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Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 2: 430 - 436

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.02.021

Original articles

Efficacy and safety of Qingwei Zhitong pellets (清胃止痛微丸)-containing quadruple therapy for Helicobacter pylori eradication: a prospective, single-center, randomized trial

  • Jianping CHENG ,
  • Chanjuan FAN ,
  • Lili ZHAI ,
  • Hui WANG ,
  • Dongling XIE ,
  • Yong CAI ,
  • Zhen LI ,
  • Kun HUANG ,
  • Qixuan BAI
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  • Department of Gastroenterology and Oncology, Civil Aviation General Hospital, Beijing 100123, China

Received date: 2024-01-22

  Accepted date: 2024-06-12

  Online published: 2025-03-10

Supported by

China Zhongguancun Precision Medicine Science and Technology Foundation: Study on the Evaluation of Eradication Rate and Safety of Helicobacter Pylori in a Quadruple Therapy using Qingwei Zhitong Pellets as a Substitute for Bismuth Agent(320.6799.2022.09.24)

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Abstract

OBJECTIVE: To evaluate the efficacy and safety of 14-day Qingwei Zhitong pellets (清胃止痛微丸, QZ)-containing quadruple therapy (QZQT) compared to bismuth-containing quadruple therapy (BQT) in treatment-naive patients with Helicobacter pylori (H. pylori) infection.

METHODS: This single-center, randomized controlled clinical trial enrolled 333 patients, who were divided into either the QZQT group (QZ pellets, 3.2 g, three times daily; rabeprazole, 10 mg, twice daily; amoxicillin 1000 mg, twice daily; clarithromycin, 500 mg, twice daily) or the BQT group (bismuth potassium citrate, 1000 mg, three times daily; rabeprazole, 10 mg, twice daily; amoxicillin, 1000 mg, twice daily; clarithromycin, 500 mg, twice daily) for 14 d. The 13C-urea breath test assessed eradication success at least four weeks after treatment. The primary outcome focused on the eradication rate, with secondary outcomes including safety and patient compliance.

RESULTS: From August 2022 to June 2023, 342 subjects were screened, and 333 were randomized. The QZQT and BQT groups showed eradication rates of 68.9% and 67.8% (P = 0.838) by intention-to-treat (ITT) analysis, respectively, and 71.1% and 68.3% (P = 0.612) by per-protocol (PP) analysis, respectively. QZQT was non-inferior to BQT in both ITT and PP analyses. QZQT was associated with fewer side effects (57.8% of patients) than BQT (90.4%) (P < 0.001).

CONCLUSION: The 14 d QZQT treatment demonstrates equal efficacy in eradicating H. pylori infection and improved patient compliance and safety compared to BQT. These results provide evidence supporting 14-day QZQT as an acceptable treatment for H. pyloriinfection.

Key words： Helicobacter pylori; bismuth; randomized controlled trial; quadruple therapy; eradication; Qingwei Zhitong pellets

Cite this article

Jianping CHENG , Chanjuan FAN , Lili ZHAI , Hui WANG , Dongling XIE , Yong CAI , Zhen LI , Kun HUANG , Qixuan BAI . Efficacy and safety of Qingwei Zhitong pellets (清胃止痛微丸)-containing quadruple therapy for Helicobacter pylori eradication: a prospective, single-center, randomized trial[J]. Journal of Traditional Chinese Medicine, 2025 , 45(2) : 430 -436 . DOI: 10.19852/j.cnki.jtcm.2025.02.021

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