澳大利亚墨尔本大学Jane S. Hocking团队研究了阿奇霉素或多西环素治疗无症状性直肠沙眼衣原体感染的疗效。该研究成果发表在2021年6月23日出版的《新英格兰医学杂志》上。

直肠沙眼衣原体是男男性行为中常见的细菌性传播感染。需要随机对照试验的数据来指导治疗。

研究组在澳大利亚5家性健康诊所进行了一项双盲试验，招募发生过男男性行为且直肠沙眼衣原体感染无症状的患者，将其随机分组，分别接受多西环素或阿奇霉素治疗，均为期7天。选择无症状直肠沙眼衣原体感染者作为该试验重点人群，是因为超过85%的男性直肠沙眼衣原体感染是无症状的，而根据临床指南建议，有症状感染需进行较长治疗。主要结局是4周时直肠沙眼衣原体核酸扩增试验阴性（微生物学治愈）。

2016年8月至2019年8月，研究组共招募了625名男性，其中多西环素组314名，阿奇霉素组311名。多西环素组290名（92.4%）男性、阿奇霉素组297名（95.5%）男性的主要结局数据可用。在改良意向治疗人群中，多西环素组中有281名（96.9%）发生了微生物学治愈，显著高于阿奇霉素组（76.4%）。多西环素组有98名（33.8%）男性报道了恶心、腹泻和呕吐等不良事件，阿奇霉素组有134名（45.1%）。

研究结果表明，男性性行为后直肠沙眼衣原体感染的患者接受多西环素7天治疗的效果显著优于单剂量阿奇霉素。

附：英文原文

Title: Azithromycin or Doxycycline for Asymptomatic Rectal Chlamydia trachomatis

Author: Andrew Lau, M.S.,, Fabian Y.S. Kong, Ph.D.,, Christopher K. Fairley, Ph.D.,, David J. Templeton, Ph.D.,, Janaki Amin, Ph.D.,, Samuel Phillips, Ph.D.,, Matthew Law, Ph.D.,, Marcus Y. Chen, Ph.D.,, Catriona S. Bradshaw, Ph.D.,, Basil Donovan, M.D.,, Anna McNulty, M.D.,, Mark A. Boyd, M.D.,, Peter Timms, Ph.D.,, Eric P.F. Chow, Ph.D.,, David G. Regan, Ph.D.,, Carole Khaw, M.D.,, David A. Lewis, Ph.D.,, John Kaldor, Ph.D.,, Mahesh Ratnayake, M.D.,, Natalie Carvalho, Ph.D.,, and Jane S. Hocking, Ph.D.

Issue&Volume: 2021-06-23

Abstract:

Background

Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment.

Methods

In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receive doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks.

Results

From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, 11.3 percentage points; 95% CI, 19.5 to 3.2).

Conclusions

A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men.

DOI: 10.1056/NEJMoa2031631

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2031631