黄芪注射液治疗糖尿病肾病有效性及安全性的系统评价

Systematic Review of the Effectiveness and Safety of HuangQi Injection in Treating Diabetic Nephropathy

目的:系统评价黄芪注射液治疗糖尿病肾病的有效性及安全性。方法:计算机检索Cochrane图书馆临床对照试验库、MEDLINE、EMBASE、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库,同时手工检索相关会议论文、学位论文及所获文献的参考文献,收集黄芪注射液治疗糖尿病肾病的随机或半随机对照试验。由2名研究者独立筛选和提取资料,并按照改良Jadad评分量表对纳入文献质量进行评价,应用Rev Man 4.2.2软件进行Meta分析。结果:共纳入16个RCT,1058例DN患者。大部分试验方法学质量较低且样本含量小。"漏斗图"呈不对称分布,提示可能存在发表偏倚(提示阴性结果的试验可能未发表)及试验方法质量低下。Meta分析结果显示:①与空白对照组相比,黄芪注射液可降低DN患者24小时尿蛋白、血尿素氮、甘油三酯,并且可改善DN患者症状和体征的总有效率;②与空白对照组相比,黄芪注射液可降低早期DN患者24小时尿白蛋白排泄率、24小时尿蛋白、血清肌酐、血尿素氮、甘油三酯、总胆固醇,但不能降低临床期和晚期DN患者的血清肌酐和总胆固醇;③黄芪注射液降低早期DN患者的24小时尿白蛋白排泄率、血清肌酐、血尿素氮的疗效与卡托普利相似;降低早期DN患者24小时尿白蛋白排泄率、血尿素氮的疗效与奥扎格雷钠注射液相似,但降低早期DN患者血清肌酐的疗效不如奥扎格雷钠注射液。治疗期间尚未发现严重不良反应。结论:黄芪注射液可能是一种相对安全和有效治疗早期糖尿病肾病的药物。由于纳入试验方法质量低下和可能存在的发表偏倚,使本系统评价的证据强度不足,有待进一步进行高质量的大样本、随机双盲对照试验来证实。

Objective： To assess the effectiveness and safety of HuangQi injection in treating diabetic nephropathy （DN） systematically. Methods： The papers about randomized or semi-randomized controlled trials （RCT） of HuangQi injection in treating DN were collected and searched in Cochrane library clinical controlled trials database, MEDLINE, EMBASE, CNKI, CBM, WangFang database, as well as related conference papers, dissertations and the reference in the obtained literature. Two investigators chose the trials and drew the informations indenpedently, the quality of the included studies was evaluated with modified Jadad rating scale, Meta analysis was performed with software Rev Man 4.2.2. Results：Altogether 16 RCTs were included and there were 1058 patients. Most of trial methodologies were of lower quality and with small sample size.“Funnel plots” were not equally distributed, which suggested that publication bias might be existed （it showed that trial with negative results might not be published） and the qualities of trial methodologies were lower. The results of Meta analysis showed：①compared with blank control group, HuangQi injection could reduce 24 hours urinary protein, blood urea nitrogen （BUN） and glycerin trilaurate （TG） of DN patients, and improve total effective rates of body signs and symptom of DN patients; ②compared with blank control group,HuangQi injection could decrease 24 hours urine albumin excretion rate （UAER）, 24 hours urinary protein, serum creatinine（Scr）, BUN, TG and total cholesterol（TC） of DN patients at early stage,but it couldn’t lower Scr and TC of DN patients at clinical stage and advanced stage;③HuangQi injection presented similar effects to captopril in decreasing 24 hours UAER, Scr and BUN of DN patients at early stage;it also was similar to sodium ozagrel injection in lowering 24 hours UAER and BUN of DN patients at early stage, but it showed less effects in decreasing Scr of DN patients at early stage as sodium ozagrel injection. There was no severe adverse reaction during the treatment. Conclusion：HuangQi injection might be a kind of drug which is relatively safe and effective in treating early DN. Due to low methodological quality of included trial and the might existing publication bias, the evidence is not strong enough, therefore, randomized double-blind controlled trials of high quality large sample are needed to be proved further.