中医药治疗高血压性脑出血近三年随机对照试验结局指标的现状分析  

Situation analysis of outcome indicators of randomized controlled trials of traditional Chinese medicine in treatment of hypertensive intracerebral hemorrhage in recent three years

作　　者：杜琬晴 贾敏[3] 王敏 张昕洋 焦薇薇 陈倩 雷林 段佳钰 童晨光[3] 申伟 梁晓 陈心智[4] 伍大华[5] 张允岭 廖星[2] DU Wan-qing;JIA Min;WANG Min;ZHANG Xin-yang;JIAO Wei-wei;CHEN Qian;LEI Lin;DUAN Jia-yu;TONG Chen-guang;SHEN Wei;LIANG Xiao;CHEN Xin-zhi;WU Da-hua;ZHANG Yun-ling;LIAO Xing(Graduate School,Beijing University of Chinese Medicine,Beijing 100029,Chirm;Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;the First Clinical Hospital of Jilin Academy of Chinese Medical Sciences,Changchun 130021,China;Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine,Changsha 410006,China)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国中医科学院中医临床基础医学研究所循证医学基础研究室,北京100700 [3]中国中医科学院西苑医院,北京100091 [4]吉林省中医药科学院第一临床医院,吉林长春130021 [5]湖南省中医药研究院附属医院,湖南长沙410006

出　　处：《中国中药杂志》2021年第18期4601-4614,共14页China Journal of Chinese Materia Medica

基　　金：中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2,2020YJSZX-3);2019国家中医药管理局中医药循证能力建设项目(ZZ13-024-3);国家中医药管理局中医药传承与创新“百千万”人才工程(岐黄学者-国家中医药领军人才支持计划)项目(国中医药人教发[2018]12号)。

摘　　要：通过分析中医药治疗高血压性脑出血(hypertensive intracerebral hemorrhage,HICH)近三年随机对照试验的结局指标现状,探讨存在的问题和可能的策略,为开展高质量的临床研究提供佐助。该研究检索4个英文数据库,4个中文数据库和2个临床试验注册中心,按照预定标准筛选出2018年1月—2020年9月相关随机对照试验,评估偏倚风险,对结局指标进行分类和描述。初步检索出文献151839篇,最终纳入44篇。结果表明,纳入研究总体偏倚风险较高,共涉及110种结局指标,分为7个指标域,即中医症状/证候、症状/体征、理化检查、生活质量、远期预后、经济学评估和安全性事件。其中,症状/体征类指标报告率最高,美国国立卫生研究院卒中量表(NIHSS)(72.73%)是报告最多的项目,颅内血肿体积(36.36%)是报告最多的理化检测指标。多数研究在治疗结束时测量结局指标,9项研究报告了3个月及以上的远期结局。结合国际临床试验结局指标报告情况分析表明,该领域部分结局指标应用较为合理,重视患者症状、生活质量及客观指标,但仍存在主、次要结局指标不明确,远期预后的关注不足,社会功能的关注不足,中医特色证候指标少,主观结局指标缺少测量盲法,使用不规范的复合指标等问题。建议研究者合理设计结局指标,开展中医药领域核心指标集的建立工作。The study aims to analyze the outcome indicators of randomized controlled trial(RCT)of traditional Chinese medicine(TCM)in the treatment of hypertensive intracerebral hemorrhage(HICH)in recent three years,and thus provide suggestions for the future studies in this field.Four English databases,four Chinese databases and two online registration websites of clinical trials were searched.The RCTs published between January 2018 and September 2020 were screened.The risk of bias was assessed and outcome measures were classified.A total of 151839 articles were retrieved,of which 44 RCTs were included for analysis after screening.The outcome measures of the included RCTs were classified into 7 categories,among which the symptoms/signs category showed the highest reporting rate.National Institute of Health stroke scale(72.73%)was the most frequently reported outcome indicator,while the vo-lume of intracerebral hemorrhage determined by computerized tomography(36.36%)was the most frequently reported lab test outcome.Most studies collect the outcomes at the end of treatment,while 9 studies reported long-term outcomes 3 months or more after onset.Compared with those of international clinical trials,the application of some of the outcomes was reasonable,focusing on patients'symptoms,quality of life and objective outcomes.However,there were still several problems:unclear primary and secondary outcome measures,insufficient attention to long-term prognosis,insufficient attention to social function,few TCM outcomes,lack of measurement blindness and the use of unreasonable composite outcomes.It is recommended that researchers should rationally design the outcome indicators of clinical trials and develop the core outcome set.

关 键 词：中医药 高血压性脑出血 结局指标 随机对照试验 局限性 

分 类 号：R259[医药卫生—中西医结合] R277.7[医药卫生—中医内科学]