摘要
目的系统评价灯盏细辛治疗糖尿病肾病(DN)的疗效及安全性。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,手工检索《中华内分泌代谢杂志》等14种相关中文期刊、相关会议记录及所获文献的参考文献。收集灯盏细辛治疗糖尿病肾病的随机或半随机对照试验。由两名研究者独立选择试验、提取资料,并按照Cochrane系统评价的方法评价纳入研究的质量和提取有效数据,而后应用RevMan5.0.18软件进行Meta分析。结果共纳入32个RCT和1个半随机试验,共计2322例DN患者。大部分试验方法质量学较低且样本含量小。"漏斗图"呈不对称分布,提示可能存在发表偏倚及试验方法质量低下,发表偏倚提示阴性结果的试验可能未发表。Meta-析结果显示:①灯盏细辛可减少糖尿病肾病的24小时尿白蛋白排泄率、24小时尿总蛋白、降低血清肌酐、血浆胆固醇、甘油三酯、血浆粘度及纤维蛋白原。②灯盏细辛在降低DN患者24小时尿白蛋白排泄率和血清肌酐方面与ACEI类药物的疗效相似,但審低24小时尿蛋白总量效果不如ACEI。③灯盏细辛在减少DN患者24小时尿蛋白和血浆纤维蛋白原方面,疗效优于丹参。④灯盏细辛与凯时(前列腺素E1)相比,降低24小时尿白蛋白排泄率不如凯时。治疗期间尚未发现严重的不良反应。结论灯盏细辛可能是一种相对安全和有效治疗糖尿病肾病的药物。由于纳入试验方法质量低下和可能存在发表偏倚,使本系统评价的证据强度不足,有待进一步进行大样本、高质量的多中心随机双盲对照试验来证实。
Objective To assess the effectiveness and safety of breviscapine on diabetic nephropathy. Methods All randomized or quasi-randomized controlled trials of breviscapine on diabetic nephropathy were performed. All of the clinical trials were searched from the Cochrane Controlled Trials Registered, Medline, Embase, National Knowledge Infrastructure Database, the Chinese Biological Medicine Database, the Chinese Science and Technology Journal Full-text and the references of all included trials. The selection of studies, assessment of methodological quality and data extraction were performed independently by two reviewers according to predefined inclusion and exclusion criteria. Results Thirty-three clinical trials including 2 322 patients of diabetic nephropathy met the inclusion criteria. But most included trials were of low quality and small sample. Until now, there were no clinical trials with multicentre, large sample and high quality. A ＂Funnel plot＂ showed asymmetry, which indicated possible publication bias and low quality in methodology. And publication bias showed that the trials with negative results might not be published. The results of meta-analysis indicated that： 1. Breviscapine showed more effects on the decrease of the 24-hour urinary albumin excretion rate （UAER）, 24-hour urinary protein, serum creatinine （Scr）, total cholesterol, triglyceride, plasma viscosity and fibrinogen. 2. Breviscapine showed less effect on the decrease of the 24-hour urinary protein when compared to angiotensin-converting enzyme inhibitor, it seemed as same effective as ACEI on decrease of 24-hour urinary albumin excretion rate （UAER）, serum creatinine （Scr） and blood urea nitrogen （BUN）; 3. Breviscapine showed more effect on the decrease of 24-hour urinary protein and fibrinogen when compared to other Chinese herbal medicine （Salvia miltiorrhiza）; 4. Breviscapine showed less effect on decrease of the 24-hour urinary albumin excretion rate （UAER） when compeard to Prostaglandin El. No significant adverse effects were reported. Conclusion Breviscapine shows some effects and relatively safe on diabetic nephropathy. However, the evidence is not strong enough because of some of the low-quality trials and publications bias. Rigorous designs, randomized, double-blind, placebo-controlled trials of Breviscapine for diabetic nephropathy are needed to further assess the effect.
出处
《中国循证医学杂志》
CSCD
2009年第10期1099-1109,共11页
Chinese Journal of Evidence-based Medicine
关键词
灯盏细辛
糖尿病肾病
系统评价
随机对照试验
META分析
Breviscapine
Diabetic Nephropathy
Systematic review
Randomized controlled clinical trials
Quasi- randomized controlled clinical trials
Meta-analysis
