澳大利亚墨尔本大学Catriona S. Bradshaw课题组的最新研究揭示了男性伴侣治疗预防细菌性阴道病复发。这一研究成果于2025年3月6日发表在国际顶尖学术期刊《新英格兰医学杂志》上。

背景:细菌性阴道病影响三分之一的育龄妇女，复发是常见的。伴侣之间细菌性阴道炎相关生物体的性交换证据表明，男性伴侣治疗可能会增加治愈的可能性。

方法:这项开放标签、随机对照试验涉及一对夫妻，其中一名女性患有细菌性阴道病，并与一名男性伴侣保持一夫一妻制关系。在伴侣治疗组，女性接受一线推荐的抗菌药物治疗，男性伴侣接受口服和局部抗菌治疗（甲硝唑400毫克片和2%克林霉素乳膏涂抹于阴茎皮肤，每日两次，连续7天）。在对照组中，女性接受一线治疗，男性伴侣不接受治疗（标准治疗）。主要结局是细菌性阴道病在12周内复发。

结果:共有81对夫妇被分配到伴侣治疗组，83对夫妇被分配到对照组。在150对夫妇完成了12周的随访期后，数据和安全监测委员会停止了这项试验，因为对女性的治疗低于对女性和男性伴侣的治疗。在修改意向治疗人群中，伴侣治疗组69名妇女中有24名（35%）发生复发(复发率，1.6 /人/年；95%可信区间，1.1 - 2.4)，对照组68名女性中有43名（63%）(复发率，4.2人/年；95% CI, 3.2 ~ 5.7)，对应于每人年复发的绝对风险差异为2.6 (95% CI, 4.0 ~ 1.2；P＜0.001)。治疗男性的不良事件包括恶心、头痛和金属味。

研究结果表明，在治疗女性细菌性阴道病的同时，对男性伴侣进行口服和局部抗菌药物联合治疗，使细菌性阴道病在12周内的复发率低于标准治疗。

附：英文原文

Title: Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis

Author: Lenka A. Vodstrcil, Erica L. Plummer, Christopher K. Fairley, Jane S. Hocking, Matthew G. Law, Kathy Petoumenos, Deborah Bateson, Gerald L. Murray, Basil Donovan, Eric P. F. Chow, Marcus Y. Chen, John Kaldor, Catriona S. Bradshaw

Issue&Volume: 2025-03-06

Abstract: BACKGROUND

Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis–associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure.

METHODS

This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks.

RESULTS

A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of 2.6 recurrences per person-year (95% CI, 4.0 to 1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.

CONCLUSIONS

The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care.

DOI: NJ202503063921006

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2405404