甲基维生素B_(12)治疗糖尿病周围神经病变的系统评价(英文)

Effects of Methylcobalamin on Diabetic Peripheral Neuropathy: A Systematic Review

目的了解甲基维生素B12治疗糖尿病周围神经病变的疗效和安全性。方法按照国际Cochrane协作网的系统评价方法,检索全世界关于甲基维生素B12治疗糖尿病周围神经病变的随机或半随机对照试验,包括Cochrane图书馆2003年第4期、临床对照试验资料库、MEDLINE、EMBASE、中国生物医学文献光盘数据库、中文科技期刊全文数据库以及所有纳入研究的参考文献。由两位评价者独立地对符合纳入标准的试验进行质量评价和资料提取。采用下列指标对甲基维生素B12治疗糖尿病周围神经病变的疗效和安全性进行评价:临床症状体征的总有效率、感觉及运动神经传导速度以及严重不良反应的发生率。结果30个试验共纳入1949例糖尿病周围神经病变患者。大部分试验的方法学质量较低。甲基维生素B12与其他B族维生素比较的13个试验的“漏斗图”图分析显示基本对称,提示发表偏倚的可能性较小,结果比较可靠,但是不一定能代表整体发表偏倚情况。Meta分析结果显示:甲基维生素B12可明显改善糖尿病周围神经病变的临床症状和体征,且疗效优于其他B族维生素;甲基维生素B12改善某些周围神经传导速度的疗效优于其他B族维生素;在治疗期间,试验未发现严重不良反应。结论甲基维生素B12可能是一种相对安全和有效的治疗糖尿病周围神经病变的药物。但由于纳入试验的方法学质量低下和可能存在发表偏倚,证据强度不足,尚有待大样本、高质量的多中心随机双盲对照试验加以证实。

Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy. Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Chnical trials were searched from Cochrane Controlled Trials Register （ Issue 4, 2003）, MEDLINE （January 1966 to January 2004） , EMBASE （January 1980 to January 2004）, the Chinese Biological Medicine Database （ 1978 to January 2004） , the Chinese Science and Technology Journal Full-text Database （1989 to January 2004） and references of all included trials. The selection of studies, data extraction and assessment of methodological quahty were performed independently by two reviewers. The following outcomes were assessed： effectiveness of chnical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quahty of the most included trials was of low level. The“funnel plot” of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of recta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period. Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not strong because of the low quality of most trials. Rigorously designed, randomized, double-bhnded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.