论文部分内容阅读
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 evaluate the quality of the reports of safety / adverse events / adverse reactions in Shuxuetong injection as a therapeutic randomized controlled trial. Methods The databases of medical journals at home and abroad were retrieved by computer and the language was restricted to Chinese and English. Randomized controlled trials of Shuxuetong Injection which met the inclusion criteria were selected. The CONSORT Statement on Article 19, CONSORT Declaration on Extended Hazards and Adverse Events / Adverse Events Report Specification Proposal “to evaluate the quality of the safety reports included in the literature. Results included in the Shuxuetong injection of therapeutic randomized controlled trials in English literature a total of 1072. The inclusion of literature quality evaluation showed that most of the literature on the safety of the report is harmful to the collection of information related to the details are not detailed, adverse events / adverse clinical manifestations of the report is not sufficient, no relevant examination evidence, subjects without detailed description of withdrawal and other issues, there is no literature Reference is made to the definition of adverse events, analysis programs that endanger information, and subgroup analyzes related to the hazard. A total of 179 articles described the number of adverse events / reactions and related details, of which only 5.6% and 19.6% described the suspect period of use of traditional Chinese medicine and the response after discontinuation, 47.5% and 63.7% of the literature describes the adverse events / Response to deal with the situation and results. Conclusion The reported quality of Shuxuetong injection randomized controlled trials in safety / adverse events / adverse reactions is generally low. To improve the quality of the reporting of adverse events / reactions in randomized controlled trials, reference should be made to Article 19 of the CONSORT Statement, the CONSORT Guidelines for Hazard Extension and the ”Recommendations on Adverse Events / Adverse Events Reporting Practices for Traditional Chinese Medicines" in the Randomized Controlled Trials Adverse events / reactions reported.