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.docVIP

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 　　[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。 　　[关键词]肾衰宁胶囊； 慢性肾衰竭； 随机对照试验； 系统评价； Meta分析 　　[Abstract]Chronic renal failure（CRF） is one of the common diseases. Shenshuaining capsule （SSN） can be used to treat patients with CRF， and many randomized control trials（RCTs） have been conducted to investigate its efficacy. The current review aims to systematically evaluate the efficacy and safety of SSN as an adjuvant treatment for patients with CRF. Eleven English and Chinese electronic databases （up to October 2015）， were searched to identify RCTs on SSN for CRF. Two reviewers independently extracted the data and assessed the quality of included studies by using Cochrane Handbook 5.1.Meta-analysis was carried out by using Revman 5.3 software. If the Meta-analysis was not suitable for some outcomes， only descriptive analysis would be conducted.429 related articles were identified and finally a total of 25 RCTs （1 937 patients including 1 059 patients of treatment group and 878 patients of control group） were included. The SSN treatment group was more effective than the control group in terms of clinical efficiency， blood urea nitrogen（BUN）， serum creatinine（Scr） and creatinine clearance（Ccr）. However， the efficacy of SSN on increasing hemoglobin （Hb） could not be determined. No serious adverse drug events or reactions were reported. SSN capsules have certain efficacy and safety in the adjuvant treatment for chronic renal failure. However， due to the generally low methodological quality of the included studies， this review can not provide