中医药治疗慢性心力衰竭临床随机对照研究结局指标相关问题的探讨

发布时间：2018-06-08 06:25

  本文选题：慢性心力衰竭 + 结局指标　； 参考：《河南中医药大学》2016年硕士论文

【摘要】：目的:通过检索关于中医药治疗慢性心衰临床随机对照研究的相关文献,分析研究中存在的问题,尤其是心衰结局指标的选择和应用的问题,为以后的中医临床研究提供思路和借鉴。方法:检索中国知网数据库、重庆维普数据库和万方数据资源系统收录的中医临床随机对照研究文献,以“心衰”、“心力衰竭”、“心功能不全”为“主题”、“篇名”、“关键词”,以“2014年”为抽样年份,通过下载文献题录,阅读文献摘要,筛选出中医临床随机对照研究,提取相关信息,包括研究中心数量、方案注册、伦理审核、知情同意、结局指标的选择和评价方法等,进行分析。结果:共检索到606篇相关文献,通过初步筛选,最终纳入281篇,总样本量24662例。患者年龄在18-98岁,病程在3月至41年不等;基础疾病主要包括冠心病,其次为肺源性心脏病、高原性心脏病、风湿性心脏病和扩张型心肌病;NYHA心功能分级为Ⅱ-Ⅳ级者9612例(占38.97%),Ⅱ-Ⅲ级者4557例(占18.48%),Ⅲ-Ⅳ级者3124例(占12.67%),Ⅰ-Ⅳ级者1045例(占4.24%),Ⅳ级者408例(占1.65%);干预类型为中成药者14930例(占60.54%),其中采用中药针剂者9787例(占39.68%),采用口服制剂者5045例(占20.46%),干预类型为自拟方者9732例(占39.46%);中医证型出现频率高者依次为阳虚证(2923例,占11.85%)、气虚血瘀证(2479例,占10.05%)、气阳两虚证(1742例,占7.06%)、气阴两虚证(1403例,占5.69%)、阴阳两虚证(72例,占0.29%);共收集到慢性心衰的疗效评价指标45个,包括心脏彩超、心功能分级、临床症状、BNP、NT-pro BNP、中医证候、6分钟步行试验、生存量表等,出现频率最高的疗效评价指标组合为“心脏彩超+心功能分级”。结论:心脏彩超、心功能分级、临床症状、中医证候、BNP、6分钟步行试验、NT-pro BNP、生存质量等是慢性心力衰竭疗效评价最常选用的指标;慢性心衰中医临床随机对照研究的设计、结局指标的选择和使用有待规范。
[Abstract]:Objective: to search the literature on randomized controlled clinical study on the treatment of chronic heart failure with traditional Chinese medicine, and to analyze the problems in the study, especially the choice and application of the outcome index of heart failure. For the future clinical research of TCM to provide ideas and reference. Methods: to search the literature of Chinese medicine clinical randomized controlled study collected by Chinese knowledge Network Database, Chongqing Weipu Database and Wanfang data Resource system. The subjects were Heart failure, Heart failure, and the title was "Heart failure", "Heart failure" and "Heart failure". "key words", taking "2014" as the sampling year, through downloading the bibliography, reading the abstract of the literature, screening out the randomized controlled study of TCM clinical, extracting relevant information, including the number of research centers, the registration of the project, the ethics audit, and so on. Informed consent, the selection of outcome indicators and evaluation methods, etc. Results: a total of 606 related literatures were retrieved, and by preliminary screening, 281 articles were included, with a total sample size of 24662 cases. The age of the patients ranged from 18 to 98 years, and the course of disease ranged from 3 months to 41 years. The underlying diseases mainly included coronary heart disease, followed by pulmonary heart disease and high altitude heart disease. There were 9612 cases (38.97 cases) with rheumatic heart disease and dilated cardiomyopathy, 4557 cases (18.4848) with grade 鈪，

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