Page 263 2.7.6 個々の試験のまとめ リバビリン ኂ⽎㧔08㧕 ེቭಽ㘃 ోり㓚ኂ ⚻♽㓚ኂ ⢗⣺㓚ኂ ╭㛽ᩰ㧘⚿ว⚵❱ ߮㛽㓚ኂ ⊹⤏߮⊹ਅ⚵❱ 㓚ኂ ♖㓚ኂ ᗵᨴ∝߮ነ↢⯻∝ ๆེ㧘⢷ㇳ߮❑ 㓒㓚ኂ ኂ⽎ ∋ഭ ⊒ᾲ ᖡኙ ήജ∝ ᵈㇱἻ∝ −∩ NOS ⣕ജ 㗡∩ NOS ਇ⌁∝ ᶋേᕈ߹㧔࿁ォ ᕈ⌇ᥝࠍ㒰ߊ㧕 ཌྷ᳇ ਅ∯ NOS ⣻ㇱ∩ ཌྷฯ NOS ⣻∩ NOS ญౝੇ῎ ᶖൻਇ⦟ ଢ⒁ ญ⣧ౝẩ≌ᒻᚑ ╭∩ 㑐▵∩ ⢛ㇱ∩ ⣕Ძ∝ ߘ߁∣∝ ⊹⤏Ἳ NOS ⊹⤏ੇ῎ ᄙ᳨ Ḩ∐ NOS ⚃ᕈ⊹∐ ᤃೝỗᕈ ߁ߟ∛ NOS ਇ 㓸ਛജ㓚ኂ ⸥ᙘ㓚ኂ ⚻ㆊᢅ 㥦⣧Ἳ NOS ᳇ᗵᨴ NOS ࠗࡦࡈ࡞ࠛࡦࠩ න⚐ࡋ࡞ࡍࠬ ᱤ⤥≌ ๆ࿎㔍 ຕ༿ ຜ༄∩ NOS 㥦ຜ㗡Ἳ ഭᕈๆ࿎㔍 PEG-IFNĮ-2a න⁛⟲ (N=223) 98 (44%) 85 (38%) 52 (23%) 26 (12%) 26 (12%) 14 (6%) 10 (4%) 115 (52%) 52 (23%) PEG-IFNĮ-2a + ࡃࡆࡦ⟲ (N=451) 242 (54%) 195 (43%) 106 (24%) 69 (15%) 56 (12%) 36 (8%) 24 (5%) 211 (47%) 168 (37%) rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ (N=443) 244 (55%) 247 (56%) 157 (35%) 72 (16%) 44 (10%) 30 (7%) 23 (5%) 230 (52%) 174 (39%) 31 (14%) 81 (18%) 70 (16%) 58 54 35 17 28 14 9 4 4 94 64 29 48 41 29 20 10 3 12 56 44 18 28 12 6 12 13 18 15 9 20 23 18 17 8 (26%) (24%) (16%) (8%) (13%) (6%) (4%) (2%) (2%) (42%) (29%) (13%) (22%) (18%) (13%) (9%) (4%) (1%) (5%) (25%) (20%) (8%) (13%) (5%) (3%) (5%) (6%) (8%) (7%) (4%) (9%) (10%) (8%) (8%) (4%) 130 77 41 52 44 33 35 24 22 189 121 52 128 101 95 50 30 30 18 109 95 51 41 20 17 35 23 18 22 23 70 73 42 28 22 (29%) (17%) (9%) (12%) (10%) (7%) (8%) (5%) (5%) (42%) (27%) (12%) (28%) (22%) (21%) (11%) (7%) (7%) (4%) (24%) (21%) (11%) (9%) (4%) (4%) (8%) (5%) (4%) (5%) (5%) (16%) (16%) (9%) (6%) (5%) 145 68 50 51 34 37 30 33 25 220 112 46 151 88 80 64 23 23 14 123 131 60 53 16 23 23 25 22 20 12 72 51 30 20 31 (33%) (15%) (11%) (12%) (8%) (8%) (7%) (7%) (6%) (50%) (25%) (10%) (34%) (20%) (18%) (14%) (5%) (5%) (3%) (28%) (30%) (14%) (12%) (4%) (5%) (5%) (6%) (5%) (5%) (3%) (16%) (12%) (7%) (5%) (7%) # 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 264 2.7.6 個々の試験のまとめ リバビリン ኂ⽎㧔08㧕㧔⛯㧕 ེቭಽ㘃 ઍ⻢ᩕ㙃㓚ኂ ౝಽᴲ㓚ኂ ⌒㓚ኂ ኂ⽎ 㘩᰼ᷫㅌ ㊀ᷫዋ 㘩᰼ਇᝄ ↲⁁⣼ᯏ⢻ૐਅ∝ 㔵ⷞ PEG-IFNĮ-2a + ࡃࡆࡦ⟲ (N=451) 96 (21%) 52 (12%) 21 (5%) 19 (4%) 25 (6%) PEG-IFNĮ-2a න⁛⟲ (N=223) 24 (11%) 18 (8%) 7 (3%) 14 (6%) 11 (5%) rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ (N=443) 98 (22%) 49 (11%) 24 (5%) 23 (5%) 15 (3%) ห৻∝ߦห৻ߩኂ⽎߇ⶄᢙઙ⊒ߒߚ႐วߪ1ઙߣߒߡ㓸⸘ߒߚޕ ԙ ㊀◊ߥኂ⽎ ㊀◊ߥኂ⽎ࠍ 2.7.6.2.8-9ߦ␜ߒߚޕrIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߦᲧߒ㧘PEG-IFNĮ-2a න⁛⟲ ߮ PEG-IFNĮ-2a + ࡃࡆࡦ⟲ߢߪ㧘㊀◊ߥኂ⽎ߩ⊒₸ߪ߿߿㜞߆ߞߚޕ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߦ߅ߌࠆ㊀◊ߥ♖㓚ኂߩ⊒₸㧔3%㧕ߪ㧘PEG-IFNĮ-2a ᛩਈ⟲ߦ߅ߌ ࠆ⊒₸㧔1%㧕ࠃࠅ߽ᄙߊ㧘㊀◊ߥ߁ߟ∛߮⥄Ვડ࿑ߩഀวߪ㜞߆ߞߚޕ ㊀◊ߥኂ⽎㧔08㧕 ེቭಽ㘃 ోኂ⽎ ᗵᨴ∝߮ነ↢⯻∝ ኂ⽎ 1࿁એ⊒ߒߚ✚∝ᢙ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ⱎᎽἻ ⢖Ἳ NOS ⢗⣺Ἳ NOS ᄖ⡊Ἳ㧔ᄖ⡊ߩߖߟࠍ㒰ߊ㧕 NOS ࠕࡔࡃ∝ NOS ᗵᨴᕈ㑐▵Ἳ NOS ᳇▤ᡰᒛ∝ NOS ሶች㗖▤Ἳ ਅ᳇ᗵᨴ NOS ⚻᪢Ქ ࠙ࠗ࡞ࠬᕈ⢖Ἳ NOS ⣢⋃⣢Ἳ NOS 㥦⣧Ἳ NOS ⊹⤏߮⊹ਅ⚵❱⤥≌ ࡉ࠼࠙⩶ᗵᨴ NOS ዩ〝ᗵᨴ NOS ࠙ࠗ࡞ࠬᗵᨴ NOS ✚⊒ઙᢙ rIFNĮ-2b + PEG-IFNĮ-2a න⁛⟲ N=223 No.㧔%㧕 26 (12) 31 6 ( 3) 2 ( 1) - PEG-IFNĮ-2a + ࡃࡆࡦ N=451 No.㧔%㧕 53 (12) 64 13 ( 3) 1 (< 1) 2 (< 1) 1 (< 1) - 2 (< 1) - 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 6 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 13 1 (< 1) 1 (< 1) 4 # ࡃࡆࡦ⟲ ࠞࡊ࡞# N=443 No.㧔%㧕 38 ( 9) 50 4 ( 1) 1 (< 1) 1 (< 1) 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 265 2.7.6 個々の試験のまとめ リバビリン ㊀◊ߥኂ⽎㧔08㧕 㧔⛯㧕 ེቭಽ㘃 ♖㓚ኂ ⢗⣺㓚ኂ ⚻♽㓚ኂ ⦟ᕈ߮ᖡᕈᣂ↢‛ 㧔ྙ⢩߮ࡐࡊࠍ 㧕 ኂ⽎ 1࿁એ⊒ߒߚ✚∝ᢙ ߁ߟ∛ NOS ⥄Ვડ࿑ ⥄Ვᔨᘦ ⮎‛ੂ↪ ࠕ࡞ࠦ࡞∝ ᭂᕈᗵᖱ㓚ኂ ౝ࿃ᕈ߁ߟ∛ ⮎‛ଐሽ ⮎㔌⣕∝⟲ ᅦᗐ∝ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ⣻∩ NOS ⯻ုἻ ਅ∯ NOS ⣻ㇱ⤥≌ NOS ਅ⣻ㇱ∩ ฯⴊ ∤ᩭ ⣺▤≪ ཌྷ᳇ 㘩ㅒᵹ ⢙᳝ᕈ⣻⤑Ἳ ⋥⣺ⴊ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ⟲⊒㗡∩ 㗻㕙㤗∽ 㗡∩ NOS 㗡∩ ᧃ᪳ᕈ࠾ࡘࡠࡄࠪNOS ᄙ⊒࠾ࡘࡠࡄࠪNOS ᄬ ਃ⚻∩ ⴊ▤ㅅ⚻ᕈ⊒ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ᖡᕈ⢄ᣂ↢‛ ⚿⣺≸ 㘩≸ ෆᎽߩᣂ↢‛ NOS ↲⁁⣼⣲≌ ⦟ᕈਅု⣲≌ ✚⊒ઙᢙ PEG-IFNĮ-2a න⁛⟲ N=223 No.㧔%㧕 2 ( 1) 1 (< 1) 1 (< 1) 2 2 ( 1) 1 (< 1) 1 (< 1) 2 2 ( 1) 1 (< 1) 1 (< 1) 2 3 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 3 # PEG-IFNĮ-2a + ࡃࡆࡦ N=451 No.㧔%㧕 6 ( 1) 2 (< 1) 2 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 7 8 ( 2) 3 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 8 5 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 5 2 (< 1) 2 (< 1) 2 rIFNĮ-2b + ࡃࡆࡦ ⟲ ࠞࡊ࡞# N=443 No.㧔%㧕 13 ( 3) 6 ( 1) 4 ( 1) 2 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 17 8 ( 2) 2 (< 1) 2 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 9 2 (< 1) 1 (< 1) 1 (< 1) 2 3 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 3 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 266 2.7.6 個々の試験のまとめ リバビリン ㊀◊ߥኂ⽎㧔08㧕 㧔⛯㧕 ེቭಽ㘃 ኂ⽎ ోり㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ ⊒ᾲ ⢷∩ NOS ∋ഭ ⴊ NOS −∩ NOS ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ᔃᚱ⚦േ ᔃ⤑Ἳ NOS ਇᢛ⣂ NOS ᔃ╭⯯ⴊ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ エ㛽៊் ṃᱫ 㗡ㇱ៊் ៊் NOS ✂⤑㔌 ㅢ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ๆ࿎㔍 ༎ᕷ ⴊ ᳇⢷ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ 㑐▵∩ ᬁ㑆᧼㓚ኂ NOS ╭∩ ᄙ⊒ᕈ㑐▵Ἳ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ⽺ⴊ NOS ᳢ⴊᷫዋ∝ ⴊዊ᧼ᷫዋ∝ ✚⊒ઙᢙ 1࿁એ⊒ߒߚ✚∝ᢙ ⣕᳓ ♧ዩ∛Ⴧᖡ ♧ዩ∛ᕈࠤ࠻ࠕࠪ࠼ࠪࠬ ✚⊒ઙᢙ ᔃ⤳㓚ኂ ்ኂ߮ਛᲥ ๆེ㧘⢷ㇳ߮❑㓒 㓚ኂ ╭㛽ᩰ㧘⚿ว⚵❱߮ 㛽㓚ኂ ⴊᶧ߮ࡦࡄ♽㓚ኂ ઍ⻢߮ᩕ㙃㓚ኂ PEG-IFNĮ-2a න⁛⟲ N=223 No.㧔%㧕 1 (< 1) 1 (< 1) 1 3 ( 1) 1 (< 1) 2 ( 1) 3 2 ( 1) 1 (< 1) 1 (< 1) 2 1 (< 1) 1 (< 1) 1 (< 1) 2 1 (< 1) 1 (< 1) 1 1 (< 1) 1 (< 1) 1 # PEG-IFNĮ-2a + ࡃࡆࡦ N=451 No.㧔%㧕 4 ( 1) 2 (< 1) 1 (< 1) 1 (< 1) 4 3 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 3 4 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 4 3 ( 1) 1 (< 1) 1 (< 1) 1 (< 1) 3 2 (< 1) 1 (< 1) 1 (< 1) 2 3 ( 1) 2 (< 1) 1 (< 1) 3 - rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ N=443 No.㧔%㧕 2 (< 1) 1 (< 1) 1 (< 1) 2 2 (< 1) 1 (< 1) 1 (< 1) 2 1 (< 1) 1 (< 1) 1 3 ( 1) 2 (< 1) 1 (< 1) 3 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ リバビリン Page 267 2.7.6 個々の試験のまとめ ㊀◊ߥኂ⽎㧔08㧕 ⛯ PEG-IFNĮ-2a + PEG-IFNĮ-2a ࡃࡆࡦ න⁛⟲ ኂ⽎ N=451 N=223 No.㧔%㧕 No.㧔%㧕 ⢄⢙♽㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) 1 (< 1) ⢙⍹∝ ⢄㓚ኂ NOS 1 (< 1) ⢄⢖∝⟲ ࠻ࡦࠬࠕࡒ࠽ 1 (< 1) ✚⊒ઙᢙ 1 1 ⊹⤏߮⊹ਅ⚵❱㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 2 ( 1) 1 (< 1) ⴊ▤⣲ NOS 1 (< 1) ᚳᐔ⧡⊈ 1 (< 1) ੇ⊈ 1 (< 1) ⢽⣼ྙ⣲ ✚⊒ઙᢙ 2 1 ⡊߮ㅅ〝㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 3 ( 1) ࠈ߁ NOS 1 (< 1) ⡊㡆 1 (< 1) ߹∔ᖚ 1 (< 1) ࿁ォᕈ⌇ᥝ NOS 1 (< 1) ✚⊒ઙᢙ 4 ౝಽᴲ㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) 2 (< 1) ↲⁁⣼ᯏ⢻ૐਅ∝ 1 (< 1) 1 (< 1) ᯅᧄ∛ 1 (< 1) ✚⊒ઙᢙ 1 2 ⴊ▤㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 㜞ⴊᕈᔃ∔ᖚ NOS ⢖Ⴇᩖ∝ ᷓㇱ㕒⣂ⴊᩖ∝㧔྾⢇㧕 ✚⊒ઙᢙ ⌒㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) ⶄⷞ ✂⤑ⴊ 1 (< 1) ✚⊒ઙᢙ 1 ∉♽㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) ࠕ࠽ࡈ࡚ࠖࠠࠪࠪ࠶ࠢ 1 (< 1) ✚⊒ઙᢙ 1 ↢ᱺ♽߮ᚱ㓚ኂ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) ሶችⴊ 1 (< 1) ✚⊒ઙᢙ 1 ᄖ⑼߮ౝ⑼ಣ⟎ 1࿁એ⊒ߒߚ✚∝ᢙ 1 (< 1) ᔃ⤳ࡍࠬࡔࠞᯏ⢻ਇో 1 (< 1) ✚⊒ઙᢙ 1 ห৻∝ߩਛߢหߓኂ⽎߇⊒ߒߡࠆ႐วߪวࠊߖߡ1ઙߣߒߡ⸘▚ߒߚޕ ེቭಽ㘃 # rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ N=443 No.㧔%㧕 2 (< 1) 1 (< 1) 1 (< 1) 2 1 (< 1) 1 (< 1) 1 2 (< 1) 1 (< 1) 1 (< 1) 1 (< 1) 3 1 (< 1) 1 (< 1) 1 - 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 268 2.7.6 個々の試験のまとめ リバビリン Ԛ ਛᱛᛩਈ㊂ᄌᦝ ኂ⽎߮⥃ᐥᬌᩏ୯⇣Ᏹߦࠃࠆਛᱛߪᛩਈ㊂ࠍᄌᦝߒߚ∝ߩ㗫ᐲࠍ 2.7.6.2.8-10 ߦ␜ߒߚޕᛩਈਛᱛߣߥߞߚ∝ߪ PEG-IFNĮ-2a + ࡃࡆࡦ⟲ߣ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߘࠇ ߙࠇ10%㧔44/451㧕㧘11%㧔47/443㧕ߣห᭽ߢߞߚ৻ޕᣇ㧘PEG-IFNĮ-2a න⁛⟲ߢߪ7%㧔15/223 㧕ߣࡃࡆࡦ૬↪ਔ⟲ߦᲧߒ߿߿ਛᱛ₸ߪૐ߆ߞߚޕᛩਈਛᱛߩਥߥℂ↱ߪ♖㓚ኂߢ PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧘rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲߮ PEG-IFNĮ-2a න⁛⟲ߢߘࠇߙࠇ㧘3% 㧔12/451㧕㧘4%㧔18/443㧕߮1%㧔3/223㧕ߢߞߚޕ ኂ⽎ߪ⥃ᐥᬌᩏ୯⇣Ᏹߦࠃࠅࠗࡦ࠲ࡈࠚࡠࡦࠍ↪㊂ᄌᦝߒߚ∝ߪ PEG-IFNĮ-2a න ⁛⟲㧔27%, 61/223㧕㧘PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧔32%, 145/451㧕ߣ PEG-IFNĮ-2a ᛩਈ⟲ ߢߪ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲㧔18%, 81/443㧕ࠃࠅ߽ᄙ߆ߞߚޕPEG-IFNĮ-2a ᷫ㊂ߩਥߥℂ↱ߪ ᅢਛᢙᷫዋߢߞߚޕrIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߢ⥃ᐥᬌᩏ୯⇣Ᏹߦࠃࠅ㧘rIFNĮ-2b ߩᷫ㊂߇ᔅⷐ ߢߞߚߩߪ8%㧔36/443㧕ߩ∝ߩߺߢߞߚޕ ࡃࡆࡦࠍᷫ㊂ߒߚ∝ߩഀวߪ㧘PEG-IFNĮ-2a + ࡃࡆࡦ⟲ߣ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߢ ห᭽㧔ߘࠇߙࠇ40%; 181/451, 37%; 164/443㧕ߢ㧘ߘߩ⚂ඨᢙߪ⽺ⴊߦࠃࠆ߽ߩߢߞߚޕ ኂ⽎ߪ⥃ᐥᬌᩏ୯⇣Ᏹߦࠃࠅਛᱛᛩਈ㊂ࠍᄌᦝߒߚ∝㧔08㧕 ᛩਈ⟲ ᄌᦝߒߚ↪㊂ ኂ⽎ߪ⥃ᐥᬌᩏ୯⇣Ᏹߦ ࠃࠆᛩਈ㊂ᄌᦝ ኂ⽎ߦࠃࠆᛩਈ㊂ᄌᦝ ⥃ᐥᬌᩏ୯⇣Ᏹߦࠃࠆᛩਈ㊂ᄌ ᦝ ALT ⽺ⴊ ᅢਛᢙᷫዋ ⴊዊ᧼ᢙᷫዋ ߘߩઁߩ⥃ᐥᬌᩏ୯⇣Ᏹ ኂ⽎ߪ⥃ᐥᬌᩏ୯⇣Ᏹߦ ࠃࠆਛᱛ PEG-IFNĮ-2a න⁛⟲ N=223 No.㧔%㧕 PEGIFNĮ-2a 180 ȝg ࡃࡆࡦ PEG-IFNĮ-2a + ࡃࡆࡦ N=451 No.㧔%㧕 rIFNĮ-2b + ࡃࡆࡦ ⟲ ࠞࡊ࡞# N=443 No.㧔%㧕 ࡃࡆࡦ ࠞࡊ࡞# PEGIFNĮ-2a 180 ȝg ࡃࡆࡦ No. (%) No. (%) No. (%) No. (%) rIFNĮ-2b 3 MIU No. (%) ࡊࡏ 1,000㨪 1,200 mg No. (%) 61 (27%) 46 (21%) 145 (32%) 181 (40%) 81 (18%) 164 (37%) 14 (6%) 39 (17%) 48 (11%) 95 (21%) 47 (11%) 97 (22%) 54 (24%) 9 ( 4%) 111 (25%) 108 (24%) 36 ( 8%) 84 (19%) 1 ( 0%) 38 (17%) 14 ( 6%) 1 (0%) 8 ( 4%) 1 ( 0%) - 2 ( 0%) 4 ( 1%) 91 (20%) 18 ( 4%) 4 ( 1%) 1 ( 0%) 99 (22%) 6 (1%) 2 ( 0%) 2 ( 0%) 1 ( 0%) 13 ( 3%) 24 ( 5%) 1 ( 0%) 2 ( 0%) 83 (19%) 1 ( 0%) 1 ( 0%) 15 (7%) 1,000㨪 1,200 mg 44 (10%) # 1,000㨪 1,200 mg 47 (11%) 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 269 2.7.6 個々の試験のまとめ リバビリン ԛ ᱫ ߕࠇߩᛩਈ⟲ߦ߅ߡ߽ᛩਈਛߩᱫߪࠄࠇߥ߆ߞߚޕᛩਈ⚳ੌᓟ24ㅳ㑆ߩⷰኤᦼ ߅ߥޕ㧘 㑆ਛߦ2ߩᱫ߇ࠄࠇߚ㧔PEG-IFNĮ-2a න⁛⟲߮ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߢฦ1㧕 PEG-IFNĮ-2a න⁛⟲ߦ߅ߡ1ߦ㧘⢄≸ߩߚᛩਈ⚳ੌᓟ߶߷1ᐕᓟߦᱫ߇ႎ๔ߐࠇߚ㧔 2.7.6.2.8-11㧕ࠄࠇߎޕ3ߩᱫߪ㧘ߕࠇ߽ᛩਈߣߪ㑐ㅪߥߣ್ᢿߐࠇߚޕ ᱫ∝㧔08㧕 ᛩਈ⟲ ᣉ⸳⇟ภ /ᖚ⠪ ID ᕈ ᐕ㦂 ᱫℂ↱ ᛩਈᣣᢙ ࿃ᨐ㑐ଥ PEG-IFNĮ-2a 180 ȝg 23183/1135 ᅚᕈ 40ᱦ ṃᱫ 337 㑐ㅪߥߒ PEG-IFNĮ-2a 180 ȝg 23231/1896 ᅚᕈ 57ᱦ ⢄⚦⢩≸ 316 㑐ㅪߥߒ rIFNĮ-2b 3 MIU + ࡃࡆࡦ ࠞࡊ࡞# 1,000~1,200 mg 23219/7401 ↵ᕈ 44ᱦ 㜞ⴊᕈᔃ∔ᖚ 295 㑐ㅪߥߒ ⠨ ਸ਼ゞਛߩゞ߇Ꮉߦ ⪭ਅߒ㧘ṃᱫ ᛩਈ⚳ੌ⚂1ᐕᓟ ߦ⢄⚦⢩≸ߩߚ ᱫ ᛩਈਛᱛᓟ⚂40ᣣ ᓟߦᱫ Ԝ ⥃ᐥᬌᩏ୯⇣Ᏹ ᛩਈᦼ㑆ਛ߮ᛩਈ⚳ੌᓟ24ㅳ㑆ߦࠄࠇߚ⥃ᐥᬌᩏ୯⇣Ᏹࠍ 2.7.6.2.8-12ߦ␜ߔޕ ਥߥ⥃ᐥᬌᩏ୯⇣Ᏹߪ㧘ࡋࡑ࠻ࠢ࠶࠻ᷫዋ㧘⊕ⴊᢙᷫዋ㧘ࡦࡄᢙᷫዋ㧘AST 㧘 ࡦૐਅ㧘࠻ࠣࠗ࠼㧘✚ࡆ࡞ࡆࡦߥߤߢߞߚޕ ࡋࡑ࠻ࠢ࠶࠻ᷫዋ߮ࡦࡄᢙᷫዋߪ PEG-IFNĮ-2a න⁛⟲㧔17% ߮48% 㧕ߦᲧߒ㧘 PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧔52%߮73%㧕߮ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲㧔46%߮67%㧕ߢᄙ ߊࠄࠇߚ ߪ₸⊒ߩࠄࠇߎޕPEG-IFNĮ-2a + ࡃࡆࡦ⟲߇ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ࠃࠅ߿ ߿㜞߆ߞߚⴊ⊕ޕᢙᷫዋߪ PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧔78%㧕߮ PEG-IFNĮ-2a න⁛⟲ 㧔60%㧕߇ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲㧔47%㧕ࠃࠅ߽ᄙߊࠄࠇߚޕ ✚ࡆ࡞ࡆࡦߪ PEG-IFNĮ-2a න⁛⟲㧔1%㧕ߦᲧߒ㧘PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧔6%㧕 ߮ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲㧔9%㧕ߢᄙߊࠄࠇߚߚ߹ޕ㧘࠻ࠣࠗ࠼ߦ߅ߡ PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧔36%㧕߮ PEG-IFNĮ-2a න⁛⟲㧔38%㧕߇ rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲㧔24%㧕ߦᲧߒᄙߊࠄࠇߚޕ ߘߩઁ3⟲㑆ߢ㗼⪺ߦ⇣ߥߞߚ⊒₸ࠍ␜ߒߚ㗄⋡ߪߥ߆ߞߚޕ # 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ Page 270 2.7.6 個々の試験のまとめ リバビリン ⥃ᐥᬌᩏ୯⇣Ᏹ㧔08㧕 PEG-IFNĮ-2a PEG-IFNĮ-2a + න⁛⟲ ࡃࡆࡦ⟲ 㧔n=223㧕 㧔n=451㧕 17% (37/223) 52% (235/450) ࡋࡑ࠻ࠢ࠶࠻ᷫዋ < 1% (1/217) 1% (5/434) ㇱಽ࠻ࡠࡦࡏࡊࠬ࠴ࡦᤨ㑆ᑧ㐳 3% (5/162) 2% (5/322) ࡊࡠ࠻ࡠࡦࡆࡦᤨ㑆ᑧ㐳 2% (4/200) 1% (3/393) ࡊࡠ࠻ࡠࡦࡆࡦᤨ㑆㧔INR*㧕 㧔Ყ㧕 60% (133/223) 78% (352/450) ⊕ⴊᢙᷫዋ 0% (0/223) < 1% (1/450) ᅢ㉄ᢙჇᄙ 0% (0/223) 0% (0/450) ࡦࡄᢙჇᄙ 48% (107/223) 73% (327/450) ࡦࡄᢙᷫዋ < 1% (1/223) 3% (13/450) නᢙᷫዋ < 1% (1/223) < 1% (2/450) ࠕ࡞ࡉࡒࡦૐਅ 1% (3/223) 1% (5/450) ࠕ࡞ࠞࡈࠜࠬࡈࠔ࠲ 33% (74/223) 17% (78/450) AST 1% (3/223) 6% (28/450) ✚ࡆ࡞ࡆࡦ 1% (3/222) 1% (3/444) ✚Ⱞ⊕ 1% (2/222) < 1% (1/444) ✚Ⱞ⊕ૐਅ < 1% (1/221) < 1% (2/450) BUN 1% (2/220) 1% (5/444) ࠢࡠࠗ࠼ 3% (7/220) 1% (5/444) ࠢࡠࠗ࠼ૐਅ < 1% (1/223) 1% (3/450) ࠢࠕ࠴࠾ࡦ 3% (6/223) 3% (12/450) ࠞ࠙ࡓ < 1% (1/223) < 1% (2/450) ࠞ࠙ࡓૐਅ 1% (2/223) 1% (3/450) ࠽࠻࠙ࡓ 0% (0/223) < 1% (1/450) ࠽࠻࠙ࡓૐਅ 0% (0/223) < 1% (1/450) ࠞ࡞ࠪ࠙ࡓ 4% (9/223) 6% (28/450) ࠞ࡞ࠪ࠙ࡓૐਅ 1% (2/223) < 1% (2/450) ࠦࠬ࠹ࡠ࡞ 4% (10/223) 3% (15/450) ࡦ 28% (62/223) 32% (144/450) ࡦૐਅ 38% (85/223) 36% (163/450) ࠻ࠣࠗ࠼ 1% (3/223) 1% (6/450) ዩ㉄ *: ᅢਛᢙᷫዋ㧘ⴊዊ᧼ᢙᷫዋ߮ࡋࡕࠣࡠࡆࡦᷫዋࠍ㒰ߊ ⴊᶧቇ⊛ᬌᩏ୯ rIFNĮ-2b + ࡃࡆࡦ ⟲ ࠞࡊ࡞# 㧔n=443㧕 46% (204/442) < 1% (1/421) 2% (5/323) 1% (3/379) 47% (207/442) 0% (0/442) < 1% (1/442) 67% (294/442) < 1% (2/442) < 1% (1/442) 1% (5/442) 17% (73/442) 9% (38/442) < 1% (2/438) 1% (3/438) 0% (0/442) 2% ( 7/438) 4% (17/438) 0% (0/442) 1% (6/442) < 1% (2/442) 1% (3/442) < 1% (1/442) 0% (0/442) 5% (23/442) < 1% (1/441) 4% (17/441) 31% (136/441) 24% (105/441) 4% (16/441) ԝ ᅢਛᢙᷫዋ ᅢਛᢙߩਛᄩ୯ߩផ⒖ࠍ࿑ 2.7.6.2.8-2ߦ␜ߔޕᅢਛᢙᷫዋߪ3⟲ߣ߽ߦࠄࠇ㧘ᛩਈ㐿 ᆎᓟ 2 ㅳ⋡߹ߢߦᷫዋ߇ᦨᄢߣߥߞߚߩߘޕᓟ㧘ᅢਛᢙߪቯߒ㧘ᛩਈᦼ㑆ࠍㅢߓߡ㧘 PEG-IFNĮ-2a + ࡃࡆࡦ⟲ߣ PEG-IFNĮ-2a න⁛⟲ߢߪᛩਈ೨୯ߩ⚂45%㧘rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߢߪᛩਈ೨୯ߩ⚂60%ࠍ⛽ᜬߒߚޕᛩਈ⚳ੌᓟ㧘ᅢਛᢙߪᕆㅦߦჇടߒ㧘52ㅳ⋡㧔ᛩਈ⚳ ੌᓟ4ㅳᤨ㧕߹ߢߦߪᱜᏱ୯ߦ࿁ᓳߒ㧘72ㅳ⋡㧔ᛩਈ⚳ੌᓟ24ㅳᤨ㧕߹ߢߦߪᛩਈ೨୯ߦᓳߒߚޕ ᅢਛᢙᷫዋߩࠣ࠼⊒㗫ᐲࠍ 2.7.6.2.8-13ߦ␜ߔ࠼ࠣޕ3㨪4ߩᅢਛᢙᷫዋࠍ ⊒ߒߚ∝ߩഀวߪ㧘PEG-IFNĮ-2a + ࡃࡆࡦ⟲߮ PEG-IFNĮ-2a න⁛⟲ߢߘࠇߙࠇ50% ߮40%ߣ㜞ߊ㧘rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# ⟲ߢߪ22%ߢߞߚޕ34ߦࠣ࠼4ߩᅢਛᢙᷫዋ߇ ⊒ߒߚ߇㧔PEG-IFNĮ-2a + ࡃࡆࡦ⟲㧦21㧘PEG-IFNĮ-2a න⁛⟲㧦8㧘rIFNĮ-2b + ࡃࡆࡦ ࠞࡊ࡞# # 㧦ᣂ⮎ᛚᖱႎឭଏᤨߦ⟎߈឵߃ߚ
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