Elexacaftor/tezacaftor/ivacaftor (Trikafta) was approved by the Food and Drug Administration in October 2019 for treatment of cystic fibrosis (CF) in patients 12 years and older with at least one F508del mutation in the CFTR protein. There were no documented reports of testicular pain during clinical trials. In this case series, we discuss 7 males between 17 and 39 years of age who reported testicular pain or discomfort within the first two weeks of starting therapy. The precise mechanism of this side effect is unknown, but it may be related to restoration of CFTR function in the male reproductive tract. All patients experienced resolution of this side effect within a week after onset, regardless of the management, except for one. Further research is needed to determine short- and long-term impact of this drug on male fertility. Until more data is available, the authors recommend counseling patients on contraceptive options.

中文翻译：

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在患有囊性纤维化的男性中开始使用 elexacaftor/tezacaftor/ivacaftor 后的睾丸疼痛

Elexacaftor/tezacaftor/ivacaftor (Trikafta) 于 2019 年 10 月获得美国食品和药物管理局的批准，用于治疗 CFTR 蛋白中至少有一个 F508del 突变的 12 岁及以上患者的囊性纤维化 (CF)。临床试验期间没有睾丸疼痛的记录报告。在本病例系列中，我们讨论了 7 名 17 至 39 岁的男性，他们在开始治疗的前两周内报告了睾丸疼痛或不适。这种副作用的确切机制尚不清楚，但可能与男性生殖道中 CFTR 功能的恢复有关。所有患者在发病后一周内都经历了这种副作用的消退，无论管理如何，除了一个。需要进一步的研究来确定这种药物对男性生育能力的短期和长期影响。