Clinical efficacy and safety of a new epalrestat in diabetic peripheral neuropathy—a multicenter and randomized controlled clinical trial / 中华内分泌外科杂志

ABSTRACT

Objective To evaluate the efficacy and safety of new epalrestat on diabetic peripheral neuropathy (DPN) compared with Tang Lin.Methods A total of 235 patients with DPN were enrolled in our study.They were randomly divided into two groupsthe new epalrestat group (n=117) and the Tang Lin group (n=118).Their clinical,biochemistry,electrocardiogram,clinical symptoms and physical examinations,by using Michigan Neuropathy Screening Instrument (MNSI),and electrophysiological assessments were performed.Results The mean changes of MNSI scores both decreased compared with baseline in two groups after treatment for 12 weeks (P＜0.05) and nerve conduction velocity improved in the two groups (P＜0.05),but there were no difference of MNSI scores and nerve conduction velocity between the two groups.There was no difference of adverse event,blood pressure,heart rate,blood and urine routine examinations,liver and renal function between the two groups.Conclusion The new epalrestat is effective and safe as Tang Lin in treatment of DPN.