摘要
目的 :探讨甲基维生素B1 2 +PGE1 治疗男性 2型DM并ED的有效性、安全性。方法 :81例糖尿病并ED患者随机分为两组 (Ⅰ组给予PGE1 +安慰剂 ,Ⅱ组给予PGE1 +甲基维生素B1 2 ) ,采用双盲、安慰剂对照方法进行临床试验。结果 :Ⅱ组的注射勃起比率明显高于Ⅰ组 ,分别为 5 8.4%和 48.7% (χ2 =17.9,P <0 .0 5 ) ;国际勃起功能指数 (internationalindexoferectilefunction ,IIEF)中问题 3和 4评分分别改善 94.2 %vs 73 .7%和 85 .3 %vs 61.4% ;而且Ⅱ组积分增加显著高于Ⅰ组 (u =2 .1和 3 .8,P <0 .0 5 )。与Ⅰ组相比 ,Ⅱ组注射疼痛 (75 .0 %vs 3 5 .9% )和糖尿病周围神经病变 (88.9%vs 2 8.2 % )明显减少 ,χ2 =8.4和 2 5 .7,P <0 .0 5。糖尿病其他并发症均无明显变化 ,但两组患者的血糖均显著上升。结论 :以甲基维生素B1 2 +PGE1 治疗糖尿病并ED为安全、有效的方法 。
Objective: To investigate efficacy and safety of PGE 1 and VitB 12 therapy for erectile dysfunction in men with type 2 DM.Method: 81 diabetics with ED were randomly divided into 2 groups (groupⅠand groupⅡ). Using double blind and placebo controlled clinical trails, groupⅠwas treated with PGE 1+placebo and groupⅡ with PGE 1+methyl VitB 12 .Results: The rate of erecting and injection in group Ⅱ was increased more compared with group Ⅰ(58.4% and 48.7%, respectively, χ 2=17.9, P <0.05). The mean scores to IIEF question3 and question 4 were significantly improved in group Ⅰ and group Ⅱ. Moreover, group Ⅱ was more efficacious compared with group Ⅰ (73.7% vs 94.2% and 61.4 vs 85.3%, u=2.1 and 3.8, P <0.05). In 24 weeks follow up, injection pain and DM peripheral neuropathy in group Ⅱwere decreased more compared with group Ⅰ(35.9% vs 75.0% and 28.2% vs 88.9%, χ 2=8.4 and 25.7, P <0.05). DM complications of all patients were not changed, but plasma glucose was increased markedly.Conclusion: Methyl VitB 12 + PGE 1 may be a more efficacious and safer treatment to DM with ED, but plasma glucose should be controlled intensively.
出处
《微循环学杂志》
2003年第4期35-37,共3页
Chinese Journal of Microcirculation
