Pôle de Gynécologie, Obstétrique et Reproduction, Maternité Régionale Universitaire de Nancy, Université Henri-Poincaré, 10 rue du Dr Heydenreich, Nancy, France.
BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.
To evaluate the efficacy and safety of moxifloxacin versus levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease (uPID) in Asia.
Prospective, randomised, double-blind, double-dummy, parallel-group study.
Multicentre, multinational study in the inpatient and/or outpatient setting.
Women (aged ≥18 years) with uPID (defined as PID with no pelvic or tubo-ovarian abscess on pelvic ultrasonography and at laparoscopic examination) and not requiring intravenous treatment.
Women received a 14-day course of either oral moxifloxacin, 400 mg once daily, or oral levofloxacin, 500 mg once daily, plus oral metronidazole, 500 mg twice daily. Additionally, a single dose of ceftriaxone, 250 mg intramuscularly, was administered to women who had a positive screening test for Neisseria gonorrhoeae.
The primary measure of efficacy was clinical response at test-of-cure (TOC) (7-14 days after the last dose of study drug) in the per-protocol population. Non-inferiority of moxifloxacin to the comparator regimen was demonstrated if lower limit of 95% CI was >-15%. Other measures were clinical response during therapy and at 4-week follow up, microbiological response at TOC, and safety.
A total of 460 women were randomised to the study. For the primary measure of efficacy (clinical cure at TOC), moxifloxacin was noninferior to levofloxacin plus metronidazole (moxifloxacin: 152/194, 78.4%; comparator 155/190, 81.6%; 95% CI -10.7 to +4.9). The most commonly isolated pathogens at baseline included Neisseria gonorrhoeae, Chlamydia trachomatis, Escherichia coli, Staphylococcus aureus, Peptostreptococcus spp., Proteus mirabilis, Streptococcus agalactiae and Klebsiella pneumoniae. Bacteriological success rates were high and comparable between treatment arms (microbiologically valid populations, moxifloxacin 27/30, 90.0%; comparator 22/26, 84.6%; 95% CI -12.7 to +20.3). Both treatments were well tolerated.
Moxifloxacin monotherapy, 400 mg once daily for 14 days, is an effective and well-tolerated oral treatment for women with uPID.
评估莫西沙星与左氧氟沙星加甲硝唑治疗亚洲单纯性盆腔炎（uPID）的疗效和安全性。
前瞻性、随机、双盲、双模拟、平行组研究。
多中心、多国研究，包括住院和/或门诊环境。
患有 uPID（定义为经盆腔超声和腹腔镜检查无盆腔或输卵管卵巢脓肿的 PID）且无需静脉治疗的年龄≥18 岁的女性。
女性接受为期 14 天的治疗，每日一次口服莫西沙星 400mg，或每日一次口服左氧氟沙星 500mg，加每日两次口服甲硝唑 500mg。此外，对于淋球菌筛查试验阳性的女性，给予单次肌内注射头孢曲松 250mg。
基于方案人群的治疗后评估（治疗结束后 7-14 天）的临床应答是主要疗效测量指标。如果 95%置信区间（CI）下限＞-15%，则表明莫西沙星不劣于对照方案。其他疗效测量指标包括治疗期间和 4 周随访时的临床应答、治疗结束时的微生物学应答以及安全性。
共有 460 名女性被随机分配至研究。对于主要疗效测量指标（治疗结束时的临床治愈），莫西沙星不劣于左氧氟沙星加甲硝唑（莫西沙星：152/194，78.4%；对照 155/190，81.6%；95%CI-10.7 至 +4.9）。基线时最常见的分离病原体包括淋病奈瑟菌、沙眼衣原体、大肠埃希菌、金黄色葡萄球菌、消化链球菌属、奇异变形杆菌、无乳链球菌和肺炎克雷伯菌。治疗后细菌学成功率较高，且两种治疗方案的成功率相当（微生物学有效人群，莫西沙星 27/30，90.0%；对照 22/26，84.6%；95%CI-12.7 至 +20.3）。两种治疗方案均具有良好的耐受性。
莫西沙星单药治疗，每日一次 400mg，疗程 14 天，是治疗女性 uPID 的一种有效且耐受良好的口服治疗方法。
