Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women.
Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women.
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多西环素预防可预防女性性传播感染。
DOI：
10.1056/nejmoa2304007
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Bukusi,ElizabethA
中科院分区：
文献类型：
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作者：
Stewart,Jenell;Oware,Kevin;Donnell,Deborah;Violette,LaurenR;Odoyo,Josephine;Soge,OlusegunO;Scoville,CaitlinW;Omollo,Victor;Mogaka,FelixO;Sesay,FrederickaA;McClelland,RScott;Spinelli,Matthew;Gandhi,Monica;Bukusi,ElizabethA
多西环素暴露后预防(PEP)已被证明可以预防顺性男性和变性人女性中的性传播感染(STI)，但涉及顺性女性的试验数据缺乏。方法我们在18至30岁接受暴露前预防人类免疫缺陷病毒(HIV)的肯尼亚妇女中进行了一项随机、开放的试验，比较了多西环素PEP(多西环素200 mg，在无避孕套发生性行为后72小时内服用)与标准护理。主要终点是任何沙眼衣原体、淋球菌或梅毒螺旋体的意外感染。每季度采集头发样本，以客观评估多西环素的使用。结果共449名参与者接受了随机分组，224人被分配到多西环素-PEP组，225人被分配到标准护理组。每季度对参与者进行为期12个月的跟踪调查。总共发生了109起事件性传播感染(多西环素-PEP组50例[25.1/100人年]，标准护理组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%可信区间0.60至1.29；P=0.51)。在109例发生的性传播感染中，衣原体感染占85例(78.0%)(强力环素-PEP组35例，标准护理组50例；相对危险度0.73；95%可信区间0.47-1.13)。试验调查人员认为没有严重的不良事件与多西环素有关，也没有发生艾滋病毒感染事件。在随机选择的50名多西环素-PEP组参与者中，200例头发样本中有58例检测到多西环素(29.0%)。全都是。淋球菌阳性分离株对多西环素耐药。结论在顺性女性中，使用多西环素PEP的性病发病率并不显著低于标准护理。根据头发样本分析，被分配接受多西环素PEP的人中，多西环素PEP的使用率很低。(由美国国立卫生研究院资助；dPEP ClinicalTrials.gov编号，NCT04050540。)
BackgroundDoxycycline 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.MethodsWe 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 withChlamydia trachomatis,Neisseria gonorrhoeae, orTreponema pallidum. Hair samples were collected quarterly for objective assessment of doxycycline use.ResultsA 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%). AllN. gonorrhoeae–positive isolates were resistant to doxycycline.ConclusionsAmong 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.)