疏风解毒胶囊辅助治疗成人社区获得性肺炎有效性和安全性的Meta分析

Efficacy and Safety of Shufeng Jiedu Capsules in the Adjuvant Treatment of Community-acquired Pneumonia in Adult:a Meta-analysis

背景 社区获得性肺炎(CAP)是常见的感染性疾病之一,其发病率高,疾病负担重,尽管诊断技术在不断进步,新型抗菌药物在陆续上市,但CAP的发病率和病死率仍然较高。疏风解毒胶囊用于治疗CAP的临床研究不断增加,尚缺乏系统的评价与分析。目的 系统评价疏风解毒胶囊辅助治疗CAP的有效性与安全性。方法 计算机检索中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、维普网(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、EMBase数据库中有关疏风解毒胶囊治疗CAP的随机对照试验(RCT),对照组采用西医常规治疗,试验组在对照组的基础上口服疏风解毒胶囊,检索时限为建库至2021年11月。采用RevMan 5.3软件进行数据分析,并采用GRADE标准评价结局指标的证据等级。结果 共纳入13项研究,1 355例患者。Meta分析结果显示,试验组痊愈率〔RR=1.49,95%CI(1.28,1.74),P<0.000 01〕、总有效率〔RR=1.18,95%CI(1.13,1.24),P<0.000 01〕、影像学完全吸收率〔RR=1.57,95%CI(1.13,1.89),P<0.000 01〕高于对照组,抗生素使用时间〔MD=-1.25,95%CI(-1.90,-0.61),P=0.000 1〕、发热消失时间〔MD=-1.15,95%CI(-1.93,-0.37),P=0.004〕、咳嗽消失时间〔MD=-0.96,95%CI(-1.13,-0.80),P<0.000 01〕、咳痰消失时间〔MD=-1.44,95%CI(-2.40,-0.48),P=0.003〕、肺部啰音消失时间〔MD=-1.60,95%CI(-2.33,-0.87),P<0.000 1〕短于对照组,C反应蛋白〔MD=-4.12,95%CI(-6.95,-1.30),P=0.004〕和白细胞计数〔MD=-2.20,95%CI(-3.36,-1.05),P=0.000 2〕低于对照组。两组不良反应发生率比较,差异无统计学意义〔RR=0.84,95%CI(0.26,2.67),P=0.76〕。绘制痊愈率的漏斗图结果显示,左右不对称,提示可能存在发表偏倚。GRADE分级结果显示,痊愈率、总有效率、咳嗽消失时间以及影像学完全吸收率为中等质量证据,发热消失时间、咳痰消失时间、肺部啰音消失时间、C反应蛋白、白细胞计数为低质量证据,抗生素使用时间、不良反应发生率为极低质量证据。结论 疏风解毒胶囊辅助治疗CAP的疗效显著,安全性较好。但由于纳入的研究方法学质量不高,仍需更多高质量、多中心、大样本的研究进行验证。

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.