Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection
Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection
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DOI：
10.1007/s10620-017-4564-4
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发表时间：
2017-06-01
影响因子：
3.1
通讯作者：
Wang, Li
中科院分区：
文献类型：
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作者：
Fu, Wei;Song, Zhiqiang;Wang, Li
根除幽门螺杆菌感染仍然是一个挑战，特别是在不适合服用青霉素的患者中。头孢菌素有可能取代阿莫西林治疗H.为了比较阿莫西林和头孢呋辛四联疗法在初治患者中的有效性、安全性和依从性，在这项开放标签的随机对照研究中，400例幽门螺杆菌感染患者接受了阿莫西林和头孢呋辛四联疗法。幽门螺杆菌感染分为含阿莫西林（埃索美拉唑20 mg两次/天，阿莫西林1000 mg两次/天，左氧氟沙星500 mg一次/天，铋剂220 mg两次/天，持续14天）或含头孢呋肟（埃索美拉唑20 mg两次/天，头孢呋辛500 mg两次/天，左氧氟沙星500 mg一次/天，铋剂220 mg，2次/d，连用14 d。根除后1-3 d评价安全性和依从性。根除后8-12周进行尿素呼气试验以确定治疗结果，两组基线数据包括抗生素耐药性均匹配良好。含阿莫西林和头孢呋肟的四联疗法组之间的根除率无显著差异[意向治疗分析：83.5%（95%置信区间78.3-88.7%）vs. 81.0%（75.5-86.5%），P = 0.513;改良意向治疗分析：90.3%（86.0-94.6%）vs. 88.5%（83.9-93.2%），P = 0.586;符合方案分析：91.6%（87.5-95.7%）vs. 89.8%（85.3-94.3%），P = 0.560]。不良反应发生率（18.4 vs. 20.1%，P = 0.678）和依从性（94.7 vs. 94.2%，P = 0.813）也相似。变量分析显示抗生素耐药性和依从性差是根除失败的独立危险因素，埃索美拉唑、铋剂、左氧氟沙星、阿莫西林或头孢呋辛在一线H.根除幽门头孢呋辛可能是一种很好的替代阿莫西林的根除药物，对于不适合使用青霉素的患者。
The eradication of Helicobacter pylori infection remains a challenge, especially in the patients unsuitable to take penicillin. Cephalosporin has the potential to replace amoxicillin for H. pylori eradication.To compare the effectiveness, safety, and compliance of amoxicillin- and cefuroxime-containing quadruple regimens in treatment-na < ve patients.In this open-label randomized control study, 400 patients with H. pylori infection were divided into amoxicillin-containing (esomeprazole 20 mg twice/day, amoxicillin 1000 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) or cefuroxime-containing (esomeprazole 20 mg twice/day, cefuroxime 500 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) quadruple therapy groups. The safety and compliance were assessed 1-3 days after eradication. Urea breath test was performed 8-12 weeks after eradication to determine treatment outcome.The baseline data including antibiotic resistance were well matched between the two groups. The eradication rates between amoxicillin- and cefuroxime-containing quadruple therapy groups were not significantly different [intention-to-treat analysis: 83.5% (95% confidence interval 78.3-88.7%) vs. 81.0% (75.5-86.5%), P = 0.513; modified intention-to-treat analysis: 90.3% (86.0-94.6%) vs. 88.5% (83.9-93.2%), P = 0.586; per-protocol analysis: 91.6% (87.5-95.7%) vs. 89.8% (85.3-94.3%), P = 0.560]. The incidence of adverse effects (18.4 vs. 20.1%, P = 0.678) and compliance (94.7 vs. 94.2%, P = 0.813) were also similar. Variate analyses showed that antibiotic resistance and poor compliance were the independent risk factors for eradication failure.Esomeprazole, bismuth, levofloxacin, and amoxicillin or cefuroxime achieved similar and relatively satisfactory cure rates, safety, and compliance in first-line H. pylori eradication. Cefuroxime may be a good alternative medicine for eradication instead of amoxicillin for the patients unsuitable to take penicillin.