᪥ᮏ⢾ᒀ⑓Ꮫ఍㹁㹍㹇㛤♧⢾ᒀ⑓἞⒪䛾ཎ๎䜢᫂䜙䛛䛻䛧䛯QOL ᐃ䠊་⒪⤒῭ホ౯䜈䛾ᒎ㛤➹㢌Ⓨ⾲⪅ྡ㸸▼஭ ᆒ₇㢟Ⓨ⾲䛻㛵㐃䛧䚸㛤♧䛩䜉䛝COI㛵ಀ䛻䛒䜛௻ᴗ䛺䛹䛸䛧䛶䚸ㅮ₇ᩱ䠖䜲䞊䝷䜲䝸䝸䞊䚸䝜䝞䝹䝔䜱䝇䚸䝃䝜䝣䜱䚸Ṋ⏣⸆ရ䚸䝜䝪䝜䝹䝕䜱䝇䜽䚸䜰䝇䝖䝷䝊䝛䜹䠈䠩䠯䠠䚸⏣㎶୕⳻䚸䝧䞊䝸䞁䜺䞊䞉䜲䞁䝀䝹䝝䜲䝮ዡᏛᐤ㝃㔠䠖⏣㎶୕⳻ዉⰋ┴❧་⛉኱Ꮫ⢾ᒀ⑓Ꮫㅮᗙ▼஭㻌 ᆒ1ᆺ⢾ᒀ⑓ 䛿䜲䞁䝇䝸䞁䜢ศἪ䛩䜛⮅ȕ⣽⬊䜲䞁䝇䝸䞁䛾Ⓨぢ㻌䛾◚ቯ䛺䜙䜃䛻ᾘኻ䜢ཎᅉ䛸䛩䜛䚹

2ᆺ⢾ᒀ⑓䛿㑇ఏᅉᏊ䛻㐣㣗䚸㐠ື୙㊊䚸⫧‶䛺䛹⎔ቃᅉᏊ䜔ຍ㱋䛜ຍ䜟䛳䛶䚸䜲䞁䝇䝸䞁䛾ศἪపୗ䜔䜲䞁䝇䝸䞁᢬ᢠᛶ䛜⏕䛨䚸䜲䞁䝇䝸䞁స⏝୙㊊䛸䛺䛳䛶Ⓨ⑕䛩䜛䚹• 1921ᖺ㻌 㻌 Banting & Best
Macleod, Collip㻌㻌• 1922ᖺ㻌 ึ䜑䛶䝠䝖䛻౑⏝䜲䞁䝇䝸䞁἞⒪䛾ග㻌䈄 ⾑⢾್䛾㝆ୗ㻌䈄 䜿䝖䜰䝅䝗䞊䝅䝇䛛䜙䛾ᅇ᚟㻌䈄 ㌟యᶵ⬟䛾ᅇ᚟㻌䈄 ᪥ᖖ⏕ά䠈♫఍άື䛾ᅇ᚟㻌䈄 ᚰ䛾≧ែ䠈⏕䛝䜛ពḧ䛾ᅇ᚟㻌䜲䞁䝇䝸䞁἞⒪䛾ᙳ㻌䜲䞁䝇䝸䞁䛾ຠᯝ䜢䛹䛖⾲⌧䛩䜛䛛㻌䛣䛾Ꮚ䛾἞⒪⤒㐣䜢䛹䜣䛺᳨ᰝᡂ⦼䛷㻌 㻌㻌ㄝ᫂䛩䜛䜘䜚䜒䚸㻌᪥ᖖ⏕ά䛾ኚㇺ䛷ゝ䛔⾲䛩䛣䛸䛻຾䜛䜒䛾䛿䛺䛔㻚㻌 㻌 㻌㻱㼘㼕㼛㼠㼠㻌㻼㻌㻶㼛㼟㼘㼕㼚㻌 㻌㻌㻌• 1᪥3-4ᅇ䛾ὀᑕ• 1ᅇ10䡉䡈䛾ὀᑕ㔞• ⃭䛧䛔ᒁᡤ䛾⑊③• ప⾑⢾• ㈝⏝䚸〇ရ୙㊊⢾ᒀ⑓ࡣ㐺ษ࡟἞⒪ࡋ࡞࠸࡜ྜే⑕ࡀฟࡲࡍື⬦◳໬ᛶ⑌ᝈ⣽ᑠ⾑⟶⑕⑌ᝈ⤖ᯝࡢホ౯ἲ
Medical Outcome἞⏕໬Ꮫⓗᣦᶆ (⾑⢾,HbA1c࡞࡝)⏕⌮Ꮫⓗᣦᶆ (⾑ᅽ,⚄⤒ᶵ⬟࡞࡝)⏕Ꮡ⋡, ᖹᆒవ࿨⒪QOLෙື⬦⑌ᝈ⥙⭷⑕⭈⑕⑌ᝈࡢᙳ㡪࡜἞⒪ࡢ⤖ᯝࡢホ౯ἲ⬻⾑⟶㞀ᐖṑ࿘⑓ᮎᲈື⬦⑌ᝈ⚄⤒㞀ᐖ⢾ᒀ⑓࣭ྜే⑕

Patient Reported   ἞⒪‶㊊ᗘ  Outcomeㄆ▱⑕䠈⬡⫫⫢䠈⒴䠈㦵ᢡQOL䛿᪥ᖖ䜈䛾ᙳ㡪䜢ከ㠃ⓗḟඖ䛷 ᐃ䛩䜛⏕άୖࡢไ⣙㌟యᶵ⬟䞉③䜏᫬㛫䛸ሙᡤ᪥ᖖ⏕ά䛾ኚㇺ䛷ゝ䛔⾲䛩QOLឤ᝟≧ែ‶㊊ᗘᝈ⪅䛜ᐇឤ䛧䛯἞⒪ຠᯝ

ITR-QOLࡢෆᐜ࡜ᵓᡂ

Insulin Therapy Related QOL (ITR-QOL)ฟ᮶஦ࡢ㢖ᗘࡢㄆ㆑㸦⌧≧㸧㻙㉁ၥ䝃䞁䝥䝹㻙㻌㌟య⑕≧♫఍ⓗάື᪥ᖖάືప⾑⢾㛵㐃యㄪእฟࡘࡁ࠶࠸వᬤࡉࡑ࠸
௚ே࡟ㄝ᫂௙஦⏝஦㣗஦᫬㛫ὀᑕሙᡤ

䞉䜲䞁䝇䝸䞁ὀᑕᚋ䚸ணᐃ䛧䛯᫬㛫䛻㣗஦䛜䛸䜜䛺䛔䛣䛸䛜䛒䜛䠊㻌䞉䜲䞁䝇䝸䞁ὀᑕ䛾䛯䜑䛻እฟ᫬㛫䛜ไ㝈䛥䜜䜛䠊㻌䞉ప⾑⢾䛾䛯䜑䛻௙஦䜔ᐙ஦䛜ጉ䛢䜙䜜䜛䠊㻌䞉እ㣗䛧䛯䛸䛝䛻䜲䞁䝇䝸䞁䜢ὀᑕ䛩䜛䛣䛸䛜㞴䛧䛔䠊㻌ฟ᮶஦ࡢ㔜኱ᛶࡢㄆ㆑㸦ឤ᝟㸧࢖ࣥࢫࣜࣥ἞⒪࡬ࡢឤ᝟    ࠸ࡘࡶ   ࡋࡤࡋࡤ  ࡜ࡁ࡝ࡁ   ࡲࢀ࡟   ඲ࡃࡑ࠺       ࡑ࠺࡛࠶ࡿ ࡑ࠺࡛࠶ࡿ ࡑ࠺࡛࠶ࡿ ࡑ࠺࡛࠶ࡿ ࡛ࡣ࡞࠸

἞⒪࡟ࡼࡿไ⣙᫬㛫ࡢ㈇ᢸ
ప⾑⢾ࡢ୙Ᏻ③ࡳࡢ㈇ᢸ

   㸯   㸰   㸱   㸲   㸳                     ▼஭㻌 ᆒ䠊⢾ᒀ⑓㻌 44㻌 2001䝠䝳䞊䝬䝻䜾䛾QOL䜈䛾ຠᯝ㛤ጞ᫬䛛䜙䛾䝇䝁䜰䛾ኚ໬㔞

7H65Rὀᑕ䝍䜲䝭䞁䜾䜈䛾䝁䞁䝥䝷䜲䜰䞁䝇/<*** : P<0.05** : P<0.01

4**▼஭㻌 ᆒ䠊⢾ᒀ⑓㻌 44㻌 2001

㛤ጞ᫬
****1

ࡓ࠸࡚࠸Ᏺࡗ࡚ ༙ศࡃࡽ࠸࠸ࡿ
Ᏺࡗ࡚࠸ࡿ࡯࡜ࢇ࡝Ᏺࡗ࡚࠸࡞࠸



5*㛤ጞ᫬

0-1

࠸ࡘࡶᏲࡗ࡚࠸ࡿ㐌᫬32ࡲࡗࡓࡃᏲࡗ࡚࠸࡞࠸࠸ࡘࡶᏲࡗ࡚࠸ࡿࡓ࠸࡚࠸Ᏺࡗ࡚࠸ࡿ༙ศࡃࡽ࠸Ᏺࡗ࡚࠸ࡿ࡯࡜ࢇ࡝Ᏺࡗ࡚࠸࡞࠸ࡲࡗࡓࡃᏲࡗ࡚࠸࡞࠸㐌᫬♫఍ⓗάື㻌᪥ᖖ⏕ά㌟య⑕≧䜲䞁䝇䝸䞁἞⒪䛻ᑐ䛩䜛ឤ᝟ྜィ▼஭㻌 ᆒ,኱ᶫ㟹㞝㻌 ௚䠊㻌 ⮫ᗋ་⸆㻌 2000㻌▼஭㻌 ᆒ,኱ᶫ㟹㞝㻌 ௚䠊㻌 ⮫ᗋ་⸆㻌 2000㻌㻽㻻㻸㻛⾑⢾䝁䞁䝖䝻䞊䝹㻛ᐇ⾜ᗘ䛾㛵ಀ㻌䜲䞁䝇䝸䞁἞⒪䛻䛚䛡䜛QOL䛾ព⩏䠖௬ㄝప⾑⢾๪స⏝䜲䞁䝇䝸䞁ὀᑕ䝍䜲䝭䞁䜾䛻ᑐ䛩䜛ᐇ⾜ᗘ㧗⾑⢾⑕≧

p=0.087p=0.029㺏㺢㺼㺩㺏㺵㺻㺛

p=0.007p=0.002

ྜే⑕
ࡢῶᑡ

QOL
䠄ITR-QOL䝇䝁䜰඲య䠅

p=0.004⾑⢾䝁䞁䝖䝻䞊䝹
䠄HbA䠍䠿್䠅Ⰻዲ

p=0.038

ⰋዲQOL೺ᗣ⥔ᣢᖺᩘ᫬㛫ሙᡤ
ᢞ୚ἲ┿ࡢ฼┈㻵㼟㼔㼕㼕㻌㻴㻚㻌㼑㼠㻌㼍㼘㻚㻌㻰㼕㼍㼎㼑㼠㼑㼟㻌㻾㼑㼟㻌㻯㼘㼕㼚㻌㻼㼞㼍㼏㼠㻌㻞㻜㻜㻤㻧㻤㻝㻦㻝㻢㻥㻙㻝㻣㻤㻌㻌

DTR-QOLể඙ၲܱᘍࡇ

DTR-QOL䛷ド᫂䛥䜜䛯䛣䛸

9085

ᒓᛶ

἞⒪⤖ᯝᖺ㱋

HbA1c8075

᏶඲
䛰䛔䛯䛔

70

⑓ᆺ

QOLప⾑⢾

༙ศ
䛒䜎䜚

65

඲䛟

἞⒪ἲ

య㔜ቑຍ

6055

䜰䝗䝠䜰䝷䞁䝇
50
㣗஦⒪ἲ

㐠ື⒪ἲ

⤒ཱྀ⸆

䜲䞁䝇䝸䞁
Ishii H. et al.: J med Econ.,15,556-563,2012.

἞⒪ཧຍ ἞⒪ᐇ⾜ᗘ་ᖌᝈ⪅㛵ಀ೺ᗣ≧ែྜే⑕Ishii H.J Med Econ.2012;15:556-63

佥⻎䡔42/᧤㽊䣑䄏恂ㄵ᧥役⟞嫷PRO䡏䡏 :Patient reported outcome(s)It is becoming increasingly difficult for a newtreatment to show differentiation fromcompetitors on the basis of biomedical
outcomes (e.g. HbA1c) alone.
In addition, given that medication adherence isnotoriously difficult to assess accurately, somePROs offer useful insights in this respect byassessing the acceptability of treatment fromthe patients’ perspective.
Historically, many PRO measures have beenreferred to as ‘quality of life’ (QoL) measures,• DQOL㻌 㻌 㻌 㻌 㻌 䠄QOL䠖䛩䜉䛶䠖἞⒪䛰䛡䛷䛺䛔䠅• DTSQ㻌 㻌 㻌 㻌 㻌 䠄἞⒪‶㊊ᗘ䠖䛩䜉䛶䠖⩻ヂ∧䠅• ITR-QOL㻌 㻌 㻌 㻌 (἞⒪QOL䠖䜲䞁䝇䝸䞁䠅• ITR-QOLN㻌 㻌 (἞⒪QOL䠖䜲䞁䝇䝸䞁䠖ኪ㛫䠅 㻌 㻌•••••ITR-QOLT㻌 㻌 (἞⒪QOL䠖䜲䞁䝇䝸䞁䠖඲᪥䠅㻌 㻌 㻌 㻌 䞉SF36䠄ໟᣓⓗᑻᗘ䠅
IDSQ㻌 㻌 㻌 㻌 㻌 㻌 䠄἞⒪‶㊊ᗘ䠖ᢞ୚ἲ䠖⩻ヂ∧䠅㻌 㻌 䞉PAID(ឤ᝟㈇ᢸᗘ)ITSQ㻌 㻌 㻌 㻌 㻌 㻌 䠄἞⒪‶㊊ᗘ䠖䛩䜉䛶䠖⩻ヂ∧䠅㻌 㻌 㻌OHA-Q㻌 㻌 㻌 㻌 㻌 䠄἞⒪‶㊊ᗘ䠖⤒ཱྀ⸆䠅ITSS㻌 㻌 㻌 (䝉䝹䝣䜶䝣䜱䜹䝅䞊䠖䜲䞁䝇䝸䞁䠅䝥䝻䝣䜯䜲䝹ᆺ

䞉EQ-5D-5L䜲䞁䝕䝑䜽䝇ᆺຠ⏝್䜢⟬ฟDavies M. Diabetes, Obesity and Metabolism 14: 882–892, 2012.

⫼ᬒ䠖㻥㻜ᖺ௦䛾་⒪䛾ၥ㢟Ⅼ䛸ᑐ⟇㻌1䠅་⒪䛾᭷ຠᛶ䛾᰿ᣐ䛜ஈ䛧䛔㻌 ĺEBM䛾☜❧2䠅་⒪䛾ᐇ⾜䛾᪋タ㛫䛾䜀䜙䛴䛝䜔ᆅᇦᕪĺ་⒪ィ⏬(་⒪ᅪ䠈4⑌ᝈ5஦ᴗ),㻌 EBM䛾ᐇ⾜3䠅㈝⏝䛻ᑐ䛩䜛⪃៖䛜䛺䛔(་⒪⤒῭ᏛどⅬḞዴ)㻌 ĺ䛂ᢚไ䛃䛰䛡䛷䛿䛺䛟䚸㻌 ㈝⏝䛻ぢྜ䛳䛯ຠᯝ䛜ᚓ䜙䜜䜛䛛ホ౯䛩䜛㻌 ĺ㈝⏝䞉ຠᯝ䠄ຠ⏝䠅ศᯒ᪥ᮏே2ᆺ⢾ᒀ⑓ᝈ⪅䛻ᑐ䛩䜛䝕䝳䝷䜾䝹䝏䝗䛾㈝⏝ຠᯝศᯒ䠉䜲䞁䝇䝸䞁 䜾䝷䝹䜼䞁䛸䛾ẚ㍑

ᮏ◊✲䛾ศᯒ᪉ἲ䈄 ྜే⑕䜔ணᚋ䛻㛵䛩䜛⢾ᒀ⑓䝅䝭䝺䞊䝅䝵䞁䝰䝕䝹䛷䛒䜛䛆㻯㻻㻾㻱㻌㻰㼕㼍㼎㼑㼠㼑㼟㻌㻹㼛㼐㼑㼘䛇䛻䚸⮫ᗋヨ㦂䜘䜚ᚓ䜙䜜䛯ᝈ⪅⫼ᬒ᝟ሗ䚸⸆≀἞⒪䛾᭷ຠᛶ䞉Ᏻ඲ᛶ䝕䞊䝍䜢ᤄධ䛧䛯㻌䈄 ྛ✀ྜే⑕䛻ᑐ䛩䜛㻽㻻㻸್䛿Ⓨ⾲ㄽᩥ➼䛛䜙⟬ฟ䛧䛯㻌䈄 ་⒪㈝䠄┤᥋㈝䠅䛿㐣ཤ䛾ㄽᩥ➼䛛䜙ᘬ⏝䛧䛯㻌་⒪⤒῭ホ౯◊✲䛻䛚䛡䜛ศᯒᡭἲ䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁⚟⏣ᩗ䠈ⓑᒾ೺䠈ụ⏣ಇஓ䠈஬༑ᔒ୰䠈㉥ἑᏛ䠈▼⏣༤䠈㻌⬟Ⓩ┿୍䠈㰻⸨ಙஓ䠈ᆏᕳᘯஅ䠈ୗጔ᫭஧㑻䠈⏣಴ᬛஅ䠈㻌⚟⏣἞ஂ䠈᳃⬥೺௓䠈෠⏣ዉ✑Ꮚ䠈ᑠᯘៅ㻌ಖ೺་⒪⛉Ꮫ㻌 㻞㻜㻝㻟㻌 㼂㼛㼘㻚㻢㻞㻌 㻺㼛㻚㻢㻌 㼜㻚㻢㻞㻡䠉㻢㻠㻜㻌㻌㻌䖃ศᯒ㛫䛾ẚ㍑ྍ⬟ᛶ䜔QOLホ౯䛾㔜せᛶ䛛䜙䠈་⒪⤒῭ホ౯䛻䛚䛡䜛䜰䜴䝖䜹䝮ᣦᶆ䛸䛧䛶䠈ྍ⬟䛺㝈䜚QALY䜢⏝䛔䛯ศᯒ䜢ྵ䜑䜛䛣䛸䜢᥎ዡ䛧䛶䛔䜛䠊㻌㻌䖃ᅜෆ䛷䝇䝁䜰䝸䞁䜾䜰䝹䝂䝸䝈䝮䛜᪤䛻㛤Ⓨ䛪

EQ-5D䠄-䠏L)䛿䠄⢾ᒀ⑓἞⒪䛾ᕪ䛾᳨ฟ䛻䛴䛔䛶䠅ឤᗘ䛜ప䛔ྜే⑕䛜ฟ䛺䛔䛸἞⒪ἲ䛾ᕪ䛜᳨ฟ䛷䛝䛺䛔㻌 㻌 㻌 㻌 㻌 㻌 Ѝ䛝䜟䜑䛶㛗ᮇⓗ䛺ヨ㦂䛜ᚲせ៏ᛶ⑌ᝈ἞⒪⸆䛾ຠᯝ䛾ᕪ䛜᳨ฟ䛷䛝䜛䛛䜏䛾䜲䞁䝕䝑䜽䝇ᆺᑻᗘ䠄౛䠖㻌㻱㻽㻙㻡㻰㻌䛺䛹䠅䜢౑⏝䛩䜛䛣䛸䜢᥎ዡ䛧䛶䛔䜛䠊㻌㻌 㻌 㻌 㻌 㻌 Ѝ䝃䝻䝀䞊䝖䝬䞊䜹䞊䛷ホ౯䛧䛶䛔䜛䛧䛛䛧䠈䜲䞁䝕䝑䜽䝇ᆺᑻᗘ䛻䜘䜛 ᐃ್䛜Ꮡᅾ䛧䛺䛔ሙྜ䠈䝥䝻䝣䜯䜲䝹ᆺᑻᗘ䜔⑕≧䝇䜿䞊䝹䛷䛾 ᐃ⤖ᯝ䛛䜙䠈་⒪⤒῭ホ౯䛷౑⏝䛩䜛㻽㻻㻸್䜢⟬ฟ䛩䜛䛣䛸䛜᭷⏝䛺ሙ㠃䜒䛒䜛䠊䛣䛾䜘䛖䛺ᑻᗘ㛫䛾䝇䝁䜰ኚ᥮䜢䝬䝑䝢䞁䜾䠄㼙㼍㼜㼜㼕㼚㼓䠅䛸࿧䜆㻌䠊