| 引用本文:严毓倩1，梁士兵1,2，梁宁1，赵楠琦1，王莹1，胡瑞学1，刘建平1.中药及草药治疗丙型肝炎随机对照试验的质量评价[J].世界中医药,2019,(03):. |
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| 中药及草药治疗丙型肝炎随机对照试验的质量评价 |
| Quality Evaluation on Randomized Controlled Trials of Herbal Remedy for Hepatitis C |
| 投稿时间：2019-01-11 |
| DOI：10.3969/j.issn.1673-7202.2019.03.020 |
| 中文关键词: 丙型肝炎 中药 随机对照试验 方法学 报告质量 方法学质量 现状 |
| English Keywords:Hepatitis C Herbal remedy Randomized controlled trials Methodology Reporting quality Methodological quality Current situation |
| 基金项目:国家自然科学基金项目面上项目(81673828)——基于中医药治疗艾滋病注册数据库的贝叶斯及倾向性评分疗效评价方法学研究 |
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| 中文摘要: |
| 目的:评价中药及草药治疗丙型肝炎随机对照试验(RCT)的质量现状。方法:检索CNKI数据库、万方数据库、VIP、SinoMed、PubMed、Cochrane图书馆、Embase等数据库,获取相关RCT。使用Cochrane“偏倚风险评估”工具及CONSORT(2010版)条目对纳入RCT的方法学质量和报告质量进行评价,采用SPSS 23.0软件进行描述性统计分析。结果:截止至2018年12月,共纳入114篇RCT,其中英文15篇,中文99篇。随机方法、分配隐匿、盲法、脱落及方案注册的实施报告率分别为17.5%、4.4%、14%、20.2%、5.3%。CONSORT(2010版)37个条目中,报告质量好的是结构式摘要、纳入标准、干预措施、统计学方法;报告质量一般的是资料收集的场所和地点、招募期和随访时间、危害;其余条目报告质量差或极差(条目报告率≤10%)。英文RCT报告条目数更多(P<0.001)。结论:从总体上看,中药及草药治疗丙型肝炎RCT的方法学质量和报告质量尚低,有较大提升空间。 |
| English Summary: |
| To evaluate the quality of randomized controlled trials(RCTs)of herbal remedy for hepatitis C. Methods:A literature search was thoroughly conducted on multiple databases(CNKI，Wanfang data，VIP，SinoMed，PubMed，Cochrane Library，Embase)to identify RCTs on herbal remedy for hepatitis C. Based on the Cochrane “Risk of Bias” Tool and CONSORT(2010)checklists，the evaluation of methodological quality and reporting quality of RCTs was performed. SPSS 23.0 software was used to perform descriptive statistics analysis. Results:A total of 114 RCTs，including Fifteen English RCTs and 99 Chinese RCTs were included by December 2018. The reported rates of randomized methods，allocation concealment，blinding，drop-outs，and protocol registration were 17.5%，4.4%，14%，20.2%，and 5.3%，respectively. Among the 37 items in CONSORT(2010)，the structured abstract，subject qualification criteria，interventions，and statistical methods were evaluated with high reporting quality; the data collection of sites and locations，recruitment period and follow-up duration，and harm were evaluated with medium reporting quality. The remaining items were evaluated with poor or very poor reporting quality(rate of reporting items ≤10%). The English RCTs has a better compliance than Chinese RCTs(P<0.001). Conclusion:The overall methodological quality and reporting quality of RCTs of herbal remedy for hepatitis C are generally low，which remain much room for improvement. |
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