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一项关于沃克帕唑和四环素联合疗法治疗青霉素过敏或既往含阿莫西林治疗失败的特殊人群幽门螺杆菌感染可行性的真实世界探索性研究。

A real-world exploratory study on the feasibility of vonoprazan and tetracycline dual therapy for the treatment of Helicobacter pylori infection in special populations with penicillin allergy or failed in previous amoxicillin-containing therapies.

作者信息

Gao Wen, Xu Ying, Liu Jianxiang, Wang Xiaolei, Dong Xinhong, Teng Guigen, Liu Binbin, Dong Jinpei, Ge Chaoyi, Ye Hui, Zhang Xuezhi, Cheng Hong

机构信息

GI Department, Peking University First Hospital, Beijing, China.

TCM and Integrative Medicine Department, Peking University First Hospital, Beijing, China.

出版信息

Helicobacter. 2023 Apr;28(2):e12947. doi: 10.1111/hel.12947. Epub 2023 Jan 17.

Abstract

BACKGROUND

The treatment of Helicobacter pylori (H. pylori) infection is a challenge for those who cannot use amoxicillin.

OBJECTIVE

To evaluate the eradication rate and adverse effects of vonoprazan and tetracycline dual therapy as first-line and rescue treatment regimens used in special populations with penicillin allergy or failed in previous amoxicillin-containing therapies.

DESIGN

Patients enrolled were those who were H. pylori-positive with selected conditions: (1) allergic to penicillin, either naïve to treatment or had failed before; or (2) failed in previous amoxicillin-containing therapies. All enrolled patients accepted 14-day vonoprazan and tetracycline dual therapy (VT dual therapy) as follows: vonoprazan (20 mg b.i.d.) and tetracycline (500 mg t.i.d. [body weight < 70 kg] or 500 mg q.i.d. [body weight ≥ 70 kg]). H. pylori status was evaluated by C-urease breath test 6 weeks after treatment. All adverse effects were recorded. Some patients underwent bacterial culture and antibiotic susceptibility testing.

RESULTS

A total of 62 patients were enrolled; 18 of them received VT dual therapy as first-line treatment, 44 patients received VT dual therapy as rescue treatment. Overall, 58 of 62 patients achieved successful eradication (93.5%), while all involved (100%,18/18) succeeded in the first-line treatment group and 40 cases (90.9%, 40/44) succeeded in the rescue treatment group. Sixty-one (61/62, 98.4%) patients completed the whole course of treatment. Adverse events occurred in 6 patients (6/62, 9.7%), while one patient quit because of skin rash. All adverse effects were mild and relieved spontaneously after H. pylori treatment. Five patients achieved successful H. pylori culture, and all strains isolated were sensitive to tetracycline.

CONCLUSIONS

For the treatment of H. pylori infection in special populations with penicillin allergy or failed in previous amoxicillin-containing therapies, a 14-day vonoprazan and tetracycline dual therapy was effective and safe as first-line and rescue treatment in our study. Further study is warranted to verify its efficacy, especially for those who cannot use amoxicillin.

摘要

背景

对于那些无法使用阿莫西林的患者而言,幽门螺杆菌(H. pylori)感染的治疗是一项挑战。

目的

评估沃克和四环素联合疗法作为一线及挽救治疗方案在青霉素过敏或既往含阿莫西林治疗失败的特殊人群中的根除率及不良反应。

设计

入选患者为符合特定条件的幽门螺杆菌阳性患者:(1)对青霉素过敏,初治或既往治疗失败;或(2)既往含阿莫西林治疗失败。所有入选患者接受为期14天的沃克和四环素联合疗法(VT联合疗法),具体如下:沃克(20毫克,每日两次)和四环素(500毫克,每日三次[体重<70千克]或500毫克,每日四次[体重≥70千克])。治疗6周后通过¹³C-尿素呼气试验评估幽门螺杆菌感染状况。记录所有不良反应。部分患者进行了细菌培养及抗生素敏感性检测。

结果

共纳入62例患者;其中18例接受VT联合疗法作为一线治疗,44例接受VT联合疗法作为挽救治疗。总体而言,62例患者中有58例成功根除(93.5%),其中一线治疗组全部成功(100%,18/18),挽救治疗组40例成功(90.9%,40/44)。61例(61/62,98.4%)患者完成了整个疗程。6例患者(6/62,9.7%)出现不良事件,1例患者因皮疹退出。所有不良反应均较轻,幽门螺杆菌治疗后自行缓解。5例患者幽门螺杆菌培养成功,分离出的所有菌株对四环素敏感。

结论

在我们的研究中,对于青霉素过敏或既往含阿莫西林治疗失败的特殊人群,为期14天的沃克和四环素联合疗法作为一线及挽救治疗有效且安全。有必要进一步研究以验证其疗效,尤其是对于无法使用阿莫西林的患者。

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