中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2018, Vol. 13 ›› Issue (6): 1087-1095.doi: 10.4103/1673-5374.233453

• 原著:周围神经损伤修复保护与再生 • 上一篇    下一篇

依帕司他和α-硫辛酸联合与单药治疗糖尿病周围神经病变：20项随机对照研究的Meta分析

  

  • 收稿日期:2018-04-22 出版日期:2018-06-15 发布日期:2018-06-15
  • 基金资助:

    国家自然科学基金（81370165）；中国浙江省公共利益技术和社会发展项目（2015C33309）；中国宁波科技创新团队项目（2014B82002，2015B11050）；宁波科技项目（2015A610217）；宁波市方润华基金，宁波大学王家华基金

Efficacy of epalrestat plus α-lipoic acid combination therapy versus monotherapy in patients with diabetic peripheral neuropathy: a meta-analysis of 20 randomized controlled trials

Ming Zhao1, 2, Jia-Yi Chen1, Yu-Dong Chu3, Ya-Bin Zhu4, Lin Luo4, Shi-Zhong Bu1, 4   

  1. 1 Runliang Diabetes Laboratory, Diabetes Research Center, Ningbo University, Ningbo, Zhejiang Province, China
    2 Department of Public Health, Longsai Hospital, Ningbo, Zhejiang Province, China
    3 Department of Nephrology, Ningbo Medical Center Lihuili Eastern Hospital, Ningbo, Zhejiang Province, China
    4 Medical School, Ningbo University, Ningbo, Zhejiang Province, China
  • Received:2018-04-22 Online:2018-06-15 Published:2018-06-15
  • Contact: Shi-Zhong Bu, M.D. or Lin Luo,bushizhong@nbu.edu.cn or luolin@nbu.edu.cn.
  • Supported by:

    This work was supported by the National Natural Science Foundation of China, No. 81370165; a grant from the Public Benefit Technology and Society Development Program of Zhejiang Province of China, No. 2015C33309; a grant from the Ningbo Science and Technology Innovation Team Program in China, No. 2014B82002, 2015B11050; a grant from the Ningbo Science and Technology Project in China, No. 2015A610217; the Fang Runhua Fund of Hong Kong, K. C. Wong Magna Fund in Ningbo University.

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摘要：

目的：评价α-硫辛酸与依帕司他联合治疗糖尿病周围神经病变的有效性。
资料来源：从Pubmed、Medline、Embase、Cochrane图书馆、中国知网、中国万方数据库和中国生物医学数据库检索截止到2016年10月7日的相关文献，无语言限制。检索词：糖尿病周围神经病变、糖尿病神经病变或DPN、α-硫辛酸、硫辛酸)和依帕司他汀。
资料选择：此次Meta分析中符合条件的研究应满足以下纳入标准：①比较依帕司他与α-硫辛酸联合治疗和依帕司他或α-硫辛酸单药治疗糖尿病周围神经病变患者的疗效和安全性的随机对照临床试验；②治疗的最短时间为2周；③对于2型糖尿病和糖尿病周围神经病变患者使用世界卫生组织的诊断标准；④这些研究至少包含一种能够反映药物和神经传导速度的量化评价。排除使用依帕司他或α-硫辛酸联合其他药物的研究。统计分析使用STATA软件进行Meta分析。
主要结局指标：α-硫辛酸+依帕司他联合应用及单独应用的治疗有效率，正中神经运动及感觉神经传导速度和腓总神经运动及感觉神经传导速度。
结果：纳入20项RCT研究，共1 894例糖尿病周围神经病变患者进入Meta分析，包括α-硫辛酸+依帕司他组864例，α-硫辛酸组473例，依帕司他组557例。α-硫辛酸+依帕司他联合治疗的治疗有效率优于α-硫辛酸和依帕司他单药(RR = 1.29，95％CI = 1.21-1.38；RR = 1.43，95％CI =1.34-1.54)。α-硫辛酸+依帕司他联合治疗也显着改善正中神经运动神经传导速度(WMD = 5.41，95％CI =2.07-8.75)，正中神经感觉神经传导速度(WMD=5.87，95％CI =1.52-10.22)，腓总神经运动神经传导速度(WMD=5.59，95％CI=2.70-8.47)和腓总神经感觉神经传导速度(WMD=4.57，95％CI=2.46-6.68)。
结论：α-硫辛酸+依帕司他联合治疗糖尿病周围神经病变的临床疗效较好，优于两药单独治疗。

orcid:0000-0001-5196-6030(Shi-Zhong Bu)
        0000-0003-2964-3934(Lin Luo)

关键词: 依帕司他, 硫辛酸, 糖尿病并发症, 糖尿病, 神经传导速度, 神经电生理, Meta分析, 醛糖还原酶抑制剂, 神经再生, 周围神经损伤

Abstract:

OBJECTIVE: To evaluate the efficacy of α-lipoic acid (ALA) plus epalrestat combination therapy in the treatment of diabetic peripheral neuropathy (DPN).
DATA SOURCES: The electronic databases of PubMed, Medline, Embase, the Cochrane Library, the Chinese National Knowledge Infrastructure, the Wanfang Database and the Chinese Biomedical Database were used to retrieve relevant studies without language restrictions. The search was conducted from the inception
of each database to 7 October 2016. The key terms were (diabetic peripheral neuropathy or diabetic neuropathy or DPN) AND (α-lipoic acid or lipoic acid or thioctic acid) AND epalrestat.
DATA SELECTION: All of the eligible studies met the following inclusion criteria: (1) Randomized controlled trials that compared efficacy and safety of epalrestat plus ALA combination therapy versus epalrestat or ALA monotherapy in patients with DPN. (2) The minimum duration of treatment was 2 weeks. (3) The  DPN patients were diagnosed using the World Health Organization standardized type 2 diabetes mellitus and DPN criteria. (4) Studies contained at least one measure that could reflect the efficacy of the drug and nerve conduction velocities. Studies in which the control group used epalrestat or ALA combined with other drugs were excluded. Statistical analyses were performed using STATA software for meta-analysis.
OUTCOME MEASURES: The primary outcomes were the therapeutic efficacy, median motor nerve conduction velocity (MNCV), median sensory nerve conduction velocity (SNCV), peroneal MNCV and peroneal SNCV.
RESULTS: Twenty studies with 1 894 DPN patients were included, including 864 patients in the ALA plus epalrestat group, 473 in the ALA group and 557 in the epalrestat group. The efficacy of ALA plus epalrestat combination therapy was superior to ALA and epalrestat monotherapies (RR = 1.29, 95% CI: 1.21–1.38;RR = 1.43, 95% CI: 1.34–1.54, respectively). ALA plus epalrestat combination therapy also significantly improved median MNCV (WMD = 5.41, 95% CI: 2.07–8.75), median SNCV (WMD = 5.87, 95% CI: 1.52–10.22), peroneal MNCV (WMD = 5.59, 95% CI: 2.70–8.47) and peroneal SNCV (WMD = 4.57, 95% CI: 2.46–6.68).
CONCLUSION: ALA plus epalrestat combination therapy was superior to ALA and epalrestat monotherapies for clinical efficacy and nerve conduction velocities in patients with DPN.

Key words: nerve regeneration, antioxidant, aldose reductase inhibitor, diabetic complication, diabetes, combination therapy, nerve conduction velocity, nerve electrophysiology, peripheral nerve injury, neural regeneration