基于PRISMA Harms清单的中医药安全性系统综述现状及报告质量分析

Literature Analysis of Present Situation and Reporting Quality in TCM Safety Systematic Reviews Based on PRISMA Harms Checklist

目的了解中医药安全性系统综述的报告现状,加强对中医药安全性的认识,以提高中医药安全性系统综述的报告质量。方法通过计算机检索中国知网(CNKI)、万方(Wan Fang Data)、维普(VIP)三大中文数据库中关于中医药安全性的系统综述,对纳入文献的特征进行描述并依据PRISMA Harms清单对文献对应的条目进行评价,提出改进中医药安全性系统综述报告质量的建议。结果研究最终纳入文献共116篇,发表的时间跨度为2000～2018年,文献发表数量相对较少,年发表中医药安全性系统综述的数量在逐渐上升。口服中药的安全性系统综述有69篇(59.48%),中药注射剂20篇(17.24%)。关注心血管相关疾病和中风相关疾病较多,各有14篇(12.07%)。纳入文献类型以仅纳入随机对照试验为主(63.79%)。文献质量评价主要采用Cochrane偏倚风险评价工具(57.76%)。仅有2篇文献的报告条目在25个以上。结论中医药安全性系统综述数量较少但年发表数量逐渐增多。虽然纳入的文献报告条目大多数都有涉及,但整体报告质量有待提高。应重视安全性系统综述内容的规范撰写,同时建议期刊能够依据PRISMA Harms清单进一步规范安全性系统综述的要求。

Objective To understand the present situation and reporting quality of traditional Chinese medicine(TCM)safety systematic reviews,strengthen the safety awareness of TCM and improve reporting quality of TCM safety systematic reviews.Methods Three Chinese electronic databases,including CNKI,WanFang and VIP were searched from inception to October 2018.The TCM safety systematic reviews were identified and the PRISMA Harms checklist(including 27 items)was used to assess the reporting quality.Results 116 papers were finally included.The number of TCM safety systematic reviews published are little whose number ranging from 2000 to 2018 is gradually increasing annually.69 studies(59.48%)use oral traditional Chinese medicine and 20 studies(17.24%)use TCM injection as intervention respectively.And 14 studies(12.07%)focus on cardiovascular and cerebrovascular diseases respectively.The literature type was mainly randomized controlled trials(63.79%).The quality assessment of literature mainly uses the Cochrane Collaboration's tool for assessing risk of bias(57.76%).The 27 reporting items of PRISMA Harms checklist only has two studies including more than 25 items.Conclusion The number of published TCM safety reviews is small,but the trend is increasing annually.Although most of the PRISMA Harms items were reported in the TCM safety systematic reviews we included,the overall reporting quality needs to be improved.Attention needs to be paid to the standard reporting of the contents of TCM safety systematic reviews,to enable readers to capture and understand the review results transparently.It is also recommended that the journals adopt PRISMA Harms when publishing papers to improve the reporting quality of reviews.