本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2304007

摘要内容如下：

背景

多西环素暴露后预防（PEP）已被证明可预防顺性别男性和变性女性的性传播感染（STIs），但缺乏涉及顺性别女性的试验数据。

方法

我们进行了一项随机、开放标签试验，在18至30岁的肯尼亚妇女中比较了多西环素PEP（盐酸多西环素，在无避孕套性交后72小时内服用200 mg）与标准护理，这些妇女正在接受人类免疫缺陷病毒（HIV）的暴露前预防。主要终点是沙眼衣原体、淋病奈瑟菌或梅毒螺旋体感染的任何事件。每季度收集头发样本，以客观评估多西环素的使用情况。

结果

共有449名参与者接受了随机分组。224人被分配到强力霉素-PEP组，225人被分配到标准护理组。参与者在12个月内每季度随访一次。共有109例性传播感染发生（强力霉素-PEP组50例[25.1/100人-年]，标准治疗组59例[29.0/100人-年]），组间发病率无显著差异（相对危险度0.88；95%置信区间[CI]，0.60至1.29；P=0.51）。在109例性传播感染中，衣原体感染占85例（78.0%）（强力霉素-PEP组35例，标准护理组50例；相对危险度为0.73；95%置信区间，0.47至1.13）。试验研究人员认为没有严重不良事件与强力霉素有关，也没有发生HIV感染事件。在强力霉素-PEP组随机选择的50名参与者中，200份头发样本中有58份（29.0%）检测到强力霉素。所有淋球菌阳性分离株均对强力霉素耐药。

结论

在顺性别的女性中，使用强力霉素PEP的STI发病率并未显著低于使用标准护理的STI发病率。根据头发样本分析，在指定接受强力霉素PEP的人群中，强力霉素PEP的使用率较低。（由美国国立卫生研究院资助；DPEP ClinicalTrials.gov编号，NCT04050540。）

英文原文如下：

Abstracts

BACKGROUND  Doxycycline postexposure prophylaxis (PEP) has been shown to prevent sexually transmitted infections (STIs) among cisgender men and transgender women, but data from trials involving cisgender women are lacking.

METHODS  We conducted a randomized, open-label trial comparing doxycycline PEP (doxycycline hyclate, 200 mg taken within 72 hours after condomless sex) with standard care among Kenyan women 18 to 30 years of age who were receiving preexposure prophylaxis against human immunodeficiency virus (HIV). The primary end point was any incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, or Treponema pallidum. Hair samples were collected quarterly for objective assessment of doxycycline use.

RESULTS  A total of 449 participants underwent randomization; 224 were assigned to the doxycycline-PEP group and 225 to the standard-care group. Participants were followed quarterly over 12 months. A total of 109 incident STIs occurred (50 in the doxycycline-PEP group [25.1 per 100 person-years] and 59 in the standard-care group [29.0 per 100 person-years]), with no significant between-group difference in incidence (relative risk, 0.88; 95% confidence interval [CI], 0.60 to 1.29; P = 0.51). Among the 109 incident STIs, chlamydia accounted for 85 (78.0%) (35 in the doxycycline-PEP group and 50 in the standard-care group; relative risk, 0.73; 95% CI, 0.47 to 1.13). No serious adverse events were considered by the trial investigators to be related to doxycycline, and there were no incident HIV infections. Among 50 randomly selected participants in the doxycycline-PEP group, doxycycline was detected in 58 of 200 hair samples (29.0%). All N. gonorrhoeae-positive isolates were resistant to doxycycline.

CONCLUSIONS  Among cisgender women, the incidence of STIs was not significantly lower with doxycycline PEP than with standard care. According to hair-sample analysis, the use of doxycycline PEP among those assigned to receive it was low. (Funded by the National Institutes of Health; dPEP ClinicalTrials.gov number, NCT04050540.).

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