【摘要】：慢性腎衰竭(CRF)是常見(jiàn)病之一,已有較多腎衰寧膠囊治療CRF的臨床試驗(yàn)。該研究系統(tǒng)評(píng)價(jià)腎衰寧膠囊輔助治療CRF的療效和安全性。計(jì)算機(jī)檢索了11個(gè)英文和中文數(shù)據(jù)庫(kù)(均至2015年10月),收集關(guān)于腎衰寧膠囊對(duì)CRF的隨機(jī)對(duì)照試驗(yàn)。2名研究人員獨(dú)立提取數(shù)據(jù),并根據(jù)Cochrane Handbook 5.1評(píng)價(jià)納入文獻(xiàn)質(zhì)量,采用Revman 5.3軟件進(jìn)行Meta分析。不適合Meta分析,僅進(jìn)行描述性分析。共檢索到429篇文獻(xiàn),最終納入25個(gè)研究,總樣本數(shù)為1 937例,試驗(yàn)組1 059例和對(duì)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(duì)照組;但是對(duì)于升高血紅蛋白(Hb),不能確定腎衰寧膠囊的療效。無(wú)嚴(yán)重不良事件或不良反應(yīng)報(bào)告。腎衰寧膠囊對(duì)于輔助治療CRF有一定的療效且相對(duì)安全,但由于所納入研究質(zhì)量不高,尚不能提供高質(zhì)量證據(jù)證實(shí)該藥的臨床療效,需要更多設(shè)計(jì)良好、規(guī)模較大的多中心隨機(jī)對(duì)照試驗(yàn)進(jìn)一步加以驗(yàn)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(guó)中醫(yī)科學(xué)院中醫(yī)臨床基礎(chǔ)醫(yī)學(xué)研究所;中國(guó)中醫(yī)科學(xué)院西苑醫(yī)院;中國(guó)中醫(yī)科學(xué)院望京醫(yī)院;
【基金】：中央級(jí)公益性科研院所基本業(yè)務(wù)費(fèi)項(xiàng)目(Z0406,PY1303) 國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)(2009ZX09502-030) 中國(guó)中醫(yī)科學(xué)院客座研究員聯(lián)合創(chuàng)新研究項(xiàng)目(ZZ070817)
【分類號(hào)】：R692.5

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