中国中药杂志

2021, v.46(06) 1547-1557

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近两年中医药干预原发性高血压病临床试验结局指标的分析
Analysis of RCT outcome indicators of traditional Chinese medicine for essential hypertension in recent two years

胡瑞学;熊兴江;陈仁波;杨伟;赵晖;王永炎;廖星;
HU Rui-xue;XIONG Xing-jiang;CHEN Ren-bo;YANG Wei;ZHAO Hui;WANG Yong-yan;LIAO Xing;Office of Basic Research in Evidence-based Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Guang′anmen Hospital,China Academy of Chinese Medical Sciences;China Center for Evidence Based Traditional Chinese Medicine;

摘要(Abstract):

该研究介绍了近两年中医药干预原发性高血压病临床试验结局指标的报告情况,通过系统检索4大中文数据库、3大英文数据库和2个临床试验注册库,分析临床试验结局指标的报告情况,并使用Cochrane协作网的ROB工具进行偏倚风险评价。经筛选最终纳入临床研究125篇,注册方案15项。结果显示,目前的高血压病临床研究报告了有效性与安全性指标。有效性指标主要包括血压值测量、生活质量评价、血生化指标、尿液分析、动脉超声、血管内皮功能指标、红细胞比容、血液流变学指标及其他指标;安全性指标主要包括一般体检项目,心、肝、肾功能检查,血、尿、便常规以及不良反应/事件。但所有指标均未区分主要和次要结局,而注册方案报告了主要和次要结局,但未明确报告疗效判定标准。两者均未报告相关的卫生经济学指标且研究方法学质量相对较差。鉴于目前中医药干预原发性高血压病研究结局指标报告现状,构建中医药治疗原发性高血压病的核心结局指标集,提升临床研究的方法学质量,有助于更准确地体现中医药的实际效果。
To find the status of outcome indicators reported in published randomized controlled trial(RCT) of traditional Chinese medicine(TCM) for essential hypertension in the past two years, we searched for relevant information from four Chinese databases, three English databases and two clinical trial registries in this study, from January 2018 to September 2019. The outcome indicators of RCT were extracted and categorized from trials and the risk of bias was assessed by ROB tools from the Cochrane Collaboration. A total of 125 RCTs and 15 RCT protocols were finally included after study screening. The results showed that the RCT outcomes mainly included efficacy and safety outcomes. Efficacy indicators mainly included blood pressure measurement, quality of life assessment, blood biochemical indicators, urine analysis, arterial ultrasound, vascular endothelial function indicators, hematocrit, hemorheology indicators and other indicators. The safety indicators mainly included general physical examination items, heart, liver and kidney function tests, blood, urine, and stool routine examinations as well as adverse drug reactions/events. The current RCTs cannot distinguish primary and secondary outcomes, and the RCT protocols didn′t report efficacy criteria clearly. They both didn′t report health economic indicators and the methodological qualities were relatively low. In view of the current status on outcome indicators reported in TCM RCTs, constructing a core outcome set of TCM for essential hypertension and improving the methodology quality of RCTs will help to accurately reflect the actual efficacy of TCM intervention.

关键词(KeyWords): 中医药;原发性高血压病;随机对照试验;结局指标
traditional Chinese medicine;essential hypertension;randomized controlled trial;outcome indicator

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划子课题(2017YFC1700406-2);; 中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075)

作者(Author): 胡瑞学;熊兴江;陈仁波;杨伟;赵晖;王永炎;廖星;
HU Rui-xue;XIONG Xing-jiang;CHEN Ren-bo;YANG Wei;ZHAO Hui;WANG Yong-yan;LIAO Xing;Office of Basic Research in Evidence-based Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Guang′anmen Hospital,China Academy of Chinese Medical Sciences;China Center for Evidence Based Traditional Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200730.502

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