银杏酮酯片治疗糖尿病周围神经病的临床研究

Clinical study on treatment with Yin-Xing-Tong-Zhi tablets for diabetic peripheral neuropathy

目的:观察银杏酮酯片治疗糖尿病周围神经病变(diabetic peripheral neuropathy,DPN)的临床疗效。方法:采用开放对照研究,将120例患者随机分为观察组(60例)和对照组(60例)。对照组给予常规降糖和营养神经治疗,观察组在此基础上加用银杏酮酯片治疗,共治疗3周。观察2组治疗前后多伦多临床评分系统(Toronto clinical scoring system,TCSS)、中医证候评分、神经传导速度和糖代谢指标的变化。结果:观察组失访3人,对照组失访5人。观察组57人以及对照组55人被纳入最后的分析。2组治疗后的TCSS、中医证候评分、正中神经和腓总神经运动神经传导速度和感觉神经传导速度以及糖代谢指标均较治疗前改善。其中,观察组治疗后的上述指标均较治疗前显著改善(P<0.05),也显著优于对照组治疗后的改善程度(P<0.05)。2组治疗前后的血常规、血脂水平、肝功能和肾功能无明显变化(P>0.05)。结论:银杏酮酯片在改善DPN患者的TCSS、中医证候评分、正中神经和腓总神经运动神经传导速度和感觉神经传导速度以及糖代谢指标方面均优于传统的营养神经疗法,并且2者的安全性相当。

Objective:To observe the clinical efficacy of Yin-Xing-Tong-Zhi tablets in the treatment of diabetes peripheral neuropathy(DPN).Methods:One hundred and twenty patients were randomly divided into observation group(60 cases)and control group(60 cases)in an open control study.The control group was treated with conventional hypoglycemic and nutritional nerve therapy,and the observation group was treated with Yin-Xing-Tong-Zhi tablets on this basis for a total of 3weeks.The changes of Toronto clinical scoring system(TCSS),traditional Chinese medicine(TCM)syndrome score,nerve conduction velocity and glucose metabolism index were observed before and after treatment in the two groups.Results:There were 3 cases lost in the observation group and 5 lost in the control group.Fifty-seven cases in the observation group and 55 cases in the control group were included in the final analysis.After treatment,TCSS,TCM syndrome score,motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and common peroneal nerve,and glucose metabolism index of the two groups were improved compared with those before treatment.Among them,the above indicators in the observation group after treatment were significantly improved compared with those before treatment(P<0.05),and also significantly better than those in the control group after treatment(P<0.05).There were no significant changes in blood routine,blood lipid level,liver function and renal function before and after treatment in the two groups(P>0.05).Conclusion:Yin-Xing-Tong-Zhi tablets are superior to traditional nutritional nerve therapy in improving TCSS,TCM syndrome score,motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and common peroneal nerve,and glucose metabolism index of DPN patients,and the safety is equivalent.