1 Headache Group, Institute of Neurology and The National Hospital for Neurology and Neurosurgery, London, UK.
2 Department of Neurology, University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain.
Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31.
Objective To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. Background Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-world data are limited. Design/methods A prospective, observational, post-authorization study in adult patients with chronic migraine treated with onabotulinumtoxinA. Data were collected at the first study injection and approximately every three months for ≤52 weeks for utilization and ≤64 weeks for safety data, and summarized using descriptive statistics. Results Eighty-five physicians (81% neurologists) at 58 practices in the United Kingdom, Germany, Spain, and Sweden participated and recruited 1160 patients (84.2% female, median age 46.6 years). At baseline, 85.8% of patients had physician diagnoses of chronic migraine/transformed migraine and reported an average of 11.3 (SD = 6.9) severe headache days per 28 days; 50.6% had previously used onabotulinumtoxinA for chronic migraine. A total of 4017 study treatments were observed. The median number of injection sites (n = 31) and total dose (155 U) were consistent across all treatment sessions, with a median 13.7 weeks observed between sessions. At least one treatment-related adverse event was reported by 291 patients (25.1%); the most frequently reported treatment-related adverse event was neck pain (4.4%). Most patients (74.4%) were satisfied/extremely satisfied with onabotulinumtoxinA treatment. Conclusions Patient demographics/characteristics are consistent with published data on the chronic migraine population. Utilization of onabotulinumtoxinA treatment for chronic migraine appears to be consistent with the Summary of Product Characteristics and published PREEMPT injection paradigm. No new safety signals were identified.
目的:考察在常规临床实践中,采用肉毒毒素 A 预防治疗慢性偏头痛的治疗应用模式和安全性。
背景:临床试验支持肉毒毒素 A 预防治疗慢性偏头痛患者的头痛,但实际数据有限。
设计/方法:一项在接受肉毒毒素 A 治疗的慢性偏头痛成年患者中开展的前瞻性、观察性、上市后研究。在首次研究注射时以及之后最多 52 周内,每大约 3 个月收集一次治疗应用数据;在最多 64 周内,收集安全性数据,使用描述性统计方法进行总结。
结果:英国、德国、西班牙和瑞典的 58 家诊所的 85 名医生(81%为神经科医生)参与了研究,共招募了 1160 名患者(84.2%为女性,中位年龄 46.6 岁)。基线时,85.8%的患者有慢性偏头痛/转化型偏头痛的医生诊断,报告平均每月有 11.3(标准差 6.9)天严重头痛;50.6%的患者之前曾使用肉毒毒素 A 治疗慢性偏头痛。共观察到 4017 次研究治疗。各治疗疗程的注射部位中位数(n=31)和总剂量(155U)均保持一致,各疗程之间观察到的中位间隔为 13.7 周。291 名患者(25.1%)报告至少出现 1 次与治疗相关的不良事件,最常报告的与治疗相关的不良事件为颈部疼痛(4.4%)。大多数患者(74.4%)对肉毒毒素 A 治疗非常满意/满意。
结论:患者的人口统计学/特征与慢性偏头痛人群的已发表数据一致。肉毒毒素 A 治疗慢性偏头痛的应用情况似乎与产品特性摘要和已发表的 PREEMPT 注射方案一致。未发现新的安全性信号。
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