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腔内治疗幽门螺杆菌感染。

Intraluminal therapy for Helicobacter pylori infection.

机构信息

Division of Gastroenterology, Department of Internal Medicine, MacKay Memorial Hospital, New Taipei City, Taiwan.

Division of Gastroenterology, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan.

出版信息

J Gastroenterol Hepatol. 2019 Aug;34(8):1337-1343. doi: 10.1111/jgh.14627. Epub 2019 Feb 25.

DOI:10.1111/jgh.14627
PMID:30734357
Abstract

BACKGROUND AND AIM

Several strategies have been proposed to increase the eradication rate of Helicobacter pylori. However, the widespread increasing resistance rates to current multiple-dose oral antibiotic therapies call for alternative therapeutic approaches. We aim to develop a novel intraluminal therapy for H. pylori infection (ILTHPI).

METHODS

From April 2017 to December 2017, 100 H. pylori-infected treatment-naïve patients with upper abdominal pain or discomfort underwent endoscopic examinations and concomitant ILTHPI, which comprised the control of intragastric pH, the irrigation of gastric mucosal surface with a mucolytic agent, and the application of single-dose medicaments containing antibiotic powders. The safety profiles while conducting ILTHPI and adverse events after ILTHPI were evaluated. The success of eradication was assessed based on the result of the C-urea breath test 6 weeks after ILTHPI. In addition, a patient with successful ILTHPI was reconfirmed by a negative H. pylori stool antigen test four to 6 months after ILTHPI to exclude short-term recurrence.

RESULTS

All the 100 enrolled patients completed the ILTHPI with good safety profiles and mild adverse events (6%). Five patients dropped out, and 51 of 95 patients (53.7%) achieved successful eradication immediately after endoscopic examinations. All 51 patients revealed negative stool H. pylori antigen tests four to 6 months after successful ILTHPI. No short-term recurrence was observed.

CONCLUSIONS

We have developed a novel therapeutic approach. With the ILTHPI, H. pylori can be eradicated immediately by administrating a single-dose regimen while conducting an endoscopic examination.

CLINICAL TRIALS NUMBER

NCT03124420.

摘要

背景与目的

已经提出了几种提高幽门螺杆菌根除率的策略。然而,当前多剂量口服抗生素治疗的广泛耐药率增加需要替代的治疗方法。我们旨在开发一种治疗幽门螺杆菌感染的新型腔内治疗方法(ILTHPI)。

方法

从 2017 年 4 月至 2017 年 12 月,100 名有上腹痛或不适的未经治疗的幽门螺杆菌感染初治患者接受了内镜检查和同时进行的 ILTHPI,包括控制胃内 pH 值、用粘液溶解剂冲洗胃黏膜表面和应用含有抗生素粉末的单剂量药物。评估了进行 ILTHPI 时的安全性概况和 ILTHPI 后的不良反应。根据 ILTHPI 后 6 周的 C-尿素呼气试验结果评估根除的成功率。此外,对 1 例 ILTHPI 成功的患者在 ILTHPI 后 4 至 6 个月进行了阴性幽门螺杆菌粪便抗原检测以排除短期复发,从而再次确认其成功。

结果

所有 100 名入组患者均顺利完成 ILTHPI,安全性良好,仅有轻度不良反应(6%)。有 5 名患者脱落,95 名患者中有 51 名(53.7%)在内镜检查后立即达到了根除成功。所有 51 例患者在 ILTHPI 成功后 4 至 6 个月的粪便 H. pylori 抗原检测均为阴性。未观察到短期复发。

结论

我们已经开发出一种新的治疗方法。通过在进行内镜检查的同时给予单剂量方案,ILTHPI 可以立即根除幽门螺杆菌。

临床试验编号

NCT03124420。

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