The effectiveness of the original anticonvulsant Galodif® — a GABAA receptor modulator for alcohol withdrawal syndrome

T. V. Shushpanova, Anna I. Mandel, N. A. Bokhan, E. D. Schastnyy
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Abstract

BACKGROUND: The development of new drugs to improve the effectiveness of treatment and rehabilitation programs for patients suffering from addiction diseases, which are non-addictive and have a stimulating effect on detoxification processes in the body, can increase the effectiveness of therapy and reduce the cost of treatment. A deficiency of GABAergic inhibition in brain structures plays a leading role in the occurrence of paroxysmalness. The innovative anticonvulsant Galodif® (1-[(3-chlorophenyl)(phenyl)methyl]urea), a GABAA receptor modulator, has low toxicity and hepatoprotective properties, which allows it to be recommended for use in the treatment of patients with alcohol dependence. AIM: The aim of this study is to evaluation of the effectiveness of the use of the anticonvulsant drug galodif1 in complex therapy in patients with alcohol dependence with compulsive and paroxysmal disorders with pathological craving for alcohol when withdrawing of alcohol. MATERIALS AND METHODS: A limited open-type clinical study of the therapeutic effectiveness of the innovative anticonvulsant galodif1 included 128 male patients (average age 38.3 ± 8.9 years) with a diagnosis of “Mental and behavioral disorders as a result of alcohol consumption, dependence syndrome” (F10.232) and “Mental and behavioral disorders as a result of alcohol consumption, withdrawal states” (F10.302). 68 patients received Galodif® 300 mg per day as an anticonvulsant for 21 days. 60 patients made up the comparison group, receiving carbamazepine at a dose of 400 mg per day. RESULTS: The use of the anticonvulsant Galodif® in complex therapy of patients revealed: normothymoleptic activity of the drug; when assessing depression on the Hamilton Depression Rating Scale (HDRS), the average total score decreased from 28.3 ± 1.3 to 5.7 ± 1.9, and a reduction in unmotivated fear and anxiety was noted; vegetative stabilizing effect with a sympathicolytic component with normalization of heart rate; reduction of headaches; weakening or disappearance of pathological desire during withdrawal syndrome in 88% of cases, in the post-withdrawal state — in 57% of cases; taking the drug did not cause any unwanted side effects. CONCLUSIONS: The use of the anticonvulsant Galodif®, which modulates GABAA receptors, has low toxicity and detoxification properties and does not cause side effects, has been proposed as one of the modern pharmacotherapeutic approaches in the treatment of patients with alcohol dependence.
原创抗惊厥药 Galodif® - GABAA 受体调节剂对戒酒综合征的疗效
背景:为提高成瘾性疾病患者的治疗和康复计划的有效性而开发的新药物,不具有成瘾性,对体内的解毒过程具有刺激作用,可以提高治疗效果,降低治疗成本。大脑结构中 GABA 能抑制的缺乏在阵发性癫痫的发生中起着主导作用。创新型抗惊厥药 Galodif®(1-[(3-氯苯基)(苯基)甲基]脲)是一种 GABAA 受体调节剂,具有低毒性和保肝特性,因此推荐用于酒精依赖症患者的治疗。研究目的:本研究旨在评估抗惊厥药物 galodif1 在酒精依赖症患者复合疗法中的使用效果,这些患者在戒酒时会出现强迫性和阵发性障碍,并对酒精产生病理性渴求。材料与方法:对创新型抗惊厥药物 galodif1 的疗效进行了一项有限的开放式临床研究,研究对象包括 128 名男性患者(平均年龄为 38.3 ± 8.9 岁),他们被诊断为 "饮酒导致的精神和行为障碍,依赖综合征"(F10.232)和 "饮酒导致的精神和行为障碍,戒断状态"(F10.302)。68 名患者每天服用 300 毫克的 Galodif® 作为抗惊厥药,为期 21 天。60 名患者组成对比组,每天接受 400 毫克剂量的卡马西平治疗。结果:在对患者进行综合治疗时使用抗惊厥药 Galodif® 的结果显示:该药物具有正常的抗惊厥活性;在使用汉密尔顿抑郁量表(HDRS)评估抑郁情况时,平均总分从 28.3 ± 1.3 降至 5.7 ± 1.9。9 分,无动机的恐惧和焦虑减少;具有交感溶解成分的植物稳定作用,心率正常;头痛减少;88% 的病例在戒断综合征期间病态欲望减弱或消失,57% 的病例在戒断后状态下病态欲望减弱或消失;服用该药物不会引起任何不必要的副作用。结论抗惊厥药 Galodif® 可调节 GABAA 受体,具有低毒性和解毒特性,且不会产生副作用,因此被建议作为治疗酒精依赖症患者的现代药物治疗方法之一。
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