【摘要】：慢性腎衰竭(CRF)是常見病之一,已有較多腎衰寧膠囊治療CRF的臨床試驗。該研究系統(tǒng)評價腎衰寧膠囊輔助治療CRF的療效和安全性。計算機檢索了11個英文和中文數據庫(均至2015年10月),收集關于腎衰寧膠囊對CRF的隨機對照試驗。2名研究人員獨立提取數據,并根據Cochrane Handbook 5.1評價納入文獻質量,采用Revman 5.3軟件進行Meta分析。不適合Meta分析,僅進行描述性分析。共檢索到429篇文獻,最終納入25個研究,總樣本數為1 937例,試驗組1 059例和對照組878例。在臨床有效率、血尿素氮(BUN)、血肌酐(Scr)和肌酐清除率(Ccr)方面,治療組腎衰寧膠囊均優(yōu)于各對照組;但是對于升高血紅蛋白(Hb),不能確定腎衰寧膠囊的療效。無嚴重不良事件或不良反應報告。腎衰寧膠囊對于輔助治療CRF有一定的療效且相對安全,但由于所納入研究質量不高,尚不能提供高質量證據證實該藥的臨床療效,需要更多設計良好、規(guī)模較大的多中心隨機對照試驗進一步加以驗證。
[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.
【作者單位】： 中國中醫(yī)科學院中醫(yī)臨床基礎醫(yī)學研究所;中國中醫(yī)科學院西苑醫(yī)院;中國中醫(yī)科學院望京醫(yī)院;
【基金】：中央級公益性科研院所基本業(yè)務費項目(Z0406,PY1303) 國家“重大新藥創(chuàng)制”科技重大專項(2009ZX09502-030) 中國中醫(yī)科學院客座研究員聯(lián)合創(chuàng)新研究項目(ZZ070817)
【分類號】：R692.5

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