Clinical efficacy and safety of epalrestat in diabetic neuropathy-A multicenter randomized controlled clinical trial
10.3760/cma.j.issn.1000-6699.2015.09.001
- VernacularTitle:依帕司他治疗糖尿病周围神经病变安全性和有效性的随机、对照、多中心临床研究
- Author:
Ping LI
;
Jianhua MA
;
Jialin GAO
;
Jiangyi YU
;
Heng MIU
;
Yuan SUN
;
Wei LI
;
Jun LIANG
;
Xueqin WANG
;
Jiancheng YU
;
Tao YANG
;
Jian WANG
;
Zilin SUN
;
Guoping LYU
;
Ning XU
;
Xingbo CHENG
;
Dalong ZHU
- Publication Type:Journal Article
- Keywords:
Diabetic neuropathy;
Epalrestat;
Methylcobalamine
- From:
Chinese Journal of Endocrinology and Metabolism
2015;(9):743-747
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of epalrestat, an aldose reductase inhibitor, and epalrestat plus methylcobalamine on diabetic peripheral neuropathy, as compared with methylcobalamine. Methods A total of 444 subjects with diabetic neuropathy were enrolled in the study, and divided into methylcobalamine group ( n= 145 ) , epalrestat group ( n = 143 ) , and methylcobalamine combined with epalrestat group ( n = 156 ) . Therapeutic efficacay was assessed in terms of clinical symptoms and physical examinations by using Michigan Neuropathy Screening Instrument ( MNSI ) , and electrophysiological assessments. Results After 4 to 12-weeks′treatment, symptoms and signs of neuropathy ( using MNSI ) are significantly improved in the three groups ( P<0. 01). The mean changes of MNSI ( questionnaire) score from baseline were higher in epalrestat group and methylcobalamine combined with epalrestat group as compared with that of methylcobalamine group(P<0. 05), but no difference was detected in the change of MNSI ( physical examination ) score from baseline among three groups. After treatment for 12 weeks, motor nerve conduction velocity ( MNCV ) was significantly improved in epalrestat group and methylcobalamine combined with epalrestat group(P<0. 05), but no difference was detected in MNCV at 12 week among three groups(P>0. 05). Conclusion Epalrestat is effective and safe in the treatment of diabetic neuropathy. Furthermore, epalrestat is more efficacious in ameliorating symptoms and MNCV of neuropathy than methylcobalamine. However, while no improved efficacy is shown with the combined treatment.
