莫西沙星治疗急性胆道感染的多中心随机对照研究

A multi-centric randomized controlled trial of sequential intravenous moxifloxacin in comparison to for the treatment of acute biliary tract infection

目的探讨莫西沙星治疗急性胆道感染的有效性及安全性。方法采用多中心、前瞻性、随机、对照、非盲平行研究，选择中国13家医院普外科2009年3—12月间急性胆道感染患者319例，随机人组后在外科治疗的同时给予莫西沙星400mg，1次／d静脉点滴为A组；B组采用头孢哌酮／舒巴坦（2．0g2次／d静脉点滴）联合甲硝唑（250ml1次／d静脉点滴）作为阳性对照，比较两组对急性胆道感染治疗的临床有效性和细菌学疗效，同时观察治疗期间的不良事件。统计学分析对主要疗效指标采用Wilcoxon秩和检验比较两组差别，统计学检验均采用双侧检验，安全性分析中对两组不良事件和不良反应的发生率采用X^2或Fisher确切概率法，P〈0．05为差异有统计学意义。结果在A组人选的159例患者中有138例进入疗效评价，B组有160例患者人选，其中144例进入评价，两组基线情况相似。A组疗程（7．6±2．6）d，治疗总有效率为86．2％，B组疗程（8±3）d，治疗有效率为84．7％，差异无统计学意义（P=0．7192）。两组从血液或胆汁中分别分离出55株和61株细菌，主要分离菌为大肠埃希菌、肺炎克雷伯杆菌和肠球菌，清除率分别为85．4％和82．0％，两组差异无统计学意义（X^2=0．2568，P=0．6123）。两组用药期间均无严重不良事件发生，依从性良好。结论大肠埃希菌、肺炎克雷伯杆菌、肠球菌是胆道感染主要致病菌。莫西沙星单药可安全有效治疗急性胆道感染，疗效不亚于头孢哌酮／舒巴坦＋甲硝唑联合治疗。

Objective To compare the efficacy and safety of sequential intravenous moxifloxacin treatment against eefoperazone/sulbactam in patients with acute biliary tract infection. Methods A prospective, randomized, non-blind, multi-centric study was performed to compare the efficacy and safety of moxifloxacin 400 mg IV once daily to cefoperazone-sulbactam （2 g q12 hours） and metronidazole 250 ml once daily to treat patients, from March -December 2009 in 13 hospitals, with acute biliary tract infection. The primary efficacy variable was clinical cure rate after the end of a 5 - 14 day treatment period, bacteriologic outcomes and adverse reaction effects were also determined. Results A total of 319 subjects were enrolled, 282 of whom were eligible for protocol efficacy analyses （ 138 moxifloxacin, 144 comparator）. Demographic and baseline medical characteristics were similar between the 2 groups. Clinical success rates were 86. 2% for moxifloxacin and 84.7% for the comparator（P = 0. 7192）. Pathogens （55 moxifloxacin, 61 comparator） were isolated from bile or blood cultures and the predominant strains were E. coli, Klebsiella spccies and Enterococcus species. Bacterial eradication rates were 85.4% （37 of 55 ） with moxifloxacin versus 82.0% （50 of 61 ） in the comparator group （ X2 = 0. 2568, P = 0. 6123 ）. Both treatments were safe and well tolerated. Conclusions E. coli, Klebsiella species and Enterococcus species were the most common bacteria isolated from bile or blood from patients with acute biliary tract infection. Moxifloxacin monotherapy has high clinical and bacteriological efficacies and safety for the treatment of acute biliary tract infection.