复方丹参滴丸辅助治疗糖尿病肾病疗效的Meta分析

Meta analysis of Therapeutic Efficacy of Compound Danshen Dropping Pills in Adjunctive Treatment of Diabetic Nephropathy

目的:系统评价复方丹参滴丸辅助治疗糖尿病肾病(DN)的有效性。方法:计算机检索The Cochrane Library(2013年第3期),美国医学文摘数据库(Medline),中国生物医学文献数据库(CBM),中国期刊全文数据库(CNKI),维普中文科技期刊全文数据库(VIP)和万方数据库,检索年限均为1990年1月—2014年7月,公开发表的以常规治疗为对照,在常规治疗的基础上加用复方丹参滴丸治疗糖尿病肾病的随机对照研究(RCT),评价纳入的文献质量和提取有效数据后采用Rev Man 5.2统计学软件进行Meta分析。结果:共纳入19篇RCT,合计1 491份病例。19个试验组间均衡性良好,文献质量评价B级为7篇,其余为C级。Meta分析结果显示,试验组与对照组的总有效率[OR=6.17,95%CI(3.42,11.13),P<0.05],UAER[MD=-15.95,95%CI(-21.69,-10.20),P<0.01],24 h尿量蛋白[MD=-0.06,95%CI(-0.08,-0.03),P<0.01]均有统计学差异;肌酐[MD=4.69,95%CI(-0.04,9.42),P=0.05]和血糖[MD=-0.04,95%CI(-0.17,0.08),P>0.05]均无统计学意义。结论:现有证据表明,复方丹参滴丸尽管对糖尿病肾病患者的肾功能和血糖无显著性影响,但能显著减少尿蛋白水平,因此可用于糖尿病肾病的辅助治疗,具有较高的临床应用价值。但本研究纳入的研究数量偏少,且方法学上存在缺陷,证据强度不高,因此复方丹参滴丸治疗糖尿病肾病的临床有效性仍需深入研究。

Objective： The aim of this study was to evaluate the therapeutic efficacy of compound Danshen dropping pills in the adjunctive treatment of diabetic nephropathy. Method： Retrieved from the Cochrane Library （Issue 3, 2013） , Medline, CBM, CNKI, VIP and Wangfang database online version, RCT, from January 1990 to July 2014, about compound Danshen dropping pills on the basis of conventional treatment for diabetic nephropathy with conventional treatment as control group were collected. Meta-analysis of included trials was performed using Rev Man 5.2 software. Result： A total of 19 studies were included, involving 1 491 patients. There were good balance between 19 RCTs, the quality evaluation of 7 RCTs scored class B, with the rest for class C. Meta-analysis showed that experimental group and control group had statistically difference in clinical efficacy [OR=6.17, 95%CI （3.42, 11.13）, P〈0.05], UAER [MD= -15.95, 95%CI （ -21.69, -10.20）, P〈0.01], and 24-hour urinary protein excretion [MD = -0.06, 95%CI （ -0.08, -0.03）, P 〈0.01]. But there was no statistically difference in Creatinine [ MD = 4.69, 95% CI （ - 0. 04, 9.42）, P = 0. 05 ] and Blood glucose [MD= -0.04, 95%CI （ -0.17, 0.08）, P〉0.05]. Conclusion： The existing evidence show that, to the DN patients, compound Danshen dropping pills has no significant impact on renal function and blood glucose, but it can reduce the Urine protein level. The poor methodological quality of included studies seriously weakened the validity of the meta-analysis. So the efficacy of Compound Danshen dropping pills in the treatment of diabetic nephropathy should be determined by more high quality RCTs.