Objective To systematically evaluate the clinical efficacy and safety of Shenkang injection combined with alprostadil in treatment of diabetic nephropathy .Methods Meta-analysis was used .The literatures of randomized clinical trials ( RCTs) on Shenkang injection combined with alprostadil for diabetic nephropathy in EMBASE , PUBMED, MED-LINE, AMED, CINAHL, Cochrane Library , China National Knowledge Infrastructure Database , Chongqing VIP Chinese Science and Technology Periodical Database , Chinese Biomedical Literature Database and Wanfang Database from the in-ception of each database up to 25 January 2015 were electronically searched .The Cochrane risk of bias tool was used to as-sess the risk of bias .We assessed the quality of included studies using the Jadad rating scale .The Cochrane Collaboration's RevMan5.3 software was used for meta-analysis.All the patients had diabetic nephropathy .Patients in the treatment group were treated with Shenkang injection combined with alprostadil on the basis of the conventional treatment .Patients in the control group was treated with the conventional treatment or the use of other drugs based on the conventional treatment or Shenkang injection alone based on the conventional treatment or alprostadil alone based on the conventional treatment .Re-sults Eleven studies were included and made a meta-analysis.When we compared the treatment group with the control group, the odds ratio(OR) of total efficiency rate was 3.00, 95% confidence interval (CI) was 1.57 to 5.57, and the difference was statistically significant (P=0.00 09);24-hour urinary albumin mean difference (MD) was -0.11, 95%CI[-0.18 to -0.04], and the difference was statistically significant (P=0.002);24-hour urinary micro albumin MD was -122.13, 95%CI[-185.24 to -59.01], and the difference was statistically significant (P=0.000 1);serum cre-atinine MD was -28.07, 95%CI[-35.91 to -20.24], and the difference was statistically significant (P<0.000 01);blood urea nitrogen MD was -2.18, 95%CI[-2.72 to -1.63], and the difference was statistically significant (P<0.000 01);creatinine clearance rate MD was 1.45, 95%CI[0.75 to 2.15], and the difference was statistically signifi-cant (P<0.00 01);total cholesterol MD was -0.79, 95%CI[ -1.12 to -0.46], and the difference was statistically significant (P<0.00 001); urinary albumin excretion rate MD was -40.09, 95%CI[ -63.20 to -16.99], and the difference was statistically significant (P=0.00 07).All studies included did not report any adverse reactions .Conclu-sion Shenkang injection combined with alprostadil in treatment of diabetic nephropathy has significant clinical effect , which reduces the urinary protein , improves the renal function and has good safety .%目的：系统评价肾康注射液联合前列地尔治疗糖尿病肾病的临床效果与安全性。方法采用Meta分析法。检索EMBASE、PUBMED、MEDLINE、AMED、CINAHL、Cochrane图书馆、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库和万方数据库从建库至2015年1月25日肾康注射液联合前列地尔治疗糖尿病肾病随机对照试验研究，筛选合格研究。应用Cochrane评价员手册进行偏倚风险评价，Jadad评分法进行质量评价。应用RevMan5．3软件进行Meta分析。患者均为糖尿病肾病，均采用随机对照方案，治疗组均为常规治疗基础上加用肾康注射液联合前列地尔；对照组采用常规治疗或常规治疗基础上应用其他药物或常规治疗基础上单用肾康注射液或常规治疗基础上单用前列地尔。结果符合纳入标准的文献共11篇。治疗组与对照组相比，临床疗效总有效率比值比（OR）为3．00，95％可信区间（CI）1．57～5．57，P＝0．0009；24 h尿蛋白定量均数差（MD）为－0．11，95％CI －0．18～－0．04，P＝0．002；24 h尿微白蛋白定量MD为－122．13，95％CI －185．24～－59．01，P＝0．0001）；血肌酐MD为－28．07，95％CI－35．91～－20．24，P＜0．00001；血尿素氮MD为－2．18，95％CI －2．72～－1．63，P＜0．00001；血肌酐清除率MD为1．45，95％CI 0．75～2．15，P＜0．0001；血总胆固醇MD为－0．79，95％CI －1．12～－0．46，P＜0．00001；尿白蛋白排泄率MD为－40．09，95％CI －63．20～－16．99，P＝0．0007；无重大不良反应发生，治疗组与对照组不良反应比较差异无统计学意义。结论肾康注射液联合前列地尔治疗糖尿病肾病临床疗效显著，能有效减少尿蛋白，改善肾功能，临床安全性较好。
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