目的：评价针灸治疗糖尿病周围神经病变的有效性和安全性。方法：检索MEDLINE、 EMBASE、中国知网数据库、万方数据库中相关随机对照临床研究；研究终点包括：临床总有效率、神经传导速度和不良反应；运用Review Manager 5.2软件进行偏倚风险评估及效应量的合并。运用GRADEprofiler软件进行证据质量评估。结果：共纳入18项随机对照研究，共计1158名患者。临床总有效率：针灸治疗明显优于药物对照组[RR：1.38, 95%CI（1.25，1.53），P<0.00001]。感觉神经传导速度：①正中神经：针灸治疗组优于药物对照组[MD=2.55，95%CI（1.23，3.87），P=0.0001]；②腓总神经：针灸治疗组优于药物对照组[MD=3.42，95%CI（2.56，4.28），P<0.00001]。运动神经传导速度：①正中神经：针灸治疗组优于药物对照组[MD=4.10，95%CI（1.01，7.19），P=0.009]；②腓总神经：针灸治疗组优于药物对照组[MD=3.09，95%CI（1.99，4.19），P<0.00001]。不良反应和安全性指标：2项研究报告未见不良反应，安全性指标无异常。证据质量评估：腓总神经的感觉神经传导速度证据级别为中级，正中神经和腓总神经的运动神经传导速度证据级别为低级，而临床有效率和正中神经的感觉神经传导速度证据级别为较低级。结论：根据目前的临床证据，尚不能确定针灸治疗糖尿病周围神经病变的有效性和安全性。

This study was aimed to evaluate the efficacy and safety of acupuncture treatment for diabetic peripheral neuropathy. MEDLINE, EMBASE, China National Knowledge Infrastructure (CNKI), and Wanfang database were searched. The study endpoints included clinical total efficacy, peripheral nerve conduction velocity and adverse reactions. The Review Manager software 5.2 was used in the bias and risk assessment as well as efficacy. GRADE profiler software was used to evaluate quality of evidences. The results showed that there were 18 randomized controlled trials (RCTs) with 1158 patients included. The clinical total efficacy rate of acupuncture treatment was obviously better than the drug control group [RR: 1.38, 95%CI (1.25, 1.53), P<0.00001]. The sensory nerve conduction velocity was that for nervus medianus, the acupuncture treatment group was superior to the drug control group [MD = 2.55, 95%CI (1.23, 3.87), P = 0.0001]; for nervus peroneus communis, the acupuncture treatment group was superior to the drug control group [MD = 3.42, 95%CI (2.56, 4.28), P<0.00001]. The motor nerve conduction velocity was that for nervus medianus, the acupuncture treatment group was superior to the drug control group [MD = 4.10, 95%CI (1.01, 7.19), P = 0.009); for the nervus peroneus, the acupuncture treatment group was superior to the drug control group [MD = 3.09, 95%CI (1.99, 4.19), P<0.00001]. The adverse reactions and safety indicators were that no adverse reaction was reported in both studies with no abnormal safety indicator. The quality of evidence showed that the sensory nerve conduction velocity for nervus peroneus communis was moderate; the motor nerve conduction velocities for nervus medianus and nervus peroneus communis were low. While, the clinical efficacy rate and the quality of evidence for sensory nerve conduction velocity of nervus medianus were relatively low. It was concluded that the current clinical evidences were uncertain for the efficacy and safety of acupuncture in diabetic peripheral neuropathy treatment.

昆明市科学技术局昆明市科技计划重点项目（2013-04-01-A-S-02-3099）：2型糖尿病中医体质与证候相关性研究，负责人；李军。