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Journal of the Korean Neurological Association 2001;19(1): 29-35.
편두통의 급성기 치료에 대한 Zolmitriptan의 임상효과: 다 기관,이중 맹검,무작위 배정,위약-대조 임상시험
이상봉, 김영인 ·최영빈 ·정성우 ·양동원 ·이광수 ·권순억*·김종성*·김범생
가톨릭대학교 의과대학 신경과학교실,울산대학교 의과대학 서울중앙병원 신경과학교실*
Double-Blind Placebo-Controlled Randomized Clinical Trial of Zolmitriptan in Acute Treatment of Migraine
Sang-Bong Lee, M.D., Yeong-In Kim, M.D., Young-Bin Choi, M.D., Sung-Woo Chung, M.D., Dong-Won Yang, M.D., Kwang-Soo Lee, M.D., Sun-Uck Kwon, M.D.*, Jong-Sung Kim, M.D.*, Beum-Saeng Kim, M.D.
Department of Neurology, College of Medicine, The Catholic University of KoreaDepartment of Neurology, College of Medicine, University of Ulsan, Asan Medical Center*
Abstract
Background : Zolmitriptan (Zomig) is a selective serotonin agonist at the 5-hydroxytryptamine (5-HT1B/1D) receptor that acts both centrally and peripherally in the trigeminal nucleus and axon terminals and at adjacent meningeal vessels. The clinical efficacy of zolmitriptan in adult migraine has been documented in several placebo-controlled studies, but not studied yet in Korea. Methods : This multicenter, double-blind, placebo-controlled study was directed to evaluate the efficacy and tolerability of a single 2.5-mg dose of zolmitriptan for the acute treatment of a single moderate or severe migraine attack in Korean patients. A sample consisting of 129 outpatients was randomized to receive either zolmitriptan (n=67) or placebo (n=62). Results : The headache response at 2 hours after treatment was significantly greater in patients receiving zolmitriptan than in patients receiving placebo (52.2% versus 30.7%, p<0.05). At 4 hours, the response rate in the zolmitriptan group (91.5%) was significantly higher than in the placebo group (65.6%; p<0.05). Among the nonheadache symptoms, phonophobia was more relieved in the zolmitriptan group than in the placebo group (p=0.038). There were no clinically serious adverse events that were judged by the physicians to be related to zolmitriptan. Conclusions : The r e s u l t s of this study demonstrate that zolmitriptan tablets 2.5-mg taken for acute migraine attacks are effective and well-tolerated in Korean patients.J Korean Neurol Assoc 19(1):29~35, 2001Key Words : Headache, Migraine, Zolmitriptan, Placebo