糖尿病痛性神经病变药物治疗的疗效和安全性研究

Investigation on the efficacy and safety of nimodipine, PGE_1, Lipo PGE_1, kininogenase and methylcobalamin in the treatment of painful diabetic neuropathy

目的 探讨钙离子拮抗剂(尼莫地平,商品名尼莫同)、前列腺素E1 制剂 [前列地尔 (商品名保达新),前列腺素E1 脂微球制剂(商品名凯时) ]、胰激肽原酶制剂(商品名怡开 )、维生素 (Vit)B12衍生物 (甲钴胺,商品名弥可保)治疗糖尿病痛性神经病变的疗效及安全性。方法 采用随机盲法将 150例糖尿病痛性神经病变患者随机均分为 5组:A组予尼莫地平 10mg加入 1 000ml生理盐水静脉滴注, 8h滴完,每日 1次,疗程为14d;B组予前列地尔 20μg加入 250ml生理盐水静脉滴注,疗程为 14d;C组予前列腺素E1 脂微球制剂 20μg加入40ml生理盐水静脉注射,疗程为 28d;D组予胰液肽原酶注射液 40U肌肉注射,疗程为 28d;E组予甲钴胺 500μg肌肉注射,疗程为 28d。结果 5组患者的临床症状均有不同程度改善,A、B、C、D和E组治疗有效率分别为76. 7% (23 /30例)、66. 7% (20 /30例)、70. 0% (21 /30例)、80. 0% (24 /30例 )和 70. 0% (21 /30例 );神经传导速度及踝 肱指数均有不同程度的改善,治疗过程中肝、肾功能及血、尿常规无明显改变;E组治疗后踝 肱指数有所改善,但治疗前、后的差异无显著性。结论 钙离子拮抗剂、前列腺素E1 制剂、胰激肽原酶制剂、VitB12衍生物治疗糖尿病痛性神经病变的疗效显著, 安全可靠,可推广应用于临床。

Objective To investigate the efficacy and safety of nimodipine(Nimotop), PGE 1, Lipo PGE 1, kininogenase and methylcobalamin in the treatment of painful diabetic neuropathy. Methods 150 patients with painful diabetic neuropathy were randomly divided into 5 groups:① treated with nimodipine(Nimotop);②with PGE 1;③with Lipo PGE 1;④ with kininogenase;⑤with methylcobalamin. All patients were treated for 2 or 4 weeks. The changes of the clinical symptoms and signs were observed. Liver and kidney functions, blood routine were also recorded. Results NCV, ABI, the symptoms and signs of patients in the five groups ameliorated significantly, The Liver and kidney function, blood routine had not changed remarkably.Conclusion The efficacy of nimodipine, PGE 1, Lipo PGE 1, kininogenase and methylcobalamin in the treatment of painful diabetic neuropathy is obvious.