大剂量甲钴胺对糖尿病周围神经病变疗效与安全性的meta分析

目的 系统评价大剂量甲钴胺治疗糖尿病周围神经病变的疗效和安全性，为临床合理用药及超说明书用药政策评估提供参考。方法 通过检索Cochrane图书馆、PubMed、Embase、万方、中国知网（CNKI）、中国生物医学文献服务系统（Sinomed）数据库，收集大剂量甲钴胺（试验组）对比常规剂量甲钴胺（对照组）治疗糖尿病周围神经病变的随机对照试验，检索时间截至2018年5月。提取相关资料并评价研究的方法学质量，使用RevMan 5.3软件进行meta分析。结果 共纳入10项随机对照试验，共计747例患者。Meta分析结果显示，试验组患者在腓神经运动神经传导速度MD=1.61，95%CI（0.26，2.96），P=0.02]，腓神经感觉神经传导速度MD=2.73，95%CI（2.07，3.39），P<0.001]，治疗总有效率方面显著优于对照组RR=1.16，95%CI（1.09，1.23），P<0.001]。亚组分析显示，大剂量甲钴胺1日1次给药或1日2次给药，试验组治疗总有效率均显著高于对照组（P<0.001）。试验组患者的不良反应发生率略高于对照组，差异无统计学意义。结论 大剂量甲钴胺在治疗糖尿病周围神经病变方面与常规剂量甲钴胺相比，临床疗效更优，安全性相当。

Efficacy and Safety of High-dose Mecobalamin on Diabetic Peripheral Neuropathy: A Meta-analysis

OBJECTIVE To systematically evaluate the efficacy and safety of high-dose mecobalamin in the treatment of diabetic peripheral neuropathy, and to provide a reference for the rational drug use and policy evaluation of off-label use.METHODS Retrieved from the Cochrane Library, PubMed, Embase, Wanfang, CNKI and Sinomed database from the inception to May 2018, randomized controlled trials(RCTs) about of high-dose mecobalamin(test group) compared with conventional-dose mecobalamin(control group) in the treatment of diabetic peripheral neuropathy was collected. After the data extraction and evaluation of methodological quality of RCTs, meta-analysis was conducted by using RevMan 5.3 software. RESULTS A total of 10 RCTs were included, involving 747 patients. The results of meta-analysis showed that motor nerve conduction velocity of sural nerveMD=1.61, 95%CI(0.26, 2.96), P=0.02], sensory nerve conduction velocity of sural nerveMD=2.73, 95%CI(2.07, 3.39), P<0.001], the total effective rate of treatmentRR=1.16, 95%CI(1.09, 1.23), P<0.001] of test group were significantly superior to those of control group, with statistical significance. The subgroup analysis showed that the total effective rate of high-dose mecobalamin administered by once a day or twice a day was significantly higher in the test group than in the control group, with a statistically significant difference(P<0.001). The incidence of adverse reactions in the test group was slightly higher than that in the control group, and the difference was not statistically significant. CONCLUSION High-dose mecobalamin has better clinical efficacy and similar safety compared with conventional-dose of mecobalamin in the treatment of diabetic peripheral neuropathy.