Transcription of 持続性がん疼痛・慢性疼痛治療剤 Onetram Tablets
1 2021 1 2 . 2020 6 . 871149.. 3 22700 AMX00648000. 2015 6 . Onetram Tablets . Z8.. 2.. 1 1 . 12 .. 1 100mg .. 14 .. 1 . 1 1 .. 1/8 1/4 .. 1 400mg .. 4 .. 3.. 100mg . 1 .. 100mg .. 1 .. 30% 300mg .. 1/5 .. 100mg .. 75 . 134 1 . 300mg . 4.. 8.. 5.. 6.. 100 300mg 1 . 1 . 1 400mg .. 7.. 1 100mg .. 1 .. 1. 9.. 18 .. 14 .. 2. 3 .. 1 .. SSRI . 12 . 12 .. 12 . 12 .. 10.. CYP2D6 CYP3A4 .. 2. 5% 1 5% 1% .. 11.. A S T Al-P .. A L T .. LDH .. 5% 1 5% 1% .. B U N .. C K .. QT .. 3. 13.. 100mg 200mg 300mg . Cmax ng/mL 123 39 257 89 444 117.. tmax hr t1/2, hr 2 AUC0- ng hr/mL 2640 1020 5500 2480 9720 2820. M1. 100mg 200mg 300mg . Cmax ng/mL . tmax hr t1/2, hr AUC0- ng hr/mL 610 159 1290 260 2090 520. 14. n=10 . 2 24 200mg . 50mg 1 4 . M1 . M1 Cmax .. AUC0- 1 .. PTP PTP . PTP .. 15.. CYP2D6 . Ultra-rapid Metabolizer . 1 4 M1 .. 16.. 1 10 . -O.
2 M1 9 12 Cmax 6 200mg 50mg 4 . 8 t1/2, M1 Cmax Cmax ng/mL 283 66 308 67. AUC0- 1 AUC0- ng hr/mL 5880 1660 5810 1770. M1.. 200mg 50mg 4 . Cmax ng/mL AUC0- ng hr/mL 1370 450 1370 400. n=24 . 3 9 200 300mg . 1 1 5 2 . 3 . 1 .. M1 .. 1 . 12 200mg . 30 . M1 1 . 2 . 29 200mg .. M1 Cmax 50% AUC0- .. 4. 11/61 . 3/61 2/61 . 14. C- 30mg/kg 1/61 . 1 2 . 1 107. 15 13 11 100 400mg 1 1 24 . 2 . 24 10% 2 8 .. 14. C- 10 g/mL. a . 3 in vitro .. b .. O - N - 95% . % % % . 4 . 73 19 15 O - CYP2D6 N - 2 107.. CYP3A4 5 . 63 14 11 8 88.. 6 25 50 100mg . 33 5 5 24 24 43.. 12 16% 12 15% . -O - M1 15 18% M1 6 a 3 . VAS VAS .. +10mm . 21 80mL/min +20mm . 100mg +20mm . t1/2, AUC0- 2 b . % . 40/107 . 14/107 10/107 . 5/107. 12 50mg 4/107 . 1/107 . Cmax AUC0- . t1/2, . 1 NSAIDs .. 20 66 82 50mg 1 5 100 400mg/ . 8 22 171 . 47 75 4 87. 8 65 75 12 84 . Cmax AUC0- 30 50% t1/2.
3 MRT 1 . 9 P= . 17.. 100 200 300mg / . 121 . 1 1 1 . 1 4 7 .. 24 VAS . 3 3 Kaplan-Meier . VAS 212/231 . 7 146/231 138/231 . 71/231 49/231 . VAS . 33/231 . 2 NSAIDs . 61 60 . 1 5 100 400mg/ . 3 VAS .. mm a . 172 4 . 3 VAS . 88 84 . mm a .. VAS mm a 10 P< . VAS . mm .. 95% . a . 5.. 95 . Kaplan-Meier 100 . 221/244 1 20 . 165/244 111/244 180 184 . 71/244 53/244 . 44/244 21.. 22.. 100 10 PTP 10 500 10 PTP 50 . NSAIDs 23.. 171 1 1 100 400mg 1 . 2015;31 5 :431-51. 52 VAS 2 . 6 3 . 52 11 4 . 148/171 5 in vitro . 83/171 77/171 6 . 2010;26 8 :497-512. 53/171 29/171 7 . 2015;31 5 :453-68. 25/171 8 . 2015;31 5 :469-84. 9 . 2015;31 5 :485-501. 18.. 10 . 2015;31 5 :503-22. M1 11 . 2015;31 5 :523-39. 12 Frink MC, et al . : Arzneimittelforschung. 1996;46. :1029-36. 13 Raffa RB, et al . : J Pharmacol Exp Ther. 1992;260 1 :275-85. 14 Hennies HH, et al.
4 : Arzneimittelforschung. 1988;38. :877-80. 15 Kaneko K, et al . : Neurosci Lett. 2014;562 Mar 6 :28-33. M1 24.. 12 in vitro 151-8589 3-22-7. 0120-664-467. FAX 03-3379-3053.. M1 26.. 12 in vitro .. 14.. M1.. 13 .. 2- . 2 . 14 .. 15 . 19.. Tramadol Hydrochloride JAN . 1RS ,2RS -2- Dimethylamino methyl -1- 3-methoxyphenyl cyclohexanol monohydrochloride C16H25NO2 HCl 08. 6.
