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目的 :评价甲磺酸酚妥拉明胶囊 (MP)治疗男性勃起功能障碍 (ED)的安全性和有效性。 方法 :采用随机、双盲、安慰剂对照多中心临床试验 ,入选 168例病人 ,分别服用试验药物MP和安慰剂 ,4 0mg/次。观察服药后国际勃起功能指数 (IIEF)得分变化及夜间记录表。 结果 :试验组IIEF观察表中Q3、Q4及Q3+Q4得分增加明显高于对照组 (P <0 .0 0 1) ,试验组治疗ED显效率 10 .12 %、有效率 67.4 2 % ,对照组显效率 0 ,有效率 14 .2 9% (P均 <0 .0 1) ;试验组不良反应率 4 .76% ,对照组为 1.19% (P >0 .0 5 ) ,不良反应均不需特殊处置。 结论 :MP治疗ED安全、有效。
Objective: To evaluate the safety and efficacy of phentolamine mesylate (MP) in the treatment of male erectile dysfunction (ED). METHODS: A randomized, double-blind, placebo-controlled, multi-center clinical trial was enrolled in 168 patients enrolled in the study drug MP and placebo, respectively, at 40 mg once daily. Observe the change of IIEF score and night time record after taking medicine. Results: The scores of Q3, Q4 and Q3 + Q4 in the IIEF observation table of the experimental group increased significantly (P <0.01), the effective rate of the treatment group was 10.12% and the effective rate was 67.4% The effective rate was 14.29% (P <0.01), the adverse reaction rate was 4.76% in the test group and 1.19% in the control group (P> 0.05), and the adverse reactions were neither Need special treatment. Conclusion: MP is safe and effective in treating ED.