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moxibustion，respectively. The Cochrane Library，Web of Science，PubMed，SinoMed，VIP，Wanfang Data and CNKI were
searched by computer from their inception to December 29th，2020，to screen randomized controlled trials（RCTs）about
efficacy and safety of the five commonly used external therapies of TCM combined with conventional Western medicine in treating
DPN. RevMan 5.3，Stata 15.0 and ADDIS 1.16.6 software were used for plotting and data analysis. Results A total of 44 RCTs
were enrolled，including 3 471 patients with DPN. Bayesian network Meta-analysis showed that the five commonly used external
therapies of TCM combined with Western medicine were all superior to conventional Western medicine alone in improving overall
efficacy rate，of which acupuncture had the best effect〔OR=0.20，95%CI（0.11，0.36）〕. Except for acupoint massage，
the other four commonly used external therapies of TCM combined with conventional Western medicine were all superior to
conventional Western medicine alone in improving median nerve motor conduction velocity（MNCV），with acupoint injection
being the most effective〔MD=-4.50，95%CI（-5.91，-3.11）〕. The five commonly used external therapies of TCM combined
with conventional Western medicine were all superior to conventional Western medicine alone in improving median nerve sensory
conduction velocity（SNCV），in which moxibustion had the best effect〔MD=-9.03，95%CI（-12.59，-5.47）〕. Except for
acupoint massage，the other four commonly used external therapies of TCM combined with conventional Western medicine were
all superior to conventional Western medicine alone，with moxibustion having the best effect〔MD=-6.34，95%CI（-9.31，
-3.30）〕. Except for acupoint massage，the other four commonly used external therapies of TCM combined with conventional
western medicine were all superior to conventional Western medicine alone in improving SNCV of the common peroneal nerve，
with acupuncture showing the best efficacy〔MD=-5.70，95%CI（-8.03，-3.31）〕. Conclusion Acupuncture combined
with conventional Western medicine is recommended preferentially in treating DPN based on available literature evidence，
especially in improving overall efficacy rate and SNCV of the common peroneal nerve，but more high-quality studies are still
needed for further validation.
【Key words】 Diabetic neuropathies；Peripheral nerve injuries；TCM therapy；External therapies；Integrated
Chinese traditional and western medicine therapy；Network Meta-analysis；Bayes theorem；Validation study；Safety

糖尿病周围神经病变（DPN）是糖尿病患者常见慢 国知网（CNKI），检索时限均为建库至 2020-12-29；
性并发症之一，以上下肢感觉、运动障碍为主要临床表 同时手工追溯相关会议报道、综述文献参考文献中相关
现；据统计，DPN 约占所有糖尿病患者慢性并发症的 RCTs。中文检索词包括：“针刺”“足浴”“穴位按
1/2 ［1］ 。若控制不佳，DPN 可导致肢体溃疡、感染甚至 摩”“穴位注射”“艾灸”“外治法”“糖尿病周围神
糖尿病足，而糖尿病足致残率、致死率均较高 ［2］ 。目前， 经病变”，英文检索词包括：“moxibustion”“acupun
DPN 的病因及确切发病机制尚不完全明确，西医以控制 cture”“acupoint injection”“foot bath”“acupoint mass
血糖、营养神经、管理疼痛等为主要治疗原则，但由于 age”“diabetes”“diabetic”“peripheral nervous system
这些非特异性治疗在预防及延缓 DPN 进展方面均有一 diseases”“neuropath”“polyneuropath”“controlled
定局限性 ［3］ ，因此充分发挥中医药防治 DPN 的优势具 clinical trial”“randomized controlled trial”。
有重要意义。 1.2 文献纳入与排除标准
目前，中医外治法如针刺、中药足浴、穴位按摩 1.2.1 文献纳入标准 （1）研究类型：RCTs，不论是
等已较广泛地用于 DPN 的治疗 ［4］ ，但哪种中医外治法 否使用盲法；（2）研究对象：符合 1999 年世界卫生组
联合常规西药治疗 DPN 的效果最优尚缺乏循证医学证 织（WHO）制定的《糖尿病及糖尿病周围神经病变诊
据，而这也给临床医生选择 DPN 治疗方案造成了一定 断标准》《糖尿病周围神经病变多种简易感觉检查方法
困扰。本研究结合 DPN 相关临床指南 ［5-6］ 、随机对照 的评价》《实用糖尿病学》或 2006 年美国糖尿病协会
试验（RCTs）与临床实践，采用贝叶斯网状 Meta 分析 （ADA）制定的《糖尿病诊断治疗标准》等行业公认的
评价 5 种常用中医外治法联合常规西药治疗 DPN 的有 DPN 诊断标准，中医证候分型参照中华医学会糖尿病学
效性和安全性，以期为临床制定 DPN 治疗方案提供循 分会制定的《中国 2 型糖尿病防治指南》之《糖尿病周
证医学证据。 围神经病变中医防治指南》；（3）干预措施 ：对照组
1 资料与方法 患者采用与试验组相同的常规西药治疗，包括口服甲钴
1.1 文献检索策略 经预调查后确定常用的 DPN 中医 胺、维生素 B 1 、维生素 B 6 、维生素 B 12 、硫辛酸、依帕
外治法有 5 种，分别为针刺、中药足浴、穴位按摩、 司他，肌肉注射甲钴胺、腺苷钴胺，静脉滴注甲钴胺、
穴位注射、艾灸。采用主题词与自由词结合的方式、 硫辛酸、维生素、前列地尔等（单用或几种西药合用），
计算机检索 Cochrane Library、Web of Science、PubMed 试验组患者采用 5 种常用 DPN 中医外治法中的任 1 种
及中国生物医学文献服务系统（SinoMed）、维普网 联合常规西药治疗，或对照组与试验组患者采用不同的
（VIP）、万方数据知识服务平台（Wanfang Data）、中 中医外治法联合常规西药治疗；（4）结局指标：①主