The Efficacy and Safety of Gentamicin Plus Azithromycin and Gemifloxacin Plus Azithromycin as Treatment of Uncomplicated Gonorrhea
The Efficacy and Safety of Gentamicin Plus Azithromycin and Gemifloxacin Plus Azithromycin as Treatment of Uncomplicated Gonorrhea
复制标题
DOI：
10.1093/cid/ciu521
复制
发表时间：
2014-10-15
影响因子：
11.8
通讯作者：
Hook, Edward W., III
中科院分区：
文献类型：
--
作者：
Kirkcaldy, Robert D.;Weinstock, Hillard S.;Hook, Edward W., III
背景资料。头孢曲松是目前推荐的淋病治疗的基础。迫切需要为头孢菌素过敏或疑似耐头孢菌素淋球菌感染的患者提供后备治疗方案。我们评估了现有的2种非头孢菌素类抗菌药物联合治疗泌尿生殖道淋病患者的疗效和耐受性。我们在阿拉巴马州、加利福尼亚州、马里兰州和宾夕法尼亚州的5个门诊性传播疾病诊所进行了一项随机、多点、开放标签、非对照试验。将15~60岁无并发症的泌尿生殖道淋病患者随机分为庆大霉素240 mg肌肉注射加阿奇霉素2g口服和吉米沙星320 mg加阿奇霉素2g口服。主要结果是在治疗后10-17天，401名参与者中的401名患者的泌尿生殖道感染微生物治愈(阴性随访培养)。接受庆大霉素/阿奇霉素治疗的202名可评价参与者中，微生物治愈的比例为100%(单侧确切95%可信区间下限，98.5%)；接受吉米沙星/阿奇霉素治疗的199名可评价参与者中，微生物治愈比例为99.5%(单侧确切95%可信区间下限，97.6%)。庆大霉素/阿奇霉素治愈10例咽部感染和1例直肠感染，双氧氟沙星/阿奇霉素治愈15例咽部感染和5例直肠感染。胃肠道不良反应在两臂均较常见。庆大霉素/阿奇霉素和吉米沙星/阿奇霉素治疗泌尿生殖道淋病疗效较好。胃肠道不良事件可能会限制常规使用。对于不能用头孢菌素抗菌药物治疗的患者来说，这些非头孢菌素类药物可能是有用的替代方案。淋病的其他治疗选择也是必要的。
Background. Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing non-cephalosporin antimicrobials for treatment of patients with urogenital gonorrhea.Methods. We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15-60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10-17 days after treatment among 401 participants in the per protocol population.Results. Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms.Conclusions. Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed.