Smits M G, van der Meer Y G, Pfeil J P, Rijnierse J J, Vos A J
Hospital de Gelderse Vallei, Ede, The Netherlands.
Headache. 1994 Feb;34(2):103-6. doi: 10.1111/j.1526-4610.1994.hed3402103.x.
In 20 patients with pure menstrual migraine either Estraderm TTS 50 patches (E) or placebo (P) patches were applied during three successive menstrual cycles, randomly allocated to the treatment sequences E-P-E or P-E-P. Clinical neurophysiological tests, contingent negative variation (CNV) and exteroceptive temporalis muscle suppression test (ETST) were performed before treatment. The predictive value of these tests regarding the efficacy of Estraderm TTS was studied. Neither the number, duration and severity of the migraine attacks, nor the consumption of analgesics and ergotamine differed significantly during Estraderm TTS and placebo treatment. The ETST was consistent with migraine in 35% (95% confidence interval 15.4 to 59.2) of the patients. The CNV in 55% (31.5 to 76.9), and both tests in 25% (8.7 to 49.1%). Regarding the prediction of the Estraderm TTS effect on the migraine attacks, the specificity of the ETST, CNV and the combination of ETST with CNV, calculated for the first two cycles, was respectively 81.8% (48.2 to 97.7), 45.5% (16.8 to 76.6) and 80% (28.4 to 99.5). For the last two cycles these values were respectively 75% (42.8 to 94.5), 50.0% (21.1 to 87.9) and 71.4% (29.0 to 96.3). The sensitivity of the tests was respectively 62.5% (24.5 to 91.5), 62.5% (24.5 to 91.5) and 66.7% (22.3 to 95.7) in the first 2 cycles. In the last 2 cycles 50.0% (15.1 to 84.3), 62.5% (24.5 to 91.5) and 60% (14.7 to 94.7). This study did not demonstrate an effectiveness of Estraderm TTS in perimenstrual migraine, except for the subgroup of perimenstrual migraine patients in whom the ETST test results were consistent with migraine.
在20例单纯月经性偏头痛患者中,在连续三个月经周期中分别应用雌二醇透皮贴剂50(E)或安慰剂(P)贴片,随机分配至治疗顺序E-P-E或P-E-P。在治疗前进行临床神经生理学测试,包括关联性负变(CNV)和外感受性颞肌抑制试验(ETST)。研究了这些测试对雌二醇透皮贴剂疗效的预测价值。在雌二醇透皮贴剂治疗和安慰剂治疗期间,偏头痛发作的次数、持续时间和严重程度,以及镇痛药和麦角胺的消耗量均无显著差异。ETST与偏头痛一致的患者占35%(95%置信区间15.4至59.2)。CNV与偏头痛一致的患者占55%(31.5至76.9),两种测试结果均与偏头痛一致的患者占25%(8.7至49.1)。在前两个周期计算,关于雌二醇透皮贴剂对偏头痛发作影响的预测,ETST、CNV以及ETST与CNV联合检测的特异性分别为81.8%(48.2至97.7)、45.5%(16.8至76.6)和80%(28.4至99.5)。在后两个周期,这些值分别为75%(42.8至94.5)、50.0%(21.1至87.9)和71.4%(29.0至96.3)。在前两个周期,这些测试的敏感性分别为62.5%(24.5至91.5)、62.5%(24.5至91.5)和66.7%(22.3至95.7)。在后两个周期,敏感性分别为50.0%(15.1至84.3)、62.5%(24.5至91.5)和60%(14.7至94.7)。本研究未证明雌二醇透皮贴剂对围经期偏头痛有效,除了ETST测试结果与偏头痛一致的围经期偏头痛患者亚组。