弥可保穴位注射治疗糖尿病周围神经病变的系统评价

Effect of Mecobalamin Point Injection Therapy on Diabetic Peripheral Neuropathy:A Systematic Review

目的系统评价弥可保穴位注射治疗糖尿病周围神经病变的临床疗效及安全性。方法计算机检索The Cochrane Library、Medline、Embase、AMED、CINAHL、CBM、CNKI、VIP、Wan Fang Data数据库,搜集所有弥可保穴位注射治疗糖尿病周围神经病变的随机对照试验,检索时限均为建库至2015年12月。由2名研究者独立筛选文献、提取数据,并对纳入研究的质量进行评价后,采用Revman5.3对数据进行Meta分析或仅行描述性分析。结果共纳入19项随机对照试验,共1 571例患者。Meta分析结果显示:(1)临床总有效率:弥可保穴位注射组分别优于肌内注射组[OR=4.49,95%CI(3.34,6.04),P<0.00001];静脉注射组[OR=5.06,95%CI(1.84,13.87),P=0.002]。(2)运动神经传导速度:弥可保穴位注射组正中和腓总神经的运动神经传导速度改善优于肌内注射组[MD=5.58,95%CI(4.77,6.39),P<0.00001];[MD=4.66,95%CI(2.89,6.43),P<0.00001]。(3)感觉神经传导速度:弥可保穴位注射组正中、腓总和腓浅的感觉神经传导速度改善优于肌内注射组[MD=4.12,95%CI(2.94,5.30),P<0.00001];[MD=4.21,95%CI(3.29,5.14),P<0.00001];[MD=3.28,95%CI(1.95,4.61),P<0.00001]。(4)安全性:3个研究报告出现局部疼痛,酸胀等不良反应,但经处理或休息后恢复,未见其他不良反应报告。结论弥可保穴位注射的临床疗效优于肌内注射、静脉注射、静脉点滴以及口服。但弥可保穴位注射对正中神经的运动神经传导速度改善与静脉注射比较无明显优势。受纳入研究的质量和数量的限制,本研究结论尚需要更多高质量的随机对照试验来进一步论证。

Objective To systematically evaluate the effect of mecobalamin point injection therapy on diabetic peripheral neuropathy（DPN） and its safety.Methods We electronically searched databases including The Cochrane Library,Medline,Embase,AMED,CINAHL,CMB,CNKI,VIP and Wanfang databases to collect randomized controlled trials on the effect of mecobalamin point injection therapy on DPN from the establishment of databases to December 2015.Two reviewers screened literature independently,extracted data and assessed the quality of included studies.Then meta-analysis was performed using Rev Man 5.3 software or descriptive analysis.Results A total of 19 RCTs involving 1,571 patients were included.The results of meta-analysis indicated that：（1） The clinical total effective rate：the mecobalamin point injection group was higher than that of muscle injection group[OR=4.49,95%CI（3.34,6.04）,P〈0.00001] and intravenous injection group [OR=5.06,95%CI（1.84,13.87）,P=0.002].（2）Motor nerve conduction velocity：the median and common peroneal nerve MNCV improvement of mecobalamin point injection group was better than that of muscle injection group [MD=5.58,95%CI（4.77,6.39）,P〈0.00001];[MD=4.66,95%CI（2.89,6.43）,P〈0.00001].（3） Sensory nerve conduction velocity：the median,common peroneal and superficial peroneal nerve SNCV improvement of mecobalamin point injection group were better than those of muscle injection group [MD=4.12,95%CI（2.94,5.30）,P〈0.00001];[MD=4.21,95%CI（3.29,5.14）,P〈0.00001];[MD=3.28,95%CI（1.95,4.61）,P〈0.00001].（4）Safety：three studies revealed symptoms of local pain and soreness,but restored after processing or resting and no other adverse reactions were reported.Conclusion The clinical effect of mecobalamin point injection is better than that of muscle injection,intravenous injection,intravenous drip and oral.But compared with intravenous injection,the median nerve MNCV improvement of mecobalamin point injection has no obvious advantage.Because of the quality and quantity of the literatures,the conclusion of the study needs to be confirmed through more high-quality randomized controlled trials.