Page 114 - 《中国药房》2025年14期

高剂量艾普拉唑联合阿莫西林用于老年新发幽门螺杆菌感染患

者的临床研究
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李 辰 ，王玉静 ，毛建娜 ，郭 皓 ，沈裕厚 ，董志超 ，闫彬彬 （1. 新乡市中心医院消化内科，河南 新乡
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453001；2.新乡市中心医院肿瘤外科，河南 新乡 453001；3.河南省人民医院消化内科，郑州 450003）
中图分类号 R975 文献标志码 A 文章编号 1001-0408（2025）14-1792-05
DOI 10.6039/j.issn.1001-0408.2025.14.18
摘 要 目的 评价高剂量艾普拉唑联合阿莫西林用于老年新发幽门螺杆菌（Hp）感染患者的疗效及安全性，分析Hp感染根除治
疗失败的独立危险因素。方法 选取2021年8月1日至2024年12月1日就诊于新乡市中心医院的200例老年新发Hp感染患者，
按随机数字表法分为对照组和研究组，每组各100例。对照组患者给予经典四联方案（阿莫西林胶囊+克拉霉素片+枸橼酸铋钾
片+艾普拉唑肠溶片），研究组患者给予高剂量艾普拉唑肠溶片+阿莫西林胶囊，所有患者均用药2周。比较意向性治疗（ITT）、方
案治疗（PP）分析集中两组患者的Hp根除率，记录两组患者的不良反应发生情况；采用多因素Logistic回归分析筛选影响Hp感染
根除治疗失败的独立危险因素。结果 ITT及PP分析集中，两组患者的Hp根除率比较，差异均无统计学意义（P＞0.05）。两组患
者的轻、中度不良反应发生率比较，差异均无统计学意义（P＞0.05）。体重指数（BMI）≤18.5 kg/m 、BMI＞23.9 kg/m 、农村居住、
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合并糖尿病及合并心脏病经分析确定为影响Hp感染根除治疗失败的独立危险因素（P＜0.05）。结论 高剂量艾普拉唑联合阿莫
西林用于老年新发Hp感染患者的疗效和安全性均与经典四联方案相当。BMI≤18.5 kg/m 、BMI＞23.9 kg/m 、农村居住、合并糖
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尿病及合并心脏病是Hp感染根除治疗失败的独立危险因素。
关键词 幽门螺杆菌；高剂量二联疗法；艾普拉唑；阿莫西林；意向性治疗；方案治疗；老年患者

Clinical study on high-dose ilaprazole combined with amoxicillin for newly diagnosed elderly patients with
Helicobacter pylori infection
LI Chen ，WANG Yujing ，MAO Jianna ，GUO Hao ，SHEN Yuhou ，DONG Zhichao ，YAN Binbin（1. Dept. of
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Gastroenterology， Xinxiang Central Hospital， Henan Xinxiang 453001， China；2. Dept. of Oncological Surgery，
Xinxiang Central Hospital， Henan Xinxiang 453001， China；3. Dept. of Gastroenterology， Henan Provincial
People’s Hospital， Zhengzhou 450003， China）
ABSTRACT OBJECTIVE To evaluate the efficacy and safety of high-dose ilaprazole combined with amoxicillin for newly
diagnosed elderly patients with Helicobacter pylori （Hp） infection， and analyze independent risk factors for failure of Hp infection
eradication treatment. METHODS Totally 200 cases of newly diagnosed elderly patients with Hp infection in Xinxiang Central
Hospital from August 1， 2021 to December 1， 2024 were selected and randomly divided into control group and study group， with
100 cases in each group. The control group was treated with classic quadruple therapy regimen （Amoxicillin capsules+
Clarithromycin tablets+Bismuth potassium citrate tablets+Ilaprazole enteric-coated tablets）. The study group was treated with high-
dose Ilaprazole enteric-coated tablets+Amoxicillin capsules. All patients were administered medication for 2 weeks. Hp eradication
rates in the two groups were compared using intention-to-treat （ITT） and per-protocol （PP） analyses. The incidence of adverse
reactions in both groups was also recorded. The multiple-factor Logistic regression analysis was used to identify independent risk
factors for failure of Hp infection eradication treatment. RESULTS In ITT and PP analyses， there was no significant difference of
Hp eradication rates between the two groups （P＞0.05）. There was no significant difference in incidence of mild to moderate
adverse reactions between the two groups （P＞0.05）. BMI ≤18.5 kg/m ， BMI ＞23.9 kg/m ， rural residence， concomitant diabetes
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and concomitant heart disease were identified as independent risk factors influencing the failure of Hp infection eradication
treatment （P＜0.05）. CONCLUSIONS The efficacy and safety of high-dose ilaprazole combined with amoxicillin are comparable to
classic quadruple therapy regimen in treating newly diagnosed elderly patients with Hp infection. Independent risk factors
influencing the failure of Hp infection eradication treatment
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Δ 基金项目 河南省医学科技攻关计划项目（No.LHGJ20210913） include BMI ≤18.5 kg/m ， BMI ＞23.9 kg/m ， rural residence，
＊第一作者 主治医师，硕士。研究方向：消化内科常见病、疑难病 concomitant diabetes and concomitant heart disease.
的临床研究。E-mail：lichen12126@163.com KEYWORDS Helicobacter pylori； high-dose dual therapy；
# 通信作者 主任医师，硕士。研究方向：消化内科常见病、疑难病 ilaprazole； amoxicillin； intention-to-treat； per-protocol； elderly
的临床研究。E-mail：a20250220111@163.com patient

· 1792 · China Pharmacy 2025 Vol. 36 No. 14 中国药房 2025年第36卷第14期