中药糖痛方外洗治疗糖尿病周围神经病变的临床观察

Clinical Study of Chinese Herb Formula Tangtongfang by Bathing the Affected Feet with Diabetic Peripheral Neuropathy

目的观察中药"糖痛方"外洗疗法对糖尿病周围神经病变(DPN)(气虚血瘀证)患者的临床症状和神经电生理指标的改善情况。方法临床入选70例DPN(气虚血瘀证)患者,采用平行、随机、对照的试验设计方法,分为治疗组、对照组各35例。两组均口服维生素B1、维生素B6各20mg,每日3次;同时,治疗组给予糖痛方外洗患肢每日2次,对照组给予温水外洗患肢每日2次。整个疗程为8周。观察两组患者治疗前后中医症状、神经传导速度等变化(对中医症状的临床评价采用量化计分法),计算和比较临床综合疗效。同时检测和记录治疗前后血常规、尿常规、血糖、肝肾功能、心电图和不良事件。结果疗程结束后,两组共脱落9例患者,实际完成试验61例,其中治疗组31例,对照组30例。①临床综合疗效:治疗组的总有效率为45.2%,对照组为10%。疗程结束时,治疗组优于对照组(P<0.05)。②中医证候疗效:治疗组总有效率为61.3%,对照组为3.3%。疗程结束时,治疗组明显优于对照组(P<0.001)。③中医证候积分:疗程结束时,治疗组与本组治疗前及与对照组治疗后相比具有非常显著性差异(P<0.001)。其中下肢发凉症状改善:疗程结束时,治疗组优于对照组(P<0.05)。④胫运动神经和感觉神经传导速度:疗程结束时,治疗组改善均优于治疗前(P<0.05)。对照组的胫运动神经传导速度改善治疗后优于治疗前(P<0.05)。治疗后在胫运动神经传导速度上治疗组改善优于对照组(P<0.05)。⑤安全性评价:治疗组在试验前后血常规、尿常规、肝肾功能、心电图检查未见显著性差异(P>0.05)。全部患者治疗期间未发生不良事件。结论糖痛方外洗能够改善DPN患者的临床症状,明显缓解局部不适,同时能够使部分神经的传导速度得到恢复。糖痛方外洗未发现不良反应。

Objective To investigate the effects of Chinese herb formula Tangtongfang by bathing the affected feet of patients with diabetic peripheral neuropathy （DPN） in the pattern of Qi deficiency and blood stasis. Methods A parallel, randomized, controlled clinical research was performed. 70 diabetics in the inpatient and outpatient divisions of the Department of Endocrinology, Guangan men Hospital, from January 2005 to October 2007 were investigated. They were divided randomly into two groups, treatment group and control group, 35 cases in each group. Before study, there were no statistic differences between the two groups, including gender, age, course of diabetes mellitus（DM）, course of DPN, blood glucose （including fasting blood glucose and postprandial blood glucose）, traditional Chinese medicine（TCM） symptom scores and nerve conduction velocity （NCV）. The treatment group were treated with Tangtongfang bathing and the control group were treated with warm water bathing. Each group was also administered Vitamin B1 20 mg, t. i. d and Vitamin B6 20 mg, t. i. d respectively. All patients were keeping their routine treatment and diabetic care to control their blood glucose, such as diets, practices and drugs. Clinical symptoms and electrophysiological tests in diabetic peripheral neuropathy syndrome were investigated. The period of treatment was 8 weeks. Results After study, 9 cases retreated from this clinical trial totally, 4 cases in the treatment group whereas 5 in the control group. Among 4 common single symptoms, coolness feeling of the feet of diabetic patients was significantly improved （P 〈0. 05） after bathed with Tangtongfang. The change of TCM symptom scores and tibialis NCV was significantly improved （P 〈0. 001, P 〈0.05） in the treatment group. The improvement ratio was 45.2% and 61.3% in the treatment group, while was 10% and 3.3% in the control group. In each group there was no statistical difference between pre-and post-study with blood test, urine test, blood ALT, blood BUN and Cr, ECG examination （P 〉0.05）. No adverse event was observed in each group. Conclusion Tangtongfang bathing improved several symptoms of patients suffering from DPN, especially the symptom of coolness feeling of the patients feet. No adverse event was observed. This result showed that Tangtongfang bathing was worthy of using as a safe agent in treatment of DPN.