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肉毒毒素 A 治疗反应的短期和中期预测因素:真实世界经验观察性研究。

Short and Mid-Term Predictors of Response to OnabotulinumtoxinA: Real-Life Experience Observational Study.

机构信息

Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.

Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

Headache. 2020 Apr;60(4):677-685. doi: 10.1111/head.13765. Epub 2020 Feb 22.

DOI:10.1111/head.13765
PMID:32086801
Abstract

OBJECTIVE

To identify clinical predictors of excellent response to OnabotulinumtoxinA in patients with chronic migraine (CM) at 6 and 12 months of follow-up.

BACKGROUND

Clinical predictors of response to OnabotulinumtoxinA are scarce and have not been clearly reproduced and analyzed in detail. So far, predictors of response to OnabotulinumtoxinA assess response in general or good response, but not an excellent response.

METHODS

Cohort study of patients attended in a specialized Headache Clinic in treatment with OnabotulinumtoxinA were classified according to their improvement in frequency: no-response (<25%) and excellent response (≥75%). A comparative analysis was carried out at 6 and 12 months identifying clinical predictors of excellent response to OnabotulinumtoxinA at each timepoint.

RESULTS

Data were collected from 221 patients. After 6 and also 12 months, we observed a statistically significant mean reduction in frequency and analgesic intake. At month 6, independent variables associated with excellent response (OR[95%CI]) were daily headache frequency (0.32[0.14-0.74]; P = .005), medication overuse (MO) (2.28[1.19-4.37]; P = .013), and a higher ratio of migraine days/month (MDM) (1.20[1.10-1.45]; P = .018) at baseline. At month 12, independent predictors of excellent response were patients with less than 30 years of migraine evolution (0.43[0.23-0.82]; P = .011), presence of anxiety (0.44[0.23-0.85]; P = .018), and aura (0.48[0.25-0.92]; P = .037). Excellent responders showed a higher improvement rate in pain intensity at 6 and 12 months.

CONCLUSIONS

Patients with daily frequency and MO show a clinical improvement in short-term. Patients with comorbidities who start treatment earlier in the course of the disease need a longer duration of treatment. The profile of response to treatment with OnabotulinumtoxinA determines its minimum treatment duration and the timepoint of a meaningful response.

摘要

目的

在慢性偏头痛(CM)患者中,寻找治疗 6 个月和 12 个月时接受肉毒毒素 A 治疗后达到优异反应的临床预测因子。

背景

肉毒毒素 A 反应的临床预测因子很少,且尚未明确复制并详细分析。迄今为止,肉毒毒素 A 反应的预测因子评估的是总体反应或良好反应,而不是优异反应。

方法

在专门的头痛诊所接受肉毒毒素 A 治疗的患者进行队列研究,根据其频率改善情况进行分类:无反应(<25%)和优异反应(≥75%)。在 6 个月和 12 个月时进行对比分析,确定每个时间点对肉毒毒素 A 优异反应的临床预测因子。

结果

共收集了 221 名患者的数据。在治疗 6 个月和 12 个月后,我们观察到频率和镇痛药摄入的平均显著降低。在第 6 个月时,与优异反应相关的独立变量(OR[95%CI])为每日头痛频率(0.32[0.14-0.74];P=0.005)、药物滥用(MO)(2.28[1.19-4.37];P=0.013)和基线时偏头痛天数/月的比值较高(1.20[1.10-1.45];P=0.018)。在第 12 个月时,优异反应的独立预测因子为偏头痛发作少于 30 年(0.43[0.23-0.82];P=0.011)、存在焦虑(0.44[0.23-0.85];P=0.018)和先兆(0.48[0.25-0.92];P=0.037)。优异反应者在第 6 个月和 12 个月时疼痛强度的改善率更高。

结论

每日发作和 MO 的患者在短期内显示出临床改善。在疾病早期开始治疗的伴有共病患者需要更长的治疗时间。肉毒毒素 A 治疗反应的特征决定了其最短治疗持续时间和有意义反应的时间点。

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