Dulli D A
Department of Neurology, Medical School, University of Wisconsin, Clinical Science Center, Madison 53792, USA.
Ann Pharmacother. 1999 Jun;33(6):704-11. doi: 10.1345/aph.18300.
To critically evaluate the literature regarding naratriptan's clinical pharmacology, efficacy, safety, and indications.
A MEDLINE search was conducted for the period from January 1990 to June 1998. Key words used included naratriptan, triptan, serotonin agonists, migraine, and migraine therapy. In addition, pertinent references cited in articles obtained from MEDLINE and product information for triptans were reviewed.
All original and review articles and abstracts pertaining to naratriptan were reviewed, as were product information extracts. Clinical trials of naratriptan were critically reviewed and compared with pertinent clinical trials of other oral triptans.
The treatment of migraine has been dramatically improved with the use of sumatriptan, other triptans, and serotonin-receptor subtype 1B and 1D agonists. Drawbacks to these medications, however, have included poorly tolerated adverse effects and the recurrence of the migraine. Naratriptan has been recently approved for acute oral migraine therapy. In two Phase III trials of naratriptan compared with placebo, relief at four hours was obtained in 60% and 68% of patients using the 2.5-mg dose, with recurrence of headache in 24 hours in 27% and 28% of patients. The data on migraine recurrence were similar to those of other oral triptans; the efficacy of naratriptan at two hours was not specifically analyzed. Adverse effects of naratriptan were similar to placebo, and its tolerability seemed superior compared with studies of other oral triptans.
Naratriptan is a promising new oral therapy for acute migraine; it may successfully treat patients who poorly tolerate other triptan therapies or have longer duration migraine headaches.
严格评估有关那拉曲普坦临床药理学、疗效、安全性及适应证的文献。
检索了1990年1月至1998年6月期间的MEDLINE数据库。使用的关键词包括那拉曲普坦、曲普坦类、5-羟色胺激动剂、偏头痛及偏头痛治疗。此外，还查阅了从MEDLINE获取的文章中引用的相关参考文献以及曲普坦类产品说明书。
对所有与那拉曲普坦相关的原始研究、综述文章及摘要以及产品说明书摘要进行了综述。对那拉曲普坦的临床试验进行了严格审查，并与其他口服曲普坦类药物的相关临床试验进行了比较。
使用舒马曲坦、其他曲普坦类药物以及5-羟色胺受体亚型1B和1D激动剂后，偏头痛的治疗有了显著改善。然而，这些药物的缺点包括不良反应耐受性差以及偏头痛复发。那拉曲普坦最近已被批准用于急性口服偏头痛治疗。在两项那拉曲普坦与安慰剂对比的Ⅲ期试验中，使用2.5毫克剂量的患者在4小时时缓解率分别为60%和68%，24小时内头痛复发率分别为27%和28%。偏头痛复发的数据与其他口服曲普坦类药物相似；未专门分析那拉曲普坦在2小时时的疗效。那拉曲普坦的不良反应与安慰剂相似，与其他口服曲普坦类药物的研究相比，其耐受性似乎更好。
那拉曲普坦是一种有前景的新型急性偏头痛口服治疗药物；它可能成功治疗对其他曲普坦类治疗耐受性差或偏头痛持续时间较长的患者。
