伏诺拉生二联疗法在幽门螺杆菌根治中的效果观察

尚雨蒙; 柯希权; 褚正洋; 方传发; 胡东丽; 张成斌

doi:10.16766/j.cnki.issn.1674-4152.003585

伏诺拉生二联疗法在幽门螺杆菌根治中的效果观察

doi: 10.16766/j.cnki.issn.1674-4152.003585

1.
蚌埠医科大学第二附属医院消化内科，安徽蚌埠 233000
2.
蚌埠医科大学第一附属医院消化内科，安徽蚌埠 233004

基金项目:

安徽省科技厅重点研发项目 2022a05020022

详细信息

通讯作者:
张成斌，E-mail：41330568@qq.com

中图分类号: R57 R975.6
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- 被引次数: 0
出版历程
- 收稿日期: 2023-11-27
- 网络出版日期: 2024-09-05

Observation on the effect of Vonoprazan-based dual therapy in radical treatment of Helicobacter pylori

1.
Department of Gastroenterology, the Second Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233000, China

摘要

摘要: 目的观察富马酸伏诺拉生片(VPZ)联合阿莫西林胶囊10天疗法治疗幽门螺杆菌(Hp)感染患者的临床疗效、安全性、依从性以及效益。方法将2021年10月—2023年2月于蚌埠医科大学第二附属医院门诊确诊的150例Hp感染患者采用随机数字表法分为对照组(75例)和实验组(75例)。对照组给予艾司奥美拉唑镁肠溶片联合阿莫西林胶囊、甲硝唑片、胶体果胶铋胶囊；实验组给予富马酸伏诺拉生片和阿莫西林胶囊，疗程均为10 d。比较2组患者的Hp根除率、不良反应发生率、依从性和成本效果比值。结果实验组脱落5例，对照组脱落7例，共脱落12例，最终实验组70例，对照组68例。根据方案(PP)分析，实验组和对照组Hp根除率分别为91.43%(64/70)和83.82%(57/68)，差异无统计学意义(P=0.174)；根据意向性治疗(ITT)分析，实验组和对照组的Hp根除率分别为85.33%(64/75)和76.00%(57/75)，差异无统计学意义(P=0.148)。实验组和对照组不良反应发生率分别为4.29%(3/70)和14.71%(10/68)，差异有统计学意义(P＜0.05)。实验组和对照组依从性分别为97.14%(68/70)和88.24%(60/68), 差异无统计学意义(P=0.091)。实验组和对照组的成本-效果比值分别为2.22和3.64。结论与艾司奥美拉唑镁肠溶片联合2种抗生素及铋剂相比，富马酸伏诺拉生片联合1种抗生素用于根治Hp感染患者的临床疗效相当，安全性及效益较高且依从性良好，值得在临床推广。
- 幽门螺杆菌 /
- 伏诺拉生 /
- 质子泵抑制剂 /
- 根治
Abstract: Objective To observe the clinical efficacy, safety, compliance, and vonoprazan fumarate tablet (VPZ) combined with amoxicillin capsule for 10 days in the treatment of Helicobacter pylori (Hp) infection. Methods A total of 150 Hp infected patients diagnosed in the Second Affiliated Hospital of Bengbu Medical University from October 2021 to February 2023 were randomly divided into a control group (75 cases) and an experimental group (75 cases) by random number table method. The control group was given esomeprazole magnesium enteric-coated tablets combined with amoxicillin capsules, metronidazole tablets, and colloidal bismuth pectin capsules. The experimental group was given the vonoprazan fumarate tablet and amoxicillin capsule. Both groups were treated for 10 days. Hp eradication rate, incidence of adverse reactions, compliance, and cost-effectiveness ratio were compared between the two groups. Results There were 5 cases of shedding in the experimental group and 7 cases in the control group, a total of 12 cases of shedding, 70 cases in the experimental group and 68 cases in the control group. According to the protocol (PP) analysis, the eradication rates of Hp in the experimental group and control group were 91.43% (64/70) and 83.82% (57/68), respectively, with no statistical significance (P=0.174). According to intention-to-treat (ITT) analysis, the eradication rates of the experimental group and control group were 85.33% (64/75) and 76.00% (57/75), respectively, with no statistical significance (P=0.148). The incidence of adverse reactions in the experimental group and the control group was 4.29% (3/70) and 14.71% (10/68), respectively, and the difference was statistically significant (P < 0.05). The compliance of the experimental group and the control group was 97.14% (68/70) and 88.24% (60/68), respectively, with no statistical significance (P=0.091). The cost-effectiveness ratio of the experimental group and the control group were 2.22 and 3.64, respectively. Conclusion Compared with esomeprazole magnesium enteric-coated tablet combined with two antibiotics and bismuth, Vonolazan fumarate tablet combined with one antibiotic in the radical treatment of Hp infection patients has the same clinical efficacy, high safety and benefit, and good compliance, which is worthy of clinical promotion.
- Helicobacter pylori /
- Vonoprazan /
- Proton pump inhibitors /
- Eradication

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表 1 2组Hp感染患者一般资料比较

Table 1. Comparison of general data between two groups of patients with Hp infection

组别	例数	性别[例(%)]		年龄(x±s，岁)	BMI(x±s)	居住城市 [例(%)]	初中以上学历[例(%)]	生活习惯[例(%)]
组别	例数	男性	女性	年龄(x±s，岁)	BMI(x±s)	居住城市 [例(%)]	初中以上学历[例(%)]	吸烟	饮酒
实验组	70	40(57.14)	30(42.86)	47.06±12.63	23.01±1.64	42(60.00)	61(87.14)	30(42.86)	6(8.57)
对照组	68	29(42.65)	39(57.35)	45.15±14.25	22.53±1.44	44(64.71)	54(79.41)	27(39.71)	7(10.29)
统计量		2.899^a		0.834^b	1.826^b	0.325^a	1.484^a	0.141^a	0.120^a
P值		0.089		0.406	0.070	0.568	0.223	0.707	0.729
注：^a为χ²值，^b为t值。

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表 2 2组Hp感染患者不良反应发生率比较[例(%)]

Table 2. Comparison of adverse reaction rates between two groups of patients with Hp infection [cases(%)]

组别	例数	腹痛	腹泻	恶心	皮疹	合计
实验组	70	1(1.43)	0	1(1.43)	1(1.43)	3(4.29)
对照组	68	6(8.82)	1(1.47)	3(4.41)	0	10(14.71)
χ²值		2.532		0.288		4.389
P值		0.112	0.493^a	0.591	0.999^a	0.036
注：^a为采用Fisher精确检验。

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表 3 2种治疗方案根除Hp成本效益分析

Table 3. Cost-benefit analysis of H. pylori eradication using two treatment regimens

组别	药物	方案	费用 (元)	总费用 (元)	有效率 (%)	C/E
实验组	富马酸伏诺拉生片	0.02 g，2次/d	198.00	203.32	91.43	2.22
	阿莫西林胶囊	1.00 g，2次/d	5.32
对照组	艾司奥美拉唑镁肠溶片	0.02 mg，2次/d	248.60	304.96	83.82	3.64
	阿莫西林胶囊	1.00 g，2次/d	5.32
	甲硝唑片	0.40 g，3次/d	3.04
	胶体果胶铋胶囊	0.20 g，3次/d	48.00
注：富马酸伏诺拉生片69.30元/盒, 7粒/盒；艾司奥美拉唑镁肠溶片87.00元/盒，7粒/盒；阿莫西林胶囊2.66元/盒，40粒/盒；甲硝唑片5.07元/盒，100粒/盒；胶体果胶铋胶囊12.00元/盒，30粒/盒。2组疗程均为10 d。

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