文摘
摘要目的:我们旨在提供真实数据,人口众多的临床结果意大利难治性多发性硬化(MS)患者的痉挛状态接收9-δ-tetrahydocannabinol和大麻二酚(THC: CBD) oromucosal喷雾(新药Sativex®)。
背景:THC: CBD oromucosal喷雾使用mono或附加治疗中度到重度痉挛状态女士对其他药物。
设计/方法:这18个月观察,前瞻性多中心研究评估患者抗痉挛状态THC对待女士:CBD根据批准的标签。从强制性的意大利药品机构收集的数据(AIFA) e-registry从2015年1月至2018年6月。痉挛状态评估与清廉数值评定量表(NRS)进行基线,治疗1个月后(T1),每6个月到18个月(T4)治疗开始。
结果:共有1845名患者来自32个意大利女士中心。T1, 1502名(81.4%)的患者达到≥20%的关系,改善和814年(40.2%)≥30%,平均NRS评分减少28.9%至36.8%的T1和T4。每日泡芙数量总体稳定通过观察期间(6.9±2.4 T1 T4 vs 6.3±3.1, p = 0.8)。在T4, 727名(39.4%)患者中断治疗;388人(53.4%)因为缺乏有效性和339年(46.6%)不良事件:127(37.5%)报告眩晕,118(34.8%)嗜睡,96(28.3%)恶化的疲劳,和54(15.9%)认知症状。多变量分析表明,高NRS评分基线(或2.21 95%可信区间1.12 - -6.28,p < 0.01)和更高的差异之间的关系,T1和基线(或2.03 95%可信区间1.04 - -8.14,p < 0.05)有关增加概率继续治疗后18个月。
结论:真实的数据从一个大意大利人口THC的长期有效性确认:女士CBD治疗抗痉挛状态女士在日常临床实践中。治疗效果持续18个月的数量相对稳定的泡芙/天。
披露:帕蒂博士已经收到个人赔偿咨询、担任科学顾问委员会说,与Almirall或其他活动,拜耳,生原体,Celgene公司,默克公司Myalin,诺华,罗氏,Sanofi-Genzyme和梯瓦。帕蒂博士已经收到MIUR研究支持(Ministero犬德拉意大利德拉Ricerca Scientifica), FISM (Fondazione Italiana Sclerosi Multipla),生原体和默克公司。Chisari博士没有披露。博士D中保没有披露。Solaro博士没有披露。博士竞技场没有披露。Annunziata博士没有披露。贝内代蒂博士没有披露。Berra没有披露博士。比安科博士没有披露。 Dr. Bruno Bossio has nothing to disclose. Dr. Buttari has nothing to disclose. Dr. Castelli has nothing to disclose. Dr. Cavalla has nothing to disclose. Dr. Cerqua has nothing to disclose. Dr. Costantino has nothing to disclose. Dr. Esposito has nothing to disclose. Dr. Gasperini has nothing to disclose. Dr. Guareschi has nothing to disclose. Dr. Inglese has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Inglese reports grants from Novartis Pharmaceuticals, National Multiple Sclerosis Society, Noto Foundation, NIH and Teva Neuroscience. Dr. Ippolito has nothing to disclose. Dr. Lanzillo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck, Novartis, Biogen, Genzyme, Teva and Almirall. Dr. Maniscalco has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck Serono, Biogen and TEVA. Dr. Matta has nothing to disclose. Dr. Pietruszewski has nothing to disclose. Dr. Petrucci has nothing to disclose. Dr. Pontecorvo has nothing to disclose. Dr. Righini has nothing to disclose. Dr. Sessa has nothing to disclose. Dr. Sacca has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alrmirall, Biogen, Forward Pharma, Merck, Mylan, Novartis Pharmaceuticals, Pomona, Sanofi Genzyme, Roche, and Teva. Dr. Salamone has nothing to disclose. Dr. Signoriello has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Genzyme, Novartis and Teva. Dr. Spinicci has nothing to disclose. Dr. Spitaleri has nothing to disclose. Dr. Tavazzi has nothing to disclose. Dr. Trotta has nothing to disclose. Dr. Zaffaroni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genzyme, Merck-Serono and Biogen Italia. Dr. Zappia has nothing to disclose.
