血脂康治疗糖尿病肾病的系统评价

Xuezhikang for Diabetic Kidney Disease:A Systematic Review of Randomized Controlled Trials

目的系统评价血脂康治疗糖尿病肾病(DKD)的疗效和安全性。方法计算机检索Cochrane图书馆临床对照试验资料库(2008年第3期)、MEDLINE(1980～2008.9)、EMbase(1980～2008.9)、CBMdisc(1990～2008.9)、CNKI(1994～2008.9),手工检索相关文献,按纳入与排除标准选择试验、评价质量,提取资料,并用RevMan4.2软件对数据进行Meta分析。结果共纳入血脂康治疗糖尿病肾病的9个RCT,8个RCT的方法学质量评价为B级,另1个为C级。Meta分析结果显示:血脂康组在降低DKD患者24h尿蛋白[WMD=–0.87,95%CI(–1.34,–0.41)]、尿微量白蛋白[WMD=–115.39,95%CI(–127.63,–103.15)]及尿蛋白排泄率方面[WMD=–65.46,95%CI(–68.87,–62.12)]均优于常规治疗组;血脂康组在改善DKD患者Scr水平方面[WMD=–5.42,95%CI(–11.06,0.21)]与常规治疗组相似;血脂康组在降低TC[WMD=–1.71,95%CI(–2.39,–1.03)]、TG[WMD=–0.96,95%CI(–1.46,–0.46)]、LDL-C[WMD=–1.01,95%CI(–1.64,–0.38)]以及升高HDL-C[WMD=0.22,95%CI(0.09,0.36)]方面均优于常规治疗组;血脂康在改善FBS方面[WMD=–0.01,95%CI(–0.49,0.47)]与常规治疗组相当,但在改善2h-BS[WMD=–1.10,95%CI(–1.35,–0.85]、HbA1c方面[WMD=–0.41,95%CI(–0.56,–0.27)]优于常规治疗组。血脂康未见明显不良反应或过敏反应的报道。结论现有的临床证据显示,血脂康能够降低24h尿蛋白、尿微量白蛋白及尿蛋白排泄率,且能调节血脂(降低TC、TG、LDL-C和升高HDL-C)和控制血糖(降低2h-BS和HbA1c)。但由于纳入研究存在选择性偏倚和测量性偏倚的中度可能性,势必影响结果的论证强度,期待更多高质量的随机双盲对照试验提供高质量的证据。

Objective To assess the effectiveness of xuezhikang for treating diabetic kidney disease. Methods We searched the Cochrane Central Register of Controlled Trials （Issue 3, 2008）, MEDLINE （1980 to September 2008）, EMbase （1980 to September 2008）, CBMdisc （1990 to September 2008）, and CNKI （1994 to September 2008）. We also hand searched relevant journals and conference proceedings. Randomized controlled trials （RCTs） in which xuezhikang was used to treat diabetic kidney disease were collected. Then we screened the retrieved studies according to predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed metaanalyses by using The Cochrane Collaboration＇s RevMan 4.2 software. Results Nine RCTs were included. Meta-analyses showed that xuezhikang was superior to routine treatment in decreasing 24-hour urinary protein （WMD -0.87, 95%CI -1.34 to -0.41）, microalbuminuria （WMD -115.39, 95%CI -127.63 to -103.15）, and urinary albumin excretion rate （WMD -65.46, 95%CI -68.87 to -62.12）; but xuezhikang had similar effects in reducing serum creatinine compared with routine treatment （WMD -5.42, 95%CI -11.06 to 0.21）. Moreover, xuezhikang was more effective in regulating blood lipids, including TC （WMD -1.71, 95%CI -2.39 to -1.03）, TG （WMD -0.96, 95%CI -1.46 to -0.46）, LDL-C （WMD -1.01, 95%CI -1.64 to -0.38）, and HDL-C （WMD 0.22, 95%CI 0.09 to 0.36）. Xuezhikang was not superior to routine treatment in improving fasting blood sugar （WMD -0.01, 95%CI -0.49 to 0.47）, but was more effective in improving 2 h-BS （WMD -1.10, 95%CI -1.35 to -0.85） and HbAlc （WMD -0.41, 95%CI -0.56 to -0.27）. No significant adverse effects or allergic reactions were reported. Conclusions The evidence currently available shows that xuezhikang may decrease 24-hour urinary protein, microalbuminuria, serum creatinine, regulate blood lipids, and adjust blood glucose. Due to a high risk of selection bias and detection bias in the included studies, the evidence is insufficient to determine the effect of xuezhikang.Further large-scale trials are required to define the role of xuezhikang in the treatment of diabetic kidney disease.