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伏诺拉生三联疗法用于幽门螺杆菌感染初治患者的临床观察
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| 篇名： | 伏诺拉生三联疗法用于幽门螺杆菌感染初治患者的临床观察 |
| TITLE： | Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection |
| 摘要： | 目的 评价伏诺拉生三联疗法用于幽门螺杆菌（Hp）感染初治患者的疗效与安全性。方法将2022年3月－2023年8月在我院消化内科门诊就诊的198例Hp感染初治患者，按随机数字表法分为伏诺拉生三联疗法组（VAC组，98例）和铋剂四联疗法组（BQT组，100例）。VAC组患者给予富马酸伏诺拉生片20mg+阿莫西林胶囊1g+克拉霉素片0.5g，均为每天2次。BQT组患者给予艾司奥美拉唑镁肠溶片20mg，每天2次+甲硝唑片0.4g，每天4次+四环素片0.5g，每天3次+枸橼酸铋钾胶囊0.6g，每天2次。两组患者的疗程均为14d。比较意向性治疗（ITT）、改良意向性治疗（MITT）、方案治疗（PP）分析集中两组患者的Hp根除率；记录两组的不良反应发生情况及用药依从性。结果ITT、MITT、PP分析集中，VAC组患者的Hp根除率均非劣效于BQT组；VAC组患者的1～2级恶心、呕吐、食欲缺乏的发生率显著低于BQT组，依从性良好的患者比例显著高于BQT组（P＜0.05）。无论体质量指数（BMI）≤25kg/m2还是＞25kg/m2，两组患者的Hp根除率比较，差异均无统计学意义（P＞0.05）。结论伏诺拉生三联疗法用于Hp感染初治患者的疗效非劣效于铋剂四联疗法，且安全性较高，患者用药依从性良好；BMI对Hp根除率无显著影响。 |
| ABSTRACT： | OBJECTIVE To evaluate the therapeutic efficacy and safety of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori （Hp） infection. METHODS From March 2022 to August 2023， 198 treatment-naive patients with Hp infection treated at the outpatient service of department of gastroenterology in our hospital were assigned to the vonoprazan- based triple therapy group （VAC group， n＝98） and the bismuth-based quadruple therapy group （BQT group， n＝100） using the random number table method. Patients in VAC group were given Vonoprazan fumarate tablets （20 mg） + Amoxicillin capsules （1 g） + Clarithromycin tablets （0.5 g）， all twice daily. Patients in BQT group were given Esomeprazole magnesium enteric-coated tablets （20 mg， twice daily） + Metronidazole tablets （0.4 g， four times daily） + Tetracycline tablets （0.5 g， three times daily） + Bismuth potassium citrate capsules （0.6 g， twice daily）. The treatment course for both groups was 14 days. The Hp eradication rates were compared between the two groups in intention-to-treat （ITT）， modified intention-to-treat （MITT）， and per-protocol （PP） analysis sets， while adverse reaction occurrence and medication compliance of two groups were recorded. RESULTS In the ITT， MITT and PP analyses sets， the Hp eradication rates in VAC group were non-inferior to those in BQT group. The incidences of grades 1-2 nausea， vomiting， and loss of appetite in VAC group were significantly lower than in BQT group， and the proportion of patients with good compliance was significantly higher in VAC group （P＜0.05）. Regardless of whether the body mass index （BMI） ≤25 kg/m2 or ＞25 kg/m2， no statistically significant difference was observed in the Hp eradication rates between the two groups （P＞0.05）. CONCLUSIONS Vonoprazan-based triple therapy is non-inferior to bismuth-based quadruple therapy in the treatment of treatment-naive patients with Hp infection， with higher safety and good patient medication compliance. BMI has no significant impact on the Hp eradication rate. |
| 期刊： | 2024年第35卷第22期 |
| 作者： | 韩少伟；邓子杰；吕涛；王南松；曾嘉静 |
| AUTHORS： | HAN Shaowei，DENG Zijie，LYU Tao，WANG Nansong，ZENG Jiajing |
| 关键字： | 幽门螺杆菌；伏诺拉生；铋剂四联疗法；初治；疗效；安全性 |
| KEYWORDS： | Helicobacter pylori； vonoprazan； bismuth-based quadruple therapy； treatment-naive； therapeutic efficacy； safety |
| 阅读数： | 12 次 |
| 本月下载数： | 1 次 |
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