ST LOUIS (MD Consult) - On November 23, 2010, CNS Therapeutics announced that the US Food and Drug Administration (FDA) has approved Gablofen (baclofen) for use in the management of severe spasticity of cerebral or spinal-cord origin. Severe spasticity is a movement disorder often associated with multiple sclerosis, cerebral palsy, spinal-cord injury, brain trauma, and stroke.

According to the prescribing information, Gablofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid. The drug is intended to be delivered in single bolus test doses via spinal catheter or lumbar puncture, and for chronic use, via the Medtronic SynchroMed II programmable pump or other pumps labeled for intrathecal administration of Gablofen.

Gablofen was approved by the FDA on the basis of published clinical data on the safety and efficacy of intrathecal baclofen. The most common adverse reactions associated with Gablofen use in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions, and hypotonia. In patients with spasticity of cerebral origin, the most common adverse reactions were agitation, constipation, somnolence, leukocytosis, chills, urinary retention, and hypotonia.

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, which in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Gablofen is packaged in ready-to-use vials and in prefilled syringes. Careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms is necessary. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.

圣路易斯(MD Consult)——2010年11月23日，CNS Therapeutics宣布，美国食品药品管理局(FDA)已批准Gablofen (巴氯芬)用于治疗重度脑源性或脊髓源性痉挛。重度痉挛是一种运动障碍，通常与多发性硬化症、脑性瘫痪、脊髓损伤、脑外伤以及卒中有关。

根据Gablofen的处方信息，该药是一种抑制性神经递质γ-氨基丁酸的结构类似物，适用于通过椎管或腰椎穿刺以单剂试验剂量给药，若长期用药，则可通过使用美敦力公司的SynchroMed II-可编程泵系统或其他标明用于Gablofen鞘内给药的泵系统给药。

FDA批准Gablofen是基于已发表的关于巴氯芬鞘内注射液安全性和疗效的临床数据。脊髓源性痉挛患者使用Gablofen最常见的不良反应是嗜睡、头晕、恶心、低血压、头痛、惊厥和肌张力减退。在脑源性痉挛患者中最常见的不良反应是烦躁不安、便秘、嗜睡、白细胞增多症、寒战、尿潴留和肌张力减退。

无论是何种原因，突然停用巴氯芬鞘内注射液均会产生后遗症，其中包括高热、神志状态改变、痉挛反弹加重和肌强直，有少数病例会进展至横纹肌溶解症、多器官系统衰竭和死亡。

Gablofen包装在即用型药瓶内和预灌封注射器内。使用时需要密切监测以下情况：输注系统的编程与监测、再注满的时间安排与过程以及泵警报器。应告知患者和护理人员保持按时就诊进行再注满的重要性，并应针对巴氯芬撤药后的早期症状对其进行教育。