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多潘立酮处方实践使患者面临心脏风险,尽管有“黑框”警告:加拿大三级保健中心研究。

Domperidone Prescribing Practices Exposed Patients to Cardiac Risk despite a "Black Box" Warning: A Canadian Tertiary Care Center Study.

机构信息

Division of Gastroenterology, McMaster University Department of Medicine, Hamilton, ON, Canada L8S 4K1; Division of Gastroenterology, University of Calgary Therapeutic Endoscopy Training Program, Calgary, AB, Canada T2N 4Z6.

Division of Gastroenterology, McMaster University Department of Medicine, Hamilton, ON, Canada L8S 4K1.

出版信息

Can J Gastroenterol Hepatol. 2016;2016:2937678. doi: 10.1155/2016/2937678. Epub 2016 Feb 24.

DOI:10.1155/2016/2937678
PMID:27446835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4904657/
Abstract

Background. In 2012, Health Canada released a warning regarding domperidone use, based on associations with life-threatening arrhythmias and death. Objective. This study aimed to compare the appropriateness of domperidone prescribing patterns before the advisory to those afterward. Methods. Two retrospective reviews were conducted for patients prescribed domperidone during quarters in 2005 and 2012. Outcomes included appropriateness of indication, dosing regimens, monitoring of electrolytes, baseline electrocardiogram performance and characteristics, presence of left ventricular dysfunction, and coprescription of QT-prolonging medications. Univariable and multivariable logistic regression analyses were performed. p values < 0.05 were considered significant. Results. 290 and 287 patients were analyzed in 2005 and 2012, respectively. Domperidone initiation in hospital decreased from 2005 to 2012 (71.4% versus 39.4%, p < 0.0001) as did prescriptions for nonapproved indications (84.8% versus 58.2%, p < 0.0001). In-hospital initiation predicted prescription for nonapproved indications (OR = 7.01, 95% CI 4.52-10.87, p < 0.0001). Use of domperidone as the sole GI drug predicted nonapproved indications (OR = 2.51, 95% CI 1.38-4.55, p = 0.002). Conclusions. The advisory was associated with more appropriate domperidone initiation and compliance with recommended dosages. Our study suggests the need for increased awareness of the dosing and monitoring of domperidone to ensure patient safety.

摘要

背景

2012 年,加拿大卫生部发布了一项关于多潘立酮使用的警告,原因是其与危及生命的心律失常和死亡有关。目的:本研究旨在比较咨询前后多潘立酮处方模式的适宜性。方法:对 2005 年和 2012 年各季度开处方多潘立酮的患者进行了两次回顾性研究。结果包括适应证的适宜性、剂量方案、电解质监测、基线心电图表现和特征、左心室功能障碍的存在以及与 QT 延长药物的共同处方。进行了单变量和多变量逻辑回归分析。p 值<0.05 被认为具有统计学意义。结果:2005 年和 2012 年分别分析了 290 例和 287 例患者。2012 年,医院起始多潘立酮的比例从 2005 年的 71.4%下降至 39.4%(p<0.0001),非适应证处方的比例也从 84.8%下降至 58.2%(p<0.0001)。医院起始预测非适应证处方(OR=7.01,95%CI 4.52-10.87,p<0.0001)。多潘立酮作为唯一的胃肠道药物预测非适应证(OR=2.51,95%CI 1.38-4.55,p=0.002)。结论:咨询与更适宜的多潘立酮起始和遵循推荐剂量有关。本研究表明,需要提高对多潘立酮剂量和监测的认识,以确保患者安全。

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Prokinetics in the Management of Functional Gastrointestinal Disorders.促动力药在功能性胃肠病管理中的应用
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本文引用的文献

1
Effect of domperidone on insufficient lactation in puerperal women: a systematic review and meta-analysis of randomized controlled trials.多潘立酮对产后妇女泌乳不足的影响:一项随机对照试验的系统评价和荟萃分析
Obstet Gynecol Int. 2012;2012:642893. doi: 10.1155/2012/642893. Epub 2012 Feb 7.
2
Domperidone and ventricular arrhythmia or sudden cardiac death: a population-based case-control study in the Netherlands.多潘立酮与室性心律失常或心源性猝死:荷兰基于人群的病例对照研究。
Drug Saf. 2010 Nov 1;33(11):1003-14. doi: 10.2165/11536840-000000000-00000.
3
Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study.多潘立酮使用者队列中严重室性心律失常和心源性猝死的风险:一项巢式病例对照研究。
Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):881-8. doi: 10.1002/pds.2016.
4
Drug-induced long QT and torsade de pointes: recent advances.药物诱导的长QT间期和尖端扭转型室速:最新进展
Curr Opin Cardiol. 2007 Jan;22(1):39-43. doi: 10.1097/HCO.0b013e32801129eb.
5
Non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death.非心脏性QTc延长药物与心源性猝死风险
Eur Heart J. 2005 Oct;26(19):2007-12. doi: 10.1093/eurheartj/ehi312. Epub 2005 May 11.
6
QT interval prolongation associated with the oral use of domperidone in an infant.婴儿口服多潘立酮后出现QT间期延长。
Pediatr Cardiol. 2005 Sep-Oct;26(5):720-3. doi: 10.1007/s00246-004-0922-z.
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Drug-induced prolongation of the QT interval.药物引起的QT间期延长。
N Engl J Med. 2004 Mar 4;350(10):1013-22. doi: 10.1056/NEJMra032426.
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Cisapride and the Vanessa Young inquest.西沙必利与凡妮莎·杨死因调查
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Postmarketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and Food and Drug Administration regulatory actions.与西沙必利相关的QT间期延长和室性心律失常的上市后报告以及美国食品药品监督管理局的监管行动。
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