摘要
目的:观察参蝎止痛胶囊治疗糖尿病周围神经病变(DPN)脉络瘀阻证的临床疗效,评价其有效性和安全性。方法:采用随机对照试验的设计方法,在均接受基础治疗的情况下,将104例患者分为参蝎止痛胶囊治疗组(治疗组,53例)和硫辛酸片对照组(对照组,51例),观察治疗前后两组患者多伦多神经病变评分(TCSS),犹他神经症状评分(UENS),中医证候评分;视觉模拟评分(VAS),踝肱指数(ABI),震动感觉阈值(VPT);终点事件足溃疡、行经皮冠状动脉介入术(PCI),死亡及复合终点事件;糖脂代谢相关指标及安全性指标。结果:与本组治疗前比较,治疗后两组患者TCSS,UENS,中医证候评分均显著降低(P<0.01),VAS,糖化血红蛋白(HbA1c)均明显降低(P<0.05);随访时两组患者右ABI,总胆固醇(TC),低密度脂蛋白(LDL)水平均明显降低(P<0.05),高密度脂蛋白(HDL)水平均明显升高(P<0.05),对照组餐后2 h血浆葡萄糖(2 h PG),HbA1c水平均明显升高(P<0.05)。治疗后与对照组比较,治疗组的VAS明显降低(P<0.05)。治疗后及随访时,与对照组比较,治疗组的2 h PG水平均明显降低(P<0.05)。两组患者间的终点事件及安全指标,差异无统计学意义,但治疗组复合终点事件发生率趋势较对照组低。结论:参蝎止痛胶囊治疗糖尿病周围神经病变临床疗效确切,并在疼痛症状改善上比硫辛酸更安全有效。
Objective:To observe the clinical efficacy of Shenxie Zhitong capsule in the treatment of diabetic peripheral neuropathy(DPN)of stagnant blockade of collaterals,and evaluate its effectiveness and safety. Method:The 104 patients were randomly divided into the Shenxie Zhitong capsule treatment group(the treatment group,53 patients)and the alpha lipoic acid group(control group,51 patients),and two groups were compared by random and contrast test. The changes of the Toronto clinical scoring system(TCSS),utah early neuropathy scores(UENS), traditional Chinese medicine(TCM)syndrome scores, visual analysis scale(VAS),ankle brachial index(ABI),vibrating perception threshold(VPT)before and after treatment were compared between two groups,and the endpoint events,such as foot ulcers,percutaneous coronary intervention(PCI),death and composite endpoint events,related indicators of glucose and lipid metabolism and safety indicators were recorded among patients. Result: Compared with the data before treatment,the scores of TCSS,UENS,and TCM syndromes in two groups were significantly reduced(P<0.01)after treatment,and VAS and glycosylated haemoglobin A1c(HbA1c)were significantly reduced(P<0.05),during follow-up visit,the levels of right ABI,total cholesterol(TC), and low-density lipoprotein(LDL) in two groups were significantly reduced(P<0.05),and high-density lipoprotein(HDL)level was significantly increased(P<0.05).control group in control group,the 2-hour postprandial plasma glucose(2 h PG)and HbA1 c levels were significantly increased(P<0.05). Compared with control group,the VAS of the treatment group after treatment was significantly reduced(P<0.05). After treatment and during follow-up visit,compared with control group,the 2 h PG levels of the right toe in the treatment group were significantly reduced(P<0.05). There was no statistically significant difference in endpoint events and safety indicators between two groups,but the incidence trend of composite endpoint events in the treatment group was lower than that in control group. Conclusion:Shenxie Zhitong capsule has definite clinical curative effect in treating diabetic peripheral neuropathy,which is more safe and effective than alpha lipoic acid in improving pain symptoms.
作者
金燊懿
陈清光
姚政
陆灏
JIN Shen-yi;CHEN Qing-guang;YAO Zheng;LU Hao(Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200120,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第8期81-87,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(81503552,81874434)
上海市科委科研计划项目(17401970100,14401930600,17401970600)
上海市中医专科(专病)联盟建设项目中医糖尿病专科联盟建设项目[ZY(2018-2020)-FWTX-4011]
上海市中医临床重点实验室项目(14DZ2273200)
上海市临床重点专科项目(shslczdzk05401)。
关键词
参蝎止痛胶囊
硫辛酸
糖尿病周围神经病变
脉络瘀阻证
Shenxie Zhitong capsule
alpha lipoic acid
diabetic peripheral neuropathy
stagnant blockade of collaterals
