摘要
对中成药治疗流行性感冒的临床随机对照试验(RCT)进行系统的收集和分析,以期为临床决策及相关研究提供基础信息。基于中医药循证研究证据库系统(EVDS)旗下中成药临床证据数据库的收录,并补充检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、EMbase、PubMed、Cochrane Library等收录的关于中成药治疗流行性感冒的RCT,检索时间自建库至2021年7月25日,对研究的发表时间、样本量、干预及对照措施、疗程、结局指标、方法学质量等内容进行分析和评价。共纳入中成药治疗流行性感冒的RCTs 92篇,发表于2005—2021年,其中17篇研究(18.48%)样本量大于200例,平均样本量145例。涉及中成药27种,其中口服中成药21种,注射剂6种,发文量大于5篇的研究涉及中成药分别为连花清瘟胶囊/颗粒、痰热清注射液、热毒宁注射液。纳入研究的干预措施共14种,中成药+西药+常规vs西药+常规(20.65%)应用最多。85.87%的研究报告了治疗疗程,80.43%的研究以3~7 d为干预疗程。共提取45种结局指标,使用频次434次,分属于症状/体征、理化检测、安全性事件、中医症状/证候、生活质量、远期预后、经济学评估等指标域,其中症状/体征类指标(61.52%)应用最多。纳入的研究普遍存在方法学问题。中成药治疗流行性感冒的临床研究数量较少,实施过程的方法学问题突出,影响研究的可靠性和实用性,未来研究的开展需要全程把握产品的价值特点,开展科学严谨的设计,加强全过程质量控制。
The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.
作者
生晓迪
陈哲
季昭臣
胡海殷
欧益
曹璐佳
郭利平
张俊华
SHENC Xiao-di;CHEN Zhe;JI Zhao-chen;HU Hai-yin;OU Yi;CAO Lu-jia;GUO Li-ping;ZHANG Jun-hua(Centre for Evidence-based Medicine,Tianjin Unirersity of Traditional Chinese Medicine,Tianjin 301617,China;Tianjin Academy of Traditional Chinese Medicine Afiliated Hospial,Tianjin 300120,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2022年第9期2338-2342,共5页
China Journal of Chinese Materia Medica
基金
教育部青年拔尖人才基金项目(201504)。
关键词
中成药
流行性感冒
随机对照试验
循证医学
Chinese patent medicine
influenza
randomized controlled trial
evidence-based medicine
作者简介
通信作者:张俊华,研究员,主要从事中医药临床评价和循证医学研究,E-mail:xjhtcm@foxmil.com;通信作者:郭利平,主任医师,主要从事中医,治疗心血管研究,E-mail:lpgtjn@163.com;生晓迪,博士研究生,E-mail:195527736@qq.com.
