肾康注射液联合前列地尔治疗慢性肾衰竭有效性和安全性的系统评价

摘要

目的 系统评价肾康注射液联合前列地尔治疗慢性肾衰竭(CKD)的有效性和安全性.方法 计算机检索The Cochrane Library、PubMed、EMBase、中国生物医学文献数据库、中国知网、维普中文科技期刊数据库和万方数据库,搜集肾康注射液联合前列地尔治疗CKD的随机对照试验.检索时间均自建库至2017年1月.由2位研究人员独立进行文献筛选、数据提取和质量评价后,采用RevMan 5.3软件进行Meta分析.结果 共纳入15个随机对照试验,包括1 283例患者,试验组643例,对照组640例,Meta分析结果显示,试验组总有效率(相对危险度=1.40,95％置信区间:1.28 ～ 1.53,P＜0.01)、内生肌酐清除率(均数差=6.57,95％置信区间:3.24 ～9.91,P＜0.01)均高于对照组,24 h尿蛋白定量(均数差=-0.40,95％置信区间:-0.47 ～-0.33,P＜0.01)、血肌酐(均数差=-56.92,95％置信区间:-72.82 ～-41.02,P ＜0.01)和血尿素氮(均数差=-3.05,95％置信区间:-3.97～-2.13,P＜0.01)均低于对照组,2组不良反应发生率差异无统计学意义(P＞0.05).结论 肾康注射液联合前列地尔治疗CKD效果明显,且无严重不良反应发生.%Objective To analyze the effectiveness and safety of shenkang injection combined with alprostadil in the treatment of chronic renal failure.Methods Randomized controlled trials of Shenkang injection combined with alprostadil treating chronic renal failure were searched in databases including the Cochrane Library,PubMed,EMBase,China Biology Medicine disc(CMB),China National Knowledge Infrastructure (CNKI),VIP and Wanfang.Two reviewers independently screened literatures and extracted data.Meta-analysis was conducted by RevMan 5.3 software.Results Totally 1 283 patients in 15 trails were involved,including 643 patients in observation group and 640 patients in control group.Meta-analysis showed that the total effective rate[relative risk =1.40,95％ confidence interval(CI):1.28-1.53,P ＜0.01] and endogenous creatinine clearance rate[mean difference (MD) =6.57,95％ CI:3.24-9.91,P ＜ 0.01] in observation group were significantly higher than those in control group;24 h urine protein (MD =-0.40,95％ CI:-0.47 to-0.33,P ＜ 0.01),serum creatinine (MD =-56.92,95％ CI:-72.82 to-41.02,P ＜ 0.01) and blood urea nitrogen(MD =-3.05,95％ CI:-3.97 to -2.13,P ＜0.01) in observation group were significantly lower than those in control group.There was no significant difference of incidence of adverse reactions between groups (P ＞ 0.05).Conclusion Shenkang injection combined with alprostadil is safe and effective in treating chronic renal failure.