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
|
摘要
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。
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 nerve[MD=1.61, 95%CI(0.26, 2.96), P=0.02], sensory nerve conduction velocity of sural nerve[MD=2.73, 95%CI(2.07, 3.39), P<0.001], the total effective rate of treatment[RR=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.
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 nerve[MD=1.61, 95%CI(0.26, 2.96), P=0.02], sensory nerve conduction velocity of sural nerve[MD=2.73, 95%CI(2.07, 3.39), P<0.001], the total effective rate of treatment[RR=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.
引文
[1]HOU Q T,LI Y,LI S P,et al.The global burden of diabetes of mellitus[J].Chin J Diabetes,2016,24(1):92-96.
[2]WANG L,GAO P,ZHANG M,et al.Prevalence and ethnic pattern of diabetes and prediabetes in China in 2013[J].JAMA,2017,317(24):2515-2523.
[3]ZHANG Y F,NING G.Mecobalamin[J].Expert Opin Investig Drugs,2008,17(6):953-964.
[4]ZHAO L J.A retrospective study of 217 cases of diabetic neuropathy in our hospital in 2015[J].Chin J Clin Rat Drug Use,2016,9(29):1-2.
[5]XU G G,YANG Y,LI M,et al.Efficacy of different dosage of combined mecobalamin and lipo-prostaglandin E1 therapy on diabetic peripheral neuropathy:a report of 62 cases[J].New Med,2010,41(3):157-159.
[6]雷东华.不同剂量甲钴胺联合胰激肽原酶改善糖尿病周围神经病变的疗效[J].中国实用神经疾病杂志,2013,16(5):81-82.
[7]KAN Y,ZHAO Y.The curative effect of high-dose mecobalamin treating diabetes peripheral neuropathy[J].Chin Prac Med,2009,4(19):25-26.
[8]韩庆影.大剂量甲钴胺联合胰激肽原酶对糖尿病周围神经损害恢复的影响[J].中国实用医药,2011,6(34):132-133.
[9]丁为国,姚庆萍.大剂量甲钴胺治疗2型糖尿病周围神经病变临床观察[J].包头医学,2010,34(2):81-82.
[10]YANG T Q,ZHU J,LI X J.Effects ofmaximus-dosage Methycobal on diabetic perpheral neuropathy[J].West Chin Med J,2007,22(1):131-132.
[11]LIU Z Y.The observation on the effect of methylcobalamin on type 2 diabetics peripheral neuropathy[J].Mode Med J Chin,2009,16(25):44-45.
[12]杨杉.不同剂量甲钴胺在糖尿病末梢神经炎治疗中的临床效果[J].世界最新医学信息文摘,2018,18(26):112-114.
[13]杨兴强.不同剂量甲钴胺治疗糖尿病末梢神经炎的疗效对比分析[J].中国实用神经疾病杂志,2014,17(9):123-124.
[14]甘淑芳.不同剂量甲钴胺治疗糖尿病末梢神经炎患者的临床观察[J].中国民康医学,2015(13):52-53.
[15]何蕊,刘芳.糖尿病周围神经病变导致糖尿病足的机制[J].中华医学杂志,2016,96(32):2536-2538.
[16]ZHANG J P,XU N,YIN D,et al.Association between the level of serum vitamin D and peripheral neuropathy in type 2diabetic patients[J].Chin J Endocrinol Metab,2014,30(5):385-387.
[17]XU Q,PAN J,YU J,et al.Meta-analysis of methylcobalamin alone and in combination with lipoic acid in patients with diabetic peripheral neuropathy[J].Diabetes Res Clin Pract,2013,101(2):99-105.
[18]ANDRES E,LOUKILI N,NOEL E,et al.Vitamin B12(cobalamin)deficiency in elderly patients[J].CMAJ,2004,171(3):251-259.
[19]HEAD K A.Peripheral neuropathy:pathogenic mechanisms and alternative therapies[J].Altern Med Rev,2006,11(4):294-329.
[20]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2017年版)[J].中华糖尿病杂志,2018,10(1):4-67.
[21]中华医学会神经病学分会肌电图与临床神经电生理学组.糖尿病周围神经病诊断和治疗共识[J].中华神经科杂志,2013,46(11):787-789.
[22]IZUMI Y,KAJI R.Clinical trials of ultra-high-dose methylcobalamin in ALS[J].Brain Nerve,2007,59(10):1141-1147.
[2]WANG L,GAO P,ZHANG M,et al.Prevalence and ethnic pattern of diabetes and prediabetes in China in 2013[J].JAMA,2017,317(24):2515-2523.
[3]ZHANG Y F,NING G.Mecobalamin[J].Expert Opin Investig Drugs,2008,17(6):953-964.
[4]ZHAO L J.A retrospective study of 217 cases of diabetic neuropathy in our hospital in 2015[J].Chin J Clin Rat Drug Use,2016,9(29):1-2.
[5]XU G G,YANG Y,LI M,et al.Efficacy of different dosage of combined mecobalamin and lipo-prostaglandin E1 therapy on diabetic peripheral neuropathy:a report of 62 cases[J].New Med,2010,41(3):157-159.
[6]雷东华.不同剂量甲钴胺联合胰激肽原酶改善糖尿病周围神经病变的疗效[J].中国实用神经疾病杂志,2013,16(5):81-82.
[7]KAN Y,ZHAO Y.The curative effect of high-dose mecobalamin treating diabetes peripheral neuropathy[J].Chin Prac Med,2009,4(19):25-26.
[8]韩庆影.大剂量甲钴胺联合胰激肽原酶对糖尿病周围神经损害恢复的影响[J].中国实用医药,2011,6(34):132-133.
[9]丁为国,姚庆萍.大剂量甲钴胺治疗2型糖尿病周围神经病变临床观察[J].包头医学,2010,34(2):81-82.
[10]YANG T Q,ZHU J,LI X J.Effects ofmaximus-dosage Methycobal on diabetic perpheral neuropathy[J].West Chin Med J,2007,22(1):131-132.
[11]LIU Z Y.The observation on the effect of methylcobalamin on type 2 diabetics peripheral neuropathy[J].Mode Med J Chin,2009,16(25):44-45.
[12]杨杉.不同剂量甲钴胺在糖尿病末梢神经炎治疗中的临床效果[J].世界最新医学信息文摘,2018,18(26):112-114.
[13]杨兴强.不同剂量甲钴胺治疗糖尿病末梢神经炎的疗效对比分析[J].中国实用神经疾病杂志,2014,17(9):123-124.
[14]甘淑芳.不同剂量甲钴胺治疗糖尿病末梢神经炎患者的临床观察[J].中国民康医学,2015(13):52-53.
[15]何蕊,刘芳.糖尿病周围神经病变导致糖尿病足的机制[J].中华医学杂志,2016,96(32):2536-2538.
[16]ZHANG J P,XU N,YIN D,et al.Association between the level of serum vitamin D and peripheral neuropathy in type 2diabetic patients[J].Chin J Endocrinol Metab,2014,30(5):385-387.
[17]XU Q,PAN J,YU J,et al.Meta-analysis of methylcobalamin alone and in combination with lipoic acid in patients with diabetic peripheral neuropathy[J].Diabetes Res Clin Pract,2013,101(2):99-105.
[18]ANDRES E,LOUKILI N,NOEL E,et al.Vitamin B12(cobalamin)deficiency in elderly patients[J].CMAJ,2004,171(3):251-259.
[19]HEAD K A.Peripheral neuropathy:pathogenic mechanisms and alternative therapies[J].Altern Med Rev,2006,11(4):294-329.
[20]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2017年版)[J].中华糖尿病杂志,2018,10(1):4-67.
[21]中华医学会神经病学分会肌电图与临床神经电生理学组.糖尿病周围神经病诊断和治疗共识[J].中华神经科杂志,2013,46(11):787-789.
[22]IZUMI Y,KAJI R.Clinical trials of ultra-high-dose methylcobalamin in ALS[J].Brain Nerve,2007,59(10):1141-1147.