基于Cochrane风险偏倚评估工具和CONSORT中药复方声明评价中成药治疗儿童急性上呼吸道感染的随机对照试验方法学质量与报告质量

Evaluation on methodological and reporting quality of randomized controlled trials of Chinese patent medicines for acute upper respiratory infection in children based on Cochrane risk bias assessment tool and CONSORT-CHM Formulas

关键词:  急性上呼吸道感染  中成药  儿童  Cochrane  中药复方临床试验报告统一标准  方法学  报告质量

Key words:  acute upper respiratory infection  Chinese patent medicine  children  Cochrane  CONSORT-CHM Formulas  methodology  report quality

摘要:

[目的] 评价近5年口服中成药治疗儿童急性上呼吸道感染随机对照试验的方法学质量和报告质量，为日后开展相关儿童临床试验提供借鉴。[方法] 系统检索中国知网（CNKI）、万方数据库、维普数据库（VIP）、美国国立医学图书馆（PubMed）、Embase数据库、Cochrane图书馆。由两人独立参照Cochrane偏倚风险评估工具及中药复方临床试验报告统一标准（CONSORT-CHM Formulas）对文献进行筛选评价及结果统计。[结果] 纳入43篇文献，23篇（53.5%）文献偏倚风险判断为不确定，20篇（46.5%）文献偏倚风险判断为高风险，无低偏倚风险的文献。总体报告质量较低，样本量计算、期中分析、试验注册和获取试验方案的方法等报告率均为0%，在产生随机分配序列的方法、随机方法细节描述、分配隐藏方法、盲法的实施、受试者筛选、基线情况的描述、结局和估计值及研究的局限性等方面报告率分别为58.1%、4.7%、14.0%、20.9%、16.3%、23.3%、9.3%、16.3%，其他条目虽有涉及但内容不完整。试验方案设计在受试者选择、疗程设置和结局指标选择及评价等方面尚有不足之处。[结论] 目前中成药治疗儿童急性上呼吸道感染的临床试验方法学设计和报告质量不高，有较大提升空间。

Abstract:

[Objective] To evaluate the methodological quality and report quality of randomized controlled trials of Chinese patent medicine for the treatment of acute upper respiratory infection in children during the past five years,providing reference for future researches.[Methods] We identified RCT by electronic searches of the Chinese Net work Knowledge Information(CNKI),Wan fang Data,Chinese Science Journal Database(VIP),Pub Med database,EMBASE,the Cochrane library. We used the Cochrane handbook for systematic reviews and the CONSORT-CHM Formulas to evaluate the methodological quality and reporting quality of RCT,then counted the outcome measures.[Results] The 43 articles were included,23(53.5%) articles were judged as uncertain in the risk of bias,and 20 (46.5%) articles were judged as high-risk,without low-risk articles. The overall quality of the report was low,and the reporting rates such as sample size calculation,mid-term analysis,trial registration,and method of obtaining trial protocols are all 0%. The report rates in terms of methods for generating random allocation sequences,description of random methods in detail,methods of allocation concealment,implementation of blind methods,screening of subjects,description of baseline conditions,outcomes and estimates,and limitations of studies were 58.1%,4.7%,14.0%,20.9%,16.3%,23.3%,9.3%,16.3%. The other entries were related but incomplete. There were still some shortcomings in the design of the trial protocol in terms of subject selection,course setting,and outcome index selection and evaluation.[Conclusion] At present,the methodological quality and reporting quality of RCT of Chinese patent medicine for the treatment of acute upper respiratory infection in children was low,and need to be improved.