中医药治疗风湿性心脏病随机对照试验评价指标的现状分析

分析中医药治疗风湿性心脏病随机对照试验的疗效评价指标,为中医药治疗风湿性心脏病核心指标集的构建奠定基础。检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(Sino Med)、Pub Med、EMbase、Cochrane Library数据库中明确诊断为风湿性心脏病的临床随机对照试验,检索时限为2010年1月1日—2020年12月31日。共纳入35项RCTs,3314例患者,涉及41个疗效评价指标,分属于中医症状/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七大指标域,其中理化检查(56.91%)和症状/体征(29.27%)类指标应用较多。单项研究使用的指标数量为1~15个,平均4个。使用频次排名前5的指标测量时点:总有效率报告了5个测量时点(范围14 d~6个月);左室射血分数报告了8个测量时点(范围5 d~6个月);左室收缩末期内径报告了6个测量时点(范围5 d~6个月);白细胞介素-2、肿瘤坏死因子-α报告的测量时点都在治疗28 d后。目前中医药治疗风湿性心脏病临床随机对照试验的评价指标存在数量差异性大、主要和次要结局指标不清、"替代指标"选择不合理、远期预后指标关注不足、安全性指标较为欠缺、复合指标应用欠规范、测量时间跨度大、缺乏中医药特色等问题,亟需开展中医药治疗风湿性心脏病核心指标集的建立工作。

Analysis of outcome indexes in randomized controlled trials of traditional Chinese medicine for rheumatic heart disease

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs)of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set.Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI,Wanfang,VIP,Sino Med,Pub Med,EMbase,and Cochrane Library from January 1,2010,to December 31,2020.Thirty-five RCTs were included,involving 3314 patients and 41 efficacy evaluation indexes,which covered seven domainstraditional Chinese medicine(TCM)symptoms/syndromes,symp-toms/signs,physical and chemical examination,quality of life,long-term prognosis,economic evaluation,and safety events].Physi-cal and chemical examination(56.91%)and symptoms/signs(29.27%)were the more frequently applied.The number of indexes used in a single trial ranged from 1 to 15,with an average of 4.The measurement time points of the top five indexes in the frequency of use were as follows:total response rate was reported at five measurement time points,ranging from 14 days to 6 months;left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months;left ventricular end systolic diameter was measured at six time points,ranging from 5 days to 6 months;interleukin-2(IL-2)and tumor necrosis factor-α(TNF-α)were repor-ted 28 days after treatment.At present,there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM,such as large difference in quantity,unclear primary and secondary indexes,unreasonable selection of"surro-gate indexes",insufficient attention to long-term prognostic indexes and safety event indexes,non-standard application of composite in-dexes,long measurement period,and lack of TCM characteristics.It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.