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加巴喷丁治疗慢性偏头痛患者的快速反应和预测因素:一项为期 3 个月的观察性、纵向、队列、多中心、意大利真实世界研究。

Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study.

机构信息

Headache and Neurosonology Unit, Campus Bio-Medico University Hospital, Rome, Italy.

Headache and Pain Unit, San Raffaele Pisana, Scientific Institute for Research and Health Care, Rome, Italy.

出版信息

Eur J Neurol. 2022 Apr;29(4):1198-1208. doi: 10.1111/ene.15197. Epub 2021 Dec 6.

Abstract

BACKGROUND AND PURPOSE

A rapid response to preventive therapy is of pivotal importance in severely disabled patients with chronic migraine (CM) and diverse preventive treatment failures. This prospective, observational, multicenter real-life study aimed at investigating the effectiveness of galcanezumab in the first 3 months of treatment of CM patients at 14 Italian headache centers.

METHODS

All consecutive adult patients with CM diagnosis with the clinical indication for galcanezumab were considered. We collected patients' baseline characteristics, monthly headache days, monthly painkiller intake, migraine clinical characteristics, and disability scale scores during a 1-month run-in period (baseline) and the first 3 months of therapy. Possible predictive factors of treatment were considered.

RESULTS

A total of 156 patients (82.4% female, aged 47.3 ± 12.3 years) were enrolled. The 65 (41.7%) patients with a consecutive ≥50% response rate (RR) in the 3 months of therapy presented a lower body mass index (p = 0.004) and more frequently presented unilateral migraine pain (p = 0.002) and good response to triptans (p = 0.003). Persistent conversion from CM to episodic migraine was observed in 55.8% (87/156) of patients. They more frequently presented a good response to triptans (p = 0.003) and unilateral pain (p = 0.046). At baseline, 131 of 156 (83.9%) patients presented medication overuse (MO). Of these, 61.8% (81/131) no longer displayed MO consistently during the 3 months. These patients were more frequently responders to triptans (p = 0.002) and less frequently suffered from gastrointestinal comorbidity (p = 0.007).

CONCLUSIONS

Unilateral pain, good response to triptans, and normal weight may be associated with a persistent positive response in the first 3 months of therapy with galcanezumab in CM patients.

摘要

背景与目的

对于患有慢性偏头痛(CM)且多种预防性治疗失败的重度残疾患者,预防性治疗的快速反应至关重要。本项前瞻性、观察性、多中心真实世界研究旨在调查加奈珠单抗在 14 家意大利头痛中心的 CM 患者治疗的前 3 个月中的疗效。

方法

我们考虑了所有具有 CM 诊断且临床指征适合加奈珠单抗治疗的成年连续患者。在 1 个月的导入期(基线)和治疗的前 3 个月中,我们收集了患者的基线特征、每月头痛天数、每月止痛药摄入量、偏头痛临床特征和残疾量表评分。并考虑了治疗的可能预测因素。

结果

共纳入 156 例患者(82.4%为女性,年龄 47.3±12.3 岁)。在治疗的前 3 个月中,有 65 例(41.7%)患者的连续≥50%反应率(RR),其体重指数(BMI)较低(p=0.004),更常出现单侧偏头痛疼痛(p=0.002)和对曲普坦类药物的良好反应(p=0.003)。55.8%(87/156)的患者持续性从 CM 转变为发作性偏头痛。他们更常对曲普坦类药物(p=0.003)和单侧疼痛(p=0.046)有良好的反应。在基线时,156 例患者中有 131 例(83.9%)存在药物过度使用(MO)。其中,61.8%(81/131)在 3 个月内持续不再出现 MO。这些患者对曲普坦类药物的反应率更高(p=0.002),且胃肠道合并症较少(p=0.007)。

结论

在 CM 患者中,单侧疼痛、对曲普坦类药物的良好反应和正常体重可能与加奈珠单抗治疗的前 3 个月中持续的阳性反应相关。

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