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目的探索盐酸阿扑吗啡舌下片治疗男性勃起功能障碍(ED)的安全性和有效性。方法采用多中心、随机、双盲、安慰剂对照研究方法,在国内7家医院对盐酸阿扑吗啡舌下片2mg或3 mg和安慰剂的238例ED病人进行临床观察。结果3个主要疗效指标的统计学分析显示,试验药物组疗效优于安慰剂组。次要疗效指标分析结果与主要疗效指标一致。与药物相关的主要不良事件有头晕、恶心、面部潮红、出汗、胃部不适和呕吐,严重程度为轻至中度,呈一过性,无需处理。结论盐酸阿扑吗啡舌下片2 mg或3 mg治疗国人ED是安全和有效的。
Objective To explore the safety and efficacy of apomorphine hydrochloride sublingual tablet in the treatment of male erectile dysfunction (ED). Methods A multicenter, randomized, double-blind, placebo-controlled study was performed in 238 Chinese patients with ED undergoing apomorphine hydrochloride sublingual tablets 2 mg or 3 mg and placebo at seven hospitals in China. Results The statistical analysis of the three main efficacy indicators showed that the experimental drug group was superior to the placebo group. Secondary efficacy index analysis results and the main efficacy indicators. The main drug-related adverse events were dizziness, nausea, facial flushing, sweating, stomach upset and vomiting, with severity ranging from mild to moderate, transient and untreated. Conclusion Apomorphine hydrochloride sublingual tablets 2 mg or 3 mg for the treatment of Chinese people ED is safe and effective.