目的:评价前列地尔E1(PGE1)与营养补充剂甲钴胺(mecbl)联合我院自拟成药首乌保元颗粒治疗糖尿病周围神经病变疼痛(DPN)的临床疗效与安全性。方法:将309例DPN疼痛患者随机分为3组(A、B与C组),每组各103例患者。对所有患者给予静脉注射Me Cbl,给予A组患者静脉滴注PGE1治疗,B组患者在A组患者治疗基础上加服我院自拟中成药首乌保元颗粒(制首乌、黄精、女贞子、黄芪、淫羊藿、茯苓、枳壳、甘草、山茱萸)治疗,连续治疗3周。观察各组患者疗效及不良反应情况。结果:B组总有效率为89.3%,明显高于A组和C组(分别为79.6%和55.3%;P<0.05)。在治疗期间,三组均没有发生严重的不良反应。结论:用前列地尔联合中药治疗糖尿病周围神经病变疼痛疗效好,安全性高。 Objective: To evaluate the clinical efficacy and safety of alprostadil E1 (PGE1) combined with mecbl in the treatment of diabetic peripheral neuropathic pain (DPN). Methods: 309 DPN pain patients were randomly divided into 3 groups (A, B and C groups), each group of 103 patients. All patients were given intravenous injection of Me Cbl, A group of patients given intravenous infusion of PGE1 treatment, B group of patients in the A group of patients on the basis of treatment plus serving our own proprietary Chinese medicine Shouwu Baoyuan particles (Shouwu, Polygonatum, female Sadako, Astragalus, Epimedium, Poria, Citrus aurantium, licorice, dogwood) treatment, continuous treatment for 3 weeks. Observed the efficacy of each group of patients and adverse reactions. Results: The total effective rate in group B was 89.3%, which was significantly higher than that in group A and C (79.6% and 55.3%, respectively; P <0.05). During treatment, no serious adverse reactions occurred in all three groups. Conclusion: The treatment of diabetic peripheral neuropathy with alprostadil combined with traditional Chinese medicine has good curative effect and high safety.