Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial.
Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial.
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患有细菌性阴道病的女性男性性伴侣的治疗：一项随机、双盲、安慰剂对照试验。
DOI：
10.1093/cid/ciaa1903
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Sobel,JackD
中科院分区：
文献类型：
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作者：
Schwebke,JaneR;Lensing,ShellyY;Lee,Jeannette;Muzny,ChristinaA;Pontius,Angela;Woznicki,Nicole;Aguin,Tina;Sobel,JackD
背景我们的目的是确定对复发性细菌性阴道病（BV）女性的男性性伴侣口服甲硝唑2次/天，连续7天（即多剂量甲硝唑）是否能显着降低女性BV复发率。方法这是一项多中心、双臂、双盲、安慰剂对照研究。入组了复发性BV和目前经Amsel和Nugent诊断为BV的女性。多剂量甲硝唑7天分发给妇女。男性伴侣被随机分为安慰剂组和多剂量甲硝唑组，持续7天，并要求他们在14天内避免无保护措施的性行为。在第21、8和16周进行雌性随访访视。在第14-21天进行男性随访。以16周为主要终点，将BV治愈定义为女性伴侣Amsel标准0-2分和Nugent评分0-6分。在意向治疗人群中，治疗组之间的主要结局无显著差异。在第三次随访中，甲硝唑组和安慰剂组分别有81%和80%的女性发生BV治疗失败（P> 0.999）。 然而，男性伴侣坚持研究药物的女性治疗失败的可能性较小（调整后的相对风险，0.85; 95%CI，0.73 - 0.99;P= 0.035）。 这一发现持续在事后比较在metronidazole arm.ConclusionsOverall，这项研究没有发现，男性伴侣治疗与多剂量甲硝唑显着降低BV复发的女性partners.Clinical Trials注册（NCT 02209519），虽然女性的合作伙伴坚持多剂量甲硝唑不太可能失败。
BackgroundWe aimed to determine if treatment of male sexual partners of women with recurrent bacterial vaginosis (BV) with oral metronidazole 2×/day for 7 days (ie, multidose metronidazole) significantly decreased BV recurrence rates in the female.MethodsThis was a multicenter, 2-arm, double-blind, placebo-controlled study. Women with recurrent BV and current diagnosis of BV by Amsel and Nugent were enrolled. Multidose metronidazole for 7 days was dispensed to women. Male partners were randomized to placebo versus multidose metronidazole for 7 days and asked to refrain from unprotected sex for 14 days. Female follow-up visits were conducted at day 21 and 8 and 16 weeks. Male follow-up visits occurred at days 14–21. BV cure was defined as 0–2 Amsel criteria and Nugent score 0–6 in the female partner with the primary endpoint at 16 weeks.Results214 couples were enrolled. In the intent-to-treat population, there was no significant difference between treatment arms for the primary outcome. BV treatment failure occurred in 81% and 80% of women in the metronidazole and placebo arms through the third follow-up visit, respectively (P> .999). However, women whose male partners adhered to study medication were less likely to fail treatment (adjusted relative risk, .85; 95% CI, .73–.99;P= .035). This finding persisted in post hoc comparisons in the metronidazole arm.ConclusionsOverall, this study did not find that male partner treatment with multidose metronidazole significantly reduces BV recurrence in female partners, although women whose partners adhered to multidose metronidazole were less likely to fail treatment.Clinical Trials Registration(NCT02209519).