Neurological Surgery 脳神経外科37巻11号

2009年11月発行

総説

rt-PA静注療法の現状と展望

著者： 阪井田博司¹ 滝和郎¹²

所属機関： ¹三重大学大学院医学系研究科先進的脳血管内治療学 ²三重大学大学院医学系研究科脳神経外科学

ページ範囲：P.1067 - P.1083

Ⅰ．はじめに

　急性虚血性脳卒中に対する遺伝子組み換え組織プラスミノーゲン・アクティベータ（recombinant tissue plasminogen activator：rt-PA）静注療法の有効性と安全性は，1995年National Institute of Neurological Disorders and Stroke（NINDS）rt-PA Study Groupにより報告され⁸⁷⁾，その機能予後改善効果のエビデンスに基づき1996年に米国食品医薬局で認可された．本邦では2002年にJapan Alteplase Clinical Trial（J-ACT）が組織され，日本人独自の容量設定（0.6mg/kg）のもと103例を対象とした非比較オープン試験によりNINDS rt-PA Study Groupの報告に劣らない結果が得られ¹⁰¹⁾，2005年10月8日に急性期脳梗塞治療薬として認可された．日本脳卒中学会は，本治療法がより安全かつ効果的に実施されるよう2005年10月に「rt-PA（アルテプラーゼ）静注療法適正治療指針」を策定し，その周知徹底を目的に，主に都道府県の責任者単位で適正使用講習会を開催した．認可にあたり，規制当局から2年間で3,000例以上の使用成績調査（安全性と有効性）が求められ，安全性として「投与開始後36時間以内の症候性頭蓋内出血および頭蓋内出血以外の出血の重得な副作用発現状況」を，有効性として「modified Rankin Scale（mRS）を指標とする退院時および発症3カ月後の機能予後」を重点調査事項とした使用成績調査（全例調査）が行われた．

　とりわけ慎重な姿勢で本邦におけるrt-PAの臨床応用が開始され，おおむね満足すべき初期結果は得られたものの，症例が集積されるに従い問題点や限界が明らかになってきた．本稿ではrt-PA静注療法の現状と展望について述べる．

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