阿魏酸钠治疗糖尿病肾脏疾病的系统评价

Systematic Review on Sodium Ferulate for Treatment of Diabetic Nephropathy

目的系统评价阿魏酸钠治疗糖尿病肾脏疾病的疗效及安全性。方法计算机检索Cochrane Library,MEDLINE,EMBASE,中国期刊全文数据库(CNKI),维普中文科技期刊数据库(VIP),中国生物医学文献数据库(CBM)以及互联网资料。全面收集有关阿魏酸钠治疗糖尿病肾脏疾病的随机对照试验,采用Cochrane Library Handbook推荐的简单评价法,严格评价纳入研究的质量,使用Revman5·0统计软件对数据进行Meta分析。结果共纳入14个随机对照试验,共906名患者。Meta分析结果显示:阿魏酸钠治疗组与对照组相比,在降低尿白蛋白排泄率(UAER)(早期:[WMD=16·08,95%CI(11·01,21·15)];临床期:[WMD=82·66,95%CI(66·95,98·37)])、尿内皮素/内皮素-1(ET/ET-1)[WMD=10·78,95%CI(8·18,13·39)];血肌酐(SCr)[WMD=6·42,95%CI(1·83,11·01)];尿素氮(BUN)[SMD=1·45,95%CI(0·19,2·71)]、胆固醇(TC)[WMD=0·84,95%CI(0·56,1·21)]以及升高高密度脂蛋白胆固醇(HDL-C)[WMD=0·17,95%CI(0·09,0·26)]方面,差异均有统计学意义;在改善空腹血糖(FBG)[WMD=0·17,95%CI(-0·03,0·37)];甘油三酯(TG)[SMD=-0·13,95%CI(-0·49,0·23)]方面差异无统计学意义。结论目前证据表明,阿魏酸钠组在降低糖尿病肾脏疾病患者UAER、ET、SCr、BUN、TC以及升高HDL-C方面优于常规治疗组,在改善FBG和TG方面无证据显示较常规治疗更为有效。由于纳入的文献其研究方法学质量不高,需要高质量的研究对其疗效及安全性进一步予以证实。

Objective To systematically review the efficacy and safety of sodium ferulate （SF） for the treatment of diabetic nephropathy. Methods By computerized retrieving the Cochrane Library, MEDLINE, EM-BASE, CNKI, VIP, CBM （theses, conference and internet materials）, as well as data from internet materials re- garding randomized controlled clinical trials of sodium ferulate for the treatment of diabetic nephropathy were col- lected completely. Data were strictly extracted using the simple evaluation method recommended in Cochrane Handbook and Meta-analysis was performed using Revman 5.0 software. Results Fourteen randomized con- trolled trials involving 906 patients met the inclusion criteria. Meta-analysis showed that as compared with the control group, the effects in SF group were superior in terms of reducing urinary albumin excretion rate （UAER） at early stage [WMD =16.08, 95%confidence interval （95%CI） ： 11.01 to 21. 151 and clinical stage （WMD = 82.66, 95%C1：66.95 to 98.37）, urinary endothelin/endothelin-1 （ET/ET-1, WMD =10.78, 95%Cl：8.18 to 13.39）, levels of serum creatinine （SCr, WMD =6.42, 95%Cl：1.83 to 11.01 ）, blood urea nitrogen （BUN, SMD =1.45, 95%Cl： 0. 19 to 2.71 ） and total cholesterol （TC, WMD =0.84, 95%Cl：0.56 to 1.21, as well as in increasing high density lipoprotein-cholesterol （HDL-C, WMD =0. 17, 95%C1：0.09 to 0.26）, showing significant difference between groups. However, the effects of SF were insignificantly different to those of control in reducing fasting blood glucose （FBG, WMD =0.17, 95%C1：-0.03 to 0.37） and triglyceride （TG, SMD= - 0. 13, 95%CI -0.49 to 0.23）. Cenclusiens At present the evidences show that SF is superior to the conven- tional treatment in reducing UAER, ET, SCr, BUN, TC and increasing HDL-C, but there is no evidence to show that SF is superior in reducing FBG and TG. However, the evidence is not strong enough due to the low quality of included literature. More large-scale, multi-center, randomized trials are needed to confirm the efficacy and safety of SF in treating diabetic nephropathy.