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Publications

Journal Article Epublish

PubMed: 40201322 DOI: 10.3389/fmed.2025.1531620

Efficacy and safety of Jinghua Weikang capsule combined with amoxicillin-furazolidone triple/quadruple therapies in the rescue treatment of infection.

Front Med (Lausanne) 12:1531620

Authors: Yao Yang, Xin Deng, Hui-Xia Xiao, Su-Man Ye, Zi-Cheng Wang, Feng Jiang, Hai-Xiao Han, Zai-Jian Wang, Ji-Zheng Ma, Yu Lan, Hui Ye, Xue-Zhi Zhang

Affiliations

  • Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital, Beijing, China. Institute of Integrated Traditional Chinese and Western Medicine, Peking University, Beijing, China.
  • Kunming Traditional Chinese Medicine Hospital, Kunming, China.
  • Taikang Xianlin Drum Tower Hosipital, Kunming, China.
  • Beijing University of Chinese Medicine, Beijing, China.
  • Dongzhimen Hosipital Beijing University of Chinese Medicine, Beijing, China.
  • Oriental Hospital of Beijing University of Chinese Medicine, Beijing, China.
  • Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China.
  • Guang'anmen Hospital, China Academy of Traditional Chinese Medicine, Beijing, China.
  • Beijing Jishuitan Hospital, Beijing, China.

Abstract

Aim

To evaluate the efficacy and safety of Jinghua Weikang Capsule (JWC) combined with amoxicillin-furazolidone triple/quadruple therapies in the rescue treatment of drug-resistant infection.

Methods

Patients who failed eradication therapy at least once were enrolled and randomly assigned into four groups (1:1:1:1), as follows: The control group received 20 mg rabeprazole, 1,000 mg amoxicillin, 220 mg bismuth potassium citrate, and 100 mg furazolidone twice daily (b.i.d.) for 14 days; Group A received 240 mg JWC b.i.d. combined with 20 mg rabeprazole, 1,000 mg amoxicillin, and 100 mg furazolidone b.i.d. for 14 days; Group B received the same regimen as Group A for 14 days, followed by an additional 14 days of 240 mg JWC b.i.d.; and Group C received 240 mg JWC b.i.d. combined with 20 mg rabeprazole, 1,000 mg amoxicillin, 220 mg bismuth potassium citrate, and 100 mg furazolidone b.i.d. for 10 days. The primary outcome was eradication at 4 weeks after treatment.

Results

Four hundred eighty-eight patients were included in this study. The intention-to-treat (ITT) eradication rates in the four groups were 85.2, 73.8, 78.7 and 75.4% ( = 0.136), while the modified intention-to-treat (MITT) eradication rates were 92.0, 84.9, 88.9 and 86.8% ( = 0.398), respectively. And the per-protocol (PP) eradication rates were 92.5, 85.4, 87.9 and 86.7% ( = 0.405), respectively. The eradication rates were comparable among the four groups. No statistically significant differences in eradication rates were observed between each of the three treatment groups and the control group (all > 0.05). The eradication rate of in group B demonstrated non-inferiority compared with the control group ( = 0.0415; 90% CI, -0.0965 to 0.0336). The four groups exhibited similar frequencies of overall adverse events (9.84, 5.74, 6.56%, 2.46%, 0.112).

Conclusion

The eradication rate of the JWC-containing regimen demonstrated no statistically significant difference compared with bismuth-containing quadruple therapy in the rescue treatment of infection. The prolonged JWC treatment regimen exhibited non-inferiority in eradication rates. JWC-containing therapies can effectively reduce the incidence of adverse reactions and significantly alleviate certain clinical symptoms.

Clinical trial

https://clinicaltrials.gov/, identifier ChiCTR1800019326.

MeSH

Safety, Potassium Citrate, Amoxicillin, Signs And Symptoms, Capsules, Therapeutics, Infections, Furazolidone, Rabeprazole