Berger Florine, Saâïd Selma, van Gelder Teun, Stricker Bruno, Becker Matthijs, van den Bemt Patricia
Department of Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, the Netherlands.
Department of Hospital Pharmacy, Sint Franciscus Gasthuis, Rotterdam, the Netherlands.
Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1418-1424. doi: 10.1002/pds.4321. Epub 2017 Sep 19.
In March 2013, regulatory warnings concerning the potential risks of domperidone caused considerable media attention in the Netherlands. The aim of the study was to assess the effect of regulatory warnings and the resulting media hype on the frequency of electrocardiogram (ECG) monitoring of inpatients using domperidone. We also studied the effect on the frequency of prescribing domperidone by physicians.
A 2-centre, observational, retrospective cohort study was performed. Inpatients using domperidone in 2 hospitals in the Netherlands during a period of 384 days before and after the media hype were included. The main outcomes were (1) the proportion of domperidone users with ECGs before and/or during domperidone treatment, (2) the proportion of patients with an ECG before and during treatment, and (3) the proportion of patients with an ECG during treatment. Secondary outcome was the proportion of domperidone prescriptions comparing the before- and after-period.
Four hundred twenty-eight patients were included. The main outcomes [respectively (1) relative risk (RR) 1.02, 95% confidence interval (CI), 0.85-1.21; (2) RR 1.06, 95% CI, 0.60-1.85; and (3) RR 1.27, 95% CI, 0.80-2.01) were not different. After stratifying for hospital, no significant differences were found. A statistically significant decrease (RR 0.40, 95% CI, 0.35-0.45) in numbers of prescriptions was found for the university medical centre only.
No effect of the media hype was found on the intensity of ECG monitoring in domperidone users. In the university medical centre, domperidone prescriptions were reduced.
2013年3月,有关多潘立酮潜在风险的监管警告在荷兰引起了媒体的广泛关注。本研究的目的是评估监管警告以及随之而来的媒体炒作对使用多潘立酮的住院患者心电图(ECG)监测频率的影响。我们还研究了其对医生开具多潘立酮处方频率的影响。
进行了一项双中心、观察性、回顾性队列研究。纳入了荷兰两家医院在媒体炒作前后384天内使用多潘立酮的住院患者。主要结局包括:(1)在多潘立酮治疗前和/或治疗期间进行心电图检查的多潘立酮使用者比例;(2)治疗前和治疗期间进行心电图检查的患者比例;(3)治疗期间进行心电图检查的患者比例。次要结局是比较前后两个时期多潘立酮处方的比例。
共纳入428例患者。主要结局[分别为(1)相对风险(RR)1.02,95%置信区间(CI)为0.85 - 1.21;(2)RR 1.06,95% CI为0.60 - 1.85;(3)RR 1.27,95% CI为0.80 - 2.01]并无差异。按医院分层后,未发现显著差异。仅在大学医学中心发现处方数量有统计学意义的下降(RR 0.40,95% CI为0.35 - 0.45)。
未发现媒体炒作对多潘立酮使用者的心电图监测强度有影响。在大学医学中心,多潘立酮处方量有所减少。