【摘要】 目的:比较莫西沙星与左氧氟沙星+甲硝唑治疗我国单纯性盆腔炎(PID)患者的有效性及安全性。方法:选取来自全国6家医院的306例单纯性PID患者,前瞻性、随机、对照、双盲法将患者分为A组(莫西沙星组,151例)和B组(左氧氟沙星+甲硝唑组,155例),对患者进行病原微生物检查及治疗。A组患者给予莫西沙星(400mg口服,每天1次×14天);B组患者给予左氧氟沙星(500mg口服,每天1次×14天)+甲硝唑(500mg口服,每天2次×14天)。于患者治疗开始第4天、治疗结束后第14天、治疗结束后第28天进行随访。结果:治疗结束后14天,符合方案(PP)人群A、B组的临床治愈率分别为79.71%和79.69%,无显著差异(P=0.9823)。治疗结束后14天,PP人群A组和B组的病原学清除率分别为84.2%和81.3%,无显著差异(P=0.9227)。治疗结束后28天,PP人群A、B组的临床持续治愈率分别为79.71%和79.69%,无显著差异(P=0.9931)。治疗结束后28天,PP人群A组和B组的病原学持续清除率分别为68.4%和81.3%,无显著差异(P=0.4078)。结论:莫西沙星与左氧氟沙星+甲硝唑治疗PID患者,都具有很好的疗效和安全性。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of Moxifloxacin vs levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease(uPID) in China.Methods: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/or at laparoscopic examination) and not requiring intravenous treatment.Women received a 14day course of either oral Moxifloxacin,400mg once daily,or oral levofloxacin,500mg once daily,plus oral metronidazole,500mg twice daily.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(PP).Other measures were clinical response during therapy and at 4-week follow-up,microbiological response at TOC,and safety.Results:A total of 306 subjects were randomized,including 151 cases in Moxifloxacin group and 155 cases in Levofloxacin plus Metronidazole group.For the primary measure of efficacy(clinical cure at TOC),Moxifloxacin was non-inferior to levofloxacin plus metronidazole(79.7% and 79.7% in Moxifloxacin group and Levofloxacin plus Metronidazole group respectively,P=0.9823).Bacteriological success rates were high and comparable between treatment arms(In the PP population,bacterial clearance rates at TOC visit in MBV subjects was 84.2% and 81.3% in Moxifloxacin group and Levofloxacin plus Metronidazole group respectively,P=0.9227)).For the second measure of efficacy(clinical cure at TOC),Moxifloxacin was non-inferior to levofloxacin plus metronidazole(79.7% and 79.7% in Moxifloxacin group and Levofloxacin plus Metronidazole group respectively,P=0.9931).Success rates were high and comparable between treatment arms(In the PP population,bacterial clearance rates at TOC visit in MBV subjects was 68.4% and 81.3% in Moxifloxacin group and Levofloxacin plus Metronidazole group respectively,P=0.4078).Conclusion:Moxifloxacin monotherapy,400 mg once daily for 14 days,is an effective and well-tolerated oral treatment for women with uPID.更多还原