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长期使用多潘立酮对 QT 间期的影响:一项大型单中心研究。

Effect of Chronic Domperidone Use on QT Interval: A Large Single Center Study.

机构信息

Section of Gastroenterology.

Section of Cardiology, Department of Medicine, Temple University School of Medicine, Philadelphia, PA.

出版信息

J Clin Gastroenterol. 2019 Oct;53(9):648-652. doi: 10.1097/MCG.0000000000001183.

Abstract

GOALS

The goal of this study was to determine the effect and safety of domperidone on QTc interval at the commonly prescribed doses of 30 to 80 mg daily.

BACKGROUND

Domperidone is a dopamine receptor antagonist used for the treatment of gastroparesis. However, it has been associated with QT prolongation, ventricular arrhythmias, and sudden cardiac death.

STUDY

This study analyzed patients prescribed domperidone for treatment of gastroparesis between January 2012 and September 2017 at a single center. This study reviewed EKGs, primarily the QTc interval, taken at baseline, 2 to 6 months after initiation of domperidone, 6 to 12 months after initiation, and ≥12 months after initiation. Concurrent QTc prolonging medications were recorded for each patient. The primary endpoint was QTc prolongation >500 ms. Secondary endpoints were QTc >450 ms for males, a QTc>470 ms for females, QTc prolongation ≥20 ms above baseline, and QTc prolongation >60 ms above baseline.

RESULTS

In total, 246 patients were included for analysis (age, 46.3±17.4 y; F 209). EKGs were available for all 246 patients before treatment, 170 patients at 2 to 6 months, 135 at 6 to 12 months, and 152 patients at least 1 year after domperidone initiation.Of 246 subjects, 15 patients (6.1%, 9 female) had clinically important QTc prolongation; 11 had QTc >450 ms for males or >470 ms for females; none had QTc prolongation >500 ms; 5 (2.0%) had >60 ms over baseline and 61 (24.7%) patients had QTc increase of ≥20 ms but <60 ms from baseline.

CONCLUSIONS

Domperidone at the conventionally used doses to treat gastroparesis (30 to 80 mg/d) was associated with QTc prolongation in only 6% of patients with no QT interval reaching the point considered to be clinically significant. These data suggest that domperidone can be safely prescribed at doses of 30 to 80 mg daily for the treatment of gastroparesis.

摘要

目的

本研究旨在确定在常规剂量 30 至 80mg/日下,多潘立酮对 QTc 间期的影响和安全性。

背景

多潘立酮是一种用于治疗胃轻瘫的多巴胺受体拮抗剂。然而,它与 QT 间期延长、室性心律失常和心脏性猝死有关。

研究

本研究分析了 2012 年 1 月至 2017 年 9 月在一家中心接受多潘立酮治疗胃轻瘫的患者。本研究回顾了 EKG,主要是 QTc 间期,在基线时、多潘立酮起始后 2 至 6 个月、6 至 12 个月和起始后至少 12 个月时进行测量。为每位患者记录了同时使用的 QTc 延长药物。主要终点是 QTc 延长 >500ms。次要终点是男性 QTc>450ms,女性 QTc>470ms,基线以上 QTc 延长≥20ms,以及基线以上 QTc 延长>60ms。

结果

共有 246 名患者纳入分析(年龄 46.3±17.4 岁;F 209)。246 名患者均在治疗前获得 EKG,170 名患者在 2 至 6 个月时获得,135 名患者在 6 至 12 个月时获得,152 名患者在至少 1 年后获得。在 246 名患者中,15 名患者(6.1%,9 名女性)出现有临床意义的 QTc 延长;11 名男性 QTc>450ms 或女性 QTc>470ms;无 QTc 延长>500ms;5 名(2.0%)患者 QTc 较基线增加超过 60ms;61 名(24.7%)患者 QTc 增加≥20ms 但<60ms。

结论

多潘立酮常规剂量(30 至 80mg/d)用于治疗胃轻瘫时,仅 6%的患者出现 QTc 延长,且无 QTc 间期达到临床显著延长的程度。这些数据表明,多潘立酮可以安全地以 30 至 80mg/日的剂量用于治疗胃轻瘫。

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