1.Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection
Shaowei HAN ; Zijie DENG ; Tao LYU ; Nansong WANG ; Jiajing ZENG
China Pharmacy 2024;35(22):2789-2792
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.
2.Randomized controlled study of vonoprazan dual therapy and bismuth-containing quadruple therapy with low resistance antibiotics in the treatment of Helicobacter pylori infection
Zijie DENG ; Shaowei HAN ; Mingfeng XU ; Xiaoyu LIU ; Chun NING ; Tao LYU
Chinese Journal of Digestion 2024;44(12):800-805
Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.
3.Randomized controlled study of vonoprazan dual therapy and bismuth-containing quadruple therapy with low resistance antibiotics in the treatment of Helicobacter pylori infection
Zijie DENG ; Shaowei HAN ; Mingfeng XU ; Xiaoyu LIU ; Chun NING ; Tao LYU
Chinese Journal of Digestion 2024;44(12):800-805
Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.
4.Influence of metabolic syndrome and its components on the prognosis of patients with pancreatic cancer
Huan CHEN ; Ting LI ; Zijie WANG ; Zhangqiong WANG ; Gang LUO ; Mingming DENG
Journal of Clinical Hepatology 2020;36(12):2788-2794
ObjectiveTo investigate the association of metabolic syndrome (MS) and its components with the overall survival of pancreatic cancer (PC) patients who do not receive antitumor therapy. MethodsA retrospective analysis was performed for the data of patients who were diagnosed with PC in The Affiliated Hospital of Southwest Medical University from August 2013 to November 2018. Related data were collected, including age, sex, body weight, body height, body mass index (BMI), smoking, drinking, medical history of chronic pancreatitis, medical history of biliary tract diseases and gastritis, medical history of chronic hepatitis B/C, medical history of other tumors, presence or absence of PC in first-grade relatives, blood glucose, blood pressure, high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), MS, and TNM stage. The log-rank test was used for comparison of survival curves between groups, and the univariate and multivariate Cox regression analyses were used to investigate the influencing factors for survival. ResultsA total 269 PC patients were enrolled in this study, with an average survival time of 3 months. The survival analysis showed no significant difference in survival time between the patients with MS and those without MS (P=0.754). There was no significant difference in median survival time between the patients with hypertension, high TG, high HDL-C, or abnormal BMI and those without such abnormality (all P>0.05). There was a significant difference in median survival time between the patients with hyperglycemia and those without hyperglycemia (hazard ratio [HR]=1.322, 95% confidence interval [CI]: 0.985-1.775, P=0.028), and the multivariate Cox regression analysis achieved consistent results (HR=1481, 95% CI: 1.043-2.104, P=0.028). The analysis of the influencing factors for survival time in patients with stage Ⅳ PC showed that the patients with hyperglycemia had a significant reduction in median survival time (HR=1.524, 95%CI: 1.046-2.218, P=0004). ConclusionMS is not an influencing factor for the survival of PC patients, but hyperglycemia is an independent risk factor for poor prognosis in PC patients, especially in those with advanced PC.
5.Detection of proximal serrated polyps:a single-center retrospective analysis
Qingyun LI ; Peng XIAO ; Tingsheng LING ; Yangyang SUN ; Lijun LUO ; Rong LIANG ; Zijie DENG ; Waikay SETO
Chinese Journal of Digestive Endoscopy 2019;36(2):86-90
Objective To investigate the prevalence and endoscopic detection rate of proximal serrated polyps and to screen the risk factors. Methods The data of 9010 colonoscopies performed by 22 endoscopists between September 2016 and September 2017 were reviewed. The adenoma detection rate (ADR) and proximal serrated polyp detection rate (PSDR) were calculated, and the correlation between ADR and PSDR was estimated by Pearson correlation coefficients. Multivariate logistic regression was used to analyze PSDR among endoscopists. Results For all subjects, the mean ADR was 30. 07% ( ranged from 20. 00% to 40. 78%) and mean PSDR was 4. 70% ( ranged from 1. 52% to 9. 28%) . PSDR of males was 1. 38 times of that of females ( OR=1. 38, 95%CI:1. 13-1. 69, P<0. 01) . For 3560 cases ( 39. 51%) of 50 years and older subjects, the mean ADR was 45. 01% ( 28. 99%-57. 78%) and mean PSDR was 6. 08%(2. 07%-10. 56%). PSDR was moderately correlated with ADR (r=0. 48, P=0. 02). PSDR of males was 1. 36 times of that of females (OR=1. 36, 95%CI: 1. 04-1. 80, P=0. 03). Endoscopist was a significant risk factor for detection of proximal serrated polyps ( P<0. 01) . Compared with endoscopist with the highest PSDR, odds ratio of other endoscopists ranged from 0. 16 (95%CI:0. 06-0. 40, P<0. 01) to 0. 83 (95%CI:0. 53-1. 32, P=0. 44) . Conclusion Proximal serrated polyps are more common in males, who are over 50 years old. The PSDR is highly variable and dependent on endoscopists. It is possible that a certain proportion of proximal serrated polyps are missed during colonoscopy.

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