Clinical Study In Intervention Of Epalrestat On The Syndrome Qi Deficiency And Blood Stasis Of Diabetic Peripheral Neuropathy And A Meta-analysis On The Clinical Efficacy Of Epalrestat

Objective:Evaluate the therapeutic efficacy of Epalrestat in treating the syndrome Qi deficiency and blood stasis of diabetic peripheral neuropathy(DPN) by using a randomized and control clinical study. Assess the efficacy of Epalrestat for DPN by searching the relevant literature from the recent ten years for Meta-analysis.Methods:1.Clinical part:According to the principle of randomization and contrast,45cases diagnosed by the syndrome Qi deficiency and blood stasis of DPN were divided into three groups—Epalrestat group(group E), Mecobalamin group(group M) and Epalrestat associated with Mecobalamin group(group EM). There were15cases in every group with the course was12weeks. Evaluate the MDNS, electro-neurophysiological examination, blood glucose, HbAlc, scores of Chinese medicine syndorme and so on.2.Meta-analysis:Search120trials out of relevant medicine literature database,9trials involving737participants with DPN were included. There were372participants in Epalrestat group and365participants in Mecobalamin group. Use the Revman5.1to calculate the relative risk(RR) of the effect rate of symptoms improvement,the mean difference(MD) of nerve conduction velocity(NCV) improvement and its95%confidence interval(CI).Results:1.Clinical part:At the end of the treatment, the MDNS was clearly lower than ever(p<0.01), but the comparison among groups didn’t have statistically significant(P＞0.05).The change of right tibial MCV,right sural SCV, right fibula SCV and the comparsion among groups didn’t have statistically significant(P>0.05). The right tibial motor nerve(fibula) conduction amplitude in group M was more increscent than ever(P<0.05). The change of conduction amplitude of right tibial(ankle) motor nerve, right sural sensory nerve,right fibula sensory nerve had got no statistically significant(P>0.05). The change of conduction amplitude in group E and group EM didn’t have statistically significant(P>0.05).The comparsion among groups didn’t get statistically significant(P>0.05).The change of the level of blood glucose and the comparsion among groups had got no statistically significant before or after thcrapy(P＞0.05).The level of HbAlc reduced in group E and group M after therapy (P＜0.05). The level of HbAlc in group EM also reduced, but had no statistically significant(P＞0.05). There were no statistically significants among the three groups.2.Meta-analysis:Epalrestat had got no more effective rate than Mecobalamin in improving the symptoms of DPN[RR=1.12,95%CI (0.89,1.41), P=0.32]. And it was not statistically significant in improving the speed of median MNCV/SNCV, peroneal MNCV/SNCV, and tibial MNCV/SNCV.Conclusion:Epalrestat is effective in improving symptoms of syndrome Qi deficiency and blood stasis of DPN. But in the aspect of improving the MDNS and the speed of NCV, the therapeutic effect of Epalrestat is similar with Mecobalamin.