柴黄颗粒治疗小儿上呼吸道感染的Meta分析与试验序贯分析  

Meta-analysis and trial sequential analysis of Chaihuang Granules in treatment of upper respiratory tract infection in children

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 of 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19期5377-5388,共12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：系统评价柴黄颗粒治疗小儿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)、Cochrane Library、PubMed、EMbase、Web of Science、中国临床试验注册中心、ClinicalTrials.gov等数据库,搜集柴黄颗粒治疗小儿上呼吸道感染的随机对照试验(RCT),并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、GRADE profiler 3.6.1软件进行证据质量评价。共纳入18篇RCTs,包含2 459例患者,其中试验组1 262例,对照组1 197例。Meta分析结果显示,与单纯常规治疗相比,柴黄颗粒可有效提高总有效率(RR=1.18,95%CI[1.15,1.22],P<0.000 01),减少症状/体征消失时间(MD=-1.39,95%CI[-1.66,-1.12],P<0.000 01),改善细胞因子水平(MD=-2.40,95%CI[-3.80,-1.00],P=0.000 8),改善体液免疫水平(MD=0.75,95%CI[0.60,0.90],P<0.000 01),减少病情复发次数(MD=-2.11,95%CI[-2.98,-1.25],P<0.000 01),差异均有统计学意义,但不会增加不良反应发生率(RR=0.94,95%CI[0.59,1.49],P=0.78)。亚组分析结果显示:(1)总有效率方面,单用柴黄颗粒(RR=1.19,95%CI[1.11,1.27],P<0.000 01)或柴黄颗粒+常规治疗(RR=1.18,95%CI[1.14,1.22],P<0.000 01)均能有效提高总有效率,差异均有统计学意义;(2)症状/体征消失时间方面,柴黄颗粒可有效减少发热(MD=-1.18,95%CI[-1.78,-0.58],P=0.000 1)、咳痰(MD=-1.82,95%CI[-2.38,-1.25],P<0.000 01)、咳嗽(MD=-1.31,95%CI[-1.89,-0.74],P<0.000 01)、咽痛(MD=-1.57,95%CI[-2.25,-0.89],P<0.000 01)、肺部啰音(MD=-1.49,95%CI[-2.06,-0.92],P<0.000 01)等,差异均有统计学意义;(3)细胞因子水平方面,柴黄颗粒可有效改善白细胞介素(IL)-2(MD=-0.94,95%CI[-1.16,-0.72],P<0.000 01)、IL-6(MD=-4.71,95%CI[-6.39,-3.03],P<0.000 01)、肿瘤坏死因子-α(TNF-α)(MD=-2.07,95%CI[-2.43,-1.71],P<0.000 01)的水平,差异均有统计�This study aimed to evaluate the efficacy and safety of Chaihuang Granules in the treatment of upper respiratory tract infection in children.The databases such as CNKI,Wanfang,VIP,SinoMed,Cochrane Library,PubMed,EMbase,Web of Science,Chinese Clinical Trial Registry,and ClinicalTrials.gov were searched for randomized controlled trial(RCT) of Chaihuang Granules for the treatment of upper respiratory tract infection in children,and supplemented by manual searching of gray literature.Two investigators independently screened the literature,extracted data,and assessed the methodological quality.Meta-analysis was performed using RevMan 5.4 software,trial sequential analysis was conducted using TSA 0.9.5.10 Beta software,and evidence quality evaluation was carried out using GRADE profiler 3.6.1 software.Eighteen RCTs involving 2 459 patients(1 262 in the treatment group and 1 197 in the control group) were included.Meta-analysis showed that compared with conventional therapy alone,Chaihuang Granules significantly improved the total effective rate(RR=1.18,95%CI[1.15,1.22],P<0.000 01),reduced the disappearance time of symptoms/signs(MD=-1.39,95%CI[-1.66,-1.12],P<0.000 01),improved cytokine levels(MD=-2.40,95%CI[-3.80,-1.00],P=0.000 8),improved humoral immune levels(MD=0.75,95%CI[0.60,0.90],P<0.000 01),and reduced the recurrence rate(MD=-2.11,95%CI[-2.98,-1.25],P<0.000 01).However,the incidence of adverse reactions was not increased(RR=0.94,95%CI[0.59,1.49],P=0.78).Subgroup analysis showed that:(1) both Chaihuang Granules used alone(RR=1.19,95%CI[1.11,1.27],P<0.000 01) and in combination with other therapies(RR=1.18,95%CI[1.14,1.22],P<0.000 01) effectively improved the total effective rate.(2) In terms of symptoms/signs disappearance time,Chaihuang Granules effectively reduced the duration of fever(MD=-1.18,95%CI[-1.78,-0.58],P=0.000 1),cough with sputum(MD=-1.82,95%CI[-2.38,-1.25],P<0.000 01),cough(MD=-1.31,95%CI[-1.89,-0.74],P<0.000 01),sore throat(MD=-1.57,95%CI[-2.25,-0.89],P<0.000 01),and lung rales(MD=-1.49,95%CI[-2.0

关 键 词：柴黄颗粒 呼吸道感染 中成药 Meta分析 试验序贯分析 

分 类 号：R272[医药卫生—中医儿科学]