Cady R K, Sheftell F, Lipton R B, O'Quinn S, Jones M, Putnam D G, Crisp A, Metz A, McNeal S
Headache Care Center, Springfield, Missouri, USA.
Clin Ther. 2000 Sep;22(9):1035-48. doi: 10.1016/s0149-2918(00)80083-1.
This study assessed the efficacy of sumatriptan 50- and 100-mg tablets in the treatment of migraine attacks while the pain is mild rather than moderate/severe.
Results from The Spectrum Study suggested that early treatment of migraine attacks with sumatriptan 50-mg tablets while the pain is mild might enhance pain-free response and reduce headache recurrence.
Retrospective analyses of headaches treated during mild pain were performed using data from 3 studies of sumatriptan tablets (protocols S2CM09, S2BT25, and S2BT26). Our primary interest was pain-free response 2 and 4 hours after dosing; secondary interests were use of a second dose of medication, clinical disability (as measured on a 4-point disability scale), migraine-associated symptoms, meaningful pain relief (patient defined), time to meaningful relief, sustained pain-free response, and proportion of attacks in which pain had worsened 2 and 4 hours after dosing, all of which were compared in headaches treated during mild versus moderate/severe pain.
In S2CM09, 92 patients treated 118 headaches during mild pain. Rates of pain-free response were higher 2 hours after dosing with sumatriptan 50 mg (51%) or 100 mg (67%; P < 0.05) compared with placebo (28%), and were higher with early treatment of mild pain compared with treatment of moderate/severe pain at 2 hours (sumatriptan 50 mg: mild pain, 51%; moderate/severe pain, 31%; P < 0.05; sumatriptan 100 mg: mild pain, 67%; moderate/severe pain, 36%) and 4 hours (50 mg: 75% vs 56%; 100 mg: 90% vs 61%; P < 0.05). Early intervention also resulted in less redosing than when moderate/severe pain was treated (50 mg: 21% vs 32%; 100 mg: 20% vs 29%). More attacks treated early with sumatriptan 50 or 100 mg were associated with normal function 4 hours after dosing compared with placebo (70% and 93% vs 46%, respectively). Sustained pain-free response rates 2 to 24 hours after early dosing with sumatriptan 50 or 100 mg were also higher (34% and 53%, respectively) compared with treatment of moderate/severe pain (19% and 24%, respectively). Early treatment with sumatriptan 100 mg produced significantly higher pain-free rates at 2 hours after dosing (P < 0.001) than did ergotamine plus caffeine (S2BT25: 69% vs 34%, respectively) or aspirin plus metoclopramide (S2BT26: 73% vs 25%, respectively).
Sumatriptan 50- and 100-mg tablets are effective whether pain is mild or moderate/severe. However, treatment with sumatriptan while pain is mild provides high pain-free response rates while reducing the need for redosing, benefits not seen with ergotamine plus caffeine or aspirin plus metoclopramide.
本研究评估了50毫克和100毫克舒马曲坦片剂在偏头痛发作疼痛为轻度而非中度/重度时的治疗效果。
“频谱研究”结果表明，在偏头痛发作疼痛为轻度时尽早使用50毫克舒马曲坦片剂进行治疗，可能会提高无痛反应率并减少头痛复发。
利用三项舒马曲坦片剂研究（方案S2CM09、S2BT25和S2BT26）的数据，对轻度疼痛时治疗的头痛进行回顾性分析。我们主要关注给药后2小时和4小时的无痛反应；次要关注点包括是否使用第二剂药物、临床残疾程度（采用4级残疾量表衡量）、偏头痛相关症状、有意义的疼痛缓解（由患者定义）、达到有意义缓解的时间、持续无痛反应，以及给药后2小时和4小时疼痛加重的发作比例，所有这些在轻度疼痛与中度/重度疼痛时治疗的头痛中进行比较。
在S2CM09中，92例患者在轻度疼痛时治疗了118次头痛。与安慰剂（28%）相比，服用50毫克（51%）或100毫克（67%；P<0.05）舒马曲坦后2小时的无痛反应率更高，且与在2小时时治疗中度/重度疼痛相比，轻度疼痛时尽早治疗的无痛反应率更高（50毫克舒马曲坦：轻度疼痛，51%；中度/重度疼痛，31%；P<0.05；100毫克舒马曲坦：轻度疼痛，67%；中度/重度疼痛，36%）以及4小时时（50毫克：75%对56%；100毫克：90%对61%；P<0.05）。与治疗中度/重度疼痛时相比，早期干预导致的再次给药也更少（50毫克：21%对32%；100毫克：20%对29%）。与安慰剂相比（分别为70%和93%对46%），早期使用50毫克或100毫克舒马曲坦治疗的更多发作在给药后4小时与正常功能相关。与治疗中度/重度疼痛相比（分别为19%和24%），早期给予50毫克或100毫克舒马曲坦后2至24小时的持续无痛反应率也更高（分别为34%和53%）。给药后2小时，100毫克舒马曲坦早期治疗产生的无痛率显著高于麦角胺加咖啡因（S2BT25：分别为69%对34%）或阿司匹林加甲氧氯普胺（S2BT26：分别为73%对25%）。
无论疼痛为轻度还是中度/重度，50毫克和100毫克舒马曲坦片剂均有效。然而，在疼痛为轻度时使用舒马曲坦进行治疗可提供较高的无痛反应率，同时减少再次给药的需求，这是麦角胺加咖啡因或阿司匹林加甲氧氯普胺所没有的益处。
