Allain H, Bentué-Ferrer D
Laboratoire de Pharmacologie Expérimentale et Clinique, Faculté de Médecine, Rennes, France.
Eur Neurol. 1998;39 Suppl 1:39-44. doi: 10.1159/000052069.
Different pharmacological properties of almitrine-raubasine show that this combination may be a good therapy for the treatment of age-related cerebral disorders and functional rehabilitation after stroke. Many clinical studies have been carried out in France and in the rest of Europe, confirming the value of this compound in such situations. Without discussing the complexity of clinical trials in both the areas of cognitive disorders and stroke, we shall present two studies demonstrating the beneficial effects of almitrine-raubasine against cognitive impairments. The first is a double-blind controlled study versus placebo with a 3-month follow-up period involving patients (aged between 60 and 85) with memory loss, lack of concentration, impaired mental altertness, and emotional instability. The second is a controlled multicenter study of 155 outpatients (age 70-85) presenting with cognitive decline (assessed by MMSE, SCAG). In both these studies, almitrine-raubasine significantly improved symptomatology and was superior to placebo, especially in the vascular cases. This confirms the validity of previous studies and justifies the indication of these compounds in the treatment of age-related cognitive disorders. Other studies also demonstrated the beneficial effect of this compound on neurosensory vascular disorders, with specific studies carried out on chorioretinal dysfunctions (visual symptomatology) and in vestibular disorders (vertigo associated with electronystagmographic modifications). The appropriate and usual dosage (2 tablets per day) and the good tolerance of the compound have been confirmed in a French multicentric study in 5,361 outpatients.
阿米三嗪-萝巴新的不同药理特性表明,这种复方制剂可能是治疗与年龄相关的脑部疾病及中风后功能康复的良好疗法。法国和欧洲其他地区已开展了多项临床研究,证实了该化合物在这些情况下的价值。在不讨论认知障碍和中风这两个领域临床试验复杂性的情况下,我们将介绍两项研究,以证明阿米三嗪-萝巴新对认知障碍的有益作用。第一项是一项为期3个月随访期的双盲对照研究,与安慰剂对比,研究对象为患有记忆力减退、注意力不集中、精神警觉性受损和情绪不稳定的患者(年龄在60至85岁之间)。第二项是一项针对155名表现出认知衰退(通过MMSE、SCAG评估)的门诊患者(年龄70 - 85岁)的多中心对照研究。在这两项研究中,阿米三嗪-萝巴新均显著改善了症状,且优于安慰剂,尤其是在血管性病例中。这证实了先前研究的有效性,并证明了这些化合物在治疗与年龄相关的认知障碍方面的适应症。其他研究还证明了该化合物对神经感觉血管疾病的有益作用,其中对脉络膜视网膜功能障碍(视觉症状)和前庭疾病(与眼震电图改变相关的眩晕)进行了专门研究。在一项针对5361名门诊患者的法国多中心研究中,已证实了该化合物适当且常用的剂量(每日2片)以及良好的耐受性。