Stoner B P, Douglas J M, Martin D H, Hook E W, Leone P, McCormack W M, Mroczkowski T F, Jones R, Yang J, Baumgartner T
Washington University School of Medicine, St Louis, Missouri 63110, USA.
Sex Transm Dis. 2001 Mar;28(3):136-42. doi: 10.1097/00007435-200103000-00003.
Treatment of gonorrhea is complicated by widespread resistance of Neisseria gonorrhoeae to antimicrobial agents of choice, including decreased susceptibility to ciprofloxacin.
To demonstrate the efficacy and safety of gatifloxacin, a novel 8-methoxy fluoroquinolone antibiotic, compared with ofloxacin in treating patients with uncomplicated gonococcal infection.
In a double-blind, randomized (2:2:1), controlled trial, 340 men and 388 women with uncomplicated gonorrhea who were 16 years or older received a single oral dose of gatifloxacin (400 mg or 600 mg) or ofloxacin (400 mg). Primary analysis of efficacy was based on bacteriologic eradication from sites of infection. Secondary analyses examined clinical response and adverse event profiles.
Bacteriologic eradication rates for gatifloxacin in evaluable men with urethral gonorrhea were 99% (400 mg) and 100% (600 mg) versus 100% for ofloxacin (n = 117, 122, and 55, respectively; P = ns). Eradication rates in evaluable women with endocervical gonorrhea were 99% for both 400 mg and 600 mg gatifloxacin versus 100% for ofloxacin (n = 101, 104, and 55, respectively; P = ns). Eradication rates were 100% for both rectal (n = 43) and pharyngeal (n = 31) infection across all treatment groups. All three drug regimens were well tolerated and exhibited similar clinical response profiles.
Gatifloxacin is safe and effective as a single 400-mg or 600-mg dose for the treatment of uncomplicated gonorrhea. Similar efficacy rates were observed with the 400-mg and 600-mg doses. A single 400-mg dose can be recommended for treatment of uncomplicated gonorrhea.
淋病奈瑟菌对首选抗菌药物广泛耐药，包括对环丙沙星敏感性降低，使得淋病治疗变得复杂。
证明新型8-甲氧基氟喹诺酮抗生素加替沙星与氧氟沙星相比，在治疗单纯性淋菌感染患者中的疗效和安全性。
在一项双盲、随机（2:2:1）对照试验中，340名年龄在16岁及以上的男性和388名患有单纯性淋病的女性接受了单次口服剂量的加替沙星（400毫克或600毫克）或氧氟沙星（400毫克）。疗效的主要分析基于感染部位细菌的根除情况。次要分析检查了临床反应和不良事件情况。
在可评估的患有尿道淋病的男性中，加替沙星（400毫克）的细菌根除率为99%，（600毫克）为100%，而氧氟沙星为100%（分别为n = 117、122和55；P = 无显著差异）。在可评估的患有宫颈淋病的女性中，400毫克和600毫克加替沙星的根除率均为99%，而氧氟沙星为100%（分别为n = 101、104和55；P = 无显著差异）。所有治疗组直肠（n = 43）和咽部（n = 31）感染的根除率均为100%。所有三种药物治疗方案耐受性良好，且临床反应情况相似。
加替沙星单次400毫克或600毫克剂量治疗单纯性淋病安全有效。400毫克和600毫克剂量的疗效相似。可推荐单次400毫克剂量用于治疗单纯性淋病。
