Klimberg Ira, Shockey Gerald, Ellison Howard, Fuller-Jonap Freida, Colgan Richard, Song James, Keating Karen, Cyrus Pamela
Florida Foundation for Healthcare Research, Ocala, FL 34474, USA.
Curr Med Res Opin. 2005 Aug;21(8):1241-50. doi: 10.1185/030079905x56358.
Few studies have investigated symptom relief in urinary tract infections. This innovative exploratory trial aimed to measure the time to improvement of the signs and symptoms of uncomplicated urinary tract infection (UTI) in women receiving extended-release ciprofloxacin. Time to return to normal daily activities was also evaluated.
An open-label, multicenter US study in adult female outpatients with uncomplicated UTI. Patients completed serial questionnaires: the Urinary tract infection Symptom Assessment [USA], tracking time to symptom improvement, and the Activity Impairment Assessment [AIA], measuring the time to return to normal daily activities, using hand-held electronic diaries. Severity on the USA questionnaire was categorized using a 4-point Likert-type scale, with improvement defined as a reduction of at least one degree of symptom severity. All patients received once-daily extended-release ciprofloxacin 500 mg tablets for 3 days.
Of 276 female patients aged 18-78 years who enrolled at 28 sites, 273 (99%) were safety-valid, 264 (96%) completed at least 24 h of questionnaires and were valid for symptom relief analysis, and 170 (62%) had pre-therapy pathogen(s) > or = 10(3) CFU/mL and were valid for efficacy analysis. Six hours after the first dose of study drug, 50% of patients reported symptom improvement; 87% by 24 h and 91% by 48 h. At study entry, 54% of patients reported considerably decreased time at work or other activities; reduced to 23% by Day 2 and 10% by Day 3. At the test-of-cure visit (5-11 days post-therapy), 96% (163/170) of patients were clinical cures. Drug-related adverse events were reported by 18 (7%) patients and were consistent with previous extended-release ciprofloxacin studies (e.g., gastrointestinal disturbance, fungal superinfections). There were no serious adverse events or discontinuations due to adverse events.
This open-label, non-comparative trial in adult women demonstrated a rapid improvement in uncomplicated UTI symptom severity (6-24 h) and the ability to return to work within 24 h following extended-release ciprofloxacin treatment. Clinical cure rate and tolerability profile were similar to results of previous extended-release ciprofloxacin studies.
很少有研究调查过尿路感染症状的缓解情况。这项创新性探索性试验旨在测定接受缓释环丙沙星治疗的女性单纯性尿路感染（UTI）体征和症状改善所需的时间。还评估了恢复正常日常活动所需的时间。
在美国进行的一项开放标签、多中心研究，对象为患有单纯性UTI的成年女性门诊患者。患者使用手持式电子日记完成一系列问卷：尿路感染症状评估问卷[USA]，用于追踪症状改善时间；活动障碍评估问卷[AIA]，用于测量恢复正常日常活动所需的时间。USA问卷的严重程度采用4级李克特量表进行分类，症状改善定义为症状严重程度至少降低一级。所有患者均接受每日一次的500毫克缓释环丙沙星片剂治疗，为期3天。
在28个研究点入组的276名年龄在18 - 78岁的女性患者中，273名（99%）安全性有效，264名（96%）完成了至少24小时的问卷调查且对症状缓解分析有效，170名（62%）治疗前病原体≥10³CFU/mL且对疗效分析有效。在首次服用研究药物6小时后，50%的患者报告症状有所改善；24小时时为87%，48小时时为91%。在研究开始时，54%的患者报告工作或其他活动时间大幅减少；到第2天降至23%，第3天降至10%。在治疗结束访视（治疗后5 - 11天）时，96%（163/170）的患者临床治愈。18名（7%）患者报告了与药物相关的不良事件，与之前的缓释环丙沙星研究一致（如胃肠道不适、真菌二重感染）。没有严重不良事件，也没有因不良事件而停药的情况。
这项针对成年女性的开放标签、非对照试验表明，单纯性UTI症状严重程度在接受缓释环丙沙星治疗后迅速改善（6 - 24小时），且能够在24小时内恢复工作。临床治愈率和耐受性与之前缓释环丙沙星研究的结果相似。
