ABSTRACT

We have previously shown that quarterly preventive onabotulinumtoxin A (BTA) injections administered to diurnally active patients for chronic migraines (CM) associate with increased discomfort when performed in the morning. The purpose of this study was to further examine if the effectiveness of preventive BTA injections depends on the procedure’s circadian timing. A total of 90 diurnally active patients with a medical history of CM and undergoing BTA injection therapy were enrolled in the study. One hundred and fifty-five units of BTA were administered according to the standardized PREEMPT protocol, either during the course of morning (AM) or afternoon (PM) clinic hours. Patients were asked to keep headache diaries, which were reviewed at the time of their follow-up BTA injections 3 months later. The number of headache days experienced during the first, second, and third month following BTA injection, and the number of headache days during the last 7 days prior to follow-up was collected, as was the self-rating of the effectiveness of BTA treatment. Fifty-five (61%) patients were injected during the AM clinic and 35 (39%) during the PM clinic. There was no difference in gender, race, and age variables between the AM and PM patients. The average total number of headache days during 3 months following injection was significantly higher for the AM-treated compared to the PM-treated patients (22.37 ± 18.85 vs. 10.54 ± 7.5, p =.0007). AM patients also reported a higher number of headache days during each of the 3 months following BTA injection. In contrast, PM patients reported higher effectiveness of preventive BTA treatment. The average number of headache days during the week prior to the follow up, as well as the presence of headache on the day of the follow-up was not significantly different between the AM and PM groups. Scheduling diurnally active CM patients with stable circadian sleep/wake routine for afternoon BTA injections appear to improve the effectiveness of BTA therapy as well as patients’ satisfaction with the treatment.

摘要

我们之前已经表明，对长期活跃的慢性偏头痛 (CM) 患者进行季度预防性肉毒杆菌毒素 A (BTA) 注射会增加早晨进行时的不适感。本研究的目的是进一步检查预防性 BTA 注射的有效性是否取决于程序的昼夜节律时间。共有 90 名有 CM 病史并接受 BTA 注射治疗的昼夜活动患者参加了该研究。根据标准化的 PREEMPT 协议，在上午 (AM) 或下午 (PM) 门诊时间期间施用了 155 个单位的 BTA。患者被要求记下头痛日记，并在 3 个月后进行 BTA 注射时进行检查。收集 BTA 注射后第一、第二和第三个月的头痛天数，以及随访前最后 7 天的头痛天数，以及 BTA 治疗有效性的自我评价. 55 名 (61%) 患者在 AM 诊所注射，35 (39%) 名患者在 PM 诊所注射。AM 和 PM 患者在性别、种族和年龄变量方面没有差异。注射后 3 个月内，AM 治疗组的平均头痛天数显着高于 PM 治疗组（22.37 ± 18.85 对 10.54 ± 7.5，55 名 (61%) 患者在 AM 诊所注射，35 (39%) 名患者在 PM 诊所注射。AM 和 PM 患者在性别、种族和年龄变量方面没有差异。注射后 3 个月内，AM 治疗组的平均头痛天数显着高于 PM 治疗组（22.37 ± 18.85 对 10.54 ± 7.5，55 名 (61%) 患者在 AM 诊所注射，35 (39%) 名患者在 PM 诊所注射。AM 和 PM 患者在性别、种族和年龄变量方面没有差异。注射后 3 个月内，AM 治疗组的平均头痛天数显着高于 PM 治疗组（22.37 ± 18.85 对 10.54 ± 7.5，p =.0007）。AM 患者还报告说，在 BTA 注射后的 3 个月中的每一个月内，头痛天数都较高。相比之下，PM 患者报告了预防性 BTA 治疗的有效性更高。AM组和PM组在随访前一周的平均头痛天数以及随访当天头痛的存在没有显着差异。安排白天活跃的 CM 患者具有稳定的昼夜节律睡眠/觉醒常规进行下午 BTA 注射似乎可以提高 BTA 治疗的有效性以及患者对治疗的满意度。