Henry D, Ellison W, Sullivan J, Mansfield D L, Magner D J, Dorr M B, Talbot G H
Foothill Family Clinic, Salt Lake City, Utah, USA.
Antimicrob Agents Chemother. 1998 Sep;42(9):2262-6. doi: 10.1128/AAC.42.9.2262.
The efficacy and safety of a 3-day regimen of sparfloxacin were compared with those of a 3-day regimen of ofloxacin for the treatment of community-acquired acute uncomplicated urinary tract infections. Four hundred nineteen women were enrolled in a randomized, open-label, observer-blinded, multicenter study; 204 received sparfloxacin as a 400-mg loading dose on the first day and 200 mg once daily thereafter, and 215 received ofloxacin as 200 mg twice daily. A total of 383 patients met the criteria for clinical evaluability, and 174 were also bacteriologically evaluable; all treated patients were included in the safety analysis. Escherichia coli (86%) and Staphylococcus saprophyticus (4.6%) were the organisms most commonly isolated. Positive clinical responses were obtained 5 to 9 days after therapy in more than 92% of the patients in each group; sustained clinical cure rates 4 to 6 weeks after therapy were 78.3 and 76.9% in the sparfloxacin and ofloxacin groups, respectively. A positive bacteriologic response was observed in 98% of the bacteriologically evaluable patients in each treatment group at 5 to 9 days posttherapy and in 88.2 and 92.6% of the patients in the sparfloxacin and ofloxacin groups, respectively, 4 to 6 weeks after therapy. Almost 90% of all adverse events were of mild or moderate severity; the most frequent events at least possibly related to drug treatment were those common to the fluoroquinolones, namely, nausea, diarrhea, headache, insomnia, and photosensitivity. Photosensitivity was more frequent in the sparfloxacin group (6.9% versus 0.5% in the ofloxacin group); insomnia was more frequent in the ofloxacin group (3.7% versus 1.0% in the sparfloxacin group). These data suggest that a once-daily, 3-day regimen of sparfloxacin is effective and generally well tolerated in the treatment of acute uncomplicated urinary tract infections.
比较了司帕沙星3日疗法与氧氟沙星3日疗法治疗社区获得性急性单纯性尿路感染的疗效和安全性。419名女性参与了一项随机、开放标签、观察者盲法、多中心研究；204名患者首日接受400mg负荷剂量的司帕沙星，之后每日一次200mg，215名患者接受氧氟沙星每日两次、每次200mg的治疗。共有383名患者符合临床可评价标准，174名患者也符合细菌学可评价标准；所有接受治疗的患者均纳入安全性分析。最常分离出的病原体为大肠埃希菌（86%）和腐生葡萄球菌（4.6%）。每组超过92%的患者在治疗后5至9天获得了阳性临床反应；治疗后4至6周，司帕沙星组和氧氟沙星组的持续临床治愈率分别为78.3%和76.9%。各治疗组中，98%的细菌学可评价患者在治疗后5至9天出现阳性细菌学反应，司帕沙星组和氧氟沙星组分别有88.2%和92.6%的患者在治疗后4至6周出现阳性细菌学反应。几乎90%的不良事件为轻度或中度严重程度；至少可能与药物治疗相关的最常见事件是氟喹诺酮类常见的事件，即恶心、腹泻、头痛、失眠和光敏反应。光敏反应在司帕沙星组中更常见（6.9%，而氧氟沙星组为0.5%）；失眠在氧氟沙星组中更常见（3.7%，而司帕沙星组为1.0%）。这些数据表明，司帕沙星每日一次、3日疗法在治疗急性单纯性尿路感染方面有效且一般耐受性良好。
