质子泵抑制剂大剂量二联与铋剂四联在幽门螺杆菌根除治疗中的疗效比较

doi:10.3969/j.issn.1004-583X.2022.03.006

摘要/Abstract

摘要：

目的比较质子泵抑制剂大剂量二联与铋剂四联对幽门螺杆菌(Helicobacter pylori, H.pylori)的根除率和不良反应的发生率。方法选择2021年1月至2021年8月就诊于河北省人民医院消化内科门诊的H.pylori阳性患者208例,随机分为试验组(质子泵抑制剂大剂量二联)和对照组(铋剂四联),其中试验组105例,对照组103例。试验组给予“艾司奥美拉唑40 mg, 2次/d、阿莫西林750 mg, 4次/d”,疗程14天。对照组给予“艾司奥美拉唑20 mg,2次/d 、枸橼酸铋钾220 mg,2次/d 、阿莫西林1 000 mg,2次/d 、呋喃唑哃100 mg,2次/d ”,疗程14天。疗程结束4周后复查¹³C或¹⁴C-尿素呼气试验,比较两组H.pylori根除率及不良反应的发生情况。结果试验组及对照组的ITT根除率分别为77.1%、82.5%(P=0.334),PP根除率分别为82.7%和87.6%(P=0.329);试验组的不良反应发生率低于对照组(9.0% vs 19.0%,P=0.042),其中试验组不良反应主要表现为腹胀、腹泻及皮疹等,对照组不良反应主要表现为口腔异味、便秘及腹痛等。结论质子泵抑制剂大剂量二联方案根除H.pylori的疗效与铋剂四联方案相当,但不良反应发生率更低,有望成为H.pylori治疗的一线根除方案。

关键词: 幽门螺杆菌, 质子泵抑制剂, 铋剂四联, 根除率, 不良反应

Abstract:

Objective To compare the eradication rate and adverse incidence of proton pump inhibitor high dose dual therapy with bismuth-containing quadruple therapy for Helicobacter pylori (H.pylori). Methods From January 2021 to August 2021, a total of 208 patients with positive H.pylori admitted to the Department of Gastroenterology, Hebei General Hospital were enrolled and randomly grouped into experimental group (n=105, proton pump inhibitor high dose dual therapy) and control group (n=103, bismuth-containing quadruple therapy). The patients in experimental group were given oral administration of esomeprazole 40 mg two times a day and amoxicillin 750 mg a day, and patients in control group were given esomeprazole 20 mg two times a day, colloidal bismuth subcitrate 220 mg two times a day, amoxicillin 1 000 mg two times a day, Furazolidone 100 mg two times a day. The treatment period for both groups was 14 days; after 4 week, ¹³C/¹⁴C urease breath test (¹³C/¹⁴C-UBT) for detecting H.pylori infection was performed and the eradication rate and adverse incidence were compared.Results The eradication rate of H.pylori for the experimental group and the control group were 77.1% and 82.5% (P=0.334) in intention-to-treat (ITT) analysis; the eradication rate of H.pylori for the experimental group and the control group were 82.7% and 87.6%(P=0.329) in per-protocol (PP) analysis. The incidence of adverse reactions in the experimental group was 9.0%, which was significantly lower than 19.0% in the control group (P=0.042). Adverse reactions in the experimental group were mainly bloating, diarrhea and rash; adverse reactions were mainly oral odor, constipation and abdominal pain in the control group. Conclusion The eradication rate was similar both proton pump inhibitor high dose dual therapy and bismuth-containing quadruple therapy; but proton pump inhibitor high dose dual therapy has significantly lower incidence for adverse reactions, expecting to be optimal eradication program.

Key words: Helicobacter pylori, proton pump inhibitors, bismuth-containing quadruple therapy, eradication rate, adverse reactions

中图分类号:

R377

黄业鸿, 刘改芳, 忻晨曦, 赵云红, 吴婧. 质子泵抑制剂大剂量二联与铋剂四联在幽门螺杆菌根除治疗中的疗效比较[J]. 临床荟萃, 2022, 37(3): 230-233.

Huang Yehong, Liu Gaifang, Xin Chenxi, Zhao Yunhong, Wu Jing. Searching for an optimal therapy for H.pylori eradication: High-dose proton-pump inhibitor dual therapy vs. bismuth-containing quadruple therapy[J]. Clinical Focus, 2022, 37(3): 230-233.

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链接本文: https://huicui.hebmu.edu.cn/CN/10.3969/j.issn.1004-583X.2022.03.006

https://huicui.hebmu.edu.cn/CN/Y2022/V37/I3/230

图/表 3

参考文献 15

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组别	例数	PP根除率		ITT根除率
组别	例数	例数	根除率[例(%)]	例数	根除率[例(%)]
试验组	105	98	81(82.7)	105	81(77.1)
对照组	103	97	85(87.6)	103	85(82.5)
χ²值			0.953		0.934
P值			0.329		0.334

组别	例数	PP根除率		ITT根除率
组别	例数	例数	根除率[例(%)]	例数	根除率[例(%)]
试验组	105	98	81(82.7)	105	81(77.1)
对照组	103	97	85(87.6)	103	85(82.5)
χ²值			0.953		0.934
P值			0.329		0.334

组别	例数	不良反应
试验组	100	9(9.0)
对照组	100	19(19.0)
χ²值		4.153
P值		0.042

组别	例数	不良反应
试验组	100	9(9.0)
对照组	100	19(19.0)
χ²值		4.153
P值		0.042

项目	试验组(n=100)	对照组(n=100)
头晕	0(0)	1(1.0)
头痛	0(0)	1(1.0)
恶心	1(1.0)	0(0)
呕吐	1(1.0)	0(0)
腹痛	1(1.0)	2(2.0)
腹胀	2(2.0)	1(1.0)
腹泻	2(2.0)	1(1.0)
便秘	0(0)	2(2.0)
口干	0(0)	1(1.0)
口苦	0(0)	1(1.0)
口腔异味	0(0)	2(2.0)
心悸	0(0)	1(1.0)
纳差	0(0)	1(1.0)
疲乏	0(0)	1(1.0)
周身痛	0(0)	1(1.0)
嗳气	0(0)	1(1.0)
皮疹	2(2.0)	1(1.0)
失眠、兴奋	0(0)	1(1.0)