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甲钴胺单独及联合前列腺素E1治疗糖尿病周围神经病变的Meta分析

Meta-analysis of methylcobalamin alone and in combination with prostaglandin E1 in the treatment of diabetic peripheral neuropathy.

作者信息

Deng Houliang, Yin JinJin, Zhang JingJing, Xu Qian, Liu Xiaoxia, Liu Li, Wu Zhuomin, Ji Aimin

机构信息

Center for Drug Research and Development, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, People's Republic of China.

出版信息

Endocrine. 2014 Aug;46(3):445-54. doi: 10.1007/s12020-014-0181-6. Epub 2014 Feb 13.

Abstract

This study aimed to compare the efficacy and safety of prostaglandin E1 plus methylcobalamin (PGE1-MC) with that of methylcobalamin alone (MC) on diabetic peripheral neuropathy (DPN). We searched published randomized controlled trials (RCTs) of PGE1 combined with MC for DPN up to June 1, 2013. Data were extracted to evaluate methodological quality and describe characteristics of studies in duplicate. A random or a fixed effect model was used to analyze outcomes which were expressed as relative risk (RR) or mean difference with a 95 % confidence interval (CI). All data were analyzed using Review Manager 5.2 software. Twenty-six RCTs involving 2,107 individuals were included. Meta-analysis showed that PGE1-MC combination therapy was significantly better than MC monotherapy (RR = 1.40; 95 % CI 1.33-1.48) on efficacy. The weighted mean differences in nerve conduction velocities (NCVs) were 6.72 (95 % CI: 5.42-8.02) for median motor nerve conduction velocity (MNCV), 5.13 (CI 4.13-6.13) for median sensory nerve conduction velocity (SNCV), 5.74 (CI 4.87-6.61) for peroneal MNCV and 4.62 (CI 3.89-5.34) for peroneal SNCV in favor of the PGE1 + MC combination group. Moreover, there were no serious adverse events in both groups during the treatment period. The results of the meta-analysis show that treatment with PGE1-MC is safe and can gain better outcomes in neuropathic symptoms and NCVs compared with MC alone. However, the conclusion may not be strong because most of the studies included in this meta-analysis have poor methodological quality.

摘要

本研究旨在比较前列腺素E1联合甲钴胺(PGE1-MC)与单用甲钴胺(MC)治疗糖尿病周围神经病变(DPN)的疗效和安全性。我们检索了截至2013年6月1日发表的关于PGE1联合MC治疗DPN的随机对照试验(RCT)。提取数据以评估方法学质量,并对研究特征进行双人提取。采用随机或固定效应模型分析结果,结果以相对危险度(RR)或均值差及95%置信区间(CI)表示。所有数据均使用Review Manager 5.2软件进行分析。纳入了26项涉及2107例个体的RCT。Meta分析显示,在疗效方面,PGE1-MC联合治疗显著优于MC单药治疗(RR = 1.40;95%CI 1.33 - 1.48)。正中运动神经传导速度(MNCV)的加权均值差为6.72(95%CI:5.42 - 8.02),正中感觉神经传导速度(SNCV)为5.13(CI 4.13 - 6.13),腓总神经MNCV为5.74(CI 4.87 - 6.61),腓总神经SNCV为4.62(CI 3.89 - 5.34),均有利于PGE1 + MC联合治疗组。此外,治疗期间两组均未出现严重不良事件。Meta分析结果表明,与单用MC相比,PGE1-MC治疗安全,在神经病变症状和神经传导速度方面能获得更好的疗效。然而,该结论可能不够有力,因为本Meta分析纳入的大多数研究方法学质量较差。

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