替戈拉生联合米诺环素二联疗法根除老年患者幽门螺杆菌感染的疗效和安全性评价^*

Evaluation of the efficacy and safety of tegoprazan combined with minocycline dual therapy for eradicating Helicobacter pylori infection in elderly patients

摘要

目的 评估替戈拉生联合米诺环素二联疗法根除老年患者幽门螺杆菌 (Hp) 感染的疗效和安全性。方法 选取 Hp 感染老年患者 100 例, 以随机数字表法分为治疗组及对照组, 各 50 例。治疗组采取替戈拉生联合米诺环素二联疗法治疗, 对照组采取传统含铋剂四联疗法治疗。两组疗程均为 14 d, 治疗过程中的第 7 天及第 14 天进行电话或微信随访, 记录患者的服药情况和不良反应发生情况。治疗结束后 4 周复查碳-13 或碳-14 尿素呼气试验。采用意向性治疗 (ITT) 分析、改良意向性治疗 (MITT) 分析和符合方案 (PP) 分析来比较两组患者 Hp 根除率, 同时比较不良反应发生率和依从性。结果 治疗组及对照组 ITT 分析根除率分别为 88.0%、76.0%, MITT 分析根除率分别为 89.8%、77.6%, PP 分析根除率分别为 91.7%、90.5%; 在这 3 种分析方法中, 治疗组的根除率均高于对照组, 差异均无统计学意义 (P>0.05)。治疗组的依从性良好率高于对照组, 差异无统计学意义 (P>0.05)。治疗组不良反应发生率低于对照组, 差异有统计学意义 (P<0.05)。结论 替戈拉生联合米诺环素二联疗法治疗老年患者 Hp 感染安全有效, 且相较于含铋剂四联疗法不良反应更少, 值得临床推广应用。

Abstract

Objective To evaluate the efficacy and safety of tegoprazan combined with minocycline dual therapy in eradicating Helicobacter pylori (Hp) infection in elderly patients. Methods A total of 100 elderly patients with Hp infection were selected and randomly divided into a treatment group and a control group, with 50 patients in each group. The treatment group received a combination therapy of tegoprazan and minocycline, while the control group received a traditional four-drug regimen containing bismuth. The treatment duration for both groups was 14 days. Telephone or WeChat follow-up was conducted on days 7 and 14 of treatment to record medication adherence and adverse reactions. A carbon-13 or carbon-14 urea breath test was performed 4 weeks after treatment completion. Intention-to-treat (ITT) analysis, modified intention-to-treat (MITT) analysis, and per-protocol (PP) analysis were used to compare Helicobacter pylori eradication rates between the two groups, as well as to compare adverse reaction incidence rates and treatment adherence. Results The eradication rates of the treatment group and the control group were 88.0% and 76.0% by ITT analysis, 89.8% and 77.6% by MITT analysis, and 91.7% and 90.5% by PP analysis, respectively; among these three analysis methods, the eradication rates of the treatment group were higher than those of the control group, and the difference was not statistically significant (P>0.05). The compliance rate of the treatment group was higher than that of the control group, and the difference was not statistically significant (P>0.05). The incidence of adverse reactions in the treatment group was lower than that in the control group, and the difference was statistically significant (P<0.05). Conclusion The combination therapy of tegoprazan and minocycline is safe and effective for treating Helicobacter pylori infection in elderly patients, and compared with the bismuth-containing quadruple therapy, it has fewer adverse reactions, making it worthy of clinical promotion and application.

关键词

幽门螺杆菌感染 / 替戈拉生 / 米诺环素

Key words

Helicobacter pylori infection / Tegoprazan / Minocycline

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基金资助

^*吉林大学横向科研项目(LXQT-2025-291)