摘要
目的:观察国产依帕司他在Ⅱ期临床试验中改善糖尿病性周围神经病变患者感觉神经传导速度的作用。方法:2000-07/2001-07解放军总医院院门诊及住院糖尿病周围神经病变患者350例。符合标准患者40例。将其随机分为依帕司他治疗组(n=20)和甲钴胺治疗组(n=20)。对比两组患者自觉症状、神经功能及实验室检查结果。结果:两组糖尿病神经病变患者经治疗后4周依帕司他治疗组和甲钴胺治疗组的主观症状均有改善,至16周时改善程度达最大,但两组间改善程度差异无显著性意义(P=0.61)。治疗后第8周依帕司他治疗组和甲钴胺治疗组的客观体征开始改善,无论从客观征评分还是从疗效判断上,改善程度不如主观症状改善明显,两组间平均改善程度差异无显著性意义(P=0.57)。治疗16周后依帕司他治疗组和甲钴胺治疗组正中神经的感觉神经传导速度均有所增加。依帕司他治疗组尺神经的感觉神经传导速度下降,甲钴胺治疗组尺神经感觉神经传导速度增加,胫后神经感觉神经传导速度、腓神经感觉神经传导速度均增加。有效率上肢分别为50.0%和68.4%,下肢分别为55.6%和61.9%。两组主客观症状、体征和感觉神经传导速度的综合疗效分别为76.2%和84.2%。结论:国产依帕司他与甲钴胺疗效相似,且具有安全,耐受性良好,无毒副作用的特点,可有效的改善糖尿病?
AIM:To observe the effect of homemade epalrestat on the sensory nerve conduction velocity(SNCV) in patients with diabetic peripheral nervous disease in stage Ⅱclinical trials. METHODS:Totally 350 patients with diabetic peripheral nervous disease were selected from the inpatients or outpatients of General Hospital of Chinese PLA from July 2000 to July 2001.Only 40 patients met the inclusive criteria,and averagely randomized into epalrestat group and mecobalamin group.Subjective symptomsm neurological function and measuring results were compared between the two groups. RESULTS:After four-week treatment,subjective symptoms were improved in the two groups,and optimal improvement in subjective symptoms occurred after 16 weeks,but there were no significant differences between the two groups(P=0.61).Improvement in subjective sign began at the 8th week,but it was not more obvious than that in subjective symptoms,and there were still no differences between the two groups(P=0.57).Sixteen weeks after treatment,SNCV in median nerve increased a little.In the epalrestat group,SNCV in ulnar nerve decreased;in the mecobalamin group,SNCV in ulnar nerve,posterior tibial nerve and peroneal nerve.The effective rates of upper limbs and lower limbs were 50.0%and 55.6%in the epalrestat group,and 68.4%and 61.9%in the mecobalamin group respectively.The total effective rates of subjective symptom and sign and SNCV were 76.2%and 84.2%in the two groups respectively. CONCLUSION:The Epalresfat made in china is safe and has similar effect to mecobalamin,and has good tolerance and no toxic and side effects.It can improve the subjective symptom and SNCV of patients with diabetes peripheral nervous disease.
出处
《中国临床康复》
CSCD
北大核心
2005年第3期38-40,共3页
Chinese Journal of Clinical Rehabilitation
