Guo Tao, Wang Qiang, Wu Xi, Li Xiao Qing, Li Yue, Fei Gui Jun, Shu Hui Jun, Li Jing Nan, Qian Jia Ming
Department of Gastroenterology,PUMC Hospital,CAMS and PUMC,Beijing 100730,China.
Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Feb 28;41(1):75-79. doi: 10.3881/j.issn.1000-503X.11025.
Objective To evaluate the efficacy and safety of amoxicillin-clarithromycin-containing bismuth quadruple regimen as a primary therapy for Helicobacter pylori (Hp) eradication.Methods A total of 102 Hp-infected outpatients diagnosed by C-or C-urea breath test from December 2015 to June 2017 were enrolled and received 14-day bismuth quadruple therapy (esomeprazole 20 mg bid,bismuth potassium citrate 220 mg bid,amoxicillin 1000 mg bid,and clarithromycin 500 mg bid for 14 days). Hp status was assessed by C-or C-urea breath test 4 weeks,8 weeks,6 months,and 12 months after the treatment. The primary outcome was Hp eradication rate,which was analyzed by intention-to-treat (ITT) and per-protocol (PP) analyses. The second outcomes were Hp infection recurrence,symptomatic benefit from Hp eradication,and safety. Results A total of 101 patients,of which 65 patients had dyspeptic symptoms before eradication,completed the study. Hp eradication rates by ITT analysis and by PP analysis were 88.2% and 89.1%,respectively. Only in two of 84 patients,who were followed for 8 weeks after eradication,Hp became positive. No Hp recurrence happened at the 6-month and 12-month follow-up and the annual recurrence rate was 2.4%. The symptomatic relief rates at the 4-week,8-week,6-month and 12-month follow-up were 81.5%,75.4%,71.2%,and 70.2% respectively. Eleven of 101 patients had mild and similar side-effects,which were well tolerated.Conclusion Amoxicillin-clarithromycin-containing bismuth quadruple regimen can be used as the standard therapy for Hp eradication.
目的 评估含阿莫西林-克拉霉素的铋剂四联方案作为根除幽门螺杆菌（Hp）一线治疗方案的疗效和安全性。方法 选取2015年12月至2017年6月期间，经碳-13或碳-14尿素呼气试验确诊为Hp感染的102例门诊患者，给予14天铋剂四联疗法（埃索美拉唑20 mg，每日2次；枸橼酸铋钾220 mg，每日2次；阿莫西林1000 mg，每日2次；克拉霉素500 mg，每日2次，疗程14天）。治疗后4周、8周、6个月和12个月采用碳-13或碳-14尿素呼气试验评估Hp状态。主要结局为Hp根除率，采用意向性分析（ITT）和符合方案分析（PP）。次要结局为Hp感染复发、根除Hp后的症状改善情况及安全性。结果 共101例患者完成研究，其中65例患者根除前有消化不良症状。ITT分析和PP分析的Hp根除率分别为88.2%和89.1%。根除治疗后8周随访的84例患者中仅2例Hp复阳。6个月和12个月随访均无Hp复发，年复发率为2.4%。4周、8周、6个月和12个月随访时症状缓解率分别为81.5%、75.4%、71.2%和70.2%。101例患者中有11例出现轻微且相似的副作用，耐受性良好。结论 含阿莫西林-克拉霉素的铋剂四联方案可作为根除Hp的标准治疗方案。
