| 摘要: |
| 目的 探讨钾离子竞争性酸阻滞剂伏诺拉生治疗幽门螺杆菌感染的疗效及安全性。方法 选择2020年 5月至2021年12月在我院接受基于伏诺拉生四联方案治疗的幽门螺杆菌感染患者60例（伏诺拉生治疗组），治疗方案为富马酸伏诺拉生片20 mg早晚各1次口服、胶体果胶铋胶囊150 mg 3次/d口服、阿莫西林胶囊1.0 g早晚各 1次口服、克拉霉素片500 mg早晚各1次口服，持续用药2周。采用回顾性配对研究设计，选择同期接受基于质子泵抑制剂兰索拉唑四联方案治疗的幽门螺杆菌感染患者60例（兰索拉唑治疗组），治疗方案为兰索拉唑肠溶片 30 mg早晚各1次口服、胶体果胶铋胶囊150 mg 3次/d口服、阿莫西林胶囊1.0 g早晚各1次口服、克拉霉素片 500 mg早晚各1次口服，持续用药2周。统计两组患者幽门螺杆菌根除情况、服药依从性及不良反应（如恶心、呕吐、腹痛、腹泻和皮疹等）发生情况，纳入所有患者进行意向性分析，排除依从性差及失访患者后进行符合方案分析。结果 120例患者中失访5例，其中兰索拉唑治疗组失访4例，伏诺拉生治疗组失访1例。兰索拉唑治疗组和伏诺拉生治疗组患者的服药依从性分别为94.6%（53/56）和96.6%（57/59），差异无统计学意义（P＞0.05）。按照意向性和符合方案分析，伏诺拉生治疗组患者的幽门螺旋杆菌根除率分别为93.3%（56/60）和98.2%（56/57），高于兰索拉唑治疗组的76.7%（46/60）和86.8%（46/53），差异均有统计学意义（P均＜0.05）。伏诺拉生治疗组用药过程中出现食欲减退1例、腹泻1例，兰索拉唑治疗组用药过程中出现恶心2例、腹部不适1例，两组不良反应发生率差异无统计学意义［3.33%（2/60） vs 5.00%（3/60），P＞0.05］。结论 基于伏诺拉生四联方案治疗幽门螺杆菌感染的疗效优于基于兰索拉唑四联方案，2种方案的治疗安全性和服药依从性相当。 |
| 关键词: 幽门螺杆菌感染 伏诺拉生 质子泵抑制剂 治疗结果 安全性 |
| DOI：10.16781/j.CN31-2187/R.20220708 |
| 投稿时间：2022-09-03修订日期：2023-05-18 |
| 基金项目: |
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| Effect of vonoprazan on patients with initial infection of Helicobacter pylori |
| XIE Ting,SHI Rui-hua* |
(Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, Jiangsu, China
*Corresponding author) |
| Abstract: |
| Objective To investigate the efficacy and safety of potassium-competitive acid blocker vonoprazan in the treatment of Helicobacter pylori infection. Methods A total of 60 patients with Helicobacter pylori infection in our hospital from May 2020 to Dec. 2021 were selected and treated with a 4-drug combination regimen based on vonoprazan (vonoprazan treatment group). The treatment regimen was vonoprazan fumarate tablets 20 mg orally in the morning and evening, colloidal bismuth pectin capsules 150 mg orally 3 times a day, amoxicillin capsules 1.0 g orally in the morning and evening, and clarithromycin tablets 500 mg orally in the morning and evening, for 2 weeks. A retrospective paired study was conducted to select 60 patients with Helicobacter pylori infection treated with a 4-drug combination regimen based on proton pump inhibitor lansoprazole (lansoprazole treatment group) during the same period. The treatment regimen was lansoprazole enteric-coated tablets 30 mg orally in the morning and evening, colloidal bismuth pectin capsules 150 mg orally 3 times a day, amoxicillin capsules 1.0 g orally in the morning and evening, and clarithromycin tablets 500 mg orally in the morning and evening, for 2 weeks. The Helicobacter pylori eradication, medication compliance and adverse reactions (nausea, vomiting, abdominal pain, diarrhea, rash, etc.) of the 2 groups were statistically analyzed, and all patients were included for intention to treat (ITT) analysis. The patients with poor compliance and lost to follow-up were excluded for per-protocol (PP) analysis. Results Of the 120 patients, 5 were lost to follow-up, including 4 in the lansoprazole treatment group and 1 in the vonoprazan treatment group. The medication compliance of the lansoprazole treatment group and vonoprazan treatment group were 94.6% (53/56) and 96.6% (57/59), respectively, with no significant difference (P＞0.05). According to the analyses of ITT and PP, the eradication rates of Helicobacter pylori in the vonoprazan group were 93.3% (56/60) and 98.2% (56/57), respectively, which were significantly higher than those in the lansoprazole group (76.7% ［46/60］ and 86.8% ［46/53］) (both P＜0.05). There were 1 case of decreased appetite and 1 case of diarrhea during the medication process in the vonoprazan treatment group, and 2 cases of nausea and 1 case of abdominal discomfort in the lansoprazole treatment group. There was no significant difference in the incidence of adverse reactions between the 2 groups (3.33% ［2/60］ vs 5.00% ［3/60］, P＞0.05). Conclusion Four-drug combination regimen based on vonoprazan is more effective in the treatment of Helicobacter pylori infection compared with 4-drug combination regimen based on lansoprazole, and the safety and medication compliance of the 2 regimens are similar. |
| Key words: Helicobacter pylori infection vonoprazan proton pump inhibitor outcomes safety |
