桃红四物汤及其加减方治疗糖尿病肾病的随机对照系统评价

Title:

Systematic evaluation on the treatment of diabetic nephropathy with Tao Hong Si Wu Decoction and its modified prescription

作者:

朴珍嬉 曲志成 孙其伟

100700 北京，中国中医科学院2009级硕士研究生（朴珍嬉）；100091 北京，中国中医科学院西苑医院老年病科（曲志成、孙其伟）

Author(s):

PIAO Zhen-xi;  QU Zhi-cheng;  SUN Qi-wei*

*Xiyuan hospital of China academy of Chinese medical sciences, Beijing 100091, China

关键词:

糖尿病肾病; 桃红四物汤及其加减方; 系统评价; Meta分析

Keywords:

Diabetic nephropathy; Tao Hong Si Wu decoction; System review; Meta-analysis

DOI:

10.3760/cma.j.issn.1673-4246.2012.04.003

摘要:

目的 系统评价桃红四物汤及其加减方治疗糖尿病肾病（diabetic nephropathy，DN）的疗效及安全性。方法 收集Cochrane图书馆临床对照试验库、MEDLINE、中国期刊全文数据库（CNKI），中国生物医学文献数据库和中文科技期刊全文数据库中相关桃红四物汤及其加减方治疗DN的随机或半随机对照试验文献。检出文献由两名研究人员选择并提取资料，按照Cochrane系统评价的方法评价纳入研究的质量和提取有效数据，应用RevMan 5.0.24软件对所收集的数据进行Meta分析。结果 共收集文献11篇，患者956例。11篇研究的样本含量小且方法学质量较差，故无法进行高质量研究的敏感性分析。Meta分析结果显示，桃红四物汤及其加减方在一定程度上可减少早期和临床期DN患者的24小时尿蛋白定量（24 h UPE），降低Ⅲ、Ⅳ期患者血肌酐（Scr），可在一定程度上改善患者的肾功能。对DN患者的甘油三酯（TG），胆固醇（CHO）有降低；可更好控制DN患者的空腹血糖（FBG）及糖化血红蛋白（HbA1c）。治疗期间尚未发现严重的不良反应。结论 桃红四物汤及其加减方可能是一种相对安全和有效治疗DN的药物。由于纳入试验方法质量较低，以及可能存在发表偏倚，使本系统评价的证据强度不足。

Abstract:

Objective To evaluate the effectiveness and safety of Tao Hong Si Wu decoction in treating Diabetic nephropathy (DN). Methods Randomized controlled trials (RCTs) on Tao Hong Si Wu decoction in treatment of DN were searched in PubMed, EMbase, Cochrane Library, CMCC, VIP, CNKI, CBM. Data were strictly extracted using the fundamental evaluation method recommended in Cochrane Handbook and Meta-analysis was performed using RevMan 5.0.24 software. Results Eleven RCTs of 956 patients of DN were analyzed. The content and methodological quality of these 11 test samples were low, which could not be undertaken high quality research of sensitivity analysis. Meta-analysis results showed that: Tao Hong Si Wu decoction could be reduced to some extent, the early and clinical stage of DN patients with 24 h UPE reduce the III, IV of Scr, and improve renal function to a certain extent. The results also showed that Tao Hong Si Wu decoction could lower TG and CHO, better control FBG and HbA1c of DN patients, besides, serious adverse reactions have not been found during the treatment. Conclusion Tao Hong Si Wu Decoction could be a relatively safe and effective treatment of DN drugs. However, a high probability of selection bias and measurement bias in the included studies was bound to affect the strength of the results.