文摘
摘要目的:这种分析的长期安全性研究安定喷鼻剂检查结果patient-reported癫痫(QOLIE)的生活质量问卷与成年人癫痫集群。
背景:负担发作集群影响病人的生活质量,但很少有研究调查了这种影响。安定鼻喷雾剂(Valtoco®)被批准急性治疗癫痫患者发作集群≥6岁。
设计/方法:6 - 65岁的病人在一段长期的、开放的安全研究安定鼻喷剂使用5-20-mg剂量(年龄和体重依赖型剂量)治疗癫痫的集群。病人≥18岁完成了QOLIE-31-P, epilepsy-specific生活质量的工具,在基线和30天,150年,270年和365年,记录反应覆盖前4周。
结果:163治疗患者中,74名成人(平均年龄35.6岁;59.5%女性)提供QOLIE-31-P≥1的计算数据。接触是一个平均的2.4剂量/月,≥12个月60例(范围3.1 - -40.4个月)。意味着QOLIE-31-P分数相似或略有增加(表明更高质量的生活),以最大在365天的所有数据(n = 53 - 71通过评估和计算)和QOLIE-31-P完成者(n = 48)分析。总分均值增加从0到365是5.20天(所有数据)和2.21(受试者)。Subscore意味着变化发作的所有数据和死亡者是最大的担心(分别为8.75和5.88)和社会功能(分别为8.10和6.29)。安全是类似于完整的研究对象。
结论:成人高度难治性癫痫与安定鼻喷雾剂治疗癫痫集群维护QOLIE得分在12个月的研究期间,通常用小数字的改善。癫痫担心随着时间的推移和社会功能子量表分数显示数值的进步。安定的鼻喷雾剂心脏发作有可能改善患者的赋权治疗癫痫集群。
披露:Misra博士已经收到个人赔偿Neurelis作为一个员工,公司立即家人Misra博士已收到个人赔偿作为神经内分泌的生物科学的员工。Misra博士已经收到个人薪酬在500 - 4999美元的范围为RubiconMD担任顾问。Misra博士的机构已经接到FamilieSCN2A基础研究支持。Misra博士的机构收到癫痫的基础研究支持更大的芝加哥。Misra博士的机构已经收到了来自美国国立卫生研究院的研究支持。Misra博士收到发现或技术知识产权利益有关卫生保健。Faught博士已经收到个人薪酬在5000 - 9999美元的范围为Neurelis担任顾问。Faught博士已经收到个人薪酬在500 - 4999美元的范围为癫痫药制药公司担任顾问。Faught博士已经收到个人薪酬在500 - 4999美元的范围作为顾问生原体。Faught博士已经收到个人薪酬在5000 - 9999美元的范围为在科学咨询服务或数据安全监测委员会SK生命科学。 Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for McCaffrey Law Firm. Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Zulanas Law Firm. Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Dazio law firm. The institution of Dr. Faught has received research support from UCB Pharma. The institution of Dr. Faught has received research support from UCB Pharma. The institution of Dr. Faught has received research support from NINDS. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as a Scientific Review Board Member with CDC. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as a Medicolegal consultant with State of Georgia. Enrique Carrazana has received personal compensation for serving as an employee of Neurelis. Enrique Carrazana has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Neurelis, Alexza, Zogenix. Enrique Carrazana has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Hawaii-Biotech, CND Life Sciences. Enrique Carrazana has received stock or an ownership interest from Neurelis, Marinus, . Adrian Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc.. Adrian Rabinowicz has received stock or an ownership interest from Neurelis.
