Yüksel Kıvanç, Tuğlular Işık
Center for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR), Ege University, Izmir, Turkey.
Int J Clin Pharm. 2019 Apr;41(2):387-390. doi: 10.1007/s11096-019-00803-9. Epub 2019 Mar 12.
European Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30 mg and treatment duration to 7 days. This paper presents a critical review of the scientific basis of the literatures having a role in the decision of EMA on domperidone with an approach based on statistical and epidemiological perspective. Although observational studies used by EMA were published, the EMA didn't use an algorithm including "randomized clinical trials" according to evidence-based medicine when presenting their results. In conclusion, the results obtained from published studies are controversial, especially for the bias. From these publications, it cannot be concluded that domperidone exposure definitely increases the risk of "sudden cardiac death", "death associated with ventricular arrhythmia" or "ventricular arrhythmia" The most concrete result of these studies is that the risk is higher with metoclopramide exposure compared to domperidone exposure.
欧洲药品管理局（EMA）于2014年9月1日发布了最终决定，将多潘立酮的最大日剂量限制为30毫克，治疗疗程限制为7天。本文基于统计和流行病学视角，对在EMA关于多潘立酮的决定中起作用的文献的科学依据进行了批判性综述。尽管EMA使用的观察性研究已发表，但EMA在展示其结果时并未根据循证医学使用包括“随机临床试验”在内的算法。总之，已发表研究得出的结果存在争议，尤其是在偏差方面。从这些出版物中，无法得出多潘立酮暴露肯定会增加“心源性猝死”“与室性心律失常相关的死亡”或“室性心律失常”风险的结论。这些研究最确切的结果是，与多潘立酮暴露相比，甲氧氯普胺暴露的风险更高。
