小牛血去蛋白提取物注射液治疗2型糖尿病周围神经病变的临床研究

Efficacy of Deproteinized Hemoderivative of Calf Blood Injection on Diabetic Peripheral Neuropathy:Multicenter,Positive Parallel Controlled Clinical Trial

目的：观察小牛血去蛋白提取物注射液(deproteinized hemoderivative of calf blood injection,DHCBI)治疗2型糖尿病周围神经病变的疗效及安全性。方法：本试验为开放、平行对照、多中心临床研究。DHCBI组123例,甲钴胺组52例。DHCBI组每天1次静脉滴注DHCBI 800mg,疗程2周。甲钴胺组每天1次,肌肉注射甲钴胺针剂500μg．疗程2周。结果：疼痛改善方面,DHCBI组与甲钴胺组相似,总有效率分别为82．9%和84．6%；在麻木的改善方面,DHCBI组显著优于甲钴胺组．总有效率分别为87．0%和76．9%(P＜0．05)。另外DHCBI显著改善正中神经和腓浅神经的感觉和运动传导速度(P＜0．001)。结论：DHCBI对2型糖尿病神经病变所致的疼痛、麻木有较好疗效,并能改善神经传导速度。

Objective：To evaluate the efficacy and safety of Deproteinized hemoderivative of calf blood injection（DHCBI） in the treatment of neuralgia and numbness in type 2 diabetes mellitus patients with peripheral neuropathy and compare it with Mecobalamin. Methods：123 cases in 7 centers in China were enrolled in DHCBI group （800 mg/d, IV for 2 weeks）, while 52 patients from 4 hospitals were in enrolled in controlled Mecobalamin group （500 μg/day, IM for 2 weeks）. Results：DHCBI and Mecobalarnin significantly improved neuralgia. The total efficacy rate was 82. 9% and 84. 6%, respectively. For numbness, DHCBI was significantly more effective than Mecobalarnin （87. 0% vs. 76. 9%, P〈0. 05）. In addition, both DHCBI and Mecobalamin significantly increased the conductive velocity of median motor and sensory nerves and superficial peroneal motor and sensory nerves. Conclusion：DHCBI has good effects in the treatment of diabetic neuralgia and numbness and can improve nerve conduction velocity. The efficacy of DHCBI on numbness is better than that of Mecobalamin.