疏血通注射液治疗性随机对照试验中安全性报告质量的评价

Assessment of Safety Reporting Quality of Randomized Controlled Trials of Shuxuetong Injection

目的评价疏血通注射液治疗性随机对照试验中安全性/不良事件/不良反应的报告质量。方法计算机检索国内外医学期刊数据库,语种限制为中英文,筛选出符合入选条件的疏血通注射液随机对照试验,采用CONSORT声明第19条、CONSORT关于危害扩展版和《中药不良反应/不良事件报告规范建议》对纳入文献的安全性报告进行质量评价。结果纳入疏血通注射液治疗性随机对照试验中英文文献共1072篇。纳入文献质量评价表明,大部分文献安全性报告存在危害相关信息收集描述不详细、不良事件/不良反应临床表现细节报告不充分、无相关检查证据、受试者退出无详细描述等问题,没有文献提及不良事件的定义、危害信息的分析计划、与危害相关的亚组分析。共179篇文献描述了不良事件/反应的例数及相关细节,其中仅5.6%和19.6%描述了可疑中药的使用时间以及停药后的反应,47.5%和63.7%的文献描述了不良事件/反应的处理情况以及结果。结论目前疏血通注射液随机对照试验中安全性/不良事件/不良反应的报告质量普遍偏低。为提高随机对照试验中不良事件/反应的报告质量,应参照CONSORT声明第19条、CONSORT关于危害扩展版及《中药不良反应/不良事件报告规范建议》中有关安全性报告规范对中药随机对照试验中的不良事件/反应进行报告。

Objective To assess the reporting quality of adverse events（AE）/adverse drug reactions（ADR） in randomized controlled trials（RCTs）of Shuxuetong Injection. Methods Computer-based online search of Chinese and English medical databases was performed. Only Chinese literature and English literature were included into the study.The included trials were screened by inclusion criteria and exclusion criteria,and the reporting quality of AE/ADR in these trials were evaluated according to the 19 th item of CONSORT Statement,the CONSORT extension for harms and Recommendations for Reporting Adverse Drug Reactions and Adverse Events of Traditional Chinese Medicine（Recommendations for TCM AE/ADR）. Results A total of 1072 Chinese and English reports on RCTs of Shuxuetong Injection were included. The analysis of the included literature showed that most of the included literature had no detailed description of harms-related information collection, insufficient report of clinical manifestation details of AE/ADR,absence of related examination evidence,or no detailed description of drop-out. None of the reports had mentioned the definition of AEs,plans for presenting and analyzing harms information,subgroup analysis of harms. Of179 literatures had reported the case and related details of AE/ADR. Only 5.6 % and 19.6 % of these literatures had described the application timing of suspicious drugs and the reactions of stopping medication,respectively. 47.5 % and 63.7 % of these literatures had described the treatment and results of AE/ADR, respectively. Conclusion The reporting quality of AE/ADR in RCTs of Shuxuetong Injection was generally low. To improve the reporting quality of AE/ADR in RCTs of Chinese medicine,the 19 th item of CONSORT Statement,the CONSORT extension for harms and the important information which contributes to assessing causality of AEs and suspicious drugs in Recommendations for Reporting Adverse Drug Reactions and Adverse Events of Traditional Chinese Medicine should be followed in the standardized report of AE/ADR in RCTs on TCM field.