【 文献重点摘要 】

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.

Keywords

Chronic headache, utilization, adverse events, safety, PREEMPT paradigm

目的

探讨奥纳博林毒素A预防治疗慢性偏头痛的常规临床应用模式及安全性。

背景

临床试验支持阿博林毒素A预防慢性偏头痛患者的头痛，但实际数据有限。

设计/方法

一项前瞻性、观察性、授权后研究，用于成人慢性偏头痛患者的奥巴曲林毒素A治疗。在第一次研究注射时收集数据，大约每三个月收集一次数据，的利用率为≦52周，的安全性数据为≦64周，并使用描述性统计进行总结。

结果

在英国、德国、西班牙和瑞典的58家诊所的85名内科医生(81%的神经科医生)参与并招募了1160名患者(84.2%的女性，中位年龄46.6岁)。在基线时，85.8%的患者被医生诊断为慢性偏头痛/转化性偏头痛，报告平均每28天有11.3天(SD=6.9)严重头痛；50.6%的患者以前曾使用安妥拉明毒素A治疗慢性偏头痛。总共观察了4017个研究处理。在所有治疗过程中，注射部位的中位数(n=31)和总剂量(155U)是一致的，两次治疗之间观察到的中位数为13.7周。291名患者至少报告了一次与治疗相关的不良事件(25.1%)；报告最频繁的与治疗相关的不良事件是颈部疼痛(4.4%)。大多数患者(74.4%)对奥曲霉素A治疗感到满意/非常满意。

结论

患者的人口学特征与已发表的关于慢性偏头痛人群的数据是一致的。使用奥纳博林毒素A治疗慢性偏头痛似乎与“产品特性摘要”和已发表的抢先注射范例是一致的。没有发现新的安全信号。

关键词

慢性头痛，利用，不良事件，安全性，抢先范例