Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study
Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study
复制标题
交替使用诺氟沙星和利福昔明作为肝硬化腹水患者自发性细菌性腹膜炎一级预防的有效性和安全性：一项前瞻性随机开放标签多中心比较研究
DOI：
10.1007/s12072-015-9688-z
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发表时间：
2016-03-01
影响因子：
6.6
通讯作者：
El-Azab, G.
中科院分区：
文献类型：
--
作者：
Assem, M.;Elsabaawy, M.;El-Azab, G.
自发性细菌性腹膜炎（SBP）的一级预防是降低腹水型腹膜炎患者发病率和死亡率的重要策略。利福昔明和诺氟沙星交替作为一级预防的有效性和安全性值得怀疑。（千分之一日元1.1）腹水，腹水中的蛋白质水平低于1.5 g/dL，伴有晚期肝病（Child-Pugh评分> 9分，血清胆红素水平> 3 mg/dL）或肾损害（血清肌酸酐水平> 1.2 mg/dL，血尿素氮水平> 25 mg/dL，或血清钠水平< 130 mEq/L）纳入开放标签，一项旨在比较交替使用诺氟沙星和利福昔明与单用诺氟沙星或利福昔明作为SBP一级预防的随机研究。治疗6个月后，通过评估腹水中性粒细胞计数进行意向治疗和符合方案疗效分析。对所有意向性治疗人群进行安全性分析，诺氟沙星和利福昔明交替治疗的预防效果上级意向性治疗（74.7% vs. 56.4% vs. 68.3%，p < 0.048）。成对分析显示，在意向治疗（p = 0.016）和符合方案分析（p = 0.039）中，与基于去甲阿那霉素的方案相比，交替方案发生SBP的概率较低。研究组间不良事件的发生率和严重程度无差异。与诺氟沙星单药治疗相比，交替使用诺氟沙星和利福昔明作为SBP的一级预防治疗具有更高的疗效和相同的安全性。
Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable.Three hundred thirty-four cirrhotic patients with high SAAG (a parts per thousand yen1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score > 9 points with serum bilirubin level > 3 mg/dL) or renal impairment (serum creatinine level > 1.2 mg/dL, blood urea nitrogen level > 25 mg/dL, or serum sodium level < 130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations.Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4 % vs. 68.3 %, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported.Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.