Guan Jia-Lun, Han Ying-Ying, Wang Mu-Ru, Xia Su-Hong, Li Ji-Yan, Zhang Ming-Yu, Zhao Kai, Feng Li-Na, Zhang Yu, Dong Ruo-Nan, Liao Jia-Zhi, Li Pei-Yuan
Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China.
Helicobacter. 2023 Apr;28(2):e12953. doi: 10.1111/hel.12953. Epub 2023 Feb 3.
High-dose dual therapy (HDDT) is an emerging and promising therapeutic regime for Helicobacter pylori (H. pylori) eradication. However, the pharmacokinetics of the components of HDDT, amoxicillin and proton pump inhibitor, are likely to be affected by body size. In this study, we aimed to find out the impact of body size on the efficacy of HDDT.
We collected the medical data of 385 treatment-naive patients infected with H. pylori who received HDDT (esomeprazole 20 mg and amoxicillin 750 mg four times daily) for 14 days from July 2020 to December 2021. The associations among the eradication efficacy, adverse events, and variables (sex, age, height, body weight, body mass index (BMI), body surface area (BSA), smoking, drinking, etc.) were analyzed respectively in our study. Among these factors, continuous variables were classified into categorical variables using the cut-off values which were calculated by receiver operating characteristic analysis.
The eradication rate of HDDT was 89.9%. There were 55 (14.3%) patients who occurred adverse events during the treatment. Patients with height <170.5 cm, body weight <60.5 kg, BMI <20.55 kg/m , BSA <1.69 m had a higher eradication rate (92.1% vs. 84.0%, 93.1% vs. 86.8%, 96.0% vs. 87.8%, 93.4% vs. 84.8%, all p < .05). The multivariate analysis showed that BSA ≥1.69 m (OR 2.53, 95% CI: 1.28-4.99, p = .007) was the only independent predictor of eradication failure.
HDDT could achieve better eradication efficacy in patients with small BSA. Clinicians should be aware of the impact of BSA on the H. pylori eradication rate and pay more attention to patients with large BSA.
大剂量双联疗法（HDDT）是一种新兴且有前景的根除幽门螺杆菌（H. pylori）的治疗方案。然而，HDDT的组成成分阿莫西林和质子泵抑制剂的药代动力学可能会受到体型的影响。在本研究中，我们旨在探究体型对HDDT疗效的影响。
我们收集了2020年7月至2021年12月期间385例初治的幽门螺杆菌感染患者的医疗数据，这些患者接受了为期14天的HDDT治疗（埃索美拉唑20mg和阿莫西林750mg，每日4次）。在我们的研究中，分别分析了根除疗效、不良事件与变量（性别、年龄、身高、体重、体重指数（BMI）、体表面积（BSA）、吸烟、饮酒等）之间的关联。在这些因素中，连续变量通过受试者工作特征分析计算出的临界值被分类为分类变量。
HDDT的根除率为89.9%。有55例（14.3%）患者在治疗期间发生了不良事件。身高<170.5cm、体重<60.5kg、BMI<20.55kg/m²、BSA<1.69m²的患者根除率较高（分别为92.1%对84.0%、93.1%对86.8%、96.0%对87.8%、93.4%对84.8%，均p<0.05）。多因素分析显示，BSA≥1.69m²（OR 2.53，95%CI：1.28 - 4.99，p = 0.007）是根除失败的唯一独立预测因素。
HDDT在体表面积小的患者中可取得更好的根除疗效。临床医生应意识到体表面积对幽门螺杆菌根除率的影响，并更多地关注体表面积大的患者。
