Verspeelt J, De Locht P, Amery W K
Janssen Research Foundation, Beerse, Belgium.
Cephalalgia. 1996 Aug;16(5):328-36; discussion 288. doi: 10.1046/j.1468-2982.1996.1605328.x.
A comparative post-marketing surveillance study of the safety and efficacy of flunarizine and propranolol in the treatment of migraine was carried out. General practitioners in Belgium and the Netherlands each recruited patients for whom they would prescribe one of the study medications in the normal course of their treatment and recorded all medical events on follow-up forms for up to 8 months. A total of 1601 migraine patients were enrolled; 838 in the flunarizine cohort and 763 in the propranolol cohort. Propranolol was somewhat better than flunarizine in reducing the severity of migraine attacks, although this may have been due to a selection bias. Discontinuations of therapy due to events considered likely to be treatment-related were mostly due to the recognized side effects of the two drugs. As regards the occurrence of depressions, a total of 58 patients had depressive events, 34 in the flunarizine cohort and 24 in the propranolol cohort. Whereas migraine itself appears to be associated with an increased risk of depression, the number of previous migraine treatments was shown to be an additional risk factor for the development of depression in patients receiving flunarizine as was a history of depression. Overall, there was no appreciable difference in the risk/benefit ratio between flunarizine and propranolol.
开展了一项关于氟桂利嗪和普萘洛尔治疗偏头痛安全性和有效性的上市后对比监测研究。比利时和荷兰的全科医生各自招募了他们在正常治疗过程中会为其开具其中一种研究药物的患者，并在随访表格上记录所有医疗事件，随访期长达8个月。总共招募了1601名偏头痛患者；氟桂利嗪队列中有838名，普萘洛尔队列中有763名。在减轻偏头痛发作的严重程度方面，普萘洛尔比氟桂利嗪稍好一些，不过这可能是由于选择偏倚所致。因被认为可能与治疗相关的事件而停药，大多是由于这两种药物已知的副作用。关于抑郁症的发生情况，共有58名患者出现抑郁事件，氟桂利嗪队列中有34名，普萘洛尔队列中有24名。虽然偏头痛本身似乎与抑郁症风险增加有关，但既往偏头痛治疗次数被证明是接受氟桂利嗪治疗患者发生抑郁症的一个额外风险因素，抑郁症病史也是如此。总体而言，氟桂利嗪和普萘洛尔的风险/效益比没有明显差异。
