川芎嗪联合甲钴胺治疗糖尿病周围神经病变的系统评价

目的:评价川芎嗪( tetramethylpyrazine,TMP)联合甲钴胺治疗糖尿病周围神经病变(diabetic peripheral neuropathy,DPN)的疗效和安全性.方法:通过计算机检索和手工检索收集1979-2011年32年间以川芎嗪联合甲钴胺为干预措施治疗DPN的RCT.按Cochrane系统评价方法,由两位研究者独立地对符合纳入标准的试验进行资料提取,并进行研究方法的质量评估和对提取的有效数据进行Meta分析.结果:有11个试验,共918例DPN患者符合纳入标准,Meta分析结果显示,川芎嗪联合甲钴胺治疗较单用甲钴胺能明显改善患者肢体麻木和疼痛 OR =0.29,95％CI(0.21,0.41),P=0.000]以及正中神经运动神经传导速度(MNCV)与感觉神经传导速度(SNCV) MD=5.57,95％CI(4.79,6.35),P=0.000；MD =4.53,95％CI(3.73,5.33),P=0.000]和腓神经MNCV与SNCV MD=4.92,95％CI(4.39,5.45),P=0.000；MD=5.24,95％ CI(4.73,5.75),P=0.000].仅有1个试验报道了大剂量TMP联合甲钴胺出现了不良反应,如头晕和头痛.结论:川芎嗪联合甲钴胺对治疗DPN可能有一定疗效,但还需进行更多高质量的RCT才能对其疗效得出肯定性结论.

A Systematic Review on Tetramethylpyrazine Combining with Mecobalaminein for Treatment of Diabetic Peripheral Neuropathy

Objective:To evaluate the efficacy and safety of tetramethylpyrazine(TMP) combining with mecobalaminein in treatment of diabetic peripheral neuropathy(DPN).Method: Randomized trial controlled(RCT) on TMP combining mecobalamine in treatment of DPN was retrieved by computer search and manual collection from 1979 to 2011.There were two researchers independently doing a data extraction according to the inclusion criteria of trials and quality assessment about the method of research and the extraction of valid data were then made based on Meta analysis.Result:In eleven RCTs involving 918 patients who met the standards,Meta-analysis indicated that TMP combining mecobalamine in treatment of DPN was more effective in alleviatingpain or numbness of extremities than mecobalamine medicine alonelyand the conduction velocity between(motor nerve)MNCV and(sensory nerve)SNCV in sensory nerve and pheroneal nerve.Only one trial reported an adverse reactions occurrence induced by high-dose TMP combining with Methylcobalamin,such as dizziness and headache.Conclusion:Based on the review,TMP combining with mecobalamine may have positive effect on DPN,but the need more high-quality RCT in order to draw firm conclusions of large randomized,double blind and placebo-controlled trial.