Stein G E
Department of Medicine, Michigan State University, East Lansing 48824, USA.
Clin Ther. 1999 Nov;21(11):1864-72. doi: 10.1016/S0149-2918(00)86734-X.
This multicenter clinical trial compared single-dose fosfomycin tromethamine with a 7-day course of nitrofurantoin for the treatment of acute uncomplicated lower urinary tract infection (UTI) in female patients. Healthy females with symptoms of acute uncomplicated UTI were enrolled in a double-masked, randomized clinical trial. Assessable patients had >10(5) colony-forming units per milliliter of a uropathogen in a clean-voided midstream urine sample. Patients received a single 3-g dose of fosfomycin tromethamine plus 7 days of placebo capsules or a single 3-g dose of placebo plus 7 days of nitrofurantoin monohydrate/macrocrystal 100-mg capsules. Treatment efficacy was assessed by both bacteriologic and clinical response 5 to 11 days after the initial treatment dose (visit 2) and 5 to 11 days (visit 3) and 4 to 6 weeks (visit 4) after the last day of medication. Of the 749 patients initially enrolled in the study, 375 received fosfomycin and 374 received nitrofurantoin. There were no clinical differences in patient characteristics between the 2 groups at study entry. Overall, 94% of pretreatment isolates were susceptible to fosfomycin and 83% were susceptible to nitrofurantoin. Bacteriologic cure rates at the first follow-up visit (5 to 11 days after initiation of treatment) were 78% and 86% for fosfomycin and nitrofurantoin, respectively (P = 0.02). At visit 3 (1 week posttreatment), they were 87% and 81% for fosfomycin and nitrofurantoin, respectively (P = 0.17). Both treatment groups had an 80% overall clinical success rate (cure and improvement). Twenty patients (5.3%) who received fosfomycin and 21 patients (5.6%) who received nitrofurantoin reported an adverse effect related to study medication. The most common side effects related to fosfomycin treatment were diarrhea (2.4%), vaginitis (1.8%), and nausea (0.8%). Both bacteriologic and clinical cure rates observed with a single 3-g dose of fosfomycin were comparable to those achieved with a 7-day course of nitrofurantoin in female patients with acute uncomplicated UTI.
这项多中心临床试验比较了单剂量磷霉素氨丁三醇与7天疗程的呋喃妥因用于治疗女性患者急性单纯性下尿路感染（UTI）的疗效。有急性单纯性UTI症状的健康女性被纳入一项双盲随机临床试验。可评估的患者在清洁中段尿样本中每毫升尿病原体的菌落形成单位>10(5)。患者接受单次3克剂量的磷霉素氨丁三醇加7天的安慰剂胶囊，或单次3克剂量的安慰剂加7天的100毫克一水合呋喃妥因/大晶体胶囊。在初始治疗剂量后5至11天（访视2）、用药最后一天后5至11天（访视3）和4至6周（访视4），通过细菌学和临床反应评估治疗效果。在最初纳入研究的749例患者中，375例接受了磷霉素治疗，374例接受了呋喃妥因治疗。研究开始时两组患者的特征在临床上无差异。总体而言，94%的治疗前分离株对磷霉素敏感，83%对呋喃妥因敏感。在首次随访（治疗开始后5至11天）时，磷霉素和呋喃妥因的细菌学治愈率分别为78%和86%（P = 0.02）。在访视3（治疗后1周）时，磷霉素和呋喃妥因的细菌学治愈率分别为87%和81%（P = 0.17）。两个治疗组的总体临床成功率（治愈和改善）均为80%。接受磷霉素治疗的20例患者（5.3%）和接受呋喃妥因治疗的21例患者（5.6%）报告了与研究用药相关的不良反应。与磷霉素治疗相关的最常见副作用是腹泻（2.4%）、阴道炎（1.8%）和恶心（0.8%）。在患有急性单纯性UTI的女性患者中，单次3克剂量的磷霉素观察到的细菌学和临床治愈率与7天疗程的呋喃妥因相当。
