Vogel Thomas, Verreault René, Gourdeau Marie, Morin Michèle, Grenier-Gosselin Lise, Rochette Louis
Unité de recherche en gériatrie de l'Université Laval, Québec.
CMAJ. 2004 Feb 17;170(4):469-73.
The optimal duration of antibiotic therapy in older patients with uncomplicated urinary tract infection (UTI) is still a matter of debate. The aim of this randomized controlled double-blind noninferiority trial was to compare the efficacy and safety of 3-day and 7-day courses of oral ciprofloxacin for uncomplicated symptomatic UTI in older women.
A total of 183 women at least 65 years of age with acute uncomplicated UTI were recruited from ambulatory clinics and hospital acute care units. Patients with pyelonephritis, contraindications to fluoroquinolones, recent use of antibiotics, urinary tract abnormalities and diabetes mellitus were excluded. Women were randomly assigned to receive either ciprofloxacin 250 mg twice daily orally for 3 days followed by placebo for 4 days (the 3-day group, 93 patients) or ciprofloxacin 250 mg twice daily orally for 7 days (the 7-day group, 90 patients). Bacterial eradication, clinical improvement and occurrence of adverse events were determined 2 days after completion of treatment, and occurrence of reinfection or relapse were determined 6 weeks after completion of treatment. Bacterial eradication and relapse were determined by urine culture. Double-blind procedures were maintained throughout data collection.
The proportion of patients with bacterial eradication at 2 days after treatment was 98% (91/93) in the 3-day group and 93% (83/89) in the 7-day group (p = 0.16). The frequency of adverse events, including drowsiness, headache, nausea or vomiting, and loss of appetite, was significantly lower in the 3-day group.
These results suggest that a 3-day course of antibiotic therapy is not inferior to a 7-day course for treatment of uncomplicated symptomatic UTI in older women, and that the shorter course is better tolerated.
老年单纯性尿路感染（UTI）患者抗生素治疗的最佳疗程仍存在争议。这项随机对照双盲非劣效性试验的目的是比较口服环丙沙星3天疗程与7天疗程治疗老年女性单纯性症状性UTI的疗效和安全性。
从门诊和医院急症科招募了183名至少65岁的急性单纯性UTI女性患者。排除患有肾盂肾炎、对氟喹诺酮类药物有禁忌证、近期使用过抗生素、尿路异常和糖尿病的患者。女性患者被随机分配接受以下两种治疗：每日口服250mg环丙沙星，每日两次，共3天，随后4天服用安慰剂（3天组，93例患者）；或每日口服250mg环丙沙星，每日两次，共7天（7天组，90例患者）。在治疗结束后2天确定细菌清除情况、临床改善情况和不良事件的发生情况，在治疗结束后6周确定再感染或复发的发生情况。通过尿培养确定细菌清除和复发情况。在整个数据收集过程中保持双盲程序。
3天组治疗后2天细菌清除的患者比例为98%（91/93），7天组为93%（83/89）（p = 0.16）。3天组包括嗜睡、头痛、恶心或呕吐以及食欲不振在内的不良事件发生率显著较低。
这些结果表明，对于老年女性单纯性症状性UTI的治疗，3天疗程的抗生素治疗并不劣于7天疗程治疗，且较短疗程的耐受性更好。
