磷霉素氨丁三醇治疗急性单纯性下尿路感染疗效和安全性分析

Analysis of efficacy and safety of fosfomycin-trometamol in treatment of acute uncomplicated lowerurinary tract infection

目的评价磷霉素氨丁三醇（FMT）治疗急性单纯性下尿路感染（LUTI）的疗效和安全性。方法收集2015年1月至2017年10月在青岛市市立医院住院接受FMT或左氧氟沙星（LEV）单药治疗的急性单纯性LUTI患者的病历资料进行回顾性分析。比较FMT组和LEV组患者临床疗效，细菌学疗效，尿培养细菌检出情况、检出菌株药物敏感试验结果，以及不良反应发生情况。结果FMT组纳入患者70例，男性31例，女性39例；年龄29-68岁，平均（51±10）岁；LEV组纳入患者56例，男性26例，女性30例；年龄31-66岁，平均（52±10）岁；疗程均为3-7 d，治疗前血常规和肝肾功能均正常。治疗后FMT组痊愈59例，显效5例，临床有效率为91.4%（64/70）；LEV组痊愈28例，显效4例，临床有效率为57.1%（32/56）；组间差异有统计学意义（χ^2=20.16，P＜0.001）。FMT组尿培养细菌阳性者46例，46株细菌中大肠埃希菌35株，其中产超广谱β内酰胺酶（ESBLs）菌株17株（48.6%）；变形杆菌3株，其中产ESBLs菌株1株；粪肠球菌3株；金黄色葡萄球菌3株；表皮葡萄球菌2株。LEV组尿培养细菌阳性者37例，37株细菌中大肠埃希菌29株，其中产ESBLs菌株14株（48.3%）；变形杆菌3株，其中产ESBLs菌株1株；粪肠球菌2株；表皮葡萄球菌2株；金黄色葡萄球菌1株。FMT组和LEV组细菌学有效率分别为91.3%（42/46）和56.8%（21/37），组间差异有统计学意义（χ^2=13.38，P＜0.001）。FMT组检出的产ESBLs大肠埃希菌对FMT的敏感率为76.5%（13/17），LEV组检出的产ESBLs大肠埃希菌对LEV的敏感率为35.7%（5/14），组间差异有统计学意义（P=0.033）。FMT组和LEV组不良反应发生率差异无统计学意义［11.4%（8/70）比16.1%（9/56）, χ^2=0.575，P=0.448］。结论FMT是一种治疗急性单纯性LUTI有效且安全的药物。

ObjectiveTo evaluate the efficacy and safety of fosfomycin-trometamol （FMT） in the treatment of acute uncomplicated lower urinary tract infection （LUTI）.MethodsThe medical records of acute uncomplicated LUTI patients, who had acute uncomplicated LUTI and received FMT or levofloxacin （LEV） in Qingdao Municipal Hospital from January 2015 to October 2017, were collected and analyzed retrospectively. Comparisons were made between the FMT group and the LEV group to investigate the patients＇ clinical efficacy, bacteriological efficacy, bacteria isolated from urine cultures, the susceptibility of isolated strains to drugs and the occurrence of adverse reactions.ResultsSeventy patients entered the FMT group, including 31 males and 39 females, aged from 29 to 68 years with an average age of （51±10） years.56 patients entered the LEV group, including 26 males and 30 females, aged from 31 to 66 years with an average age of （52±10） years.The treatment periods of patients in the two groups were 3 to 7 days. Routine blood tests and liver and renal function tests were normal before the treatment. After the treatments, 59 patients were cured, 5 patients improved, and the clinical efficacy was 91.4% （64/70） in the FMT group; while 28 patients were cured, 4 patients improved, and the clinical efficacy was 57.1% （32/56） in the LEV group. And the difference was statistically significant （χ^2=20.16, P〈0.001）. Positive bacteria were found in urine culture of 46 patients in the FMT group, including 35 strains of Escherichia coli[17 of which were extended-spectrum β-lactamases （ESBL）-producing Escherichia coli], 3 strains of Bacillus proteus [1 of which was ESBL-producing Bacillus proteus], 3 strains of Enterococous faecalis, 3 strains of Staphylococcus aureus, and 2 strains of Staphylococcus epidermidis. Positive bacteria were found in urine culture of 37 patients in the LEV group, including 29 strains of Escherichia coli （14 of which were ESBL-producing Escherichia coli）, 3 strains of Bacillus proteus （1 of which was ESBL-producing Bacillus proteus）, 2 strains of Enterococous faecalis, 1 strain of Staphylococcus aureus, and 2 strains of Staphylococcus epidermidis. Bacteriological efficacy were 91.3% and 56.8%, for the FMT group and the LEV group, respectively and the difference was statistically significant （χ^2=13.38, P〈0.001）. Thirteen of the 17 ESBL-producing Escherichia coli strains isolated from patients in the FMT group were susceptible to FMT （susceptibility rate： 76.5%）. Five of the 14 ESBL-producing Escherichia coli strains isolated from patients in the LEV group were susceptible to LEV （susceptibility rate： 35.7%）. And the difference was statistically significant （P=0.033）. The difference of the incidence of adverse reactions was not statistically significant between the FMT group and the LEV group [11.4% （8/70） vs 16.1% （9/56）, χ^2=0.575, P=0.448].ConclusionFMT was more effective and safer than LEV in the treatment of patients with acute uncomplicated LUTI.