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Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study
Judlin, P.1; Liao, Q.2; Liu, Z.2; Reimnitz, P.3; Hampel, B.4; Arvis, P.5
关键词Levofloxacin metronidazole moxifloxacin uncomplicated pelvic inflammatory disease
刊名BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
2010-11-01
DOI10.1111/j.1471-0528.2010.02687.x
117期:12页:1475-1484
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Obstetrics & Gynecology
资助者GlaxoSmithKline ; Sanofi-Pasteur-MSD ; Bayer HealthCare ; Bayer HealthCare AG, Leverkusen, Germany ; GlaxoSmithKline ; Sanofi-Pasteur-MSD ; Bayer HealthCare ; Bayer HealthCare AG, Leverkusen, Germany
研究领域[WOS]Obstetrics & Gynecology
关键词[WOS]SEXUALLY-TRANSMITTED-DISEASES ; IN-VITRO ACTIVITY ; NEISSERIA-GONORRHOEAE ; OUTPATIENT TREATMENT ; RANDOMIZED-TRIAL ; BAY 12-8039 ; TREATMENT-GUIDELINES ; 8-METHOXY QUINOLONE ; CLINICAL-TRIALS ; DOUBLE-BLIND
英文摘要

Objective

To evaluate the efficacy and safety of moxifloxacin versus levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease (uPID) in Asia.

Design

Prospective, randomised, double-blind, double-dummy, parallel-group study.

Setting

Multicentre, multinational study in the inpatient and/or outpatient setting.

Population

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.

Methods

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.

Main outcome measures

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. Noninferiority 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.

Results

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.

Conclusions

Moxifloxacin monotherapy, 400 mg once daily for 14 days, is an effective and well-tolerated oral treatment for women with uPID.

语种英语
资助者GlaxoSmithKline ; Sanofi-Pasteur-MSD ; Bayer HealthCare ; Bayer HealthCare AG, Leverkusen, Germany ; GlaxoSmithKline ; Sanofi-Pasteur-MSD ; Bayer HealthCare ; Bayer HealthCare AG, Leverkusen, Germany
WOS记录号WOS:000282878800006
引用统计
被引频次:23[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/65447
专题北京大学第一临床医学院
作者单位1.Bayer Schering Pharma, Loos, France
2.Bayer Schering Pharma, Berlin, Germany
3.Bayer Vital GmbH, Leverkusen, Germany
4.Univ Henri Poincare, Maternite Reg Univ Nancy, F-54042 Nancy, France
5.Peking Univ, Hosp 1, Dept Obstet & Gynaecol, Beijing, Peoples R China
推荐引用方式
GB/T 7714
Judlin, P.,Liao, Q.,Liu, Z.,et al. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study[J]. BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY,2010,117(12):1475-1484.
APA Judlin, P.,Liao, Q.,Liu, Z.,Reimnitz, P.,Hampel, B.,&Arvis, P..(2010).Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study.BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY,117(12),1475-1484.
MLA Judlin, P.,et al."Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study".BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY 117.12(2010):1475-1484.
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