Division of Gastroenterology, Texas Tech University Health Sciences Center, El Paso, Texas.
Data Coordinating Center, Johns Hopkins University, Baltimore, Maryland.
Clin Gastroenterol Hepatol. 2022 Mar;20(3):e452-e464. doi: 10.1016/j.cgh.2021.05.063. Epub 2021 Jun 2.
BACKGROUND & AIMS: The use of domperidone (DOM) for gastroparesis (GP) remains controversial and limited. We aimed to present outcomes of DOM therapy for treatment of patients participating in the multicenter National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium (GpCRC) Registries (GpR).
The GpCRC cohort consisted of patients with GP (75%) and with GP-like symptoms but with normal gastric emptying (25%). The DOM group initiated therapy during the 96 weeks of enrollment in GpR1 and GpR2. Patients who had previously taken or who were on DOM therapy at enrollment were excluded from this analysis. The control group did not use domperidone (non-DOM group) before or after enrollment. The following outcome measures were identified: change from baseline in Gastroparesis Cardinal Symptom Index total score, with 3 subscales, plus Gastroesophageal Reflux Disease and Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scores.
Overall, of 748 patients, 181 (24%) were in the DOM group, whereas 567 were in the non-DOM group. Sixty-three percent of participants had idiopathic GP. At baseline, DOM patients compared with non-DOM patients were significantly younger, had lower body mass index, non-Hispanic ethnicity, a higher annual household income, lower narcotic utilization, lower supplemental and complimentary medication use, and were more likely to have delayed gastric emptying time, as well as worse nausea and fullness scores. Compared with non-DOM patients, DOM patients experienced moderate but significantly more improvement in GP outcome measures: Gastroparesis Cardinal Symptom Index total score (P = .003), nausea (P = .003), and fullness subscales (P =.005), upper abdominal pain score (P = .04), Gastroesophageal Reflux Disease score (P = .05), and Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score (P = .05).
Utilizing the method of pragmatic modeling to evaluate long-term treatment of GP in a large GpCRC database, DOM treatment resulted in moderately but significantly improved GP. NOTE: This project was based on data generated by 2 GpCRC Registry studies recognized under the Clinicaltrial.gov numbers: NCT00398801 and NCT01696747 symptoms compared with a group receiving standard-of-care but not DOM.
多潘立酮（DOM）治疗胃轻瘫（GP）的应用仍然存在争议且有限。我们旨在介绍参与多中心国家糖尿病、消化和肾脏疾病胃轻瘫临床研究联合会（GpCRC）注册中心（GpR）的多潘立酮治疗患者的治疗结果。
GpCRC 队列由 GP（75%）和具有 GP 样症状但胃排空正常的患者（25%）组成。在 GpR1 和 GpR2 的 96 周入组期间，DOM 组开始接受治疗。在此分析中，排除了之前服用或在入组时正在服用多潘立酮的患者。对照组在入组前后均未使用多潘立酮（非 DOM 组）。以下是确定的结果测量：从基线到胃轻瘫关键症状指数总分的变化，包括 3 个亚量表，以及胃食管反流病和患者对上消化道疾病生活质量的评估。
总体而言，在 748 名患者中，181 名（24%）为 DOM 组，567 名为非 DOM 组。63%的参与者患有特发性 GP。在基线时，与非 DOM 组相比，DOM 组患者明显更年轻，体重指数较低，非西班牙裔，年收入较高，使用麻醉剂较少，补充和补充药物使用较少，并且胃排空时间延迟，恶心和饱胀评分更高。与非 DOM 组相比，DOM 组患者的 GP 结果测量指标有中度但显著改善：胃轻瘫关键症状指数总分（P=.003）、恶心（P=.003）和饱胀亚量表（P=.005）、上腹痛评分（P=.04）、胃食管反流病评分（P=.05）和患者对上消化道疾病生活质量的评估（P=.05）。
利用实用建模方法评估 GpCRC 大型数据库中 GP 的长期治疗，多潘立酮治疗导致 GP 中度但显著改善。注：本项目基于由 2 项 GpCRC 注册研究产生的数据，这些研究在 Clinicaltrial.gov 编号下得到认可：NCT00398801 和 NCT01696747 症状与接受标准护理但未接受多潘立酮治疗的组相比。
