Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with <italic style="font-style: italic">Helicobacter pylori</italic> infection

HAN Shaowei; DENG Zijie; LYU Tao; WANG Nansong; ZENG Jiajing

doi:10.6039/j.issn.1001-0408.2024.22.15

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Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection

更新时间：2024-11-26

- Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection
- ZHONGGUO YAOFANG Vol. 35, Issue 22, Pages: 2789-2792(2024)
- 作者机构：
  
  1.香港大学深圳医院药学部，广东深圳　518053
  2.香港大学深圳医院消化内科，广东深圳　518053
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.22.15
  CLC： R975;R969.3
- Published：30 November 2024，
  
  Received：20 June 2024，
  
  Revised：24 October 2024，
- 稿件说明：
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韩少伟,邓子杰,吕涛等.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 ^Δ[J].中国药房,2024,35(22):2789-2792.

HAN Shaowei,DENG Zijie,LYU Tao,et al.Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection[J].ZHONGGUO YAOFANG,2024,35(22):2789-2792.
韩少伟,邓子杰,吕涛等.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 ^Δ[J].中国药房,2024,35(22):2789-2792. DOI： 10.6039/j.issn.1001-0408.2024.22.15.

HAN Shaowei,DENG Zijie,LYU Tao,et al.Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection[J].ZHONGGUO YAOFANG,2024,35(22):2789-2792. DOI： 10.6039/j.issn.1001-0408.2024.22.15.

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20 mg+阿莫西林胶囊1 g+克拉霉素片0.5 g，均为每天2次。BQT组患者给予艾司奥美拉唑镁肠溶片20 mg，每天2次+甲硝唑片0.4 g，每天4次+四环素片0.5 g，每天3次+枸橼酸铋钾胶囊0.6 g，每天2次。两组患者的疗程均为14 d。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（

＜0.

05）。无论体质量指数（BMI）≤25 kg/m

还是＞25 kg/m

，两组患者的Hp根除率比较，差异均无统计学意义（

＞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，

＝98） and the bismuth-based quadruple therapy group （BQT group，

＝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 （

＜0.05）. Regardless of whether the body mass i

ndex （BMI） ≤25 kg/m

or ＞25 kg/m

， no statistically significant difference was observed in the Hp eradication rates between the two groups （

＞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.

关键词

幽门螺杆菌伏诺拉生铋剂四联疗法初治疗效安全性

Keywords

vonoprazanbismuth-based quadruple therapytreatment-naivetherapeutic efficacysafety

references

SUGANO K，TACK J，KUIPERS E J，et al. Kyoto global consensus report on Helicobacter pylori gastritis[J]. Gut，2015，64（9）：1353-1367.

张建中.《中国幽门螺杆菌感染防控》白皮书要点解读[J]. 中国中西医结合消化杂志，2024，32（4）：279-282.

ZHANG J Z . Interpretation of key points from the White Paper on Helicobacter pylori Infection Prevention and Control in China[J]. Chin J Integr Tradit West Med Dig，2024，32（4）：279-282.

中华医学会消化病学分会幽门螺杆菌学组. 2022中国幽门螺杆菌感染治疗指南[J]. 中华消化杂志，2022，42（11）：745-756.

Helicobacter pylori Study Group，Chinese Society of Gastroenterology.2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment[J]. Chin J Dig，2022，42（11）：745-756.

吕涛，倪丽，吴娟，等. 深圳幽门螺杆菌根除率变化和耐药分析多中心研究[J]. 中华消化杂志，2020，40（8）：557-561.

LYU T，NI L，WU J，et al. Multi-center study on the change of eradication rate and drug resistance analysis of Helicobacter pylori in Shenzhen[J]. Chin J Dig，2020，40（8）：557-561.

刘芳勋，张晶，张华，等. 铋剂在幽门螺杆菌根除中的不良反应及预防[J]. 临床药物治疗杂志，2014，12（5）：59-62.

LIU F X，ZHANG J，ZHANG H，et al. Types and prevention of adverse reactions related with bismuth-containing regimens for Helicobacter pylori eradication[J]. Clin Med J，2014，12（5）：59-62.

SUN Y C，YUE L，HU W L. Effectiveness and safety of vonoprazan-based regimens compared with those of proton pump inhibitor（PPI）-based regimens as first-line agents for Helicobacter pylori：a meta-analysis of rando-mized clinical trials[J]. Eur J Clin Pharmacol，2023，79（2）：279-288.

ROKKAS T，GISBERT J P，MALFERTHEINER P，et al. Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection：a network meta-analysis[J]. Gastroenterology，2021，161（2）：495-507.e4.

LYU Q J，PU Q H，ZHONG X F，et al. Efficacy and safety of vonoprazan-based versus proton pump inhibitor-based triple therapy for Helicobacter pylori eradication：a meta-analysis of randomized clinical trials[J]. Biomed Res Int，2019，2019：9781212.

BEST L M，TAKWOINGI Y，SIDDIQUE S，et al. Non-invasive diagnostic tests for Helicobacter pylori infection[J]. Cochrane Database Syst Rev，2018，3（3）：CD012080.

National Cancer Institute，National Institutes of Health.Common terminology criteria for adverse events（CTCAE）v5.0[EB/OL]. [2024-10-05] https：//ctep.cancer.gov/pro- tocoldevelopment/electronic_applications/ctc.htm#ctc_50https://ctep.cancer.gov/pro-tocoldevelopment/electronic_applications/ctc.htm#ctc_50.

DECLERCQ J，CHOI L. Statistical considerations for medication adherence research[J]. Curr Med Res Opin，2020，36（9）：1549-1557.

FURUTA T，YAMADE M，KAGAMI T，et al. Dual therapy with vonoprazan and amoxicillin is as effective as triple therapy with vonoprazan，amoxicillin and clarithromycin for eradication of Helicobacter pylori[J]. Digestion，2020，101（6）：743-751.

JUNG Y S，KIM E H，PARK C H. Systematic review with meta-analysis：the efficacy of vonoprazan-based triple therapy on Helicobacter pylori eradication[J]. Aliment Pharmacol Ther，2017，46（2）：106-114.

SHINMURA T，ADACHI K，YAMAGUCHI Y，et al. Vonoprazan-based triple-therapy could improve efficacy of the tailored therapy of Helicobacter pylori infection[J]. J Gastrointestin Liver Dis，2019，28（4）：389-395.

GRAHAM D Y，FISCHBACH L. Helicobacter pylori treatment in the era of increasing antibiotic resistance[J]. Gut，2010，59（8）：1143-1153.

NYSSEN O P，PEREZ-AISA A，TEPES B，et al. Adverse event profile during the treatment of Helicobacter pylori：a real-world experience of 22 000 patients from the European registry on H. pylori management（hp-EuReg）[J]. Am J Gastroenterol，2021，116（6）：1220-1229.

CHEY W D，MÉGRAUD F，LAINE L，et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe：randomized clinical trial[J]. Gastroenterology，2022，163（3）：608-619.

孟彤，张灵健，沈智文，等. 临床药物依从性评价的研究进展[J]. 医药导报，2021，40（4）：466-471.

MENG T，ZHANG L J，SHEN Z W，et al. The research progress of medication adherence assessment[J]. Her Med，2021，40（4）：466-471.

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Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection

DOI：10.6039/j.issn.1001-0408.2024.22.15

摘要

Abstract

关键词

Keywords

references