阿利马嗪缓释形式治疗广泛性焦虑障碍的临床疗效及安全性

J. Azimova, Y. Sivolap, K. Ishchenko
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引用次数: 0

摘要

延长释放片剂形式的alimemazine被认为是一个有前途的药物,长期治疗广泛性焦虑症(GAD)。目的:探讨alimemazine (Teraligen®缓释薄膜包衣片)治疗广泛性焦虑症(GAD)的疗效和安全性。材料和方法。研究设计是一项多中心、开放标签、非比较临床试验(CT),使用两种剂量的alimemazine 20和40mg (Teraligen®缓释缓释薄膜包膜片)。诊断为广泛性焦虑症的患者129例(根据ICD-10分类标准),其中女性86例,男性43例,平均年龄38.0±11.1岁。在第0周(第1次访问),汉密尔顿HARS量表评估的焦虑水平为24.8±7.3分。到第6周,焦虑水平显著下降,平均得分为10.8±6.6,而平均得分相对于基线的动态变化为-14.0±6.27 (p<0.0001)。与初始值相比,HARS量表总分下降50%或以上的患者比例为:治疗1周后- 10.3% (n=13);治疗3周后- 60.5% (n=75;与基线相比,p<0.0001);治疗6周后- 69.4% (n=86;与基线相比,p<0.0001)。在不良事件(ae)患者中,该疗法耐受性良好:早晨嗜睡(7.8%;n = 10);口干(7.8%);n = 10);普遍疲软(4.7%;n = 6)。其他ae(头晕、头痛、注意力不集中、肌肉无力、记忆力减退、耳鸣、心动过速)则不太常见。肝侧未见ae,肝酶活性未见变化。延长释放alimemazine片剂20毫克和40毫克,持续6周,导致焦虑水平显著降低,至少三分之二的患者的焦虑程度超过一半。随着你继续服药,效果每周都在增加。alimemazine的缓释形式耐受性良好,用该药治疗广泛性焦虑症是有效和安全的,可能是抗抑郁药物治疗的合理选择。
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Clinical effectiveness and safety of prolonged release form of alimemazine in patients with generalized anxiety disorder
The prolonged release tablets form of alimemazine is seen as a promising agent for the long-term treatment of generalized anxiety disorder (GAD).Objective: to investigate the efficacy and safety of therapy with alimemazine (Teraligen® retard, prolonged release film-coated tablets) in patients with GAD.Material and methods. The study design was a multicentre, open-label, non-comparative clinical trial (CT) with two doses of alimemazine 20 and 40 mg (Teraligen® retard, prolonged-release film-coated tablets). 129 patients diagnosed with GAD (criteria according to the ICD-10 classification), 86 women and 43 men were included, mean age 38.0±11.1 years. The level of anxiety, assessed by the Hamilton HARS scale, at Week 0 (Visit 1) was 24.8±7.3 points.Results. By Week 6, the level of anxiety statistically significantly decreased to a mean score of 10.8±6.6, while the dynamics of the mean score relative to baseline was -14.0±6.27 (p<0.0001). The proportion of patients with a decrease in the total score on the HARS scale by 50% or more compared with the initial value was: after 1 week of therapy – 10.3% (n=13); after 3 weeks of therapy – 60.5% (n=75; compared to baseline, p<0.0001); after 6 weeks of therapy – 69.4% (n=86; compared to baseline, p<0.0001). The therapy was well tolerated, among the adverse events (AEs) patients noted: morning sleepiness (7.8%; n=10); dry mouth (7.8%; n=10); general weakness (4.7%; n=6). Other AEs (dizziness, headache, impaired concentration, muscle weakness, memory impairment, tinnitus, tachycardia) were much less common. From the side of the liver, no AEs were detected, including changes in the activity of liver enzymes.Conclusion. Prolonged release alimemazine tablets 20 mg and 40 mg for six weeks resulted in a statistically significant reduction in anxiety levels, with at least two-thirds of patients experiencing more than half their anxiety. The effect increases with each week as you continue to take the drug. The prolonged release form of alimemazine is well tolerated, the treatment of GAD with the drug is effective and safe and may represent a rational alternative to antidepressant therapy.
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