Department of Neuroscience, Faculty of Medicine and Nursing, University of the Basque Country, Leioa, Spain.
Department of Preventive Medicine and Public Health, Faculty of Medicine and Nursing, University of the Basque Country, 48080, Leioa, Spain.
Arch Sex Behav. 2020 Nov;49(8):2963-2979. doi: 10.1007/s10508-020-01817-5. Epub 2020 Sep 22.
Sublingual apomorphine could be an option in patients with erectile dysfunction who cannot take phosphodiesterase type 5 inhibitors (e.g., using nitrates). We have completed a systematic review to evaluate the effects of sublingual apomorphine comparing with placebo for treating erectile dysfunction. The evidence searching process finished on 9 January 2019. We included nine randomized controlled trials (RCTs). Treatment length varied from 4 to 8 weeks and doses ranged from 2 to 6 mg. The percent of successful sexual intercourse attempts per ingested dose of apomorphine was evaluated in eight studies. All the studies found that apomorphine was better than placebo (6-27% more successful intercourse attempts than with placebo), but differences were not statistically significant in one study done in patients previously treated with radical prostatectomy. Regarding erectile function scores, three studies reported higher improvement on the erectile function scores for apomorphine. Differences with placebo were not clinically relevant in another two studies, one in which only diabetic patients were included and one in which only patients with radical prostatectomy were involved. Discontinuation of treatment due to adverse events was higher for apomorphine, particularly for higher doses. Available evidence suggests that sublingual apomorphine is more effective than placebo, except for patients previously treated with radical prostatectomy, and is generally well tolerated at doses of 2 or 3 mg. Nowadays, sublingual apomorphine is the only licensed oral drug for erectile dysfunction not absolutely contraindicated with nitrates use, and more RCTs should be performed to evaluate its effects and safety for treating ED.
舌下阿莫酚可能是不能服用磷酸二酯酶 5 抑制剂(例如,使用硝酸盐)的勃起功能障碍患者的选择。我们已经完成了一项系统评价,评估了舌下阿莫酚与安慰剂治疗勃起功能障碍的效果。证据检索过程于 2019 年 1 月 9 日结束。我们纳入了 9 项随机对照试验(RCT)。治疗时间从 4 周到 8 周不等,剂量从 2 毫克到 6 毫克不等。八项研究评估了每摄入剂量的阿莫酚的成功性交尝试的百分比。所有研究都发现阿莫酚优于安慰剂(与安慰剂相比,性交成功率提高了 6-27%),但在一项对先前接受根治性前列腺切除术治疗的患者进行的研究中,差异无统计学意义。关于勃起功能评分,三项研究报告了阿莫酚对勃起功能评分的更高改善。另外两项研究中,差异与安慰剂相比无临床意义,一项研究仅包括糖尿病患者,另一项研究仅包括根治性前列腺切除术患者。由于不良反应而停止治疗的患者中,阿莫酚更高,特别是高剂量。现有证据表明,舌下阿莫酚比安慰剂更有效,除了先前接受根治性前列腺切除术治疗的患者,并且在 2 毫克或 3 毫克剂量下通常耐受良好。如今,舌下阿莫酚是唯一一种获准用于勃起功能障碍的口服药物,与硝酸盐的使用没有绝对禁忌,应该进行更多的 RCT 来评估其治疗 ED 的效果和安全性。