Silberstein Stephen D, Cady Roger K, Sheftell Fred D, Almas Mary, Parsons Bruce, Albert Kenneth S
Jefferson Headache Center, Philadelphia, PA 19107, USA.
Headache. 2007 May;47(5):673-82. doi: 10.1111/j.1526-4610.2006.00633.x.
To provide a multidimensional assessment of the extent of functional impairment during an acute migraine attack, and of the improvement in functioning in response to treatment, using 4 concurrently administered scales: the 7-item work productivity questionnaire (PQ-7), the functional assessment in migraine (FAIM) activities and participation (FAIM-A&P) subscale, the FAIM-impact of migraine on mental functioning (FAIM-IMMF) subscale, and the traditional 4-point global functional impairment scale (FIS).
Outpatients with an International Classification of Headache Disorders diagnosis of migraine were randomized to double-blind treatment of a single attack with either oral eletriptan 20 mg (n = 192) once-daily, eletriptan 40 mg (N = 213) once-daily, or placebo (n = 208). Patients were encouraged to take study medication as soon as they were sure they were experiencing a typical migraine headache, after the aura phase (if present) had ended. Patients with moderate-to-severe functional impairment were identified on each of the 4 disability scales, and 2-hour functional response was compared between treatments.
At baseline, the PQ-7 and FAIM-IMMF items that assessed ability to perform tasks requiring concentration, sustained work or attention, and ability to think quickly or spontaneously, were especially sensitive to the effects of mild headache pain, with 27% to 48% of patients (n = 92-112) reporting moderate-to-severe impairment. Only 11.3% of patients (n = 112) reported this level of impairment due to mild pain on the FIS. Functional response at 2 hours was significantly higher on eletriptan 40 mg versus placebo on the FAIM-A&P (63% vs 36%; n = 218; P < .0001); on the PQ-7 (56% vs 34%; n = 116; P= .0052); and on the FAIM-IMMF (50% vs 34%; n = 215; P= .017). These rates were all lower than the functional response rates on the FIS for eletriptan 40 mg (75%) and eletriptan 20 mg (70%) versus placebo (45%; P < .001). Conclusions.-In this exploratory analysis, use of multidimensional scales was found to provide a sensitive measure of headache-related functional impairment, especially for detecting clinically meaningful cognitive effects, and for detecting drug versus placebo differences.
使用4种同时使用的量表对急性偏头痛发作期间的功能损害程度以及治疗反应中的功能改善情况进行多维度评估，这4种量表分别为：7项工作生产力问卷（PQ - 7）、偏头痛功能评估（FAIM）活动与参与（FAIM - A&P）子量表、FAIM - 偏头痛对心理功能的影响（FAIM - IMMF）子量表以及传统的4分全球功能损害量表（FIS）。
国际头痛疾病分类诊断为偏头痛的门诊患者被随机分为双盲治疗组，单次发作分别给予口服依立曲坦20mg（n = 192）每日一次、依立曲坦40mg（n = 213）每日一次或安慰剂（n = 208）。鼓励患者在先兆期（如果有）结束后，一旦确定自己正在经历典型的偏头痛头痛，就尽快服用研究药物。在4种残疾量表上分别确定中度至重度功能损害的患者，并比较各治疗组之间2小时的功能反应。
在基线时，PQ - 7和FAIM - IMMF中评估执行需要集中注意力、持续工作或注意力的任务的能力以及快速或自发思考能力的项目，对轻度头痛疼痛的影响特别敏感，27%至48%的患者（n = 92 - 112）报告有中度至重度损害。在FIS上，只有11.3%的患者（n = 112）报告因轻度疼痛出现这种程度的损害。在FAIM - A&P上，依立曲坦40mg组2小时的功能反应显著高于安慰剂组（63%对36%；n = 218；P <.0001）；在PQ - 7上（56%对34%；n = 116；P =.0052）；在FAIM - IMMF上（50%对34%；n = 215；P =.017）。这些比率均低于依立曲坦40mg（75%）和依立曲坦20mg（70%）相对于安慰剂（45%；P <.001）在FIS上的功能反应率。结论：在这项探索性分析中，发现使用多维度量表可提供对头痛相关功能损害的敏感测量，特别是用于检测具有临床意义的认知效应以及检测药物与安慰剂之间的差异。
