葛兰素史克中枢神经系统治疗药物利必通获批双相情感障碍新适应症

2021-03-07 医药魔方 医药魔方

2021年3月3日,中国上海——全球领先的跨国医疗保健公司葛兰素史克(以下简称“GSK”)今日宣布,利必通(通用名:拉莫三嗪分散片)获得中国国家药品监督

2021年3月3日,中国上海——全球领先的跨国医疗保健公司葛兰素史克(以下简称“GSK”)今日宣布,利必通(通用名:拉莫三嗪分散片)获得中国国家药品监督管理局新增适应症批准,适用于控制成人双相情感障碍患者情绪发作的复发或复燃[1]。作为国内外众多指南推荐用于双相情感障碍治疗的一线药物,利必通新适应症的获批将为中国双相情感障碍患者带来更多治疗选择,以期帮助提高患者生活质量及预后,进一步提升我国双相情感障碍临床规范化治疗水平。

GSK中国处方药和疫苗总经理齐欣女士表示:“利必通是GSK的一款经典中枢神经系统治疗药物,我非常高兴地看到其适应症拓展至双相情感障碍。作为全球中枢神经系统疾病领域领先者,GSK始终秉持为人们‘做得更多、感觉更舒适、生活更长久’的理念,致力于将创新成果惠及更多中国患者。利必通新适应症的获批为中国双相情感障碍患者带来一项新的治疗选择,不仅帮助患者改善预后,更有助于控制疾病进展、及早令患者回归正常生活。未来,GSK将继续把更多创新药物和新适应症带入中国,助力全面提升我国中枢神经系统疾病诊疗水平,造福患者和大众。”

双相情感障碍诊疗面临诸多挑战,识别、诊断、治疗“三率皆低”

双相情感障碍是临床常见疾病,一般指临床上既有躁狂或轻躁狂发作,又有抑郁发作的一类心境障碍[2],患者会经历两种完全相反的情绪。中国精神健康调查显示,我国双相情感障碍的终生患病率达0.6%[3]。然而,相较于抑郁症等其他精神类疾病,双相情感障碍疾病诊疗面临诸多挑战,识别率、诊断率和治疗率“三率皆低”。

在我国,由于大众缺乏对双相情感障碍的疾病认知,患者去医院接受正规诊断的比例不高,这导致了识别率和诊断率低。加之该疾病病情隐匿,症状及病程复杂,因而在诊疗过程中,也极易被误诊,规范化治疗率低。双相情感障碍首次发作平均在20岁左右,在至少50%的患者中,双相情感障碍最初表现为抑郁发作,通常会被误诊为抑郁症[4]。由于与抑郁症存在鉴别诊断困难,双相情感障碍患者往往存在治疗延迟的情况,平均未经治疗的时间长达9.6年[5]。在双相情感障碍中,50%以上的现症患者长达5年以上未接受治疗,其中36%甚至超过10年尚未接受治疗[6]。即使患者在发病初期就接受了治疗,研究显示,在首次确诊后,有近60%的患者在最初两年内经历了复发,约75%的患者在5年内复发[7],而双相情感障碍累积发作次数的增多会导致恢复延迟。

首都医科大学附属北京安定医院院长、国家精神心理疾病临床医学研究中心主任、抑郁症治疗中心主任王刚教授表示:“目前国内双相情感障碍的治疗方法,主要包括药物治疗、心理治疗、支持治疗以及非药物躯体治疗等。心境稳定剂、抗精神病药和抗抑郁药是三类主要的治疗药物。由于双相情感障碍病程长,许多患者在其一生中不断经历复发。因此,坚持及早治疗、长期治疗和规范化治疗至关重要,可以有效降低疾病复发、复燃风险。”

利必通获批治疗双相情感障碍,助力提升我国双相情感障碍规范化治疗水平

除却识别难、诊断难,双相情感障碍患者目前面临的另一大挑战是治疗选择的局限。目前国内双相情感障碍治疗控制躁狂发作的药物较多,但治疗双相抑郁的药物选择较少,且大多疗效有限。

王刚教授认为:“可以说,对双相抑郁的治疗是目前双相情感障碍临床治疗上面临的主要挑战。利必通(活性成分:拉莫三嗪)近年来被发现对于双相情感障碍、特别是双相抑郁具有经临床研究验证的疗效,为应对这一挑战提供了一把新的‘钥匙’。随着利必通双相情感障碍适应症在中国获批,我期待中国双相情感障碍患者将得到与国际一线接轨的治疗方案,获得更好的疗效和长期预后改善。“

事实上,利必通(活性成分:拉莫三嗪)用于治疗双相情感障碍已在国外被广泛认可和使用。两项关于拉莫三嗪的国际三期临床试验合并分析结果证实:与安慰剂相比,拉莫三嗪显着延迟至任何情感发作的干预时间长达197天,疗效与锂盐相似;与锂盐不同,拉莫三嗪较安慰剂显着延迟至抑郁发作的干预时间[9]。

鉴于经科学验证的临床疗效,包括美国精神病学协会指南、世界生物精神病学联合会指南、英国精神药理协会指南、加拿大心境和焦虑治疗指导组/国际双相障碍学会、中国双相障碍防治指南等众多国内外指南推荐利必通(活性成分:拉莫三嗪)作为双相情感障碍治疗的一线用药。

关于GSK:GSK是一家以科学为导向的全球医疗保健公司,旨在帮助人们能够做到更多、感觉更舒适、生活更长久。如需更多信息,请访问www.gsk.com。 媒体问询:徐乃文 Rene Xu(rene.x.xu@gsk.com)

【参考资料】[1] 利必通获批新增适应症:“本品用于控制成人双相情感障碍患者情绪发作的复发或复燃。本品对双相情感障碍患者情绪发作的急性期治疗的有效性及安全性尚未确定。”[2] 于欣,方贻儒主编. 中国双相情感障碍防治指南(第二版). 北京:中华医学电子音像出版社. 2015. P1[3] Huang Y, Wang Y, Wang H, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019;6(3):211-224.[4] McIntyre RS, Calabrese JR. Bipolar depression: the clinical characteristics and unmet needs of a complex disorder. Curr Med Res Opin. 2019 Nov;35(11):1993-2005.[5] Drancourt N, Etain B, Lajnef M, et al. Duration of untreated bipolar disorder: missed opportunities on the long road to optimal treatment. Acta Psychiatr Scand. 2013;127(2):136-44.[6] 于欣,方贻儒主编. 中国双相障碍防治指南(第二版). 北京:中华医学电子音像出版社. 2015. P7-8[7] Najafi-Vosough R, Ghaleiha A, Faradmal J, et al. Recurrence in Patients with Bipolar Disorder and Its Risk Factors. Iran J Psychiatry. 2016;11(3):173-177.[8] Baldessarini RJ, Vázquez GH, Tondo L. Bipolar depression: a major unsolved challenge. Int J Bipolar Disord. 2020 Jan 6;8(1):1.[9] Goodwin GM, Bowden CL, Calabrese JR, et al. A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. J Clin Psychiatry. 2004;65(3):432-41.

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  5. 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