高质量的随机对照试验可平衡组间混杂因素,是提供获益与危害综合信息的重要来源.为进一步提高随机对照试验中干预措施危害相关信息的报告质量,试验报告统一标准(consolidated standards of reporting trials,CONSORT)工作组更新发布了 CONSORT Harms 2022声明.中药复方在运用中,有配伍禁忌、有毒中药等独特之处.CONSORT Harms 2022提示中药复方危害需要规范报告,研究者应注意提升研究团队专业素养、开发适宜中药复方临床随机对照试验危害报告规范、相关规范纳入杂志发表要求等,为中医药走向世界的普及与推广提供必要基础.
Abstract
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms.The CONSORT(consolidated standards of reporting trials)working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials.Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs.The harms of traditional Chinese medicine formulas need to be reported in a standard.This study suggests that researchers should pay attention to enhancing the professional competence of research teams,developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials,and incorporating relevant guidelines into journal publication requirements.These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
关键词
随机对照试验/CONSORT/Harms/安全性/中医药/方法学
Key words
Randomized controlled trials/CONSORT Harms/Safety/Traditional Chinese medicine/Methodology
万方数据