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[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与Meta分析]

[Shenshuaining capsules as adjuvant treatment for chronic renal failure: systematic review and Meta-analysis of randomized controlled trials].

作者信息

Cui Rui-Zhao, Xie Yan-Ming, Liao Xing, Wang Ji-Dong

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2016 Jun;41(11):2149-2161. doi: 10.4268/cjcmm20161128.

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 high-quality evidence to prove the clinical efficacy of this drug. More well-designed and large-scale multi-center randomized controlled trials should be conducted in the future for verification.

摘要

慢性肾衰竭(CRF)是常见疾病之一。肾衰宁胶囊(SSN)可用于治疗CRF患者,并且已经开展了许多随机对照试验(RCT)来研究其疗效。本综述旨在系统评价SSN作为CRF患者辅助治疗的疗效和安全性。检索了11个英文和中文电子数据库(截至2015年10月),以查找关于SSN治疗CRF的RCT。两名研究者独立提取数据,并使用Cochrane手册5.1评估纳入研究的质量。使用Revman 5.3软件进行Meta分析。如果Meta分析不适用于某些结局,则仅进行描述性分析。共识别出429篇相关文章,最终纳入25项RCT(1937例患者,其中治疗组1059例,对照组878例)。在临床疗效、血尿素氮(BUN)、血清肌酐(Scr)和肌酐清除率(Ccr)方面,SSN治疗组比对照组更有效。然而,SSN对提高血红蛋白(Hb)的疗效尚不能确定。未报告严重不良药物事件或反应。肾衰宁胶囊在慢性肾衰竭辅助治疗中具有一定的疗效和安全性。然而,由于纳入研究的方法学质量普遍较低,本综述无法提供高质量证据证明该药物的临床疗效。未来应开展更多设计良好的大规模多中心随机对照试验进行验证。

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