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目的 :为了解甲磺酸酚妥拉明在治疗阴茎勃起功能障碍 ( ED)中的有效性和安全性。方法 :采用随机安慰剂对照试验研究的方法进行分析。试验分为片剂组 ( A组 )、胶囊组 ( B组 )、安慰剂的片剂和胶囊组并为一组 ( C组 )。组间比例为 1∶ 1∶ 1 ( A∶B∶C)。共有 2 41例参加了临床试验 ,其中 2 1 7例完成试验。试验药物 (片剂或胶囊 )必须在性交前 1h服用 ,每次服 1片 ( 4 0 mg) ;两周内至少有 3次服药并尝试性交以保证达到统计学要求 ,但服药不能超过 8次 ;整个试验持续 1 0周。药物的有效性按国际性功能量表 ( IIEF)衡量 ,安全性以监测试验过程中的不良反应来反映。结果 :有效率 ,A组为 6 8% ,B组为 6 2 % ,C组为 45%。 A、B组和 C组比效有显著性差异。整个试验未发生严重不良反应。结论 :甲磺酸酚妥拉明片和胶囊是一种治疗勃起功能障碍的有效且安全的药物
Objective: To understand the efficacy and safety of phentolamine mesylate in the treatment of erectile dysfunction (ED). METHODS: Randomized placebo-controlled trials were conducted to analyze the data. The test was divided into a group (group A), a capsule group (group B), a placebo group and a capsule group (group C). The ratio between groups was 1: 1: 1 (A: B: C). A total of 241 cases participated in the clinical trial, of which 21.7 completed the trial. Test drugs (tablets or capsules) must be taken 1h prior to sexual intercourse, taking 1 tablet (40 mg) at least once; taking at least 3 doses over a two week period and attempting to intercourse to ensure that the statistics meet the criteria but not taking more than 8 doses ; The entire trial lasted 10 weeks. The effectiveness of the drug is measured by the International Function Scale (IIEF) and safety is monitored by monitoring the side effects of the test. Results: The effective rate was 68% in group A, 62% in group B and 45% in group C. A, B group and C group than the significant difference. The entire trial did not occur serious adverse reactions. Conclusions: Phentolamine mesylate tablets and capsules are a potent and safe drug for the treatment of erectile dysfunction