Yang Yao, Deng Xin, Xiao Hui-Xia, Ye Su-Man, Wang Zi-Cheng, Jiang Feng, Han Hai-Xiao, Wang Zai-Jian, Ma Ji-Zheng, Lan Yu, Ye Hui, Zhang Xue-Zhi
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.
Front Med (Lausanne). 2025 Mar 25;12:1531620. doi: 10.3389/fmed.2025.1531620. eCollection 2025.
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.
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.
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).
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.
https://clinicaltrials.gov/, identifier ChiCTR1800019326.
评估荆花胃康胶囊（JWC）联合阿莫西林-呋喃唑酮三联/四联疗法挽救治疗耐药感染的疗效和安全性。
纳入至少一次根除治疗失败的患者，并随机分为四组（1:1:1:1），如下：对照组每日两次（bid）服用20毫克雷贝拉唑、1000毫克阿莫西林、220毫克枸橼酸铋钾和100毫克呋喃唑酮，共14天；A组每日两次服用240毫克JWC，联合20毫克雷贝拉唑、1000毫克阿莫西林和100毫克呋喃唑酮，共14天；B组接受与A组相同的方案治疗14天，随后每日两次额外服用240毫克JWC，持续14天；C组每日两次服用240毫克JWC，联合20毫克雷贝拉唑、1000毫克阿莫西林、220毫克枸橼酸铋钾和100毫克呋喃唑酮，共10天。主要结局是治疗后4周时的根除情况。
本研究共纳入488例患者。四组的意向性治疗（ITT）根除率分别为85.2%、73.8%、78.7%和75.4%（P = 0.136），而改良意向性治疗（MITT）根除率分别为92.0%、84.9%、88.9%和86.8%（P = 0.398）。符合方案（PP）根除率分别为92.5%、85.4%、87.9%和86.7%（P = 0.405）。四组的根除率相当。三个治疗组与对照组之间的根除率均未观察到统计学显著差异（均P > 0.05）。B组的根除率与对照组相比显示出非劣效性（P = 0.0415；90% CI，-0.0965至0.0336）。四组总体不良事件的发生频率相似（9.84%、5.74%、6.56%、2.46%，P = 0.112）。
在挽救治疗感染时，含JWC方案的根除率与含铋四联疗法相比无统计学显著差异。延长的JWC治疗方案在根除率方面显示出非劣效性。含JWC的疗法可有效降低不良反应的发生率，并显著缓解某些临床症状。
