Vonoprazan-amoxicillin dual regimen with Saccharomyces boulardii as a rescue therapy for Helicobacter pylori:Current perspectives and implications

Yu et al’s study in the World Journal of Gastroenterology(2023)introduced a novel regimen of Vonoprazan-amoxicillin dual therapy combined with Saccharomyces boulardii(S.boulardii)for the rescue therapy against Helicobacter pylori(H.pylori),a pathogen responsible for peptic ulcers and gastric cancer.Vonoprazan is a potassium-competitive acid blocker renowned for its rapid and long-lasting acid suppression,which is minimally affected by mealtime.Compared to proton pump inhibitors,which bind irreversibly to cysteine residues in the H+/K+-ATPase pump,Vonoprazan competes with the K+ions,prevents the ions from binding to the pump and blocks acid secretion.Concerns with increasing antibiotic resistance,effects on the gut microbiota,patient compliance,and side effects have led to the advent of a dual regimen for H.pylori.Previous studies suggested that S.boulardii plays a role in stabilizing the gut barrier which improves H.pylori eradication rate.With an acceptable safety profile,the dual-adjunct regimen was effective regardless of prior treatment failure and antibiotic resistance profile,thereby strengthening the applicability in clinical settings.Nonetheless,S.boulardii comes in various formulations and dosages,warranting further exploration into the optimal dosage for supplementation in rescue therapy.Additionally,larger,randomized,double-blinded controlled trials are warranted to confirm these promising results.

Analysis of the Effectiveness of Biling Weitong Granules Combined with Trimethoprim and Vonoprazan in The Treatment of Reflux Esophagitis

Objective:To analyze the effectiveness of Biling Weitong Granules(BLWTG)combined with trimethoprim and vonoprazan in treating reflux esophagitis.Methods:Sixty patients with reflux esophagitis admitted to our hospital from March 2020 to March 2023 were selected as study subjects and randomly divided into a control group and an experimental group,with 30 cases in each group.The control group received only the combination treatment of trimethoprim and vonoprazan,while the experimental group was treated with BLWTG based on the control group.The acid reflux and heartburn symptom scores,quality-of-life scores,clinical efficacy,Chinese medicine symptom incidences,and the occurrence of adverse reactions before and after treatment in the two groups were compared.Results:After treatment,the acid reflux and heartburn symptom scores of patients in the experimental group were lower than those of the treatment control group,and the quality-of-life scores were higher than those of the treatment control group(P<0.05).The total clinical efficacy of the experimental group was 96.66%,which was significantly higher than that of the control group(73.33%,P<0.05).After treatment,the incidence of Chinese medicine symptoms,such as nausea and vomiting,abdominal distension and abdominal pain,and loss of appetite of the patients in the experimental group were significantly lower than those of the control group(P<0.05).During the treatment period,there was no significant difference in the incidence of adverse reactions between the two groups,which indicated that the safety of the two treatments was comparable(P>0.05).Conclusion:BLWTG combined with trimethoprim and vonoprazan was safe and reliable in treating reflux esophagitis,effectively relieving the symptoms and improving its clinical efficacy.This treatment is worthy of popularization.

Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population:A prospective,multicenter,randomized,two-stage study

BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy(VAT)in the treatment of Helicobacter pylori(H.pylori)is controversial.AIM To evaluate the efficacy of VAT in the Chinese population.METHODS This prospective,multicenter,randomized,open-label,and two-stage study was conducted at 23 centers in Fujian,China(May 2021-April 2022).H.pylori-infected patients were randomized to bismuth quadruple therapy(BQT),BQT-Vonoprazan(BQT-V),seven-day VAT(VAT-7),ten-day VAT(VAT-10),and fourteen-day VAT(VAT-14)groups.The primary endpoint was the H.pylori eradication rate.The secondary endpoint was the frequency of adverse events.This study was registered with the Chinese Clinical Trial Registry,ChiCTR2100045778.RESULTS In the first stage,VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated.In the second stage,the eradication rates for BQT,VAT-10,and VA-14 were 80.2%[95%confidence interval(95%CI):71.4%-86.8%],93.2%(86.6%-96.7%),92.2%(85.3%-96.0%)in the intention-to-treat(ITT)analysis,and 80.9%(95%CI:71.7%-87.5%),94.0%(87.5%-97.2%),and 93.9%(87.4%-97.2%)in the per-protocol analysis.The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group(P=0.022 and P=0.046,respectively).The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group(25.27%and 13.73%vs 37.62%,respectively;P<0.001).CONCLUSION VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT,with a more tolerable safety profile in H.pylori-infected patients in Fujian.Huang XP et al.VAT for H.pylori eradication.

Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 20-mg Vonoprazan Fumarate Tablets in Bangladeshi Healthy Male Subjects

Background: Vonoprazan fumarate, a novel potassium-competitive acid blocker, outperforms traditional proton pump inhibitors in acid suppression and can be effectively combined with antibiotics to eradicate Helicobacter pylori. Objective: The study aimed to determine if two Vonoprazan formulations—Vonoprazan Fumarate 20 mg Tablet of Beximco Pharmaceuticals Limited, Bangladesh (test product) and Takecab 20 mg Tablet of Takeda Pharmaceutical Company Limited, Japan (reference product)—met FDA’s bioequivalence requirements by comparing their pharmacokinetic characteristics in healthy Bangladeshi adults. Methods: This was a single-center, randomized, open-label, two-period, two-sequence, laboratory-blind, double-crossover experiment. After 10 hours of fasting, 18 subjects were randomly assigned to receive a single oral dose of either formulation. During each treatment period, blood samples were collected at specific times (pre-dose and up to 48 hours post-dose) to measure plasma Vonoprazan levels using liquid chromatography-tandem mass spectrometry. A non-compartmental model was used to calculate pharmacokinetic parameters using the plasma drug concentration-time profile. A statistical comparison of the pharmacokinetic parameters of the two formulations of the test and reference product was conducted using SAS® statistical software to assess the bioequivalence. Primary pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) and secondary parameters (Tmax, T1/2, Kel, and AUC extrapolation) were calculated for both drug formulations. If the confidence intervals for the natural log-transformed Cmax, AUC0-t, and AUC0-∞ values fell between 80% and 125%, the drug products would be considered bioequivalent. Result: The geometric mean ratio of Vonoprazan between the test and reference groups was found to be 109.04% (99.47% - 119.53%), 101.37% (95.58% - 107.50%), and 101.24% (95.43% - 107.41%), with 90% confidence intervals (CIs) for the Cmax, AUC0–t, and AUC0–∞, and these outcomes met the regulatory requirements for assuming bioequivalence. Conclusion: The results demonstrated that the generic formulation of Vonoprazan 20 mg Tablet of Beximco Pharmaceuticals Limited is bioequivalent to the reference product.

Maintenance for healed erosive esophagitis:PhaseⅢcomparison of vonoprazan with lansoprazole

AIM To compare vonoprazan 10 and 20 mg vs lansoprazole 15 mg as maintenance therapy in healed erosive esophagitis(EE).METHODS A total of 607 patients aged ≥ 20 years, with endoscopically-confirmed healed EE following 8 wk of treatment with vonoprazan 20 mg once daily, were randomized 1:1:1 to receive lansoprazole 15 mg(n = 201), vonoprazan 10 mg(n = 202), or vonoprazan 20 mg(n = 204), once daily. The primary endpoint of the study was the rate of endoscopically-confirmed EE recurrence during a 24-wk maintenance period. The secondary endpoint was the EE recurrence rate at Week 12 during maintenance treatment. Additional efficacy endpoints included the incidence of heartburn and acid reflux, and the EE healing rate 4 wk after the initiation of maintenance treatment. Safety endpoints comprised adverse events(AEs), vital signs, electrocardiogram findings, clinical laboratory results, serum gastrin and pepsinogen Ⅰ/Ⅱ levels, and gastric mucosa histopathology results.RESULTS Rates of EE recurrence during the 24-wk maintenance period were 16.8%, 5.1%, and 2.0% with lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg, respectively. Vonoprazan was shown to be non-inferior to lansoprazole 15 mg(P < 0.0001 for both doses). In a post-hoc analysis, EE recurrence at Week 24 was significantly reduced with vonoprazan at both the 10 mg and the 20 mg dose vs lansoprazole 15 mg(5.1% vs 16.8%, P = 0.0002, and 2.0% vs 16.8%, P < 0.0001, respectively); by contrast, the EE recurrence rate did not differ significantly between the two doses of vonoprazan(P = 0.1090). The safety profiles of vonoprazan 10 and 20 mg were similar to that of lansoprazole 15 mg in patients with healed EE. Treatment-related AEs were reported in 11.4%, 10.4%, and 10.3% of patients in the lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg arms, respectively.CONCLUSION Our findings confirm the non-inferiority of vonoprazan 10 and 20 mg to lansoprazole 15 mg as maintenance therapy for patients with healed EE.

Comparative study: Vonoprazan and proton pump inhibitors in Helicobacter pylori eradication therapy

AIMTo compare the effectiveness and safety of vonoprazan-based therapy with proton pump inhibitor (PPI)-based therapies to treat Helicobacter pylori (H. pylori).METHODSWe retrospectively analysed data from first-line (vonoprazan or PPI with 200 mg clarithromycin and 750 mg amoxicillin twice daily for 7 d) (n = 1353) and second-line (vonoprazan or PPI with 250 mg metronidazole and 750 mg amoxicillin twice daily for 7 d) (n = 261) eradication treatments for H. pylori -positive patients with associated gastrointestinal diseases from April 2014 to December 2015 at Hattori Clinic, Japan. The primary endpoint was the eradication rate, which was assessed with a full analysis set. The secondary endpoints were adverse events and related factors.RESULTSAfter the first-line treatments, the eradication rates for vonoprazan, esomeprazol, rabeprazole, and lansoprazole were 87.9% (95%CI: 84.9%-90.5%), 71.6% (95%CI: 67.5%-75.5%), 62.9% (95%CI: 52.0%-72.9%), and 57.3% (95%CI: 50.4%-64.1%), respectively. The vonoprazan eradication rate was significantly higher than that of the PPIs (P &#x0003c; 0.01). Interestingly, smoking did not affect the H. pylori eradication rate in the vonoprazan group (P = 0.34), whereas it decreased the rates in the PPI groups (P = 0.013). The incidence of adverse events in the vonoprazan group was not different from the PPI group (P = 0.054), although the vonoprazan group exhibited a wider range of adverse events. Vonoprazan-based triple therapy was highly effective as a second-line treatment, with an eradication rate similar to that of PPI-based therapy.CONCLUSIONVonoprazan might be superior to PPIs in first-line H. pylori therapy, particularly for smokers. However, caution is required due to possible adverse events.

Usefulness of vonoprazan,a potassium ion-competitive acid blocker,for primary eradication of Helicobacter pylori

AIM To investigate usefulness of triple therapy with vonoprazan,a potassium ion-competitive acid blocker and antibiotics,for Helicobacter pylori(H.pylori) eradication.METHODS The H.pylori eradication rate was examined in 2507 patients(2055 undergoing primary eradication and 452 undergoing secondary eradication,excluding patients with subtotal gastrectomy) at the Japanese Red Cross Kyoto Daiichi Hospital from March 2013 to September 2015.For patients treated from March 2013 to February 2015,a proton pump inhibitor(PPI) was used to reduce acid secretion,while vonoprazan was used after March 2015.The success rates of the 2 regimens(PPI + amoxicillin + clarithromycin/metronidazole,or vonoprazan + amoxicillin + clarithromycin/metronidazole) were compared.RESULTS The success rate of primary H.pylori eradication was significantly higher in the vonoprazan group.When stratified by the underlying disease,a significant increase of the H.pylori eradication rate was observed in patients with chronic gastritis.A significantly lower H.pylori eradication rate was observed in younger patients compared to older patients in the PPI group,but there was no difference according to age in the vonoprazan group.On the otherhand,the success rate of secondary eradication was similar at approximately 90% in both groups.CONCLUSION Vonoprazan is very useful for primary eradication of H.pylori,and may become a first-line acid secretion inhibitor instead of PPIs.

Safety and effectiveness of vonoprazan-based rescue therapy for Helicobacter pylori infection

BACKGROUND Vonoprazan(VPZ)-based regimens are an effective first-line therapy for Helicobacter pylori(H.pylori)infection.However,their value as a rescue therapy needs to be explored.AIM To assess a VPZ-based regimen as H.pylori rescue therapy.METHODS This prospective,single-center,clinical trial was conducted between January and August 2022.Patients with a history of H.pylori treatment failure were administered 20 mg VPZ twice daily,750 mg amoxicillin 3 times daily,and 250 mg Saccharomyces boulardii(S.boulardii)twice daily for 14 d(14-d VAS regimen).VPZ and S.boulardii were taken before meals,while amoxicillin was taken after meals.Within 3 d after the end of eradication therapy,all patients were asked to fill in a questionnaire to assess any adverse events they may have experienced.At least 4-6 wk after the end of eradication therapy,eradication success was assessed using a 13C-urea breath test,and factors associated with eradication success were explored.RESULTS Herein,103 patients were assessed,and 68 patients were finally included.All included patients had 1-3 previous eradication failures.The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6%(63/68)and 92.3%(60/65),respectively.The eradication rate did not differ with the number of treatment failures(P=0.433).The rates of clarithromycin,metronidazole,and levofloxacin resistance were 91.3%(21/23),100.0%(23/23),and 60.9%(14/23),respectively.There were no cases of resistance to tetracycline,amoxicillin,or furazolidone.In 60.9%(14/23)patients,the H.pylori isolate was resistant to all 3 antibiotics(clarithromycin,metronidazole,and levofloxacin);however,eradication was achieved in 92.9%(13/14)patients.All patients showed metronidazole resistance,and had an eradication rate of 91.3%(21/23).The eradication rate was higher among patients without anxiety(96.8%)than among patients with anxiety(60.0%,P=0.025).No severe adverse events occurred;most adverse events were mild and disappeared without intervention.Good compliance was seen in 95.6%(65/68)patients.Serological examination showed no significant changes in liver and kidney function.CONCLUSION VAS is a safe and effective rescue therapy,with an acceptable eradication rate(>90%),regardless of the number of prior treatment failures.Anxiety may be associated with eradication failure.

Vonoprazan 20 mg vs lansoprazole 30 mg for endoscopic submucosal dissection-induced gastric ulcers

AIM To compare the healing effects of vonoprazan and lansoprazole on gastric ulcers induced by endoscopic submucosal dissection(ESD).METHODS Data were obtained from a total of 26 patients.Fourteen patients were randomized to the vonoprazan group and 12 were randomized to the lansoprazole group.Patients were administered either 20 mg vonoprazan or 30 mg lansoprazole per day after ESD.Endoscopic images just after ESD,on day 8,and on day 28 were used for the evaluation of the shrinking rate of ESD ulcers.The shrinking rates and the incidence of delayed bleeding were compared between the 2 groups.RESULTS The shrinking rates of ESD ulcers on day 8 [vonoprazangroup: 61.8%(range: 24.0%-91.1%),lansoprazole group: 71.3%(range: 25.2%-88.6%)] and on day 28 [vonoprazan group: 95.3%(range: 76.2%-100%),lansoprazole group: 97.2%(range: 81.1%-99.8%)] were not statistically different between the 2 groups.On day 28,most of the ulcers in both groups healed to more than 90%,whereas 3 of 14(21.4%) in the vonoprazan group and 1 of 12(8.3%) in the lansoprazole group had delayed ulcer healing,which was not statistically different(P = 0.356).The frequency of delayed bleeding was 0 in the both groups.Taken together,there were no significant differences between the two drug groups.CONCLUSION Our study indicates that vonoprazan is potent for the management of ESD ulcers although lansoprazole is also sufficient and cost-effective.

Efficacy and Tolerability of Second-Line Metronidazole Triple Therapy Using Vonoprazan for Helicobacter pylori Eradication in Japan—Comparative Study: Vonoprazan vs. Proton Pump Inhibitors

Aim: To investigate the efficacy and tolerability of second-line metronidazole triple therapy with vonoprazan (VPZ) for Helicobacter pylori (H. pylori). Methods: We retrospectively reviewed medical records of patients who experienced clarithromycin triple therapy failure and were treated with second-line (20 mg VPZ (n = 274)/30 mg lansoprazole (n = 323) or 10 mg rabeprazole (n = 141) twice daily, 750 mg amoxicillin twice daily, 250 mg metronidazole twice daily for 7 days) eradication therapies. Successful eradication rates were compared between two groups: those receiving VPZ and those receiving a proton pump inhibitor (PPI). Adverse events were also investigated. Results: Successful second-line eradication rates according to ITT analysis and PP analysis, respectively, were 79.9% and 92.4% for VPZ therapy and 83.6% and 93.3% for PPI therapy. There were no significant differences between treatment groups. The eradication rates in those who had received first-line VPZ therapy previously according to ITT and PP analysis were 75.2% and 88.1%, respectively;in contrast, values were 82.5% and 95.4%, respectively, for those who had received first-line PPI therapy previously. In second-line therapy, the overall adverse event rate for VPZ therapy was the same as for PPI therapy. Conclusions: The efficacy and tolerability of metronidazole-containing second-line triple therapy with VPZ or a PPI were equivalent.

Gastric Mucosal Atrophy Might Be Associated with the Efficacy of First-Line Therapy Using Vonoprazan for <i>Helicobacter pylori</i>

Aim: To investigate the factors related to the effect of eradication therapy with vonoprazan for Helicobacter pylori (H. pylori). Methods: We retrospectively reviewed medical records of H. pylori-positive patients who received first-line (40 mg vonoprazan/60 mg lansoprazole or 20 mg rabeprazole, 1500 mg amoxicillin, 400 mg clarithromycin, all 2/day for 7 days) (n = 4118). H. pylori eradication was assessed by the 13C-urea breath test with success defined as a result of H. pylori eradication therapy using vonoprazan was more effective than standard triple therapy with proton pump inhibitor. Gastric mucosal atrophy was associated with treatment success.

Progress in the Study of Vonoprazan Fumarate vs. Proton Pump Inhibitors in the Treatment of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease, and proton pump inhibitors (PPIs) have been recommended as the first-line treatment for GERD. In recent years, studies on vonoprazan fumarate in the treatment of GERD have attracted widespread attention. In this paper, we review the research progress of vonoprazan fumarate and proton pump inhibitors in the treatment of GERD in recent years, and compare and analyze the efficacy, safety, tolerability, and advantages and disadvantages of long-term application of both. By reviewing the relevant literature, we found that vonoprazan fumarate has similar performance with proton pump inhibitors in terms of efficacy and safety, but has potential advantages in terms of tolerability and long-term application. Therefore, we believe that vonoprazan fumarate may become a new option for GERD treatment, helping clinicians to develop more appropriate treatment plans for patients and providing new ideas and directions for research in related fields.

Real-world evidence on the efficacy and safety of vonoprazanamoxicillin dual therapy for Helicobacter pylori treatment in elderly patients

BACKGROUND A dual therapy regimen containing amoxicillin is a common treatment option for the eradication of Helicobacter pylori(H.pylori).While substantial research supports the efficacy and safety of vonoprazan and amoxicillin(VA)dual therapy in the general population,there is still a lack of studies specifically focusing on its safety in elderly patients.AIM To evaluate efficacy and safety of VA dual therapy as first-line or rescue treatment for H.pylori in elderly patients.METHODS As a real-world retrospective study,data were collected from elderly patients aged 60 years and above who accepted VA dual therapy(vonoprazan 20 mg twice daily+amoxicillin 1000 mg thrice daily for 14 days)for H.pylori eradication in the Department of Gastroenterology at Peking University First Hospital between June 2020 and January 2024.H.pylori status was evaluated by^(13)C-urease breath test 6 weeks after treatment.All adverse events(AEs)during treatment were recorded.RESULTS In total,401 cases were screened.Twenty-one cases were excluded due to loss to follow-up,lack of re-examination,or unwillingness to take medication.The total of 380 included cases comprised 250 who received VA dual therapy as first-line treatment and 130 who received VA dual therapy as rescue treatment.H.pylori was successfully eradicated in 239 cases(95.6%)in the first-line treatment group and 116 cases(89.2%)in the rescue treatment group.The overall incidence of AEs was 9.5%for both groups.Specifically,9.2%of patients experienced an AE in the first-line treatment group and 10.0%in the rescue treatment group.Five patients discontinued treatment due to AE,with a discontinuation rate of 1.3%.No serious AE occurred.CONCLUSION The VA dual therapy regimen as a first-line treatment and a rescue therapy was effective and safe for elderly patients aged 60 and older.

Vonoprazan 10 mg or 20 mg vs.lansoprazole 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis:A randomized controlled trial

Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still relapse.In this trial,we evaluated the noninferiority of vonoprazan vs.lansoprazole as maintenance therapy in patients with healed EE.Methods:We performed a double-blind,double-dummy,multicenter,phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019.Patients from China,South Korea,and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 weeks.The primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10%using a two-sided 95%confidence interval(CI).Treatment-emergent adverse events(TEAEs)were recorded.Results:Among 703 patients,EE recurrence was observed in 24/181(13.3%)and 21/171(12.3%)patients receiving vonoprazan 10 mg or 20 mg,respectively,and 47/184(25.5%)patients receiving lansoprazole(differences:-12.3%[95%CI,-20.3%to-4.3%]and-13.3%[95%CI,-21.3%to-5.3%],respectively),meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks.Evidence of superiority(upper bound of 95%CI<0%)was also observed.At 12 weeks,endoscopically confirmed EE recurrence was observed in 5/18,2/20,and 7/20 of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.TEAEs were experienced by 66.8%(157/235),69.0%(156/226),and 65.3%(158/242)of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.The most common TEAE was upper respiratory tract infection in 12.8%(30/235)and 12.8%(29/226)patients in vonoprazan 10 mg and 20 mg groups,respectively and 8.7%(21/242)patients in lansoprazole group.Conclusion:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration:https://clinicaltrials.gov;NCT02388737.

Efficacy and safety of triple therapy containing berberine,amoxicillin,and vonoprazan for Helicobacter pylori initial treatment:A randomized controlled trial

Background:With the development of traditional Chinese medicine research,berberine has shown good efficacy and safety in the eradication of Helicobacter pylori(H.pylori).The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine,amoxicillin,and vonoprazan for the initial treatment of H.pylori.Methods:This study was a single-center,open-label,parallel,randomized controlled clinical trial.Patients with H.pylori infection were randomly(1:1:1)assigned to receive berberine triple therapy(berberine 500 mg,amoxicillin 1000 mg,vonoprazan 20 mg,A group),vonoprazan quadruple therapy(vonoprazan 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg,colloidal bismuth tartrate 220 mg,B group),or rabeprazole quadruple therapy(rabeprazole 10 mg,amoxicillin 1000 mg,clarithromycin 500 mg,colloidal bismuth tartrate 220 mg,C group).The drugs were taken twice daily for 14 days.The main outcome was the H.pylori eradication rate.The secondary outcomes were symptom improvement rate,patient compliance,and incidence of adverse events.Furthermore,factors affecting the eradication rate of H.pylori were further analyzed.Results:A total of 300 H.pylori-infected patients were included in this study,and 263 patients completed the study.An intention-to-treat(ITT)analysis showed that the eradication rates of H.pylori in berberine triple therapy,vonoprazan quadruple therapy,and rabeprazole quadruple therapy were 70.0%(70/100),77.0%(77/100),and 69.0%(69/100),respectively.The per-protocol(PP)analysis showed that the eradication rates of H.pylori in these three groups were 81.4%(70/86),86.5%(77/89),and 78.4%(69/88),respectively.Both ITT analysis and PP analysis showed that the H.pylori eradication rate did not significantly differ among the three groups(P>0.05).In addition,the symptom improvement rate,overall adverse reaction rate,and patient compliance were similar among the three groups(P>0.05).Conclusions:The efficacy of berberine triple therapy for H.pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy,and it was well tolerated.It could be used as one choice of H.pylori initial treatment.

伏诺拉生对幽门螺杆菌根除率和肠道菌群的影响

目的探讨伏诺拉生对幽门螺杆菌(Hp)根除率和肠道菌群的影响。方法选取2021年1月—2023年1月徐州市第一人民医院收治的92例Hp患者,根据治疗方式不同分为对照组和观察组,各46例。对照组采用以质子泵抑制剂雷贝拉唑为基础的四联疗法,观察组采用伏诺拉生联合阿莫西林二联疗法,两组均治疗2周。比较两组溃疡症状改善时间、Hp根除率和复发率;通过胃电图检查患者正常慢波、节律过缓及节律过速百分比,测定胃蛋白酶原Ⅰ(PGⅠ)、胃蛋白酶原Ⅱ(PGⅡ)水平,并计算胃蛋白酶原比(PGR),比较两组患者的胃肠动力学和胃功能情况;取患者粪便标本,通过聚合酶链反应测定16S rDNA拷贝数,比较两组患者双歧杆菌属、乳酸杆菌属、大肠杆菌属和肠球杆菌属数量。结果观察组治疗总有效率高于对照组(P<0.05)。观察组溃疡改善时间短于对照组(P<0.05),复发率低于对照组(P<0.05),Hp根除率高于对照组(P<0.05)。观察组治疗前后PGⅠ、PGⅡ和PGR的差值高于对照组(P<0.05)。观察组治疗前后正常慢波百分比、节律过缓百分比、节律过速百分比的差值高于对照组(P<0.05)。观察组治疗前后双歧杆菌属、乳酸杆菌属、大肠杆菌属、肠球杆菌属的差值高于对照组(P<0.05)。观察组不良反应总发生率低于对照组(P<0.05)。结论伏诺拉生可以有效提高患者Hp根除率,并改善其肠道菌群情况,对提高患者胃肠功能有重要影响。

伏诺拉生不良反应研究进展

伏诺拉生是新型的抑酸药物,药理作用与质子泵抑制剂不同,抑酸作用较质子泵抑制剂可能更为强大、持久。随着伏诺拉生临床应用时间和病例数的增加,不良反应报道也逐渐增多,同时随着临床药理研究的深入,伏诺拉生潜在的不良反应也逐渐呈现。本文通过检索文献,了解伏诺拉生抑酸作用导致的潜在不良反应,以及伏诺拉生与其他药物联合应用时可能出现的潜在不良反应。

富马酸伏诺拉生治疗慢性萎缩性胃炎的临床疗效评价

目的评价探讨富马酸伏诺拉生治疗慢性萎缩性胃炎(CAG)的疗效及安全性。方法按随机数字表法将2021年2月至2023年4月金华市中医医院收治的100例幽门螺杆菌(HP)阳性CAG患者分为对照组和观察组,每组50例。两组均采取清淡饮食,忌辛辣和酸性食物,戒烟忌酒,避免使用对胃黏膜有刺激性的药物等,两组患者均服用阿莫西林胶囊、克拉霉素片和胃黏膜保护剂胶体果胶铋胶囊;此外对照组服用传统质子泵抑制剂奥美拉唑肠溶胶囊,观察组患者服用新型质子泵抑制剂富马酸伏诺拉生片。对比两组患者的临床疗效及不良反应。结果观察组临床总有效率[98.00%(49/50)]高于对照组[76.00%(38/50)](χ^(2)=10.698,P=0.001),观察组HP根除率[90.00%(45/50)]高于对照组[74.00%(37/50)](χ^(2)=4.336,P=0.037)。治疗后,两组患者胃蛋白酶原(PG)Ⅰ和PGⅠ/PGⅡ水平均较治疗前升高,PGⅡ水平均较治疗前降低(均P<0.05);治疗后,观察组患者PGⅠ、PGⅠ/PGⅡ水平均高于对照组[PGⅠ:(6.91±1.58)ng·mL^(-1),(5.43±1.91)ng·mL^(-1);PGⅠ/PGⅡ:(6.91±1.58),(5.43±1.91)](t=4.115,4.222,均P<0.05),PGⅡ水平低于对照组(P<0.05)。治疗后两组血清肿瘤坏死因子-α(TNF-α)、白细胞介素6(IL-6)、白细胞介素8(IL-8)水平均低于治疗前,且治疗后观察组TNF-α、IL-6和IL-8水平均低于对照组,差异有统计学意义(均P<0.05);此外,治疗后两组患者胃动力均得到改善,且观察组患者胃电节律和胃运动节律高于对照组(P<0.05);同时治疗后两组患者的不良反应差异无统计学意义(P>0.05)。结论富马酸伏诺拉生能够改善CAG患者胃肠道黏膜功能,增强胃动力水平,还具有抗炎作用,临床疗效显著且安全性良好。

Treatment of Helicobacter pylori with potassium competitive acid blockers:A systematic review and meta-analysis

BACKGROUND Helicobacter pylori(H.pylori)infects over half the global population,causing gastrointestinal diseases like dyspepsia,gastritis,duodenitis,peptic ulcers,GMALT lymphoma,and gastric adenocarcinoma.Eradicating H.pylori is crucial for treating and preventing these conditions.While conventional proton pump inhibitor(PPI)-based triple therapy is effective,there’s growing interest in longer acid suppression therapies.Potassium competitive acid blocker(P-CAB)triple and dual therapy are new regimens for H.pylori eradication.Initially used in Asian populations,vonoprazan(VPZ)has been recently Food and Drug Administration-approved for H.pylori eradication.AIM To assess the efficacy of regimens containing P-CABs in eradicating H.pylori infection.METHODS This study,following PRISMA 2020 guidelines,conducted a systematic review and meta-analysis by searching MEDLINE and Scopus libraries for randomized clinical trials(RCTs)or observational studies with the following command:[("Helicobacter pylori"OR"H pylori")AND("Treatment"OR"Therapy"OR"Eradication")AND("Vonaprazan"OR"Potassium-Competitive Acid Blocker"OR"P-CAB"OR"PCAB"OR"Revaprazan"OR"Linaprazan"OR"Soraprazan"OR"Tegoprazan")].Studies comparing the efficacy of P-CABs-based treatment to classical PPIs in eradicating H.pylori were included.Exclusion criteria included case reports,case series,unpublished trials,or conference abstracts.Data variables encompassed age,diagnosis method,sample sizes,study duration,intervention and control,and H.pylori eradication method were gathered by two independent reviewers.Meta-analysis was performed in R software,and forest plots were generated.RESULTS A total of 256 references were initially retrieved through the search command.Ultimately,fifteen studies(7 RCTs,7 retrospective observational studies,and 1 comparative unique study)were included,comparing P-CAB triple therapy to PPI triple therapy.The intention-to-treat analysis involved 8049 patients,with 4471 in the P-CAB intervention group and 3578 in the PPI control group across these studies.The analysis revealed a significant difference in H.pylori eradication between VPZ triple therapy and PPI triple therapy in both RCTs and observational studies[risk ratio(RR)=1.17,95%confidence interval(CI):1.11-1.22,P<0.0001]and(RR=1.13,95%CI:1.09-1.17,P<0.0001],respectively.However,no significant difference was found between tegoprazan(TPZ)triple therapy and PPI triple therapy in both RCTs and observational studies(RR=1.04,95%CI:0.93-1.16,P=0.5)and(RR=1.03,95%CI:0.97-1.10,P=0.3),respectively.CONCLUSION VPZ-based triple therapy outperformed conventional PPI-based triple therapy in eradicating H.pylori,positioning it as a highly effective first-line regimen.Additionally,TPZ-based triple therapy was non-inferior to classical PPI triple therapy.

伏诺拉生二联方案根除幽门螺杆菌的疗效观察

目的本研究针对幽门螺杆菌(Hp)感染的患者,比较含伏诺拉生的大剂量二联方案和含质子泵抑制剂的大剂量二联方案的疗效和安全性。方法采用随机对照,前瞻性的研究方法。研究对象为2023年2月至2023年12月于兰州大学第一医院消化科门诊就诊的243例符合纳入及排除标准的幽门螺杆菌感染患者,随机分为两组,伏诺拉生大剂量二联组(VPZ-HDDT组)予以富马酸伏诺拉生片20 mg,2/天+阿莫西林750 mg,4/天,连续用药14天,PPI大剂量二联组(PPI-HDDT组)予以艾司奥美拉唑40 mg,2次/天+阿莫西林750 mg,4次/天,连续用药14天。患者服药和不良反应发生情况:在开始治疗的第7、14天通过电话或微信随访,与患者沟通并记录。复查13 C或14 C尿素呼气试验需在用药结束后至少1个月。分别采用符合方案治疗(PP)分析、改良意向治疗(mITT)和意向性治疗(ITT)来对比两组患者Hp根除率,同时比较两组依从性和不良反应发生率。结果VPZ-HDDT组和PPI-HDDT组在初次治疗患者中的PP分析根除率分别为94.0%、88.5%(P=0.209),mITT分析根除率分别为91.8%、87.5%(P=0.358),ITT分析根除率分别为86.7%、81.9%(P=0.377);在再次治疗患者中,这两组PP分析与mITT分析根除率一致,分别为87.0%、84.2%(P=0.800),ITT分析根除率分别为83.3%、76.2%(P=0.550);对于难治性Hp的病人,这两组的PP分析与mITT分析根除率也一致,分别为71.4%、50.0%(P=0.429),ITT分析的根除率分别为62.5%、50.0%(P=0.640)。在不同分层中,VPZ-HDDT组的根除率均高于PPI-HDDT组,但差异均无统计学意义。这两组的不良反应发生率及依从性均相似,差异无统计学意义。结论两种二联方案在首次治疗的患者中,都可以达到临床可接受的根除率(>85%),对于再次治疗和难治性的患者,抑酸剂选择伏诺拉生会获益更大。