Department of Internal Medicine, Texas Tech University Health Sciences Center El Paso Paul L Foster School of Medicine, El Paso, Texas, USA.
Department of Internal Medicine, Texas Tech University Health Sciences Center El Paso Paul L Foster School of Medicine, El Paso, Texas, USA
J Investig Med. 2022 Jun;70(5):1225-1232. doi: 10.1136/jim-2021-001968. Epub 2022 Feb 25.
Domperidone is an effective antiemetic used worldwide, but there have been reports of possible cardiotoxicity. Our goal was to explore the cardiac safety and clinical efficacy of long-term domperidone, titrated as high as 120 mg/day, in patients not responding or unable to tolerate other therapies for gastroparesis (GP).This retrospective cohort study was conducted at a single tertiary care academic center. We objectively assessed the safety and efficacy of domperidone through questionnaires, clinical follow-up and frequent ECGs as mandated by the Food and Drug Administration. We excluded patients with a history of dangerous arrhythmias, prolonged QTc, clinically significant electrolyte disturbances, gastrointestinal hemorrhage or obstruction, presence of a prolactinoma, pregnant or breastfeeding females, or allergy to domperidone. A total of 21 patients met the inclusion criteria for eligibility in this study (52.4% white, 42.9% Hispanic; mean age 50.1 years; 90.5% female). The mean duration of domperidone therapy was 52.3 (range 16-97) months with a mean highest dose of 80 mg/day (range 40-120 mg). Two patients (9.5%) taking 120 mg/day experienced asymptomatic meaningful QTc prolongation (>450 ms in males, >470 ms in females). One-third of patients had asymptomatic non-meaningful QTc prolongation. Palpitations or chest pain was reported in 19% of patients without ECG abnormalities or adverse cardiac events. The mean severity of vomiting and nausea was improved by 82% and 55%, respectively.Long-term treatment with high doses of domperidone (40-120 mg/day) improved GP symptoms in patients previously refractory to other medical therapies and with a satisfactory cardiovascular risk profile.
多潘立酮是一种在全球范围内广泛使用的有效止吐药，但有报道称其可能具有心脏毒性。我们的目标是探索长期使用多潘立酮（剂量高达 120mg/天）治疗胃轻瘫（GP）的患者的心脏安全性和临床疗效，这些患者对其他治疗方法无反应或无法耐受。这项回顾性队列研究在一家三级学术医疗中心进行。我们通过问卷调查、临床随访和根据食品和药物管理局的要求频繁进行心电图检查来客观评估多潘立酮的安全性和疗效。我们排除了有危险心律失常、QTc 延长、临床显著电解质紊乱、胃肠道出血或梗阻、存在催乳素瘤、怀孕或哺乳期女性或对多潘立酮过敏病史的患者。共有 21 名患者符合本研究的入选标准（52.4%为白人，42.9%为西班牙裔；平均年龄为 50.1 岁；90.5%为女性）。多潘立酮治疗的平均持续时间为 52.3 个月（范围为 16-97 个月），平均最高剂量为 80mg/天（范围为 40-120mg）。两名（9.5%）服用 120mg/天的患者出现无症状性有意义的 QTc 延长（男性>450ms，女性>470ms）。三分之一的患者出现无症状性非有意义的 QTc 延长。19%的患者报告有心悸或胸痛，但心电图无异常或无不良心脏事件。呕吐和恶心的平均严重程度分别改善了 82%和 55%。长期使用高剂量多潘立酮（40-120mg/天）可改善对其他药物治疗无反应且心血管风险状况良好的 GP 患者的症状。
