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ӳޠڭҭݚڀͰΤϏσϯεΛʮͭ͘Δʯɿ ϝλ෼ੳɺ࠶ݱੑɺ௥ࢼ Ӝ໺ ݚʢ๺ւֶԂେֶʣ email: [email protected] JACET๺ւಓࢧ෦2021೥౓ୈ2ճࢧ෦ݚڀձ ɹɹ2022. 3. 8. https://www.urano-ken.com/research/jacethokkaido2022

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ΤϏσϯε • ʮΤϏσϯεʯͷଟٛੑ • จ຺ʹΑΔҧ͍ • ྺ࢙తมભ

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ΤϏσϯε • ʮࠜڌʯ΍ʮূڌʯͱݴΘͣʮΤϏσϯεʯ ͱݴ͏ཧ༝

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ΤϏσϯε • ݚڀऀ͕ʮΤϏσϯεʯΛ࢖͏ࡍʹ͸ͦͷ 
 ఆٛΛҙࣝ͢΂͖ • ΤϏσϯεʹج͍ͮͨʓʓ • ΤϏσϯεɾϕʔεͷʓʓ

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ΤϏσϯε • ݯྲྀ͸ΤϏσϯεʹجͮ͘ҩྍ 
 evidence-based medicine (EBM)

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ΤϏσϯεͷఆٛ • EBM ౳ʹ͓͚ΔΤϏσϯεͱ͸ • ࣮ূ͞ΕͨҼՌޮՌͰ • ͦͷ͔֬Β͕֨͠͞෇͚͞ΕΔ

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ҼՌޮՌͱ͸ • σʔλ͔Βಋ͖ग़͢͜ͱͷͰ͖Δ 
 ݪҼ͕݁Ռʹٴ΅͢ޮՌʢͷڧ͞ʣ

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ҼՌޮՌͱ͸ • Aͱ͍͏ࢦಋΛडֶ͚ͨशऀͷ 
 Bͱ͍͏ςετͷ੒੷͕C޲্ͨ͠ • A: ॲ۰ɾհೖʢઆ໌ม਺ɾಠཱม਺ʣ • B: ݁Ռʢ݁Ռม਺ɾैଐม਺ʣ • C: ޮՌ

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ΤϏσϯεͷ֨෇͚ ΤϏσϯεͷ಺༰ Lv. 1ʢ্૚ʣ ϥϯμϜԽൺֱࢼݧʢRCTʣͷγεςϚςΟοΫɾϨϏϡʔ Lv. 2 ݸʑͷRCTʗܶతͳޮՌΛࣔͨ͠؍࡯ݚڀ Lv. 3 ࣮ݧ܈ɾඇ࣮ݧ܈ΛϥϯμϜʹׂΓ౰͍ͯͯͳ͍ൺֱݚڀ Lv. 4 ঱ྫΛूΊͯൺֱͨ͠ݚڀ Lv. 5ʢԼ૚ʣ ࣮ݧɾௐࠪσʔλແ͠ͷɺֶཧʹجͮ͘ਪ࿦ ΤϏσϯε֊૚ͷྫ ࿱ཧଞ (2021, p. 35)

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ϥϯμϜԽൺֱࢼݧ • Randomized controlled trial (RCT) • ඃݧऀΛ • ॲ۰Λ༩͑Δάϧʔϓʢ࣮ݧ܈ʣͱ • ༩͑ͳ͍άϧʔϓʢ౷੍܈ʣʹ • ϥϯμϜʢແ࡞ҝʣʹׂΓ౰ͯΔ

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ϥϯμϜԽൺֱࢼݧ • ϥϯμϜԽ͢Δ͜ͱͰୈ̏ͷม਺΍ 
 ະ஌ͷཁҼͷӨڹΛ૬ࡴͰ͖Δ • ҩྍͰ͸͞Βʹݫີʹೋॏ໡ݕ๏ 
 ʢdouble-blind trialʣΛ༻͍Δ

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ϥϯμϜԽൺֱࢼݧ • ӳޠڭҭݚڀʹ͓͚Δୈ̏ͷม਺ͷྫ • ࢦಋ͢Δڭࢣͷҧ͍ɺֶशऀݸਓݸਓͷ 
 ಛੑɺतۀͷ༵೔ɾ࣌ؒɺ etc.

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ΤϏσϯεͷ֨෇͚ ΤϏσϯεͷ಺༰ Lv. 1ʢ্૚ʣ ϥϯμϜԽൺֱࢼݧʢRCTʣͷγεςϚςΟοΫɾϨϏϡʔ Lv. 2 ݸʑͷRCTʗܶతͳޮՌΛࣔͨ͠؍࡯ݚڀ Lv. 3 ࣮ݧ܈ɾඇ࣮ݧ܈ΛϥϯμϜʹׂΓ౰͍ͯͯͳ͍ൺֱݚڀ Lv. 4 ঱ྫΛूΊͯൺֱͨ͠ݚڀ Lv. 5ʢԼ૚ʣ ࣮ݧɾௐࠪσʔλແ͠ͷɺֶཧʹجͮ͘ਪ࿦ ΤϏσϯε֊૚ͷྫ ࿱ཧଞ (2021, p. 35)

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• RCT Λ౷߹ͨ͠΋ͷ͕࠷ॏࢹ͞ΕΔ • ݸʑͷ RCT ͕࣍ʹॏࢹ͞ΕΔ • RCT Ͱͳ͍ൺֱݚڀ͕࣍ • ҼՌޮՌΛࣔ͞ͳ͍ݚڀ͸Ձ஋͕௿͍ • ࣮ূσʔλͷͳ͍΋ͷ͸͞Βʹ௿͍ ΤϏσϯεͷ֨෇͚

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• γεςϚςΟοΫɾϨϏϡʔ 
 systematic review • ݚڀͷݕࡧɾநग़ํ๏΍݁Ռͷ౷߹खॱ͕ ఆࣜԽ͞Ε໌ࣔ͞Εͨ΋ͷ • ݁ՌΛ౷ܭతʹ౷߹ͨ͠΋ͷΛ 
 ϝλ෼ੳʢmeta-analysisʣͱݺͿ ݚڀͷ౷߹

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1. ݚڀςʔϚͷઃఆ 2. จݙͷऩू 3. ऩूͨ͠จݙͷۛຯ 4. ෼ੳͱղऍ 5. ݚڀ݁Ռͷൃද ϝλ෼ੳͷखॱ ஛಺ɾਫຊʢ2014ʣ

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• Griesdale et al. (2009) • Intensive insulin therapy and mortality among critically ill patients: A meta-analysis including NICE-SUGAR study data. Canadian Medical Association Journal, 180, 821–827. ҩྍ෼໺ͷ࣮ྫ

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• ݚڀςʔϚͷઃఆ • ةಞঢ়ଶͷױऀʹର͢ΔΠϯεϦϯͷ 
 ूத౤༩ʢڧԽΠϯεϦϯྍ๏ʣ͕ 
 ਪ঑͞Ε͍ͯΔ • ͨͩ͠ɺ࠷ۙͷݚڀʹ͸ͦͷޮՌΛ 
 ൱ఆ͢Δ΋ͷ͕͋Δ ҩྍ෼໺ͷ࣮ྫ

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• ઌߦݚڀͷऩूͱۛຯ • Selection criteria 1. The study was a randomized controlled trial. 2. The study participants were adults. 3. A critical care setting was used. 4. The intensive insulin therapy was de fi ned by a target blood glucose concentration of 
 83 mmol/L or less. 5. The study documented mortality. ҩྍ෼໺ͷ࣮ྫ

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• ݁Ռ • ڧԽΠϯεϦϯྍ๏ʢIITʣͱࢮ๢཰ͷؔ܎ ҩྍ෼໺ͷ࣮ྫ

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• ݁Ռ • IIT ͸ɺ౷੍܈ͱൺ΂ͯࢮ๢཰ϦεΫʹ 
 มԽΛ΋ͨΒ͍ͯ͠ͳ͍ ҩྍ෼໺ͷ࣮ྫ

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• ݁࿦ • In our updated meta-analysis of randomized trials of intensive insulin therapy in critically ill patients, we found that such therapy had no e ff ect on the overall risk of death. ҩྍ෼໺ͷ࣮ྫ

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• ݁࿦ • Our fi ndings do not support the guidelines of organizations such as the American Diabetes Association, … and other organizations, … who recommend intensive insulin therapy for all critically ill patients. ҩྍ෼໺ͷ࣮ྫ

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• ݁࿦ • We suggest that policy-makers reconsider recommendations promoting the use of intensive insulin therapy in all critically ill patients. ҩྍ෼໺ͷ࣮ྫ

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• ݁࿦ͱͯ͠۩ମతͳఏҊ͕͞Ε͍ͯΔ • ͜Ε͕Մೳͳͷ͸࣏ྍ๏ʢಠཱม਺ʣͱࢮ๢ ཰ʢैଐม਺ʣ͕໌֬ʹఆٛ͞Ε͍ͯΔ͔Β ҩྍ෼໺ͷ࣮ྫ

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ͭ͘Δɾͭͨ͑Δɾ͔ͭ͏ • ΤϏσϯεΛʮͭ͘Δʯ • ࣭ͷΑ͍ʢ͔ͭ͑ΔʣΤϏσϯεΛఏڙ͢Δ • ΤϏσϯεΛʮ͔ͭ͏ʯ • ࣮຿ऀʢڭࢣɺҩࢣ౳ʣ͕ࢀߟʹ͢Δ • ΤϏσϯεΛʮͭͨ͑Δʯ • ݚڀऀͱ࣮຿ऀͷڮ౉͠Λ͢Δ

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ΤϏσϯεΛʮͭͨ͑Δʯ

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ΤϏσϯεΛʮͭͨ͑Δʯ • ίΫϥϯڞಉܭը • ྦྷੵϝλ෼ੳͷҰྫ • ৽͍͠ใࠂ͕ͰΔ౓ʹϝλɾΞφϦγεΛ܁Γฦ͠ 
 ͦͷ݁ՌΛਤ͍ࣔͯ͘͠ʢ୮ޙ, 2002, p. 16ʣ

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ΤϏσϯεΛʮͭͨ͑Δʯ Cochrane is an international network with headquarters in the UK, a registered not-for-pro fi t organization, and a member of the UK National Council for Voluntary Organizations. Cochrane is for anyone interested in using high-quality information to make health decisions. Whether you are a clinician, patient or carer, researcher, or policy-maker, Cochrane evidence provides a powerful tool to enhance your healthcare knowledge and decision-making. Cochrane’s members and supporters come from more than 220 countries, worldwide. We are researchers, health professionals, patients, carers, and people passionate about improving health outcomes for everyone, everywhere. Our global independent network gathers and summarizes the best evidence from research to help you make informed choices about treatment and we have been doing this for 28 years.

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ͭ͘Δɾͭͨ͑Δɾ͔ͭ͏ • ҩྍ෼໺Ͱ͸ɺΤϏσϯεΛʮͭ͘Δʯɺ 
 ʮͭͨ͑Δʯɺʮ͔ͭ͏ʯͱ͍͏ྲྀΕ͕Ͱ͖͍ͯΔ • ӳޠڭҭ෼໺͸Ͳ͏͔

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ӳޠڭҭͷΤϏσϯε • ࣭ͷΑ͍ΤϏσϯε͕ἧ͍ͬͯΕ͹ɺ • ڭҭ੓ࡦܾఆͷࢀߟʹͳΓ͏Δ • ݸʑͷڭࢣɾֶशऀʹΑΔࢦಋํ๏ɾ 
 ֶशํ๏બ୒ͷख͕͔ΓͱͳΓ͏Δ

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ӳޠڭҭͷΤϏσϯε • ࢒೦ͳ͕ΒɺΤϏσϯεΛʮ͔ͭ͏ʯஈ֊ʹ͸ 
 ͳ͍ͬͯͳ͍ • ʮͭͨ͑Δʯɺʮ͔ͭ͏ʯͨΊͷΤϏσϯε͕ 
 ἧ͍ͬͯͳ͍ • ࠓ͸ͻͨ͢ΒΤϏσϯεΛʮͭ͘Δʯஈ֊

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ΤϏσϯεΛʮͭ͘Δʯ • ࣭ͷߴ͍ΤϏσϯεΛͭ͘Δ͜ͱͷॏཁੑ • ϝλ෼ੳʹ࠾༻͞ΕΔݚڀΛ໨ࢦ͢

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࣭ͷߴ͍ΤϏσϯε • ݚڀ͢Δҙٛͷ͋Δ՝୊ΛબͿ • RCT ͕๬·͍͕͠ɺڭҭݚڀͰ͸೉͍͠ • ୅ସखஈͱͯ͠ɺڞมྔ΋ߟྀͨ͠ݚڀΛ • ҼՌޮՌΛ࣮ূ͢ΔσβΠϯΛ࠾༻͢Δ • ઌߦݚڀͱൺֱՄೳͳม਺Λ࠾༻͢Δ

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ҙٛͷ͋Δݚڀ՝୊ • ΤϏσϯεΛ࢖͏ଆ͕ٻΊΔ৘ใ͸ͳʹ͔ • ݚڀऀݸਓ͕͜ΕΛ൑அ͢Δͷ͸೉͍͔͠΋͠Εͳ͍ • ֶձ΍ՊݚϓϩδΣΫτɺେֶʢӃʣ౳ͷϨϕϧͰ 
 ݕ౼͢΂͖ʁ

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ڞมྔ • ैଐม਺ʢ݁Ռม਺ʣʹӨڹΛٴ΅͢Մೳੑͷ͋Δ 
 ಠཱม਺ʢઆ໌ม਺ʣҎ֎ͷཁҼͷ͜ͱ • RCT Ͱͳ͍ݚڀͰ͋Ε͹ݸʑͷݚڀͰ΋ࣄલʹ༧ଌ 
 ՄೳͳڞมྔΛ෼ੳʹՃ͑Δ͜ͱ͕Ͱ͖Δ • ϝλ෼ੳΛߦ͏ࡍʹௐ੔ม਺ͱͯ͠ܭࢉͰ͖Δ

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ҼՌޮՌͷ࣮ূ • RCT Ͱͳ͘ͱ΋ɺ࣮ݧ܈ʹՃ͑ͯඞͣඇ࣮ݧ܈ 
 ʢ౷੍܈΍ରর܈ʣΛઃఆ͢ΔʢΤϏσϯε֊૚Ͱ 
 ͍͏ Lv. 3ʣ • ඇ࣮ݧ܈ͷͳ͍ϓϨɾϙετɾσβΠϯͷݚڀ͸ 
 ΤϏσϯεͷ࣭͕௿͘ɺϝλ෼ੳ͔Βআ֎͞ΕΔ

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ൺֱՄೳͳม਺ • ैଐม਺ͱಠཱม਺ͷͲͪΒ͔·ͨ͸྆ํΛઌߦݚڀ 
 ͱൺֱՄೳͳ΋ͷʹ͢Δ • ҩྍ෼໺ͰΤϏσϯεͷ஝ੵ͕ਐΉͷ͸ɺม਺͕ 
 ݫີʹఆٛ͞Ε͍ͯΔ͔Β • ม਺Λἧ͑Δ͜ͱͰϝλ෼ੳ͕༰қʹͳΓɺͦͷ݁Ռ 
 ΑΓ۩ମతͳఏҊ͕ՄೳʹͳΔ • ௥ࢼʢreplicationʣͷॏཁੑ

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࣭ͷߴ͍ΤϏσϯε • ࣭ͷߴ͍ΤϏσϯεΛٻΊΔͱɺଟ͘ͷ৔߹ݚڀͷ 
 ಠ૑ੑ͕ࣦΘΕΔ • ֶձ΍δϟʔφϧ͸ಠ૑ੑΛա౓ʹٻΊΔ͜ͱΛ 
 ΍ΊΔ΂͖ • ֶձ΍δϟʔφϧ͸ੵۃతʹ௥ࢼΛਪ঑͢΂͖

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͓ΘΓʹ • ࠓ೔ͷ࿩͸ɺӳޠڭҭݚڀʹ͓͍ͯͳΜΒ͔ͷޮՌΛ 
 ଌఆ͍ͨ͠ݚڀऀʹ޲͚ͨ΋ͷͰ͢ • ͢΂ͯͷݚڀऀ͕͜͜Ͱ͍͏ʮ࣭ͷߴ͍ΤϏσϯεʯ Λͭ͘Δ͜ͱΛ໨ࢦ͢΂͖ͱ͸ߟ͍͑ͯ·ͤΜ • ΄͔ͷܗͰӳޠڭҭʹߩݙ͢Δํ๏΋͋Δͱࢥ͍·͢ • ͨͩ͠ɺ͍ΘΏΔޮՌΛଌఆ͢ΔݚڀΛߦ͏ࡍʹ͸ 
 ͜ͷϫʔΫγϣοϓͷ಺༰Λҙ͍͖͍ࣝͯͨͩͨ͠

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• ӳޠڭҭͷΤϏσϯεɿ͜Ε͔Β ͷӳޠڭҭݚڀͷͨΊʹʢݚڀ ࣾʣ • ࠓ೔࿩ͨ͜͠ͱʢҎ্ͷ͜ͱʣ͕ ॻ͔Ε͍ͯ·͢ ओͳࢀߟจݙ

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• ϝλɾΞφϦγεೖ໳ɿΤϏσϯ εͷ౷߹ΛΊ͟͢౷ܭख๏ 
 ʢே૔ॻళʣ • ҩྍ෼໺ͷϝλ෼ੳͷೖ໳ॻͰ͢ ओͳࢀߟจݙ

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• ϝλ෼ੳೖ໳ɿ৺ཧɾڭҭݚڀͷ ܥ౷తϨϏϡʔͷͨΊʹ 
 ʢ౦ژେֶग़൛ձʣ • ৺ཧɾڭҭ෼໺ͷೖ໳ॻͰ͢ ओͳࢀߟจݙ

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• ΤϏσϯεͷࣾձֶɿূݴͷফ໓ ͱਅཧͷݱࡏʢ੨౔ࣾʣ • ΤϏσϯε͕ͲͷΑ͏ʹͯ͠ݱࡏ ͷܗʹͳͬͨͷ͔ͷܦҢΛࣾձ ֶɺ఩ֶͷࢹ఺͔Βղઆ ओͳࢀߟจݙ

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• Replication research in applied linguistics (CUP). • ௥ࢼݚڀʹؔ͢Δ֓આॻͰ͢ ओͳࢀߟจݙ

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શମͷ·ͱΊ • ΤϏσϯεͷఆٛ • ҼՌޮՌͱΤϏσϯε֊૚ • ݚڀͷ౷߹ͱϝλ෼ੳ • ΤϏσϯεΛͭ͘Δɾͭͨ͑Δɾ͔ͭ͏ • ӳޠڭҭͷΤϏσϯε • ࣭ͷߴ͍ΤϏσϯεΛͭ͘Δ Ken Urano [email protected] https://www.urano-ken.com/research/jacethokkaido2022

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• Griesdale D. E., de Souza, R.J., van Dam, R. M., Heyland, D.K., Cook, D.J., Malhotra, A., Dhaliwal, R., Henderson, W. R., Chittock, D. R., Finfer, S., & Talmor, D. (2009). Intensive insulin therapy and mortality among critically ill patients: A meta-analysis including NICE-SUGAR study data. Canadian Medical Association Journal, 180(8), 821–827. https://doi.org/10.1503/cmaj.090206 • ஛಺ཧɾਫຊಞ (ฤ) (2014) ʰ֎ࠃޠڭҭݚڀϋϯυϒοΫɿݚڀख๏ͷΑΓྑ͍ཧղͷͨΊʹ ʦվగ൛ʧʱদദࣾ • ୮ޙढ़࿠ (2002) ʰϝλɾΞφϦγεೖ໳ɿΤϏσϯεͷ౷߹Λ໨ࢦ͢౷ܭख๏ʱே૔ॻళ • দଜҰࢤ (2021) ʰΤϏσϯεͷࣾձֶɾূݴͷফ໓ͱਅཧͷݱࡏʱ੨౔ࣾ • ࢁా߶࢙ɾҪ্ढ़࠸ (ฤ) (2012) ʰϝλ෼ੳೖ໳ɿ৺ཧɾڭҭݚڀͷܥ౷తϨϏϡʔͷͨΊʹʱ ౦ژେֶग़൛ձ • ࿱ཧཅҰɾ૲ಽ๜޿ɾࣉ୔୓ܟɾӜ໺ݚɾ޻౻༸࿏ɾञҪӳथ (2021) ʰӳޠڭҭͷΤϏσϯ εɿ͜Ε͔ΒͷӳޠڭҭݚڀͷͨΊʹʱݚڀࣾ Ҿ༻จݙ