莫西沙星与环丙沙星+甲硝唑预防重症急性胰腺炎腹腔感染的随机对照研究

Randomized controlled trial of moxifloxacin vs ciprofloxacin plus arilin in the prevention of abdominal infection in severe acute pancreatitis

目的评价莫西沙星对重症胰腺炎患者感染预防的有效性和安全性。方法采用随机、双盲、对照开放试验。临床确诊重症急性胰腺炎的患者随机分为实验组与对照组,实验组每日应用莫西沙星400mg,对照组每日应用环丙沙星400mg+甲硝唑1.25g,疗程均为7～14d,记录两组患者生命体征、APACHⅡ评分、血常规、肝肾功能以及恶心、呕吐、腹痛、腹胀等,统计患者感染发生率及死亡率。结果两组均有28例患者纳入本研究,各有26、25例可进行疗效评价,各组有24例可进行安全性评价。腹腔感染发生率实验组为14.3%,对照组为17.9%;不良反应发生率实验组为15.3%,对照组为20%。结论在急性胰腺炎预防性应用抗生素治疗中,单用莫西沙星可达到环丙沙星+甲硝唑联用同样的效果。

Objective To evaluate the efficacy and safety of moxifloxacin in the prevention of infection in severe acute pancreatitis. Methods Patients with severe acute pancreatitis were randomly arranged to receive either moxifloxacin 400 mg for 7 - 14 days or ciprofloxacin 400 mg plus arilin 1.25 g for 7--14 days. Their vital sign,APACH Ⅱ score, blood routine, liver function and renal function, as well as objective signs such as nausea, vomiting, abdominal pain and distension were recorded. Their death rate and incidence of infection were analyzed. Results There were 28 patients enrolled in each group ： 26 in moxifloxacin group and 25 in ciprofloxacin plus arilin group could receive curative effect evaluation, and 24 patients in each group could receive safety evaluation. The incidence of abdominal infection in moxifloxacin group and ciprofloxacin plus arilin group was 14.3 % and 17.9 % respectively. The incidence of adverse effect in moxifloxacin group and ciprofloxacin plus arilin group was 15.3 % and 20 % respectively. Conclusion Single-agent moxifloxacin therapy had the same effect as the ciprofloxacin plus arilin therapy in the prophylactic antibiotics treatment in severe acute pancreatitis.