Department of Epidemiology, University of Washington, Seattle, WA, USA.
Clin Infect Dis. 2013 Apr;56(7):934-42. doi: 10.1093/cid/cis1022. Epub 2012 Dec 7.
Azithromycin or doxycycline is recommended for nongonococcal urethritis (NGU); recent evidence suggests their efficacy has declined. We compared azithromycin and doxycycline in men with NGU, hypothesizing that azithromycin was more effective than doxycycline.
From January 2007 to July 2011, English-speaking males ≥16 years, attending a sexually transmitted diseases clinic in Seattle, Washington, with NGU (visible urethral discharge or ≥5 polymorphonuclear leukocytes per high-power field [PMNs/HPF]) were eligible for this double-blind, parallel-group superiority trial. Participants received active azithromycin (1 g) + placebo doxycycline or active doxycycline (100 mg twice daily for 7 days) + placebo azithromycin. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Ureaplasma urealyticum biovar 2 (UU-2), and Trichomonas vaginalis (TV) using nucleic acid amplification tests. Clinical cure (<5 PMNs/HPF with or without urethral symptoms and absence of discharge) and microbiologic cure (negative tests for CT, MG, and/or UU-2) were determined after 3 weeks.
Of 606 men, 304 were randomized to azithromycin and 302 to doxycycline; CT, MG, TV, and UU-2 were detected in 24%, 13%, 2%, and 23%, respectively. In modified intent-to-treat analyses, 172 of 216 (80%; 95% confidence interval [CI], 74%-85%) receiving azithromycin and 157 of 206 (76%; 95% CI, 70%-82%) receiving doxycycline experienced clinical cure (P = .40). In pathogen-specific analyses, clinical cure did not differ by arm, nor did microbiologic cure differ for CT (86% vs 90%, P = .56), MG (40% vs 30%, P = .41), or UU-2 (75% vs 70%, P = .50). No unexpected adverse events occurred.
Clinical and microbiologic cure rates for NGU were somewhat low and there was no significant difference between azithromycin and doxycycline. Mycoplasma genitalium treatment failure was extremely common. Clinical Trials Registration.NCT00358462.
阿奇霉素或强力霉素被推荐用于非淋球菌性尿道炎（NGU）；最近的证据表明，它们的疗效已经下降。我们比较了阿奇霉素和强力霉素在男性 NGU 中的疗效，假设阿奇霉素比强力霉素更有效。
从 2007 年 1 月到 2011 年 7 月，在西雅图一家性传播疾病诊所就诊的、年龄在 16 岁及以上、有 NGU（可见尿道分泌物或高倍镜下每高倍视野中≥5 个多形核白细胞[PMN/HPF]）的英语使用者有资格参加这项双盲、平行组优势试验。参与者接受阿奇霉素（1 g）+安慰剂强力霉素或强力霉素（100 mg 每日 2 次，连用 7 天）+安慰剂阿奇霉素。使用核酸扩增试验检测沙眼衣原体（CT）、生殖支原体（MG）、解脲脲原体生物变种 2（UU-2）和阴道毛滴虫（TV）。在 3 周后，根据以下标准评估临床治愈（PMN/HPF 计数<5 个且无尿道症状和分泌物）和微生物学治愈（CT、MG 和/或 UU-2 检测结果阴性）：
在 606 名男性中，304 名被随机分配至阿奇霉素组，302 名被分配至强力霉素组；分别检测到 24%、13%、2%和 23%的 CT、MG、TV 和 UU-2。在改良意向治疗分析中，阿奇霉素组 216 例中的 172 例（80%；95%置信区间[CI]，74%-85%）和强力霉素组 206 例中的 157 例（76%；95% CI，70%-82%）达到临床治愈（P =.40）。在病原体特异性分析中，各组之间的临床治愈率没有差异，CT（86% vs 90%，P =.56）、MG（40% vs 30%，P =.41）和 UU-2（75% vs 70%，P =.50）的微生物学治愈率也没有差异。未发生意外不良事件。
NGU 的临床和微生物学治愈率均较低，阿奇霉素和强力霉素之间无显著差异。生殖支原体治疗失败极为常见。
NCT00358462。
