肾衰宁胶囊辅助治疗慢性肾衰竭随机对照试验的系统评价和Meta分析
发布时间：2018-09-05 12:45
【摘要】：慢性肾衰竭(CRF)是常见病之一,已有较多肾衰宁胶囊治疗CRF的临床试验。该研究系统评价肾衰宁胶囊辅助治疗CRF的疗效和安全性。计算机检索了11个英文和中文数据库(均至2015年10月),收集关于肾衰宁胶囊对CRF的随机对照试验。2名研究人员独立提取数据,并根据Cochrane Handbook 5.1评价纳入文献质量,采用Revman 5.3软件进行Meta分析。不适合Meta分析,仅进行描述性分析。共检索到429篇文献,最终纳入25个研究,总样本数为1 937例,试验组1 059例和对照组878例。在临床有效率、血尿素氮(BUN)、血肌酐(Scr)和肌酐清除率(Ccr)方面,治疗组肾衰宁胶囊均优于各对照组;但是对于升高血红蛋白(Hb),不能确定肾衰宁胶囊的疗效。无严重不良事件或不良反应报告。肾衰宁胶囊对于辅助治疗CRF有一定的疗效且相对安全,但由于所纳入研究质量不高,尚不能提供高质量证据证实该药的临床疗效,需要更多设计良好、规模较大的多中心随机对照试验进一步加以验证。
[Abstract]:Chronic renal failure (CRF) is one of the common diseases. There have been more clinical trials of Shenshuining capsule in the treatment of CRF. This study systematically evaluated the efficacy and safety of Shenshuining capsule in the treatment of CRF. Eleven databases in English and Chinese (both until October 2015) were searched by computer. The data were extracted independently from 2 researchers in randomized controlled trial of Shenshuaining capsule for CRF, and the quality of literature was evaluated according to Cochrane Handbook 5.1 evaluation. Meta analysis was carried out with Revman 5.3 software. Not suitable for Meta analysis, only descriptive analysis. A total of 429 articles were retrieved and 25 studies were included. The total number of samples was 1 937, 1 059 in the trial group and 878 in the control group. In clinical effective rate, blood urea nitrogen (BUN), serum creatinine (Scr) and creatinine clearance rate (Ccr), the Shenshuining capsule in the treatment group was better than that in the control group, but the effect of Shenshuining capsule could not be determined for the increase of hemoglobin (Hb),. No serious adverse events or adverse reactions were reported. Shenshuaining capsule has certain curative effect and relative safety for adjuvant treatment of CRF, but because the quality of the research involved is not high, it can not provide high quality evidence to confirm the clinical effect of the drug, so more good design is needed. Large-scale multi-center randomized controlled trials were further validated.
【作者单位】： 中国中医科学院中医临床基础医学研究所;中国中医科学院西苑医院;中国中医科学院望京医院;
【基金】：中央级公益性科研院所基本业务费项目(Z0406,PY1303) 国家“重大新药创制”科技重大专项(2009ZX09502-030) 中国中医科学院客座研究员联合创新研究项目(ZZ070817)
【分类号】：R692.5
[Abstract]:Chronic renal failure (CRF) is one of the common diseases. There have been more clinical trials of Shenshuining capsule in the treatment of CRF. This study systematically evaluated the efficacy and safety of Shenshuining capsule in the treatment of CRF. Eleven databases in English and Chinese (both until October 2015) were searched by computer. The data were extracted independently from 2 researchers in randomized controlled trial of Shenshuaining capsule for CRF, and the quality of literature was evaluated according to Cochrane Handbook 5.1 evaluation. Meta analysis was carried out with Revman 5.3 software. Not suitable for Meta analysis, only descriptive analysis. A total of 429 articles were retrieved and 25 studies were included. The total number of samples was 1 937, 1 059 in the trial group and 878 in the control group. In clinical effective rate, blood urea nitrogen (BUN), serum creatinine (Scr) and creatinine clearance rate (Ccr), the Shenshuining capsule in the treatment group was better than that in the control group, but the effect of Shenshuining capsule could not be determined for the increase of hemoglobin (Hb),. No serious adverse events or adverse reactions were reported. Shenshuaining capsule has certain curative effect and relative safety for adjuvant treatment of CRF, but because the quality of the research involved is not high, it can not provide high quality evidence to confirm the clinical effect of the drug, so more good design is needed. Large-scale multi-center randomized controlled trials were further validated.
【作者单位】： 中国中医科学院中医临床基础医学研究所;中国中医科学院西苑医院;中国中医科学院望京医院;
【基金】：中央级公益性科研院所基本业务费项目(Z0406,PY1303) 国家“重大新药创制”科技重大专项(2009ZX09502-030) 中国中医科学院客座研究员联合创新研究项目(ZZ070817)
【分类号】：R692.5
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