Randomized Crossover Trial of Amoxapine Versus Vitamin B12 for Retrograde Ejaculation.
Randomized Crossover Trial of Amoxapine Versus Vitamin B12 for Retrograde Ejaculation.
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DOI：
10.1590/s1677-5538.ibju.2016.0468
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发表时间：
2017-05
期刊：
影响因子：
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通讯作者：
Nakajima K
中科院分区：
文献类型：
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作者：
Hu J;Nagao K;Tai T;Kobayashi H;Nakajima K
比较阿莫西林与维生素B12治疗逆行射精（RE）的疗效和安全性。 在2009年5月至2012年11月期间，这项开放标签、随机、交叉研究在大森医院生殖医学科招募了26名患有RE的男性。患者随机分为两组（每组n=13）。阿莫沙平-B12组接受阿莫沙平（50 mg，每日一次，持续4周，口服），随后（1周洗脱期后）接受维生素B12（500 μg，每日三次，持续4周）。B12-阿莫西林组给予相反的治疗方案。所有患者在每个治疗期间至少手淫两次。主要结局是患者报告的在任一治疗期间超过一次的顺行射精（定义为治疗成功）。记录任何不良事件。使用Fisher精确检验比较治疗之间的成功率。 1例患者（B12-阿莫西林组）因个人原因（婚姻关系破裂）退出研究;所有其他患者均完成研究。总成功率为88%（22/25）。阿莫西林的成功率高于维生素B12（80%，20/25 vs 16%，4/25; P<0.0001）。18例患者对阿莫西林有反应，但对维生素B12无反应，2例患者对维生素B12有反应，但对阿莫西林无反应，2例患者对两种药物均有反应，3例患者对两种药物均无反应。1例患者（4%）报告嗜睡，2例患者（8%）报告在接受阿莫西林治疗期间发生便秘。维生素B12治疗期间未报告不良事件。 阿莫西林可能是一种有效、安全和耐受性良好的RE治疗方法。
To compare the efficacy and safety of amoxapine and vitamin B12 for treating retrograde ejaculation (RE). Between May 2009 and November 2012, this open-label, randomized, crossover study enrolled 26 men suffering with RE at Department of Reproductive Medicine, Omori Hospital. Patients were randomly allocated into two groups (n=13 each). The amoxapine-B12 group received amoxapine (50 mg daily for 4 weeks, orally) followed (after a 1-week washout period) by vitamin B12 (500 μg three-times daily for 4 weeks). The B12-amoxapine group received the opposite regimen. All patients masturbated to ejaculation at least twice during each treatment period. The primary outcome was antegrade ejaculation of semen, as reported by the patient, on more than one occasion during either treatment period (defined as treatment success). Any adverse events were noted. Success rates were compared between treatments using Fisher’s exact test. One patient (B12-amoxapine group) withdrew for personal reasons (breakdown of marital relations); all other patients completed the study. Overall success rate was 88% (22/25). Success rate was higher for amoxapine than for vitamin B12 (80%, 20/25 vs 16%, 4/25; P<0.0001). 18 patients were responsive to amoxapine but not to vitamin B12, 2 patients were responsive to vitamin B12 but not amoxapine, 2 patients were responsive to both drugs, and 3 patients had no response to either drug. One patient (4%) reported sleepiness and 2 (8%) reported constipation while receiving amoxapine. No adverse events were reported during vitamin B12 treatment. Amoxapine may be an effective, safe and well-tolerated therapy for RE.