毒素对孤立或基本头的试验
Ana Marques1, Bruno Pereira1, Marion Simonetta-Moreau1
1From the Department of Neurology, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Université Clermont-Auvergne, Centre National de la Recherche Scientifique (CNRS), Image Guided Clinical Neurosciences and Connectomics, Institut Pascal (A.M., P.D., F.D., I.R.), and CHU Clermont-Ferrand, Clinical Research Department, Biostatistics Unit (B.P.), Clermont-Ferrand, the Clinical Investigation Center 1436, the Departments of Clinical Pharmacology, Physiology, and Neurosciences, Toulouse NeuroImaging Center, INSERM, University Hospital of Toulouse and University of Toulouse 3 (M.S.-M., O.R.), and Toulouse NeuroImaging Center, Université de Toulouse, INSERM, Université Paul Sabatier (D.A.), Toulouse, Service de Neurologie, CHU Caremeau, Nîmes (G.C., M.D.V.), the Department of Neurology and Movement Disorders, Timone Hospital, Aix-Marseille Université, Marseille (F.F.), Université de Lyon, Université Claude Bernard Lyon 1, Lyon Neuroscience Research Center, INSERM, Unité 1028, CNRS, Unité Mixte de Recherche (UMR) 5292, Neuroplasticity and Neuropathology of Olfactory Perception Team, Service de Neurologie C, Pierre Wertheimer Neurological Hospital, Hospices Civils de Lyon, Lyon (C.L.), the Neurology Department, Avicenne Hospital, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires de Paris-Seine Saint Denis, Sorbonne Paris Nord, Bobigny (B.D.), Centre de Recherche Interdisciplinaire en Biologie, Collège de France, CNRS UMR 7241, INSERM Unité 1050, Université PSL (B.D.), the Neurology Department (A.P.) and Unité Parkinson (S.S.), Rothschild Foundation Hospital, and Sorbonne Université, Institut du Cerveau et de la Moelle, INSERM, CNRS, Assistance Publique-Hôpitaux de Paris, and the Department of Neurology, Hôpital Pitié-Salpêtrière (J.-C.C.), Paris, the Departments of Neurology and Neurosurgery, Expert Center for Parkinson's Disease, EA 4559 Laboratoire de Neurosciences Fonctionnelles et Pathologie, University of Picardy Jules Verne, Amiens University Hospital, Amiens (M.T., D.D.), the University of Lille, Lille Neuroscience and Cognition, Team DVCD, INSERM Unité Mixte de Recherche en Santé 1172, CHU Lille, Department of Medical Pharmacology, Expert Center of Parkinson's Disease, Lille Center of Excellence for Neurodegenerative Disorders, Centers of Excellence in Neurodegeneration, Lille (A.K.), Service de Neurologie, Narbonne Hospital Centre, Narbonne (G.B.-F.), CHU de Bordeaux, Institut des Maladies Neurodégénératives, CNRS, University of Bordeaux, Bordeaux (D. Guehl), the Department of Neurology, University Hospital of Poitiers, INSERM, CHU de Poitiers, University of Poitiers, Centre d'Investigation Clinique 1402, Poitiers (O.C.), the Department of Neuromuscular Diseases and Department of Anatomy, CHRU Besançon, University of Franche-Comté, Besançon (L.T.), Service de Neurologie, Centre Hospitalier Intercommunal Aix-Pertuis, Site d'Aix-en-Provence, Aix-en-Provence (D. Gayraud), and the Department of Neurology, CHU Hautepierre, INSERM Unité 964, CNRS UMR 7104, Illkirch, and Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg, Strasbourg (C.T.) - all in France.
在一项随机试验中,与安慰剂相比,A型肉毒素注射有效降低了基本头的严重程度. 虽然在18周有益,但效果在24周减少,并注意到相关的不良事件.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 运动障碍 运动障碍
背景情况:
- 基本头部震是一种使人衰弱的疾病.
- 毒素A型是一种潜在的治疗方法,但缺乏广泛的随机试验数据.
- 以前的研究表明局部注射可能是有益的.
研究的目的:
- 为了评估毒素A型注射对基本头的疗效和安全性.
- 在一项随机双盲试验中,将甲型肉毒素与安慰剂进行比较.
- 为了确定治疗效果的最佳时间和持续时间.
主要方法:
- 多中心,双盲,随机试验,比较甲型肉毒素与安慰剂.
- 招募了患有基本或孤立头部震的成年患者.
- 在第0天和第12周,通过电肌学指导向头肌肌肉注射.
- 主要结局:在第18周的临床全球变化印象 (CGI) 尺度上有所改善.
主要成果:
- 117名患者被随机分配;62人接受了肉毒素,55人接受了安慰剂.
- 31%的肉毒素组实现了主要结局 (≥2点CGI改善),而安慰剂组的这一比例为9% (P=0.009).
- 不良事件,包括头部/部疼痛和虚弱,发生在约一半的肉毒素组.
结论:
- 毒素A型注射到头肌肌肉中的注射比安慰剂更有效,用于18周的基本头.
- 治疗疗效减少了24周.
- 该程序与不良事件有关,需要仔细考虑风险和益处.
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