硫辛酸联合依帕司他和硫辛酸治疗糖尿病周围神经病变临床疗效比较的Meta分析

摘要

Objective To compare the clinical effectiveness of lipoic acid combined with epalrestat versus lipoic acid in treating diabetic peripheral neuropathy (DPN).Methods Randomized controlled trials (RCTs) and clinical controlled trials on lipoic acid versus epalrestat for DPN before February 2016 were searched through five databases:CNKI,CBM,VIP,Wanfang,and PubMed.The quality of the included trials were assessed using Cochrane software and Jadad scores.Data were analyzed with Review Manager 5.3 software.Results Nine studies were included in the analysis.Meta analysis showed that the lipoic aid monotherapy was significantly inferior to lipoic acid-epalerestat combination therapy [RR =0.58,95％ Cl (0.47,0.71),P ＜ 0.00001].Inferiority of the lipoic acid monotherapy was also shown in nerve conduction velocity with WMDs of-4.94 [95％Cl (-7.41,-2.46),P ＜0.0001] for median motor nerve conduction velocity (MNCV),-5.08 [95％ Cl (-7.68,-2.49),P =0.0001] for peroneal MNCV,-4.24 [95％ Cl (-6.20,-2.29),P＜0.0001] for median sensory nerve conduction velocity (SNCV),and-3.66 [95％ Cl (-5.02,-2.31),P ＜0.00001] for peroneal SNCV.Sensitivity analysis showed that the results were robust.However,the included trials were limited by simple design,few subjective indicators,and short follow-up time.Conclusions Lipoic acid combined with epalrestat is better than lipoic acid alone in the treatment of DPN,as well as the MNCV and SNCV of median or peroneal nerve.Due to the low quality of the included studies,high-quality RCTs are warranted to validate the results.%目的 比较硫辛酸联合依帕司他与硫辛酸治疗糖尿病周围神经病变(DPN)患者的临床疗效.方法 收集2016年2月以前CNKI、CBM、维普、万方、PubMed等数据库中硫辛酸联合依帕司他对比硫辛酸治疗DPN的临床试验资料,采用Cochrane系统及Jadad评分对文章进行质量评估,RevMan5.3软件对多项研究结果的总体效应进行Meta分析.结果 共纳入9项研究.Meta分析结果显示:硫辛酸显效率明显低于硫辛酸联合依帕司他[RR =0.58,95％CI (0.47,0.71),P＜0.00001],正中运动神经传导速度[WMD=-4.94,95％ CI(-7.41,-2.46),P＜0.0001]、腓总运动神经传导速度[WMD=-5.08,95％ CI(-7.68,-2.49),P=0.0001]、正中感觉神经传导速度[WMD=-4.24,95％ CI(-6.20,-2.29),P＜0.0001]和腓总感觉神经传导速度[WMD=-3.66,95％ CI(-5.02,-2.31),P＜0.00001]也明显低于联合用药.敏感性分析显示结果稳健.但纳入研究存在设计报道简单、主观指标少、随访时间短等问题.结论 硫辛酸联合依帕司他可提高显效率,增加正中或腓总神经的运动神经传导速度和感觉神经传导速度.由于目前纳入文献质量普遍不高,需谨慎考虑此结论,希望有更多高质量的随机对照试验支持.