参蝎止痛胶囊治疗糖尿病周围神经病病变的临床疗效评价

摘要

目的：评价参蝎止痛胶囊治疗糖尿病周围神经病变的临床有效性和安全性。方法：入组DPN患者共62例，采用随机平行对照的研究设计方法分为两组，每组各31例。两组均给予降糖、降脂等基础治疗。一组在基础治疗的同时给予参蝎止痛胶囊口服（参蝎组）、另一组给予硫辛酸片口服（硫辛酸组）。随访期为3个月，观察两组治疗前后TCSS评分、UENS评分、中医症候积分、糖代谢等指标变化。结果：3个月治疗后，两组TCSS评分、UENS评分、中医症候积分均有下降，两组治疗后TCSS差值、中医症候积分差值比较差异均有统计学意义（P=0.038、0.013），两组UENS评分治疗后均下降（P=0.000、0.023），两组治疗后差值比较差异无统计学意义（P=0.421）。两组糖代谢指标比较，差异均无统计学意义（P=0.732、0.838）；两组ALT、BUN、Scr治疗前后比较，差异均无统计学意义（P>0.05）。结论：参蝎止痛胶囊可改善患者的神经症状、体征，安全有效，且疗效不劣于硫辛酸片。%Objective:To observe the clinical curative effect and safety of Shenxiezhitong Capsule in the treatment of diabetic peripheral neuropathy.Method:Screening for DPN in hospitalized patients, eventually into the group of 62 patients with DPN,to adopt the random parallel control design method they were divided into two groups,31 cases in each group.Two groups were given basic treatment such as sugar, lipid. A group in the foundation treatment at the same time was given Shenxiezhitong Capsule(group of Shenxiezhitong Capsule), another group was given Lipoic Acid Tablets(group of Lipoic Acid Tablets). Follow-up for 3 months,observing two groups before and after treatment, TCSS score, UENS score,the score of traditional Chinese medicine symptom, Sugar metabolic changes.Result:After 3 months treatment,two groups of TCSS score,UENS score, the score of traditional Chinese medicine symptom were declined,after treatment of two groups,there were statistically significant in TCSS score(P=0.038),the score of traditional Chinese medicine symptom(P=0.013), TCSS score,UENS score of two groups were declined(P=0.000,0.023),but there was no difference between two groups in integral before and after(P=0.421).There were no differences between two groups at the sugar metabolism(P=0.732,0.838).There was no difference between two groups ALT,BUN,Scr after and before treatment(P>0.05).Conclusion:Shenxiezhitong Capsule can improve the patient’s neurologic symptoms,signs,it is safe and effective,the curative effect is not worse than Lipoic Acid Tablets.