摘要
目的:探讨痰瘀互结证病证结合疗效评价指标分布特征。方法:通过检索中国期刊全文数据库,对其1982-2016年间病证结合治疗痰瘀互结证的临床随机对照试验进行资料提取并建立数据库。经过资料规范统一化处理后,对痰瘀互结证疗效评价指标进行频次、频率统计分析。结果:(1)纳入108个痰瘀互结证病证结合临床研究中,95.4%的Jadad评分≤3分,高质量文献只有5篇(≥4分)。(2)痰瘀互结证病证结合临床疗效评价指标中,理化指标出现频率最高(81.5%),其次是总体疗效(67.6%)、症状或证候计分(63.9%)、生存质量(13.9%)。(3)2011-2016年的临床研究中总体疗效出现频率较2000-2010年增加,其它指标呈下降趋势。(4)痰瘀互结证病证结合疗效评价指标种类数多为2种或3种,分别占52.8%和28.7%。(5)高脂血症和脂肪性肝病痰瘀互结证的全部临床研究都将理化指标作为评价指标之一。症状或证候计分在冠心病、脂肪性肝病痰瘀互结证临床研究中出现的频率较乳腺增生病和高脂血症高。结论:目前痰瘀互结证病证结合临床研究质量较低,疗效评价指标主要以替代指标为主。亟需提高临床研究质量控制意识,同时积极探索更符合临床实际的,操作性和可行性更高的观察终点指标的方法。
This study aimed to analyze the distribution of the outcome assessment of the treatment of combining diseases and the syndrome of intermingled phlegm and blood stasis（IPBS）. By retrieving literatures over clinical randomized controlled trials（RCTs） of IPBS syndrome in CNKI from 1982 to 2016, the database was established based on literature filtrating and data extracting. The count and frequency of the outcome assessment of the treatments were analyzed. As a result, among 108 IPBS syndrome related RCTs, 95.4% ones were less than three points evaluated by the Jadad Scale, and only 5 RCTs were scored over 4 points. Among all the outcomes assessment of the treatment for the IPBS syndrome, physico-chemical indexes were used with the most frequencies, accounting for 81.5%, and other evaluation indexes included general efficacy（accounting for 67.6%）, symptoms or syndrome scores（accounting for 63.9%） and the quality of life score（QOL）, accounting for 13.9%. The frequency of general efficacy during 2011 and 2016 was higher than that during 2000 and 2010, while the other indexes are lower than that during 2000 and 2010. There were two to three kinds of evaluation indexes for the effecacy in treating the combination of diseases and IPBS syndrome, accounting for 52.8% and 28.7%, respectively. All the RCT over IPBS syndrome related hyperlipidaemia and fatty liver disease（FLD） had taken physico-chemical indexes as one of the major outcomes assessment of treatments. The frequency of symptoms or syndrome scores in IPBS syndrome related coronary heart disease（CHD） and FLD were higher than those in cyclomastopathy and hyperlipidaemia. In conclusion, high-quality clinical researches for the combination of diseases and the IPBS syndrome were seldom found in the established literature databases, and the outcome assessment of treatments gave priority to the surrogate outcomes currently. The consciousness of quality-control studies for the clinical research should be pushed ahead. Meanwhile, we will remain committed to exploring the methods practically with a higher feasibility to observe the endpoint.
出处
《世界科学技术-中医药现代化》
2016年第5期800-804,共5页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
科学技术部国家重点基础研究计划"973计划"(2014CB542903):中医证候临床辨证的基础研究
负责人:胡镜清
中国中医科学院基本科研业务费自主选题研究项目(YZ-1547):中老年H型高血压中医证候特征的研究
负责人:王传池
关键词
疗效评价指标
病证结合
痰瘀互结证
替代指标
Outcome assessment of treatment
syndrome of intermingled phlegm and blood stasis
combination of diseases and syndrome
surrogate outcomes
