Corona G, Tirabassi G, Santi D, Maseroli E, Gacci M, Dicuio M, Sforza A, Mannucci E, Maggi M
Endocrinology Unit, Maggiore-Bellaria Hospital, Medical Department, Azienda-Usl Bologna, Bologna, Italy.
Division of Endocrinology, Department of Clinical and Molecular Sciences, Umberto I Hospital, Polytechnic University of Marche, Ancona, Italy.
Andrology. 2017 Jul;5(4):671-678. doi: 10.1111/andr.12353. Epub 2017 Apr 28.
Despite their efficacy in the treatment of benign prostatic hyperplasia, the popularity of inhibitors of 5α-reductase (5ARIs) is limited by their association with adverse sexual side effects. The aim of this study was to review and meta-analyze currently available randomized clinical trials evaluating the rate of sexual side effects in men treated with 5ARIs. An extensive Medline Embase and Cochrane search was performed including the following words: 'finasteride', 'dutasteride', 'benign prostatic hyperplasia'. Only placebo-controlled randomized clinical trials evaluating the effect of 5ARI in subjects with benign prostatic hyperplasia were considered. Of 383 retrieved articles, 17 were included in this study. Randomized clinical trials enrolled 24,463 in the active and 22,270 patients in the placebo arms, respectively, with a mean follow-up of 99 weeks and mean age of 64.0 years. No difference was observed between trials using finasteride or dutasteride as the active arm considering age, trial duration, prostate volume or International Prostatic Symptoms Score at enrollment. Overall, 5ARIs determined an increased risk of hypoactive sexual desire [OR = 1.54 (1.29; 1.82); p < 0.0001] and erectile dysfunction [OR = 1.47 (1.29; 1.68); p < 0.0001]. No difference between finasteride and dutasteride regarding the risk of hypoactive sexual desire and erectile dysfunction was observed. Meta-regression analysis showed that the risk of hypoactive sexual desire and erectile dysfunction was higher in subjects with lower Q at enrollment and decreased as a function of trial follow-up. Conversely, no effect of age, low urinary tract symptom or prostate volume at enrollment as well as Q at end-point was observed. In conclusion, present data show that the use of 5ARI significantly increases the risk of erectile dysfunction and hypoactive sexual desire in subjects with benign prostatic hyperplasia. Patients should be adequately informed before 5ARIs are prescribed.
尽管5α-还原酶抑制剂（5ARIs）在治疗良性前列腺增生方面疗效显著，但其与不良性副作用的关联限制了其受欢迎程度。本研究的目的是回顾和荟萃分析目前可用的随机临床试验，评估接受5ARIs治疗的男性出现性副作用的发生率。对Medline、Embase和Cochrane进行了广泛检索，检索词包括：“非那雄胺”、“度他雄胺”、“良性前列腺增生”。仅纳入评估5ARI对良性前列腺增生患者疗效的安慰剂对照随机临床试验。在检索到的383篇文章中，本研究纳入了17篇。随机临床试验中，活性治疗组和安慰剂组分别纳入24463例和22270例患者，平均随访99周，平均年龄64.0岁。在以非那雄胺或度他雄胺作为活性治疗组的试验中，就年龄、试验持续时间、前列腺体积或入组时的国际前列腺症状评分而言，未观察到差异。总体而言，5ARIs导致性欲减退风险增加[比值比（OR）=1.54（1.29；1.82）；p<0.0001]和勃起功能障碍风险增加[OR=1.47（1.29；1.68）；p<0.0001]。在性欲减退和勃起功能障碍风险方面，未观察到非那雄胺和度他雄胺之间存在差异。荟萃回归分析表明，入组时Q值较低的受试者出现性欲减退和勃起功能障碍的风险较高，且该风险随试验随访时间的延长而降低。相反，未观察到年龄、入组时的下尿路症状或前列腺体积以及终点时的Q值有影响。总之，目前的数据表明，使用5ARI会显著增加良性前列腺增生患者出现勃起功能障碍和性欲减退的风险。在开具处方前，应充分告知患者相关情况。
