Roch-Torreilles I, Camu W, Hillaire-Buys D
Centre Régional de Pharmacovigilance, Hôpital Saint-Charles, CHU de Montpellier, France.
Therapie. 2000 Mar-Apr;55(2):303-12.
Amyotrophic lateral sclerosis (ALS) is a rapidly fatal degenerative disorder of the motoneurones which was without any effective therapy until 1997. Riluzole (Rilutek) has been the first patented drug used in its specific treatment. In order to evaluate the tolerability profile of this molecule, a Pharmacovigilance study was undertaken in the Department of Neurology B at the Montpellier University Hospital. A total of 153 patients were studied and all observed side-effects were listed in the French bank of Pharmacovigilance. Riluzole induced one or more adverse effects in 50.3 per cent of patients. The most frequent were gastrointestinal disturbances, hepatotoxicity and asthenia. Dermatological, haematological, neuropsychiatric and metabolic side-effects were also reported. This study shows an acceptable safety profile for riluzole. Due to its mode of action, riluzole could potentially be used in the treatment of other neurodegenerative diseases involving glutamate excitotoxicity. Subsequently, Pharmacovigilance will have to be carried out to establish the proper use of riluzole.
肌萎缩侧索硬化症(ALS)是一种运动神经元快速致死性退行性疾病,在1997年之前没有任何有效治疗方法。利鲁唑(力如太)是首个用于其特异性治疗的专利药物。为评估该药物分子的耐受性,蒙彼利埃大学医院B神经内科开展了一项药物警戒研究。共研究了153例患者,所有观察到的副作用均列入法国药物警戒库。50.3%的患者出现了利鲁唑引起的一种或多种不良反应。最常见的是胃肠道紊乱、肝毒性和乏力。还报告了皮肤、血液、神经精神和代谢方面的副作用。该研究表明利鲁唑的安全性可接受。由于其作用方式,利鲁唑可能潜在地用于治疗其他涉及谷氨酸兴奋性毒性的神经退行性疾病。随后,必须开展药物警戒以确定利鲁唑的正确用法。