益气活血通络法治疗糖尿病周围神经病变Meta分析

张美珍 郝晓晖 李晓文 杨亚男 李艳杰 刘旭菲 倪青

摘要 目的：系统评价益气活血通络法治疗糖尿病周围神经病变的有效性。方法：检索CNKI、万方、VIP、CBM、Cochrane library、EMbase、PubMed、ClinicalTrails.gov等数据库，查找所有比较益气活血通络中药或联合西药治疗糖尿病周围神经病变的随机对照试验。利用RevMan 5.3软件进行统计分析、Risk of Bias（ROB）表进行质量评价。结果：共纳入23篇随机对照试验，包括1 608例患者。纳入文献的方法学质量较低。采用益气活血通络法治疗糖尿病周围神经病变，能够明显提高临床总有效率（RR=0.30，95%CI为0.24～0.36，P<0.000 01）和降低Toronto积分（MD=-1.35，95%CI为-1.57～-1.13，P<0.000 01），可显著提高正中神经MCV（MD=3.45，95%CI为2.45～4.45，P<0.000 01）、SCV（MD=3.27，95%CI为2.10～4.44，P<0.000 01）和腓总神经MCV（MD=2.99，95%CI为2.00～3.98，P<0.000 01）、SCV（MD=3.43，95%CI為2.02～4.84，P<0.000 01）的传导速度，降低全血高切度（MD=-0.72，95%CI为-0.98～-0.46，P<0.000 01）和低切度（MD=-1.52，95%CI为-2.82～-0.21，P=0.02）水平。观察组治愈时间优于对照组（RR=1.71，95%CI为1.49～1.97，P<0.000 01），差异有统计学意义。23篇RCTs中19篇研究明确无不良反应发生，4项研究说明有不良反应发生，无严重不良事件发生。结论：益气活血通络法治疗糖尿病周围神经病变，可提高疗效，降低Toronto积分，改善代谢紊乱症状和血流变。因纳入研究的文献质量较低，影响疗效的可靠性，今后还需高质量的随机对照试验加以证实。

关键词 益气活血通络;糖尿病周围神经病变;随机对照试验;Meta分析;有效率;中医药：神经传导速度;不良反应

Meta-analysis of Enriching Qi，Promoting Blood Circulation and Dredging Meridians

Therapy for Diabetic Peripheral Neuropathy Treatment

ZHANG Meizhen1，HAO Xiaohui1，LI Xiaowen1，YANG Yanan1，LI Yanjie2，LIU Xufei1，NI Qing1

（1 Guang′anmen Hospital，Chinese Academy of Traditional Chinese Medicine，Beijing 100053，China;

2 Graduate school，Beijing University of Traditional Chinese Medicine，Beijing 100029，China）

Abstract Objective：To systematically assess the efficacy of enriching qi，promoting blood circulation and dredging meridians therapy for treating diabetic peripheral neuropathy.Methods：A total of 8 databases（CNKI，Wanfang，VIP，CBM，Cochrane Library，EMBASE，PubMed ClinicalTrails.gov）were searched to identify all published randomized controlled trials of enriching qi，promoting blood circulation and dredging meridians herbs combined with western medicine for the treatment of diabetic peripheral neuropathy.The Revman 5.3 software was used for statistical analysis，and the risk of bias（ROB）table was used for quality evaluation.Results：A total of 23 RCTs were identified，including 1608 patients.The methodological quality of the included studies was low.Using activating qi，promoting blood circulation and dredging meridians therapy to treat diabetic peripheral neuropathy can significantly increase the total clinical efficacy [RR=0.30，95%CI（0.24～0.36），reduce the Toronto score [MD=-1.35，95%CI（-1.57～-1.13），P<0.000 01]，raise motor nerve conduction velocity of median nerve [MD=3.45，95%CI（2.45～4.45），P<0.000 01] and common peroneal nerve [MD=2.99，95%CI（2.00～3.98），P<0.000 01]，and sense nerve conduction velocity of median nerve [MD=3.27，95%CI（2.10～4.44），P<0.000 01]，and common peroneal nerve [MD=3.43，95%CI（2.02～4.84），P<0.000 01].The Meta-analysis indicated that the therapy can lower the level of high shear rate of whole blood [MD=-0.72，95%CI（-0.98～-0.46）P<0.000 01]，and Whole blood low cut [MD=-1.52，95%CI（-2.82～-0.21），P=0.02].The cure time of the treatment group was better than that of the control group[RR=1.71，95%CI（1.49～1.97），P<0.000 01].A total of 19 studies clearly showed no adverse reactions among the 23 RCTs，4 studies showed adverse reactions.However，no serious adverse events occurred in all studies.Conclusion：Enriching qi，promoting blood circulation and dredging meridians therapy in the treatment of diabetic peripheral neuropathy can improve the efficacy，reduce the Toronto score，improve the symptoms of metabolic disorders and hemorheology.Due to the quality of included studies is low，which affects the reliability of efficacy，high-quality RCTs are needed to confirm such conclusion in the future.

Keywords Enriching qi，promoting blood circulation and dredging meridians; Diabetic peripheral neuropathy; Randomized controlled trials; Meta-analysis; Efficacy; Traditional Chinese medicine; Nerve conduction velocity; Adverse reactions

中图分类号：R242;R-3文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.05.005

糖尿病周围神经病变（Diabetic Peripheral Neuropathy，DPN），是指在排除其他原因的情况下，60%～90%的糖尿病患者出现周围神经功能障碍相关的症状和（或）体征[1-2]。研究表明在DM诊断后10年内，50%的患者有明显的周围神经病变。根据2017年国际糖尿病联合会（IDF）的统计，全球20～79岁年龄组的糖尿病患病率为8.8%[3]。据一份新的报告估计，到2035年全世界估计有5.92亿糖尿病病例[4]。该病有严重隐忧，严重者出现肢端缺血、溃疡，甚至造成坏疽截肢和神经系统损伤的严重后果，是引起糖尿病足溃疡的最常见原因，不仅对生命质量有着毁灭性的影响，而且与令人担忧的低预期寿命相关（平均离截肢只有2年），也给医疗系统和整个社会带来了巨大的经济负担[5-6]。本病发病机制与血糖控制不良、脂质代谢紊乱、神经营养因子、自身免疫、炎症反应、氧自由基、损伤和遗传因素等有密切的关系，目前国内外尚无特效疗法，西医治疗主要以血糖控制、神经修复、抗氧化应激、改善微循环及代谢紊乱等对症治疗[7]，临床效果多不理想[8]。……