PDF(Pubmed)
Abstract：
OBJECTIVE: To compare the potential efficacy and safety of dual therapy and quadruple therapy with vonoprazan (VPZ) as well as the standard quadruple therapy of proton pump inhibitor (PPI) for the eradication of Helicobacter pylori (Hp) infection in Hainan province.
METHODS: A single-centre, non-blinded, non-inferiority randomized controlled trial was conducted at the outpatient department of gastroenterology at the Second Affiliated Hospital of Hainan Medical University from June 2022 to February 2023. 135 patients aged 18-75 years with Hp infection were enrolled and randomized into three different groups (group V1: VPZ 20 mg twice a day and amoxicillin 1.0 g three times a day for 14 days V2: vonoprazan 20 mg, amoxicillin capsules 1.0 g, furazolidone 0.1 g and bismuth potassiulm citrate 240 mg, twice daily for 14 days;; group V3: ilaprazole 5 mg, Amoxicillin 1.0 g, Furazolidone 100 mg, bismuth potassiulm citrate 240 mg, twice a day for 14 days). Four weeks after the end of treatment, Hp eradication was confirmed by rechecking 13C-urea breath test (UBT).
RESULTS: The eradication efficacy of V1 and V3 was non-inferior to that of V2, which is consistent with the results obtained from the Kruskal-Wallis H test. The eradication rate by intentional analysis was 84.4% (38/45, 95%CI 73.4%-95.5%, P>0.05) for all the three groups. If analyzed by per-protocol, the eradication rates were 88.4% (38/43, 95%CI 78.4%-98.4%), 92.7% (38/41, 95%CI 84.4%-101.0%),88.4% (38/43，95%CI 78.4%-98.4%) in groups V1, V2 and V3, respectively, which did not show a significant difference (P > 0.05). The incidence of adverse effects was significantly lower in VPZ dual therapy compared to the other two treatment regimens (P < 0.05). VPZ dual therapy or quadruple therapy was also relatively less costly than standard quadruple therapy.
CONCLUSIONS: VPZ dual therapy and quadruple therapy shows promise of not being worse than the standard quadruple therapy by a clinically relevant margin. More studies might be needed to definitively determine if the new therapy is equally effective or even superior.
METHODS: A single-centre, non-blinded, non-inferiority randomized controlled trial was conducted at the outpatient department of gastroenterology at the Second Affiliated Hospital of Hainan Medical University from June 2022 to February 2023. 135 patients aged 18-75 years with Hp infection were enrolled and randomized into three different groups (group V1: VPZ 20 mg twice a day and amoxicillin 1.0 g three times a day for 14 days V2: vonoprazan 20 mg, amoxicillin capsules 1.0 g, furazolidone 0.1 g and bismuth potassiulm citrate 240 mg, twice daily for 14 days;; group V3: ilaprazole 5 mg, Amoxicillin 1.0 g, Furazolidone 100 mg, bismuth potassiulm citrate 240 mg, twice a day for 14 days). Four weeks after the end of treatment, Hp eradication was confirmed by rechecking 13C-urea breath test (UBT).
RESULTS: The eradication efficacy of V1 and V3 was non-inferior to that of V2, which is consistent with the results obtained from the Kruskal-Wallis H test. The eradication rate by intentional analysis was 84.4% (38/45, 95%CI 73.4%-95.5%, P>0.05) for all the three groups. If analyzed by per-protocol, the eradication rates were 88.4% (38/43, 95%CI 78.4%-98.4%), 92.7% (38/41, 95%CI 84.4%-101.0%),88.4% (38/43，95%CI 78.4%-98.4%) in groups V1, V2 and V3, respectively, which did not show a significant difference (P > 0.05). The incidence of adverse effects was significantly lower in VPZ dual therapy compared to the other two treatment regimens (P < 0.05). VPZ dual therapy or quadruple therapy was also relatively less costly than standard quadruple therapy.
CONCLUSIONS: VPZ dual therapy and quadruple therapy shows promise of not being worse than the standard quadruple therapy by a clinically relevant margin. More studies might be needed to definitively determine if the new therapy is equally effective or even superior.
摘要：
目的：比较万诺拉赞(VPZ)和质子泵抑制剂(PPI)标准四联治疗根除海南幽门螺杆菌(Hp)感染的潜在疗效和安全性。
方法：单中心，非致盲,非劣效性随机对照试验于2022年6月至2023年2月在海南医科大学第二附属医院消化内科门诊进行.纳入135例年龄在18-75岁之间的Hp感染患者，并随机分为三个不同的组（V1组：VPZ20mg，每天两次，阿莫西林1.0g，每天三次，共14天V2：vonoprazan20mg，阿莫西林胶囊1.0g，呋喃唑酮0.1克和柠檬酸钾铋240毫克，每天两次，共14天；V3组：艾普拉唑5mg，阿莫西林1.0g，呋喃唑酮100毫克，柠檬酸钾铋240毫克，每天两次，共14天）。治疗结束四周后，通过重新检查13C-尿素呼气试验（UBT）确认Hp根除。
结果：V1和V3的根除功效不劣于V2，这与从Kruskal-WallisH检验获得的结果一致。有意分析的根除率为84.4%(38/45，95CI73.4%-95.5%，三组均P>0.05)。如果按协议分析，根除率为88.4%(38/43,95CI78.4%-98.4%),92.7%（38/41，95CI84.4%-101.0%），V1、V2和V3组分别为88.4%(38/43，95CI78.4%-98.4%)，差异无统计学意义(P>0.05)。与其他两种治疗方案相比，VPZ双重治疗方案的不良反应发生率明显降低（P<0.05）。VPZ双重疗法或四联疗法也比标准四联疗法成本相对较低。
结论：VPZ双重疗法和四联疗法有望在临床相关方面不会比标准四联疗法差。可能需要更多的研究来确定新疗法是否同样有效甚至更优越。
方法：单中心，非致盲,非劣效性随机对照试验于2022年6月至2023年2月在海南医科大学第二附属医院消化内科门诊进行.纳入135例年龄在18-75岁之间的Hp感染患者，并随机分为三个不同的组（V1组：VPZ20mg，每天两次，阿莫西林1.0g，每天三次，共14天V2：vonoprazan20mg，阿莫西林胶囊1.0g，呋喃唑酮0.1克和柠檬酸钾铋240毫克，每天两次，共14天；V3组：艾普拉唑5mg，阿莫西林1.0g，呋喃唑酮100毫克，柠檬酸钾铋240毫克，每天两次，共14天）。治疗结束四周后，通过重新检查13C-尿素呼气试验（UBT）确认Hp根除。
结果：V1和V3的根除功效不劣于V2，这与从Kruskal-WallisH检验获得的结果一致。有意分析的根除率为84.4%(38/45，95CI73.4%-95.5%，三组均P>0.05)。如果按协议分析，根除率为88.4%(38/43,95CI78.4%-98.4%),92.7%（38/41，95CI84.4%-101.0%），V1、V2和V3组分别为88.4%(38/43，95CI78.4%-98.4%)，差异无统计学意义(P>0.05)。与其他两种治疗方案相比，VPZ双重治疗方案的不良反应发生率明显降低（P<0.05）。VPZ双重疗法或四联疗法也比标准四联疗法成本相对较低。
结论：VPZ双重疗法和四联疗法有望在临床相关方面不会比标准四联疗法差。可能需要更多的研究来确定新疗法是否同样有效甚至更优越。
