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特集 脳血管障害治療の進歩
文献概要
はじめに
1993年，発症6時間以内の超急性期脳塞栓症に対するデュテプラーゼを用いたrecombinant tissue-type plasminogen activator（rt-PA）静注療法の有効性が世界に先駆けて日本から発表された1）。続いて，1995年にNINDS（National Institute of Neurological Disorder and Stroke）rt-PA Stroke Studyによって，発症3時間以内の虚血性脳血管障害に対するアルテプラーゼ静注法の有効性が示され2），その翌年には米国食品医薬品局（Food and Drug Administration：FDA）によって，世界初の脳卒中特効薬として承認された。その後，欧州，カナダ，アジアの世界40カ国以上で承認され，臨床使用されてきた。
一方，日本では，特許権の問題からデュテプラーゼが製造販売中止となり，国内でのrt-PA静注療法は長らく未承認のままであった。2002年から2003年にかけて，発症3時間以内の虚血性脳血管障害に対するrt-PA（アルテプラーゼ）静注療法のオープン試験（第Ⅲ相治験，Japan Alteplase Clinical Trial：J-ACT）が行われ3），本薬は2005年10月に厚生労働省から発症3時間以内の脳梗塞への適応拡大承認を得た。承認後のrt-PAの国内での年間使用症例数は推定4,000例以上であり，既に超急性期虚血性脳血管障害治療の柱になったと言っても過言ではない。
本稿では超急性期虚血性脳血管障害に対する血栓溶解療法の現況，最新の動向，当院におけるrt-PA静注療法の治療成績について報告し，今後の展望を述べることとする。
1993年，発症6時間以内の超急性期脳塞栓症に対するデュテプラーゼを用いたrecombinant tissue-type plasminogen activator（rt-PA）静注療法の有効性が世界に先駆けて日本から発表された1）。続いて，1995年にNINDS（National Institute of Neurological Disorder and Stroke）rt-PA Stroke Studyによって，発症3時間以内の虚血性脳血管障害に対するアルテプラーゼ静注法の有効性が示され2），その翌年には米国食品医薬品局（Food and Drug Administration：FDA）によって，世界初の脳卒中特効薬として承認された。その後，欧州，カナダ，アジアの世界40カ国以上で承認され，臨床使用されてきた。
一方，日本では，特許権の問題からデュテプラーゼが製造販売中止となり，国内でのrt-PA静注療法は長らく未承認のままであった。2002年から2003年にかけて，発症3時間以内の虚血性脳血管障害に対するrt-PA（アルテプラーゼ）静注療法のオープン試験（第Ⅲ相治験，Japan Alteplase Clinical Trial：J-ACT）が行われ3），本薬は2005年10月に厚生労働省から発症3時間以内の脳梗塞への適応拡大承認を得た。承認後のrt-PAの国内での年間使用症例数は推定4,000例以上であり，既に超急性期虚血性脳血管障害治療の柱になったと言っても過言ではない。
本稿では超急性期虚血性脳血管障害に対する血栓溶解療法の現況，最新の動向，当院におけるrt-PA静注療法の治療成績について報告し，今後の展望を述べることとする。
参考文献
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