目的

评价中成药治疗糖尿病肾病的临床疗效及安全性。

方法

检索中国生物医学文献数据库、中国知网数据库、维普全文期刊数据库、万方数据库及PubMed,2003年6 月至2013年6 月收录的期刊文献资料,纳入符合要求的随机对照临床研究论文,参照Cochrane 系统评价的要求,对选择纳入的临床试验进行方法学质量评估、数据提取和数据分析。 选取其中评分在3 ～7 分的文献,运用Rev.Man 5.0.23 软件进行荟萃分析。 研究结果应用危险比(RR)及其95%可信区间(95%CI)表示,文献发表偏倚用漏斗图分析。

结果

4篇中成药与西药临床疗效对照实验文献具有同质性(P=0.14 >0.10,I² =45%),采用固定效应模型荟萃分析,结果表明中成药治疗早期糖尿病肾病疗效好于西药组,差异有统计学意义(RR=1.28,95% CI 1.17 ～1.41, Z=5.31; P<0.05)。

结论

中成药可以缓解早期糖尿病肾病的症状、降低蛋白尿及改善肾功能,无严重的不良反应,为一种安全有效的治疗方法。

Objective

To evaluate the clinical efficacy and safety of treating diabetic nephropathy(DN) with traditional Chinese patent medicine.

Methods

By means of retrieving the Chinese Biological Medicine (CBM) database, China National Kmowledge Infrastructure (CNKI) database, VIP Chinese Technical Periodicals database, Wanfang database, and PubMed database, with a retrieval period from June 2003 to June 2013,randomized controlled trials (RCTs) theses meeting the requirements were enrolled. The selected RCTs were assessed in methodological quality, data extraction, and in data analysis, referring to Cochrane system requirements. Literatures scoring 3-7 points were selected and underwent meta-analysis with Rev. Man 5.0.23 software. The study results were expressed by the risk ratio (RR) and 95% confidence interval (CI). The literature publication bias was identified with funnel plot analysis.

Results

Four control literatures on clinical efficacy of Chinese patent medicine and western medicine were homogeneous (P=0.14 >0.10, I² =45%). Results of meta-analysis using a fixed-effect model indicated that traditional Chinese patent medicine showed better effects than western medicine in treating early DN,which were statistically significant (RR=1.28,95% CI 1.17-1.41, Z=5.31; P<0.05).

Conclusion

The traditional Chinese patent medicine may be as a safe and effective method of treating early diabetic nephropathy through alleviating symptoms, reducing proteinuria, and improving renal function, but with no serious adverse reactions.