摘要
目的分析、提炼儿童反复呼吸道感染药物临床试验的主要设计要素,为该病临床试验的标准化设计提供借鉴与参考。方法检索PubMed、Cochrane、Embase、Clinical trials和CNKI、CBM、VIP、WF数据库,纳入2000—2020年的随机对照试验,病种为儿童反复呼吸道感染或反复中耳炎、反复鼻窦炎、反复扁桃体炎,干预措施为药物,语种为中英文。对纳入文献从试验目的、研究设计等十个方面进行归纳分析。结果共检索出文献2322篇,最终纳入中文8篇,英文12篇,计20篇。(1)试验目的:20项研究均以减少呼吸道感染次数为主要试验目的。(2)总体设计:20项研究均采用随机对照设计,其中安慰剂对照15项(75%),空白对照3项(15%),阳性药对照2项(10%);双盲15项(75%),单盲5项(25%)。(3)受试者的选择:设计纳入标准、排除标准、脱落或剔除标准,分别为20项(100%)、19项(95%)、4项(20%)。(4)干预措施:包括西药15项(75%),中药5项(25%)。(5)疗程:多采用2~3个月(10项,50%)或4~6个月(6项,30%)。(6)导入期与随访;所有研究均未设计导入期;随访期多以6~12个月(14项,70%)为主。(7)有效性评价:20项研究均以感染次数或以其定义的治疗成功/应答/痊愈/有效,或达到某次数标准的例数占比,为主要有效性指标。(8)安全性评价:17项(85%)以不良事件为主要观察指标。(9)质量控制:9项(45%)设计受试者日志。(10)伦理审查:14项(70%)进行相关描述。结论纳入该研究的文献信息完善、质量较高,结果涵盖了儿童反复呼吸道感染临床试验设计的基本要素,具有较好的借鉴价值。
Objective To analyze and refine the main design elements of drug clinical trials for children with recurrent respiratory tract infection to provide technical reference and guidance for the standardized design of TCM clinical trials for this disease.Methods PubMed,Cochrane,EMBASE,Clinical Trials and CNKI,CBM,VIP and WF databases were searched.And the randomized controlled trials from 2000 to 2020 were included.The diseases were recurrent respiratory tract infection or recurrent otitis media,recurrent sinusitis and recurrent tonsillitis in children.The intervention measures were drugs and the language was English and Chinese.The literatures were summarized and analyzed from ten aspects,such as experiment purpose and study design Results A total of 2322 literatures were retrieved,and 20 literatures were included,including 8 Chinese literatures and 12 English literatures.(1)Objective:The main objective of the 20 studies was to reduce the number of respiratory tract infections.(2)Overall design:20 studies were randomized controlled,including 15 placebo controls(75%),3 blank controls(15%)and 2 positive controls(10%).There were 15 studies(75%)double blinded,and 5 studies(25%)were single blinded.(3)Selection of subjects:The items of inclusion criteria,exclusion criteria,shedding or elimination criteria were 20(100%),19(95%)and 4(20%),respectively.(4)Intervention measures:There were western medicine 15 items(75%)and traditional Chinese medicine 5 items(25%).(5)Course of treatment:It was 2-3 months(10 items,50%)or 4-6 months(6 items,30%).(6)Introduction and follow-up:No initiation period was designed for all the studies.The follow-up period was mostly 6-12 months(14 cases70%).(7)Effectiveness evaluation:The main effectiveness index of the 20 studies was the number of infections or the proportion of people who reached a certain number of criteria as defined by the number of successful treatment/response/recovery/effectiveness.(8)Safety evaluation:The adverse events were the main observation index in 17 cases(85%).(9)Quality control:Nine items(45%)designed subject log.(10)Ethical review:A total of 14 items(70%)were described.Conclusion The literatures included in this study are of good quality,and the results cover the basic elements of clinical trial design for children with recurrent respiratory tract infection,which has good reference value.
作者
尹俊力
胡思源
蔡秋晗
成天萌
YIN Junli;HU Siyuan;CAI Qiuhan;CHENG Tianmeng(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300193,China)
出处
《辽宁中医杂志》
CAS
2022年第6期6-10,共5页
Liaoning Journal of Traditional Chinese Medicine
基金
国家科技部“十三五”重大新药创制项目(2020ZX09201-008)
关键词
反复呼吸道感染
儿童
随机对照试验
试验设计
recurrent respiratory tract infection
children
randomized controlled trial
clinical trail design
作者简介
尹俊力(1994-),女,湖南人,硕士研究生,研究方向:儿童中药临床评价;通讯作者:胡思源(1963-),男,吉林人,教授,博士研究生导师,研究方向:中药临床评价方法学,E-mail:husiyuan1963@sina.com
