复方芩兰口服液治疗急性上呼吸道感染的Meta分析与试验序贯分析  

Meta-analysis and trial sequential analysis of Compound Qinlan Oral Liquid in treatment of acute upper respiratory tract infection

作　　者：钟妮[1] 宫文浩 万通 冯容 李智斐[2] 蔡泽琦 甘俊元 艾军 ZHONG Ni;GONG Wen-hao;WAN Tong;FENG Rong;LI Zhi-fei;CAI Ze-qi;GAN Jun-yuan;AI Jun(Graduate School,Guangxi University of Chinese Medicine,Nanning 530004,China;the First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning 530022,China;Faculty of Preclinical Medicine,Guangxi University of Chinese Medicine,Nanning 530004,China)

机构地区：[1]广西中医药大学研究生院,广西南宁530004 [2]广西中医药大学第一附属医院,广西南宁530022 [3]广西中医药大学基础医学院,广西南宁530004

出　　处：《中国中药杂志》2023年第24期6798-6811,共14页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(82260942);国家重点研发计划项目(2019YFC1709204);广西中医药大学桂派中医药传承创新团队项目(2022B002)。

摘　　要：系统评价复方芩兰口服液治疗急性上呼吸道感染的有效性与安全性。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、中国临床试验注册中心、ClinicalTrials.gov、Cochrane Library、PubMed、EMbase、Web of Science等,搜集有关复方芩兰口服液治疗急性上呼吸道感染的随机对照试验(RCT),并且辅以手工检索灰色文献。2位评价者独立筛选文献、提取资料并评价方法学质量,采用RevMan 5.4软件进行Meta分析、TSA 0.9.5.10 Beta软件进行试验序贯分析(TSA)、GRADE profiler 3.6.1软件进行证据质量评价。共纳入21篇RCTs,包含2651例患者,其中试验组1330例,对照组1321例。Meta分析结果显示,与单纯西医常规相比,复方芩兰口服液可提高总有效率(RR=1.15,95%CI[1.12,1.19],P<0.00001),且不会增加不良反应发生率(RR=0.77,95%CI[0.47,1.25],P=0.29)。亚组分析结果显示,①与单纯西医常规相比,复方芩兰口服液可提高总有效率(RR=1.10,95%CI[1.05,1.14],P<0.00001),减少症状改善时间(SMD=-0.76,95%CI[-1.02,-0.51],P<0.00001),但2组不良反应发生率差异无统计学意义(RR=1.16,95%CI[0.54,2.47],P=0.71);②与单纯西医常规相比,复方芩兰口服液+西医常规可提高总有效率(RR=1.20,95%CI[1.15,1.25],P<0.00001),降低中医证候积分(MD=-0.58,95%CI[-0.75,-0.41],P<0.00001),减少症状改善时间(SMD=-2.44,95%CI[-3.09,-1.80],P<0.00001),减少体征改善时间(MD=-2.57,95%CI[-4.11,-1.04],P=0.001),降低血清炎症因子水平(SMD=-2.16,95%CI[-2.61,-1.70],P<0.00001),改善呼吸功能指标(SMD=1.48,95%CI[1.00,1.96],P<0.00001),提高体液免疫水平(MD=0.94,95%CI[0.69,1.18],P<0.00001),但2组不良反应发生率差异无统计学意义(RR=0.57,95%CI[0.29,1.09],P=0.09)。TSA显示,总有效率的累积Z曲线穿过了传统界值和TSA界值,进一步肯定临床疗效。GRADE证据质量评价显示,上述结局指标的证据等级为低级或极低级,推荐强度为弱推荐。与�This study aims to evaluate the efficacy and safety of Compound Qinlan Oral Liquid in the treatment of acute upper respiratory tract infection.Computer-based online searching of CNKI,VIP,SinoMed,Wanfang,ChiCTR,ClinicalTrials.gov,Cochrane Library,PubMed,EMbase,and Web of Science was performed to retrieve the randomized controlled trial(RCT)regarding Compound Qinlan Oral Liquid in the treatment of acute upper respiratory tract infection.In addition,manual searching of gray literature was conducted.After two evaluators independently selected articles,extracted data,and evaluated the quality of methodology included in the studies,Meta-analysis was carried out in RevMan 5.4 and trial sequential analysis(TSA)in TSA 0.9.5.10 Beta.GRADE profiler 3.6.1 was employed to evaluate the evidence quality.A total of 21 RCTs were included in this study,involving 2651 patients(1330 patients in the observation group and 1321 patients in the control group).Meta-analysis showed that compared with conventional western medicine alone,Compound Qinlan Oral liquid improved the total response rate(RR=1.15,95%CI[1.12,1.19],P<0.00001)without increasing the incidence of adverse reactions(RR=0.77,95%CI[0.47,1.25],P=0.16).The results of subgroup analysis are described as follows:①Compared with conventional western medicine alone,Compound Qinlan Oral Liquid improved the total response rate(RR=1.10,95%CI[1.05,1.14],P<0.00001)and shortened the time to symptom relief(SMD=-0.76,95%CI[-1.02,-0.51],P<0.00001).There was no significant difference in the incidence of adverse reactions between the two groups(RR=1.16,95%CI[0.54,2.47],P=0.71).②Compared with conventional western medicine alone,Compound Qinlan Oral Liquid+conventional western medicine improved the total response rate(RR=1.20,95%CI[1.15,1.25],P<0.00001),decreased traditional Chinese medicine(TCM)syndrome scores(MD=-0.58,95%CI[-0.75,-0.41],P<0.00001),shortened the time to symptom relief(SMD=-2.44,95%CI[-3.09,-1.80],P<0.00001)and physical sign improvement(MD=-2.57,95%CI[-4.11,-1.04],P=0.001),

关 键 词：复方芩兰口服液 急性上呼吸道感染 中成药 系统评价 META分析 试验序贯分析 

分 类 号：R259[医药卫生—中西医结合]