木丹颗粒联合硫辛酸治疗糖尿病周围神经病变的系统评价和Meta分析

Systematic Review and Meta-analysis of Mudan Granules Combined with Lipoic Acid in the Treatment of Diabetic Peripheral Neuropathy

目的系统评价木丹颗粒联合硫辛酸治疗糖尿病周围神经病变(DPN)的临床疗效。方法使用计算机检索中国期刊全文数据库(CNKI)、万方数据库(WF)、中国生物医学文献数据库(CBM)、维普数据库(VIP)、PubMed、Embase、Web of Science和The Cochrane Library自建库至2020年12月期间关于木丹颗粒联合硫辛酸治疗DPN的随机对照试验(RCT),由2名研究者按照纳入与排除标准独立筛选文献、提取资料和采用Cochrane系统评价员手册5.1.0推荐的RCT的偏倚风险评估工具评估偏倚风险,并采用RevMan 5.3软件进行Meta分析。结果纳入10篇RCTs,共916例患者。Meta分析结果显示,与对照组比较,试验组采用木丹颗粒联合硫辛酸治疗DPN可提高临床总有效率[RR=1.34,95%CI(1.18,1.52),P<0.00001];增加腓总神经(运动纤维)传导速度[MD=3.35,95%CI(0.57,6.13),P<0.05]、腓总神经(感觉纤维)传导速度[MD=5.31,95%CI(3.86,6.76),P<0.05]、正中神经(运动纤维)传导速度[MD=4.51,95%CI(2.99,6.03),P<0.05],正中神经(感觉纤维)传导速度差异无统计学意义[MD=4.00,95%CI(-0.44,8.43),P>0.05];改善血清同型半胱氨酸(Hcy)水平[MD=-5.68,95%CI(-8.52,-2.84),P<0.05]。结论木丹颗粒联合硫辛酸治疗DPN的临床疗效明显优于对照组,但受纳入文献质量、数量的限制,该研究所得结论尚需谨慎对待。

Objective To systematically evaluate the clinical efficacy of Mudan Granules combined with lipoic acid in the treatment of diabetic peripheral neuropathy(DPN).Methods CNKI,Wanfang Data,CBM,VIP,PubMed,Embase,Web of Science,and The Cochrane Library were searched for the randomized controlled trials(RCTs)involving the treatment of DPN with Mudan Granules combined with lipoic acid from the establishment of database to December 2020.Two researchers independently screened the literature according to the inclusion and exclusion criteria,extracted data,and assessed the risk of bias by using the bias risk assessment tool of RCT recommended by Cochrane Handbook version 5.1.0.RevMan 5.3 was used for meta-analysis.Results Ten RCTs were included,involving 916 patients.Meta-analysis showed that compared with the control group,Mudan Granules combined with lipoic acid improved the total effective rate[RR=1.34,95%CI(1.18,1.52),P<0.00001],increased the conduction velocity in motor fibers of common peroneal nerve[MD=3.35,95%CI(0.57,6.13),(P<0.05)],increased the conduction velocity in sensory fibers of common peroneal nerve[MD=5.31,95%CI(3.86,6.76),P<0.05],increased the conduction velocity in motor fibers of median nerve[MD=4.51,95%CI(2.99,6.03),P<0.05],of which the conduction velocity in sensory fibers of median nerve[MD=4.00,95%CI(-0.44,8.43),P>0.05]is not statistically significant,and elevated the serum level of homocysteine[MD=-5.68,95%CI(-8.52,-2.84),(P<0.05)].Conclusion The clinical efficacy of Mudan Granules combined with lipoic acid is superior to that of western medicine alone in the treatment of DPN.However,considering the limited quality and number of the RCTs involved in this study,this conclusion remains to be verified.