中成药治疗肾性贫血及其临床研究现状

An umbrella review of clinical research on Chinese patent medicines in the treatment of renal anemia

目的分析并梳理中成药治疗肾性贫血的临床研究,以期为临床实践和未来研究方向提供参考。方法系统检索8个中英文数据库,收集中成药治疗肾性贫血的临床研究。采用描述性总结与图表结合的形式对结果进行展示。结果共纳入60篇研究,其中首篇关于中成药治疗肾性贫血的临床研究发表于2000年,绝大部分研究发表于近5年。研究类型最多的是随机对照试验,占比90%。关于透析依赖性肾性贫血的研究40篇,研究对象2916例;非透析依赖性肾性贫血研究2篇,研究对象174例;未提及透析或者非透析依赖的肾性贫血研究有18篇,研究对象1279例。临床研究中干预措施的对比形式主要是中成药联合西药与单用西药的对比。纳入的研究中有40篇将“血红蛋白的变化”设定为一项结局指标,其次是“总有效率”(35篇)。结论现阶段治疗肾性贫血的中成药种类繁多,其有效性和安全性尚待进一步研究。此外,临床研究的结局指标不一致,无法保证研究的科学性和严谨性。

Objective To analyze and sort out the clinical trials of traditional Chinese patent medicines and simple preparations in the treatment of renal anemia,so as to provide reference for clinical practice and future research directions.Methods Eight Chinese and English databases were systematically searched to collect the clinical studies on the treatment of renal anemia with traditional Chinese patent medicines and simple preparations.Present the results in a combination of descriptive summaries and charts.Results A total of 60 studies were included,of which the first clinical study on the treatment of renal anemia with traditional Chinese patent medicines and simple preparations was published in 2000,and most of the studies were published in the past five years.The most common type of research was randomized controlled trials,accounting for 90%.There are a total of 40 studies on dialysis dependent renal anemia,with 2916 subjects.Two studies were conducted on non dialysis dependent renal anemia,with 174 subjects included.There were 18 studies on renal anemia that did not mention dialysis or non dialysis dependence,with 1279 subjects.The comparison form of intervention measures in clinical research was mainly the comparison between traditional Chinese patent medicines and simple preparations combined with western medicine and western medicine alone.Among the included studies,40 articles set"changes in hemoglobin"as an outcome measure,followed by"total effective rate"(35 articles).Conclusions There are many kinds of traditional Chinese patent medicines and simple preparations for renal anemia at present,and its effectiveness and safety need further study.In addition,the outcome measures of clinical studies are inconsistent,which cannot guarantee the scientific and rigorous nature of the research.