Rudenko Nikolay, Dorofeyev Andrey
Department of Internal Medicine II, Medical University of Donetsk, Ukraine.
Arzneimittelforschung. 2005;55(7):420-7. doi: 10.1055/s-0031-1296881.
Three hundred and seventeen non pregnant females, suffering of recurrent lower urinary tract infections (UTIs; at least three episodes in the preceding 12 months) were enrolled in a double blind, randomized placebo (PL) controlled, parallel group clinical study, addressed to evaluate the efficacy and safety of fosfomycin trometamol (CAS 78964-85-9, FT, Monuril) in the prevention of infectious recurrences of lower urinary tract. One hundred and sixty six and 151 patients were allocated at random to FT or to PL treatment. The assigned treatment, i.e. one sachet containing FT equivalent to 3 g. of fosfomycin or PL, was taken by patients every 10 days during 6 months; thereafter they were followed up for another 6 consecutive months. Three hundred and two evaluable patients, completed the study as per protocol, 158 in the FT and 144 in the PL group, respectively. The analysis of the number of urinary tract infections/patient-year (primary end point) showed a result of 0.14 infections/patient-year in the FT group and of 2.97 infections/patient-year in the PL group. The difference was highly significant (p < 0.001). The time to first infection recurrence was significantly longer in the FT (38 days) than in the PL group (6 days); p < 0.01. The number of patients with at least one episode of recurrent infection and the number of episodes/patient during the treatment as well as during the follow-up period were statistically significantly lower in the FT group than in the PL group. Both treatments were well tolerated; only one adverse reaction possibly treatment related, i.e. an allergic skin reaction, was reported in both groups. Haematology and blood chemistry variables explored for safety at the end of the study did not show any significant difference between the two groups. The compliance with the treatment in the 302 evaluable patients was excellent. The results of this trial indicate that FT is higly effective in the prophylaxis of UTI recurrences; this beneficial effect is evident also in the 6 months of the follow-up.
317名患有复发性下尿路感染（UTIs；在过去12个月中至少发作三次）的非妊娠女性被纳入一项双盲、随机、安慰剂（PL）对照、平行组临床研究，旨在评估磷霉素氨丁三醇（CAS 78964-85-9，FT，Monuril）预防下尿路感染复发的疗效和安全性。166名和151名患者被随机分配接受FT或PL治疗。指定的治疗方法，即一袋含相当于3g磷霉素的FT或PL，患者每10天服用一次，持续6个月；此后，他们又连续随访6个月。302名可评估患者按方案完成了研究，FT组158名，PL组144名。对尿路感染/患者年数（主要终点）的分析显示，FT组为0.14次感染/患者年，PL组为2.97次感染/患者年。差异非常显著（p<0.001）。首次感染复发的时间在FT组（38天）明显长于PL组（6天）；p<0.01。FT组中至少有一次复发性感染的患者数量以及治疗期间和随访期间的发作次数/患者在统计学上显著低于PL组。两种治疗耐受性良好；两组均仅报告了一例可能与治疗相关的不良反应，即过敏性皮肤反应。研究结束时为安全性而检测的血液学和血液化学变量在两组之间未显示任何显著差异。302名可评估患者的治疗依从性极佳。该试验结果表明，FT在预防UTI复发方面非常有效；这种有益效果在随访的6个月中也很明显。
