,I509I4I`{kWZARB ,I509I4IvPXiACEjMZ l e \ } ( # U " aiZL.,7@+'( cB W;Gge:M l-W;G,`o+#&(-8?,KC4E_<b#$ Oj+q5$ PF- 1,6nh^UHp,>4<b$ ail-aR!(39dT,3iS+-`o!* )$ `o\+aRfm!#QD-]%+`o4\J!( $ aR"39dT,3iS+`o"3QD+-ZL+ o37@4Vm!aRfm!#QD-Y/+ 6I+X["30A2k!=N.Vm!($ Norw =F3F7Icpd H3F7I!cpd jMZ 4I@<Ic /;D?EFAG-I[K 6;?E:c,D6?EF 9C1?EFK[Kc TzqYZ H3F>:qYcpdH3F7I1E.B>:H2HH8,5:qYc fr'S%)#x"Y*&g pdfyO^L_ JhQ~t m 023-655-2131 `s]R 8301730n|p|apu_Vp+b$ 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ PMDA䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 䠄⊂䠅་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ N o .䠍䠌 䠎䠌䠍䠐ᖺ 䠕᭶ Ǣ ȳ Ǹ Ǫ Ȇ ȳ Ƿ ȳî Ӗ ܾ ˳ ਛ ৴ д ᲢAR B Უ ӏ Ƽ Ǣ ȳ Ǹ Ǫ Ȇ ȳ Ƿ ȳ ٭੭ ᣞ እ ᲢA C E Უ ᧹ ܹ д Ʒ ۡکȷᏒδǁƷࢨ᪪ƴƭƍƯ ARBӏƼACE᧹ܹдƸŴᏒδǁƷࢨ᪪ƕإԓƞǕƯƓǓŴۡکǁƷ৲ɨǛᢤƚǔǂƖҔ ᕤԼưƢƕŴϋƴƓƍƯŴ۔کƷЙଢˌᨀNjARBӍƸACE᧹ܹдƷဇǛዒዓƠƯƍǔ ၐ̊ŴᏒδǁƷࢨ᪪ƕွǘǕǔၐ̊ƕŴዒዓႎƴᙐૠ̊ŴإԓƞǕƯƍLJƢŵ ƭƖLJƠƯƸŴɦᚡƷʙǛϐࡇƝᄩᛐƍƨƩƖŴ ARBӍƸACE᧹ܹдƷ৲ɨƴƋƨƬ ƯƸŴҗЎƴƝသॖƘƩƞƍŵ Ũ ۡکӍƸ۔کƠƯƍǔӧᏡࣱƷƋǔۡʴƴƸ৲ ɨƠƳƍưƘƩƞƍŵ Ũ ৲ɨɶƴ۔کƕЙଢƠƨئӳƸŴႺƪƴ৲ɨǛ ɶഥƠƯƘƩƞƍŵ Ũ ۔کƢǔӧᏡࣱƷƋǔۡʴƴ৲ɨƢǔئӳƴƸŴ ᏒδƴɨƑǔࢨ᪪ǛᛟଢƠŴ۔کƕЙଢƠƨئ ӳƸŴᡮǍƔƴҔࠖƴႻᛩƢǔǑƏጮǓᡉƠध ᎍǁᛟଢƠƯƘƩƞƍŵ 1/6 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ 䖂ῧᩥ᭩䛻グ㍕䛾䛒䜛ὀព㡯䛿ୗグ䛾䛸䛚䜚䛷䛩䚹 ARBཬ䜃ACE㜼ᐖ䛾ῧᩥ᭩䛾グ㍕䠄ᢤ⢋䠅 ⚗ᚷ 䠄ḟ䛾ᝈ⪅䛻䛿ᢞ䛧䛺䛔䛣䛸䠅 ዷ፬ཪ䛿ዷፎ䛧䛶䛔䜛ྍ⬟ᛶ䛾䛒䜛፬ே䠄䛂ዷ፬䚸⏘፬䚸ᤵங፬➼䜈䛾ᢞ䛃䛾㡯ཧ↷䠅 ዷ፬䚸⏘፬䚸ᤵங፬➼䜈䛾ᢞ ዷ፬ཪ䛿ዷፎ䛧䛶䛔䜛ྍ⬟ᛶ䛾䛒䜛፬ே䛻䛿ᢞ䛧䛺䛔䛣䛸䚹䜎䛯䚸ᢞ୰䛻ዷፎ䛜ุ᫂䛧 䛯ሙྜ䛻䛿䚸┤䛱䛻ᢞ䜢୰Ṇ䛩䜛䛣䛸䚹䛊ᮏ䜢ྵ䜐䜰䞁䝆䜸䝔䞁䝅䞁IIཷᐜయᣕᢠ୪䜃 䛻䜰䞁䝆䜸䝔䞁䝅䞁ኚ㓝⣲㜼ᐖ䛷䚸ዷፎ୰ᮇ䡚ᮎᮇ䛻ᢞ䛥䜜䛯ᝈ⪅䛻⫾ඣ䞉᪂⏕ඣṚ ஸ䚸⨺Ỉ㐣ᑡ䚸⫾ඣ䞉᪂⏕ඣ䛾ప⾑ᅽ䚸⭈䚸㧗䜹䝸䜴䝮⾑䚸㢌䛾ᙧᡂ䚸⨺Ỉ 㐣ᑡ䛻䜘䜛䛸᥎ 䛥䜜䜛ᅄ⫥䛾ᣊ⦰䚸⬻䚸㢌㢦㠃䛾ወᙧ䚸⫵䛾Ⓨ⫱ᙧᡂ➼䛜䛒䜙 䜟䜜䛯䛸䛾ሗ࿌䛜䛒䜛䚹 䜎䛯䚸ᾏእ䛷ᐇ䛥䜜䛯䜰䞁䝆䜸䝔䞁䝅䞁ኚ㓝⣲㜼ᐖ䛻䛚䛡䜛 䝺䝖䝻䝇䝨䜽䝔䜱䝤䛺Ꮫㄪᰝ䛷䚸ዷፎึᮇ䛻䜰䞁䝆䜸䝔䞁䝅䞁ኚ㓝⣲㜼ᐖ䜢ᢞ䛥䜜䛯 ᝈ⪅⩌䛻䛚䛔䛶䚸⫾ඣወᙧ䛾┦ᑐ䝸䝇䜽䛿㝆ᅽ䛜ᢞ䛥䜜䛶䛔䛺䛔ᝈ⪅⩌䛻ẚ䜉㧗䛛䛳 䛯䛸䛾ሗ࿌䛜䛒䜛䚹䛋 ARBཬ䜃ACE㜼ᐖ䛻㛵䛩䜛䛭䛾䛾ὀព㡯䛿䚸ྛ་⸆ရ䛾ῧᩥ᭩ཪ䛿PMDA䛾䝩䞊䝮䝨䞊䝆 䠄http://www.pmda.go.jp䠅䛾ῧᩥ᭩ሗ䠄་⒪⏝་⸆ရ䠅䛛䜙᳨⣴䛾ୖ䛤☜ㄆ䛟䛰䛥䛔䚹 䛂௦⾲ⓗ䛺䛃 1㸸⿕⸆ࣂࣝࢧࣝࢱࣥ/࣒ࣟࢪࣆࣥ࣋ࢩࣝ㓟ሷ ᛶู ᖺ㱋 ⏝⌮⏤ 㸦ྜే㸧 ẕ㸸 30ṓ௦ ฟ⏕ඣ㸸 ⏨ඣ 㧗⾑ᅽ 㸦⫧‶㸧 స⏝ 1 ᪥ᢞ㔞 (ᢞᮇ㛫) ⤒㐣ཬࡧฎ⨨ ࣂࣝࢧࣝࢱࣥ ẕ㸸⨺Ỉ㐣ᑡࠊዷፎ37㐌ᮍ‶ࡢ๓ᮇ◚Ỉࠊ᪩⏘ 80mg/࣒ࣟ ฟ⏕ඣ㸸᪩⏘ඣࠊ㢌ෙపᙧᡂࠊ⭈ᒀ⣽⟶㞀ᐖࠊపฟ⏕య㔜ඣ ࢪࣆࣥ5mg ᢞ㛤ጞ᪥ ᝈඣࡢẕࡣࠊ㧗⾑ᅽࡢ⒪ࡢࡓࡵࠊࣂࣝࢧࣝࢱࣥ/࣒ࣟ 㸦᫂㸧 㸦᫂᪥㸧 ࢪࣆࣥ࣋ࢩࣝ㓟ሷ㸦௨ୗࠕᮏࠖ㸧ࡢෆ᭹ࢆ㛤ጞࠋ 㸦ዷፎṔ㸸1ᅇࠊฟ⏘Ṕ㸸1ᅇࠊႚ↮Ṕ㸸᭷ࠊࣝࢥ࣮ࣝ 㸸↓ࠊ㑊ዷ⸆㸸᫂㸧 ᢞ୰Ṇ᪥ 㸦ዷፎ24㐌┦ᙜ㸧 ୰Ṇ1᪥ᚋ ዷፎᛂ㝧ᛶࡢࡓࡵ๓་ཷデࠋዷፎ24㐌┦ᙜ࡛↓⨺Ỉࡢ ≧ែࠊᮏࡢෆ᭹ࢆ୰Ṇࠋ ᙜ㝔⤂࡞ࡿࠋ ୰Ṇ8᪥ᚋ 㸦ዷፎ25㐌┦ᙜ㸧 ⫾ඣࡢ⭤⬔ࡣ☜ㄆࡉࢀࡿࡀࠊ⨺Ỉ࡞ࡋࠋ ୰Ṇ29᪥ᚋ 㸦ዷፎ28㐌┦ᙜ㸧 ⨺Ỉ㔞ࡣṇᖖ⠊ᅖࡲ࡛ᅇࠋ ୰Ṇ52᪥ᚋ 㸦ዷፎ31㐌┦ᙜ㸧 ◚Ỉࠊ㝕③Ⓨ᮶ࠋ๓ᅇᖇ⋤ษ㛤ࡢࡓࡵࠊ⥭ᛴᖇ⋤ษ㛤ࠋ ᪂⏕ඣᡤぢ㸸 ᛶู㸸⏨ ㌟㛗㸸40.5cmࠊయ㔜㸸1700g apgar score㸸1ศᚋ 6ࠊ5ศᚋ 9 ඛኳ␗ᖖ㸸᭷㸦㢌పᙧᡂࠊ⭈ᒀ⣽⟶㞀ᐖ㸧 ඛኳ␗ᖖ௨እࡢ␗ᖖ㸸᭷㸦㯤⑇㸧 ⫵ࡢᙧᡂࡣ࡞ࡋࠋ ୰Ṇ 108 ᪥ᚋ 㸦ฟ⏕ 56 ᪥ᚋ㸧 ㌿ᖐ㸦ฟ⏕ඣ㸧㸸⏕Ꮡࠋ ే⏝⸆㸸࡞ࡋ 2/6 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ 2㸸⿕⸆ࢸ࣑ࣝࢧࣝࢱࣥ/ࣄࢻࣟࢡࣟࣟࢳࢪࢻ㓄ྜ ᛶู ᖺ㱋 ẕ㸸 40ṓ௦ ฟ⏕ඣ㸸 ⏨ඣ ⏝ ⌮⏤ 㸦ྜే㸧 㧗⾑ᅽ స⏝ 1 ᪥ᢞ㔞 (ᢞᮇ㛫) ⤒㐣ཬࡧฎ⨨ ࢸ࣑ࣝࢧࣝ ẕ㸸᪩⏘ࠊ⨺Ỉ㐣ᑡࠊ⫾ඣⓎ⫱㐜ᘏ ࢱࣥ40mg/ࣄ ฟ⏕ඣ㸸ప⾑ᅽࠊஈᒀࠊ⭈ᶵ⬟㞀ᐖࠊపฟ⏕య㔜ඣࠊᒀ⣽⟶ᛶࢩࢻ࣮ࢩࢫ ࢻࣟࢡࣟࣟ ᢞ⣙4ᖺ๓ 㧗⾑ᅽデ᩿ࡉࢀࡓࡀᨺ⨨ࠋ ࢳࢪࢻ ᢞ⣙8࢝᭶๓ ᒀ⺮ⓑ㝧ᛶࡀㄆࡵࡽࢀࡓࡀᨺ⨨ࠋ 12.5mg ศፔᙜ᪥ࡲ࡛ዷፎẼࡎ࠸ࡓࠋ 㸦34 ᪥㛫㸧 ᢞ㛤ጞ᪥ 㧗⾑ᅽࡢ⒪ࡢࡓࡵࠊࢸ࣑ࣝࢧࣝࢱࣥ/ࣄࢻࣟࢡࣟࣟࢳࢪ 㸦ዷፎ25㐌┦ᙜ㸧 ࢻ㓄ྜ㸦௨ୗࠕᮏࠖ㸧ࡀฎ᪉ࡉࢀࠊዷፎẼࡎࠊ ᝈඣࡢẕࡣࠊᮏࡢෆ᭹ࢆ㛤ጞࠋ ᪥᫂ ⫾ඣⓎ⫱ࢆⓎ⌧ࠋ ᢞ୰Ṇ᪥ 㸦ᢞ34᪥ᚋ㸧 㸦ዷፎ30㐌┦ᙜ㸧 ⭈㞀ᐖࡢ⢭ᰝ┠ⓗ࡛A 㝔ࢆཷデࠋࡇࡢዷፎࡀุ᫂ࡋࠊ ྠ᪥B 㝔ᦙ㏦ࡉࢀࡓࠋ᭱⤊᭶⤒ࡣ᫂(⣙7ࣧ᭶๓᥎ ᐃ)࡛ࠊ34 㐌๓ᚋ⪃࠼ࡽࢀࠊ⫾ඣࡢ᥎ᐃయ㔜ࡀ1500g ࡽ30 㐌┦ᙜุ᩿ࡉࢀࡓࠋ⨺Ỉ㐣ᑡࡀㄆࡵࡽࢀࡓࠋ⦰ᮇ ⾑ᅽࡣ190㹼200mmHg ࡛࠶ࡗࡓࠋ⨺Ỉ⭍ࢇ࡞ࡃࠊࣔࢽ ࢱ࣮ୖSevere variable deceleration ࢆ㢖ᅇㄆࡵࡓࡓ ࡵࠊ⥭ᛴᖇ⋤ษ㛤ࡀ⾜ࢃࢀࡓࠋ17:48 ฟ⏘(᪩⏘)ࠋ ᪂⏕ඣᡤぢ㸸 ᛶู㸸⏨ ㌟㛗㸸39.9cmࠊయ㔜㸸1400g 㸦ᴟపฟ⏕య㔜ඣ㸧 ඛኳ␗ᖖࠊඛኳ␗ᖖ௨እࡢ␗ᖖ㸸᭷ ప⾑ᅽ㸦ᖹᆒBP40mmHg ྎ㸧ࠊ↓ᒀࠊ⭈≧ែࡀ⥆࠸ ࡓࠋ ୰Ṇ 1 ᪥ᚋ 㸦ฟ⏕ 1 ᪥ᚋ㸧 02:35 ฟ⏕ඣࢻࣃ࣑ࣥሷ㓟ሷࡢᢞࢆ㛤ጞࠋ ௨㝆ࡶࠊ࢝ࢸࢥ࣑ࣛࣥᛂࡀஈࡋࡃప⾑ᅽࡀ⥆ࡁࠊஈᒀ ࡀㄆࡵࡽࢀࡓࠋ ୰Ṇ 2 ᪥ᚋ 㸦ฟ⏕ 2 ᪥ᚋ㸧 15:00 ฟ⏕ඣࡢஈᒀᑐࡋࣇࣟࢭ࣑ࢻ1.5mgࡀ㟼⬦ෆᢞ ࡉࢀࡓࡀᅇࡏࡎࠊ௨㝆ࡶࢻࣃ࣑ࣥሷ㓟ሷࢆ㐺ᐅቑῶࡋࠊ ⾑ᅽࡀࢥࣥࢺ࣮ࣟࣝࡉࢀࡓࠋ ୰Ṇ 5 ᪥ᚋ 㸦ฟ⏕ 5 ᪥ᚋ㸧 ฟ⏕ඣࡢᒀ㔞ࡀᑡࡋࡎࡘᚓࡽࢀࡣࡌࡵࠊࢻࣃ࣑ࣥሷ㓟ሷࢆ ῶ㔞ࠋ ୰Ṇ 6 ᪥ᚋ 㸦ฟ⏕ 6 ᪥ᚋ㸧 ฟ⏕ඣࡢஈᒀࡣ㍍ᛌࡋࡓࠋ ୰Ṇ 9 ᪥ᚋ 㸦ฟ⏕ 9 ᪥ᚋ㸧 ฟ⏕ඣࢻࣃ࣑ࣥሷ㓟ሷ3Țࢆᢞࠋᒀ㔞ࡣቑࡋࡓࡀࠊ⾑ Ύࢡࣞࢳࢽࣥ7.01mg/dLࠊᒀ㓟12.5mg/dL㧗ᗘ⭈ᶵ⬟㞀 ᐖࡢ≧ែࡀ⥆࠸࡚࠸ࡓࠋ ୰Ṇ 11 ᪥ᚋ 㸦ฟ⏕ 11 ᪥ᚋ㸧 ฟ⏕ඣࡢప⾑ᅽࡣ㍍ᛌࡋࡓࠋ ฟ⏕ඣᒀ⣽⟶ᛶࢩࢻ࣮ࢩࢫࡀⓎ⌧ࠋ ᪥᫂ ୰Ṇ 40 ᪥ᚋ 㸦ฟ⏕ 40 ᪥ᚋ㸧 ฟ⏕ඣࡢ⾑Ύࢡࣞࢳࢽࣥࡣపୗഴྥ࠶ࡗࡓࡀࠊ௦ㅰᛶ ࢩࢻ࣮ࢩࢫࡀṧᏑࡋࠊⅣ㓟Ỉ⣲Naࡢᢞࢆ㛤ጞࠋ ୰Ṇ 62 ᪥ᚋ 㸦ฟ⏕ 62 ᪥ᚋ㸧 ฟ⏕ඣ㏥㝔ࠋฟ⏕ඣࡢ㍍ᗘ⭈ᶵ⬟㞀ᐖࠊᒀ⣽⟶ᛶࢩࢻ࣮ ࢩࢫࡣࠊእ᮶࡛⤒㐣ほᐹࠋ ే⏝⸆㸸࣒ࣟࢪࣆࣥ࣋ࢩࣝ㓟ሷࠊ࢝ࣝ࣎ࢩࢫࢸࣥࠊ㯏㛛 3/6 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp 3㸸⿕⸆࢝ࣥࢹࢧࣝࢱࣥ ᛶู ᖺ㱋 ⏝ ⌮⏤ 㸦ྜే㸧 ẕ㸸 30ṓ௦ ฟ⏕ඣ㸸 ዪඣ ᮏែᛶ 㧗⾑ᅽ No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ ࢩࣞ࢟ࢭࢳࣝ స⏝ 1 ᪥ᢞ㔞 (ᢞᮇ㛫) 12mg 㸦᫂㸧 ⤒㐣ཬࡧฎ⨨ ẕ㸸⨺Ỉ㐣ᑡ ฟ⏕ඣ㸸⫾ඣ⭈ࠊ୍㐣ᛶࡢఙᒎ㞀ᐖ㸦ᅄ⫥㸧 ᢞ㛤ጞ᪥ 㸦3ᖺ๓㸧 ᝈඣࡢẕࡣࠊᮏែᛶ㧗⾑ᅽࡢ⒪ࡢࡓࡵࠊ࢝ࣥࢹࢧࣝࢱ ࣥ ࢩࣞ࢟ࢭࢳࣝ㸦௨ୗࠕᮏࠖ 㸧ࡢෆ᭹ࢆ㛤ጞࠋ ዷፎึᮇࡽ㏆་⏘፬ே⛉࡚ዷፎ⟶⌮ࡀ⾜ࢃࢀࡓࠋ ៏ᛶ㧗⾑ᅽྜేዷፎࡢデ᩿࡛ࠊᮏෆ᭹ࢆ⥅⥆ࡋࠊ⾑ᅽ ࡣ 140/90mmHg ᮍ‶࡛⤒㐣ࡋࡓࠋ ᢞ୰Ṇ᪥ 㸦ዷፎ30㐌2᪥㸧 ዷ፬デ⨺Ỉ㐣ᑡࢆㄆࡵࡓࡓࡵࠊ࿘⏘ᮇࢭࣥࢱ࣮ ࢆ᭷ࡍࡿタᦙ㏦ࡉࢀࡓࠋࡑࢀ௨๓ࠊ⨺Ỉ㔞ࡣ ᐃ ࡉࢀ࡚࠸࡞ࡗࡓࠋ᮶㝔ࡢ⾑ᅽࡣ 145/88mmHg ࡛ᒀ⺮ ⓑࡣ㝜ᛶ࡛࠶ࡗࡓࠋデᐹୖࠊ◚Ỉࡣྰᐃⓗ࡛࠶ࡗࡓࠋ ᥎ᐃయ㔜 1363g 㐌ᩘ┦ᙜ࡛࠶ࡗࡓࡀࠊ⨺Ỉᣦᩘ (AFI)㸸0cm ࡛࠶ࡗࡓࠋ୧ഃࡢ⭈⮚ᙧែⓗ࡞␗ᖖࡣㄆ ࡵ࡞ࡗࡓࡀࠊ」ᩘᅇࢃࡓࡿほᐹ࡛ࡶ⭤⬔ෆᒀࡢ ㈓␃ࢆㄆࡵ࡞ࡗࡓࠋ⬚㒌ࡣ࣋ࣝᆺ࡛ࡣ࡞࠸ࡀࠊ⬚㒌 ࿘ᅖ㛗/⭡ᅖẚ㸸0.74 ㍍ᗘࡢ⫵పᙧᡂࡀ♧၀ࡉࢀࡓࠋ ࡑࡢࡢ⮚ჾࡢᙧែ␗ᖖࡣㄆࡵ࡞ࡗࡓࠋ ARB ࡼࡿ⫾ඣ⭈ࡽ⨺Ỉ㐣ᑡ࡞ࡗࡓุ᩿ࡋࠊ ᮏࢆ୰Ṇࡋࠊ࣓ࢳࣝࢻࣃኚ᭦ࡋࡓࠋ ୰Ṇ5᪥ᚋ 㸦ዷፎ31㐌0᪥㸧 ᮏ୰Ṇࡽ 5 ᪥ᚋࡣࠊ⭤⬔ෆᒀࡢ㈓␃ࢆㄆࡵࡓࠋ ୰Ṇ 9 ᪥ᚋ 㸦ዷፎ 31 㐌 4 ᪥㸧 ᮏ୰Ṇࡽ 9 ᪥ᚋࡣࠊAFI㸸2.3cm ⨺Ỉࡢ㈓␃ ࢆㄆࡵࡓࠋ ࡑࡢᚋࠊ⨺Ỉࡣῶᑡࡍࡿࡇ࡞ࡃࠊAFI㸸3-6cm ࡛⤒㐣 ࡋࡓࠋ ධ㝔ࡢ⫾ඣᚰᢿᩘᇶ⥺ࡣ 160bpm ṇᖖୖ㝈࡛ᇶ⥺⣽ ኚືࡣஈࡋࡃࠊ୍㐣ᛶ㢖⬦ࡣࡲࡗࡓࡃㄆࡵ࡞ࡗࡓ ࡀࠊෆ᭹୰Ṇ 1 㐌㛫ᚋࡣ 140bpm ࡞ࡾࠊ୍㐣ᛶ㢖⬦ ࢆ㢖ᅇㄆࡵࡿࡼ࠺࡞ࡗࡓࠋẕయࡣ࣓ࢳࣝࢻࣃኚ ᭦ᚋࡶ⾑ᅽࡢୖ᪼ࡣㄆࡵ࡞ࡗࡓࠋ ୰Ṇ 42 ᪥ᚋ 㸦ዷፎ 36 㐌 2 ᪥㸧 ๓ᮇ◚Ỉࡢࡓࡵࠊ࢜࢟ࢩࢺࢩ࡛ࣥ㝕③ㄏⓎࢆ⾜࠸ࠊ⤒ ⭼ศፔ࡞ࡗࡓࠋ ᪂⏕ඣᡤぢ㸸 ᛶู㸸ዪ ㌟㛗㸸40.5cmࠊయ㔜㸸2416g apgar score㸸1 ศ 8 Ⅼࠊ5 ศ 8 Ⅼ ᖏື⬦⾑ pH ್㸸7.305 ඛኳ␗ᖖࠊඛኳ␗ᖖ௨እࡢ␗ᖖ㸸᭷ ศፔ㔝࡛ၷἽࢆㄆࡵࠊ᫂ࡽ࡞྾㞀ᐖࡣㄆࡵࡎࠊ⬚ 㒊ࣞࣥࢺࢤࣥୖࡶ⬚㒌ࡢపᙧᡂࡣㄆࡵ࡞ࡗࡓࠋ㢌 㦵ࡢపᙧᡂࡣㄆࡵ࡞ࡗࡓࡀࠊᅄ⫥୍㐣ᛶࡢ㍍ᗘࡢ ఙᒎ㞀ᐖࢆㄆࡵࡓࠋ ฟ⏕6㛫ᚋࡽᒀὶฟࢆㄆࡵࠊ⾑Ύࢡࣞࢳࢽࣥࡣᇶ ‽⠊ᅖෆ࡛ࠊᒀ୰ș2-microglobulinࡣ㍍ᗘୖ᪼ࡋ࡚࠸ ࡓࠋ ㉸㡢Ἴ࡛ࡣ⭈ࡢᙧែ␗ᖖࡣㄆࡵ࡞ࡗࡓࡀࠊ㍤ᗘࡢୖ ᪼ࢆㄆࡵࡓࠋ ే⏝⸆㸸᫂ 4/6 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ 䖂ARBཬ䜃㓄ྜ䠄ARB䜢ྵ䜐䜒䛾䠅䠖ዷ፬䜈䛾ᢞ䛻䜘䜛ዷ፬ཪ䛿⫾ඣ䜈䛾 ᙳ㡪䛜䜟䜜䜛స⏝ 䠄ᖹᡂ23ᖺᗘ䡚25ᖺᗘ䛻PMDA䜈ሗ࿌䛥䜜䛯䜒䛾䠅 2558௳ స⏝䛾✀㢮 ዷፎ䚸⏘〟䛚䜘䜃࿘⏘ᮇ䛾≧ែ 䛆ዷ፬䛇 እ⛉ⓗฎ⨨ స⏝ྡ ⨺Ỉ㐣ᑡ ᪩⏘ ⫾ඣⓎ⫱㐜ᘏ ዷፎ䠏䠓㐌ᮍ‶䛾๓ᮇ◚Ỉ ศፔ㛤ጞษ㏕ Ꮚ⒯๓ ⨺Ỉ㐣ከ Ꮚᐑ㢁⟶ᣑᙇ䛚䜘䜃Ꮚᐑෆᐜ≀㝖ཤ స⏝䛾✀㢮 స⏝ྡ ඛኳᛶ䚸ᐙ᪘ᛶ䛚䜘䜃㑇ఏᛶ㞀ᐖ ᪩⏘ඣ ⫾ඣṚஸ 䛆⫾ඣ / 㦵ᙧᡂ ᪂⏕ඣ䛇 ⫵పᙧᡂ ⫘㦵ᙧᡂ 䝫䝑䝍䞊ೃ⩌ పฟ⏕య㔜ඣ ඛኳᛶ㢌㒊Ḟᦆ 㢌ෙపᙧᡂ ཱྀ၁ཱྀ ᣦ⠇㦵ᙧᡂ ື⬦⟶㛤Ꮡ ⫾ඣወᙧ ඛኳᛶᄞ⬊ᛶ⭈ᝈ ඛኳ␗ᖖ ⭈䛚䜘䜃ᒀ㊰㞀ᐖ ᪂⏕ඣ⭈ ⭈ᶵ⬟㞀ᐖ ⭈ ⭈ᒀ⣽⟶㞀ᐖ ⭈ᒀ⣽⟶ᛶ䜰䝅䝗䞊䝅䝇 ஈᒀ ྾ჾ⣔㞀ᐖ ᪂⏕ඣ௬Ṛ ྾ ➽㦵᱁⣔㞀ᐖ 㛵⠇ᣊ⦰ ᚠ⎔ჾ⣔㞀ᐖ ప⾑ᅽ ⚄⤒⣔㞀ᐖ 䛶䜣䛛䜣 ⫈ぬ㞀ᐖ ⫈ぬ㞀ᐖ ௳ᩘ 9 2 2 1 1 1 1 1 ௳ᩘ 4 2 2 2 2 2 2 1 1 1 1 1 1 1 1 4 2 1 1 1 1 1 1 1 1 1 1 䖂ACE㜼ᐖ䠖ዷ፬䜈䛾ᢞ䛻䜘䜛ዷ፬ཪ䛿⫾ඣ䜈䛾ᙳ㡪䛜䜟䜜䜛స⏝ 䠄 ᖹᡂ23ᖺᗘ䡚25ᖺᗘ䛻PMDA䜈ሗ࿌䛥䜜䛯䜒䛾䠅 35௳ 䛆ዷ፬䛇 స⏝䛾✀㢮 ዷፎ䚸⏘〟䛚䜘䜃࿘⏘ᮇ䛾≧ែ 䛆⫾ඣ / స⏝䛾✀㢮 ᪂⏕ඣ䛇 ඛኳᛶ䚸ᐙ᪘ᛶ䛚䜘䜃㑇ఏᛶ㞀ᐖ ⭈䛚䜘䜃ᒀ㊰㞀ᐖ 5/6 స⏝ྡ ⨺Ỉ㐣ᑡ ௳ᩘ 1 స⏝ྡ ⭈↓ᙧᡂ ඛኳᛶᄞ⬊ᛶ⭈ᝈ ⭈ ⭈⭘ ௳ᩘ 1 1 1 1 䕔 ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ 䠬䠩䠠䠝 䛛䜙䛾་⸆ရ㐺ṇ⏝䛾䛚㢪䛔 http://www.pmda.go.jp No.䠍䠌 䠎䠌䠍䠐ᖺ䠕᭶ ஜ ᢰ ư ১ ᛐ ƞ Ǖ Ư ƍ ǔ A R B ӏ Ƽ A C E᧹ ܹ д ɟᑍӸ ǢǸȫǵȫǿȳ Ǥȫșǵȫǿȳ ARB Ǫȫȡǵȫǿȳȡȉǭǽ ȟȫ ǫȳȇǵȫǿȳǷȬǭǻ ȁȫ Ȇȫȟǵȫǿȳ Ȑȫǵȫǿȳ ȭǵȫǿȳǫȪǦȠ ɟᑍӸ ᝤ٥Ӹ ǢǸȫȐ ǢȐȗȭŴ Ǥȫșǿȳ ǪȫȡȆȃǯ ȖȭȗȬǹ ˂ ȟǫȫȇǣǹ ȇǣǪȐȳ ˂ ȋȥȸȭǿȳ ˂ ǢǸȫǵȫǿȳȷǢȠȭ Ƕǯȩǹ ǸȔȳșǷȫᣠط ǤȫșǵȫǿȳȷǢȠȭ ǢǤȟǯǹ ǸȔȳșǷȫᣠط ǤȫșǵȫǿȳȷȈȪǯ ǤȫȈȩ ȭȫȡȁǢǸȉ Ǫȫȡǵȫǿȳȡȉǭǽ ȬǶȫǿǹ ȟȫȷǢǼȫȋǸȔȳ ǫȳȇǵȫǿȳǷȬǭǻ ȁȫȷǢȠȭǸȔȳșǷ ȦȋǷǢ ȫᣠط ǫȳȇǵȫǿȳǷȬǭǻ ᣐӳд ȁȫȷȒȉȭǯȭȭȁǢ Ǩǫȸȉ ᲢARBǛ Ǹȉ ԃljNjƷᲣ ȆȫȟǵȫǿȳȷǢȠȭ ȟǫȠȭ ǸȔȳșǷȫᣠط ȆȫȟǵȫǿȳȷȒȉȭ ȟdzȳȓ ǯȭȭȁǢǸȉ ȐȫǵȫǿȳȷǢȠȭǸ ǨȃǯǹȕǩȸǸ ȔȳșǷȫᣠط ȐȫǵȫǿȳȷǷȫȋǸ ǢȆȇǣǪ Ȕȳ ȐȫǵȫǿȳȷȒȉȭǯ dzȇǣǪ ȭȭȁǢǸȉ ȭǵȫǿȳǫȪǦȠȷȒ ȗȬȟȍȳȈ ˂ ȉȭǯȭȭȁǢǸȉ ǢȩǻȗȪȫ ᝤ٥Ӹ ǻǿȗȪȫ ˂ ǤȟȀȗȪȫطᣠط ǿȊȈȪȫ ˂ ǨȊȩȗȪȫȞȬǤ ȳᣠط Ȭȋșȸǹ ˂ ǫȗȈȗȪȫ ǫȗȈȪȫ ˂ ǭȊȗȪȫطᣠط dzȊȳ ǷȩǶȗȪȫ൦ԧཋ ǤȳȒșȸǹ ˂ ACE ȆȢǫȗȪȫطᣠط Ǩȸǹdzȸȫ ˂ ᧹ܹд ȇȩȗȪȫطᣠط ǢȇǫȃȈ ȈȩȳȉȩȗȪȫ ȗȬȩȳŴ ǪȉȪȃǯ ˂ șȊǼȗȪȫطᣠط ȁȐǻȳ ˂ ȚȪȳȉȗȪȫǨȫ Ȗȟȳ dzȐǷȫ ˂ ȪǷȎȗȪȫ൦ԧཋ ǼǹȈȪȫŴ ȭȳDzǹ ˂ ᕤƷࢨ᪪Ǜ࣎ᣐƢǔࣱڡƴݣƠŴ۔کƱ ᕤऴإǻȳǿȸưႻᛩƴࣖơƯƍLJƢŵ धᎍƞǜƕƞǒƴᛇƠƍᛟଢǛࠎஓƞǕ ƨئӳƴƸŴ۔کƱᕤऴإǻȳǿȸǛƝ ኰʼƘƩƞƍŵ ģ۔کƱᕤऴإǻȳǿȸĤ ᲢᇌᏋҔၲᄂᆮǻȳǿȸᲣ http://www.ncchd.go.jp/kusuri/ ஜ ऴ إƷ သ ॖໜ ᲤžPMDAƔǒƷҔᕤԼᢘദ̅ဇƷƓᫍƍſƸŴᕤʙඥƴؕƮƖإԓƞǕƨи˺ဇज़௨ၐၐ̊ሁƷɶƔ ǒŴ ଏƴช˄૨ሁưදॖնឪƠƯƍǔNjƷƷŴӷಮƷإԓƷถݲƕᙸǒǕƳƍʙ̊ƳƲƴƭƍƯŴ ҔᕤԼƷᢘദ̅ဇਖ਼ᡶƷᚇໜƔǒҔၲ᧙̞ᎍƴǑǓЎƔǓǍƢƍ࢟ưऴإ੩̓ǛᘍƏNjƷưƢŵ ᲤƜƷऴإƷ˺ƴ࢘ƨǓŴ˺ƴƓƚǔദᄩࣱƴƭƍƯƸɢμǛƠƯƓǓLJƢƕŴƦƷϋܾǛݩ ஹƴǘƨǓ̬ᚰƢǔNjƷưƸƋǓLJƤǜŵ ᲤƜƷऴإƸŴҔၲࢼʙᎍƷᘶǛСᨂƠƨǓŴҔၲࢼʙᎍƴ፯ѦǍᝧ˓ǛᛢƢNjƷưƸƳƘŴҔᕤԼ Ʒᢘദ̅ဇǛਖ਼ᡶƢǔƨNJƷऴإƱƠƯ˺ƠƨNjƷưƢŵ ႆᘍᎍ Ჴ ᇌᘍඥʴ TEL. 03-3506-9435ᲢȀǤȤȫǤȳᲣ ƓբӳǘƤέ ܤμᇹʚᢿ ҔᕤԼҔၲೞ֥ዮӳೞನ FAX. 03-3506-9441 http://www.pmda.go.jp 6/6
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