.003〕 and time of lung rales disappearance〔MD=-1.60，95%CI
（-2.33，-0.87），P<0.000 1〕 were shorter than the control group，C-reactive protein〔MD=-4.12，95%CI（-6.95，
-1.30），P=0.004〕 and white blood cell count〔MD=-2.20，95%CI（-3.36，-1.05），P=0.000 2〕 were lower than the
control group. There was no significant difference in the incidence of adverse events between the two groups〔RR=0.84，95%CI（0.26，
2.67），P=0.76〕. The funnel chart of the cure rate showed that the left and right sides were asymmetrical，suggesting that there
may be publication bias. GRADE grading results showed that the cure rate，total effective rate，the time of cough disappearance
and imaging complete absorption rate were of moderate quality，the time of fever disappearance，expectoration disappearance
and lung rales disappearance，C-reactive protein and white blood cell count were of low quality，the time of antibiotic use and
the incidence of adverse events were of very low quality. Conclusion Shufeng Jiedu capsule has significant curative effect and
good safety in the adjuvant treatment of CAP. However，due to the low quality of the included research methodology，more high-
quality，multi-center and large sample trails are still needed for verification.
【Key words】 Community-acquired pneumonia；Shufeng Jiedu capsules；Treatment outcome；Meta-analysis

社区获得性肺炎（community-acquired pneumonia，CAP） 佳证据，旨在指导临床用药，也为同境地中成药的推广应用
是指在医院外罹患的感染性肺实质炎症，包括具有明确潜伏 提供参考。
期的病原体感染而在入院后潜伏期内发病的肺炎 ［1］ 。CAP 是 1 资料与方法
常见的感染性疾病之一，其发病率高，疾病负担重，致病菌 1.1 检索策略 计算机检索中国知网（CNKI）、万方数据
和耐药情况在不同国家和地区之间差异显著，且发病率、治 知识服务平台（Wanfang Data）、维普网（VIP）、中国生物
疗失败率、病死率等随年龄的增长而增长 ［2-4］ 。经验性抗感 医学文献服务系统（SinoMed）、PubMed、Cochrane Library、
染治疗是 CAP 治疗的基础，然而近年来随着人口老龄化、免 EMBase 数据库，检索时限为建库至 2021 年 11 月。根据各个
疫宿主增多、抗生素的滥用，CAP 病原体变迁及抗生素耐药 数据库特点，采用主题词和自由词相结合的检索策略，中文
率逐年上升，尽管诊断技术在不断进步，新型抗菌药物在陆 检索词为“疏风解毒”“肺炎”“肺部感染”“肺部炎症”“风
续上市，但 CAP 的发病率和病死率仍然较高，治疗面临新的 温 肺 热 ”， 英 文 检 索 词 为“Shufeng Jiedu”“Shufeng-
困境 ［5-6］ 。 Jiedu”“Shu Feng Jie Du”“Shu-Feng-Jie-Du”“CAP”
CAP 归属于祖国医学“风温肺热病”范畴，中医辨证论 “Pneumonia”“Pneumonitis”“Lung Inflammation”
治具有独特的优势，可发挥减毒、增效的作用 ［7］ 。中成药是 “Pulmonary Inflammation”。同时，追溯纳入研究引用的参考
在中医药理论指导下加工而成的中药制品，调查显示约 70% 文献，以补充获得相关文献。此外，检索世界卫生组织（WHO）
的中成药由西医医师开具 ［8］ ，然而由于缺乏明确适应证为 国际临床试验注册平台（https://trialsearch.who.int/）以获取已
CAP 的中成药，导致西医医师在使用中成药的过程中普遍存 完成临床试验但尚未发表的试验结果。
在按病种选药和缺乏辨证施治的问题，不仅具有潜在风险， 1.2 纳入标准
而且降低了中成药的临床应用价值。故本研究基于国家中医 1.2.1 研究类型 随机对照试验（RCT）。
药管理局标准化项目子课题——“中西医联合防治成人社区 1.2.2 研究对象 患者需符合《中国成人社区获得性肺炎诊
获得性肺炎临床应用指南”（SATCM-2015-BZ402-047）， 断和治疗指南（2016 年版）》 ［9］ 中 CAP 的诊断标准。
以疏风解毒胶囊为研究对象，系统评价其治疗 CAP 的当前最 1.2.3 干预措施 对照组采用西医常规治疗，包括抗感染（抗