Costantini Elisabetta, Zucchi Alessandro, Salvini Eleonora, Cicalese Annarita, Li Marzi Vincenzo, Filocamo Maria Teresa, Bini Vittorio, Lazzeri Massimo
Urology Department, University of Perugia, S. M. Misericordia Hospital, S. Andrea delle Fratte, 06123, Perugia, Italy.
Int Urogynecol J. 2014 Sep;25(9):1173-8. doi: 10.1007/s00192-013-2318-1. Epub 2014 Feb 20.
This multicentre, randomised, non-blinded, parallel group study is designed to assess the null hypothesis that a 3-month prophylactic schedule with fosfomycin is not inferior to prulifloxacin in reducing the number of urinary tract infection episodes during and after prophylaxis in female patients with recurrent urinary tract infections (rUTIs).
One hundred and fifty-two patients with rUTIs who were candidates for prophylaxis therapy were enrolled and randomised to prulifloxacin (group 1) or fosfomycin (group 2). The prophylaxis regimen included a single dose of fosfomycin (one 3-g cachet) per week, or a single dose (600 mg) of prulifloxacin (one tablet) a week for 12 weeks. The inclusion criteria were female patients over 18 years, urine culture responsiveness to drugs at patient recruitment and history of rUTI. Exclusion criteria were pregnancy and counter-indications to this drug therapy. Patients were prospectively randomised. Check-ups were scheduled at 2 weeks, 1 month and 3 months from the beginning of the study and 3, 6, and 12 months after suspension of the therapy. The primary end-points were the reduction of the number of UTIs (negative urine culture) during and after prophylaxis.
Final data analysis included 67 patients in group 1 and 57 in group 2. Nine out of 76 patients (group 1) and 19 out of 76 (group 2) dropped out. UTI episodes were significantly reduced in number compared with before prophylaxis (p < 0.0001) at all study end-points in both groups. No significant differences were found in disease-free duration, as achieved by the two therapy groups (log-rank test; p = 0.41), in the reduction of UTI episodes during and after prophylaxis, in the adverse effects or improved quality of life.
Both drugs provided adequate prophylaxis in patients with rUTIs, with no difference in efficacy.
本多中心、随机、非盲、平行组研究旨在评估零假设，即在复发性尿路感染（rUTI）女性患者的预防期间及之后，为期3个月的磷霉素预防方案在减少尿路感染发作次数方面不劣于普利沙星。
152例适合预防治疗的rUTI患者入组并随机分为普利沙星组（第1组）或磷霉素组（第2组）。预防方案包括每周单剂量磷霉素（1个3克的胶囊）或每周单剂量（600毫克）普利沙星（1片），共12周。纳入标准为18岁以上女性患者、入组时尿培养对药物有反应以及有rUTI病史。排除标准为妊娠和该药物治疗的禁忌证。患者进行前瞻性随机分组。从研究开始起2周、1个月和3个月以及治疗暂停后3、6和12个月安排检查。主要终点是预防期间及之后尿路感染次数的减少（尿培养阴性）。
最终数据分析包括第1组的67例患者和第2组的57例患者。76例患者中第1组有9例、第2组有19例退出。两组在所有研究终点时，尿路感染发作次数与预防前相比均显著减少（p < 0.0001）。在无病持续时间、预防期间及之后尿路感染发作次数的减少、不良反应或生活质量改善方面，两个治疗组均未发现显著差异（对数秩检验；p = 0.41）。
两种药物对rUTI患者均提供了充分的预防作用，疗效无差异。
