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个体化根除治疗:一线经验铋四联疗法的比较、开放临床试验。

Tailored eradication empirical bismuth-containing quadruple therapy for first-line eradication: A comparative, open trial.

机构信息

Department of Gastroenterology, Gil Medical Center, Gachon University, Incheon 21565, South Korea.

Department of Laboratory Medicine, Gil Medical Center, Gachon University, Incheon 21565, South Korea.

出版信息

World J Gastroenterol. 2019 Dec 14;25(46):6743-6751. doi: 10.3748/wjg.v25.i46.6743.

Abstract

BACKGROUND

Few studies have compared the efficacy and safety profile of a tailored eradication (TR) strategy based on the presence of a 23S ribosomal RNA point mutation with those of empirical bismuth-based quadruple therapy (EBQT) for first-line eradication of () in Korean patients.

AIM

To compare the efficacy and safety of a TR strategy and those of EBQT regimen as first-line eradication therapy for .

METHODS

This is an open-label, comparative study in which we prospectively enrolled patients over 18 years of age with infection and retrospectively reviewed their data. positive patients diagnosed by rapid urease test, Giemsa staining, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR) were enrolled from May 2016 to September 2018 at Gil Medical Center. Patients with infection received either a TR regimen or the EBQT regimen. In the tailored therapy group that underwent DPO-PCR testing, patients with A2142G and/or A2143G point mutations were treated with a bismuth-containing quadruple regimen. The eradication rate, patient-reported side effect rate, and eradication success rate were evaluated and compared between the groups.

RESULTS

A total of 150 patients were assigned to the TR ( = 50) or EBQT group ( = 100). The first-line eradication rate of did not differ between the groups (96.0% 95.7%, = 0.9). The rate of eradication-related side effects for TR was 12.0%, which differed significantly from that of EBQT (43.0%) for first-line treatment ( < 0.001).

CONCLUSION

DPO-PCR-based TR for eradication may be equally efficacious, with less treatment-related complications, compared to EBQT in Korea, where clarithromycin resistance is high.

摘要

背景

在韩国,很少有研究比较基于 23S 核糖体 RNA 点突变的个体化根除(TR)策略与经验性铋四联疗法(EBQT)在一线根除幽门螺杆菌( )的疗效和安全性。

目的

比较 TR 策略与 EBQT 方案作为一线根除治疗 的疗效和安全性。

方法

这是一项开放标签、前瞻性比较研究,我们前瞻性地招募了年龄在 18 岁以上且 感染的患者,并回顾性地分析了他们的数据。通过快速尿素酶试验、吉姆萨染色或双重引物寡核苷酸聚合酶链反应(DPO-PCR)诊断为 阳性的患者,于 2016 年 5 月至 2018 年 9 月在 Gil 医疗中心招募。 感染患者接受 TR 方案或 EBQT 方案治疗。在接受 DPO-PCR 检测的个体化治疗组中,对于 A2142G 和/或 A2143G 点突变的患者,采用含铋四联方案治疗。评估并比较两组间的根除率、患者报告的副作用发生率和 根除成功率。

结果

共 150 例患者被分配至 TR( = 50)或 EBQT 组( = 100)。两组间一线 根除率无差异(96.0% 95.7%, = 0.9)。TR 的根除相关副作用发生率为 12.0%,与 EBQT(43.0%)一线治疗相比差异有统计学意义( < 0.001)。

结论

在韩国,克拉霉素耐药率较高,与 EBQT 相比,基于 DPO-PCR 的 TR 根除 可能同样有效,且治疗相关并发症更少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d93/6920661/6846d31a1979/WJG-25-6743-g001.jpg

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