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- さみ いいはた
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1 30mg 2
2 ...i... iii GCP AD SIAD i
3 ii
4 ACT AD ALT GPT AST GT AUC AUC t AUC xh BU camp C max CYP DA DTM DR GCP γ-gtp LD 3MM 3M QTc SIAD t 1/2,z T 3 T 4 t max TS AD antidiuretic hormone 0 AUC 0 x AUC 3, 5 - P450 Dextromethorphan Dextrorphan - 3-Methoxymorphinan 3-ydroxymorphinan QT syndrome of inappropriate secretion of antidiuretic hormone AD iii
5 JA PC PC-129 M1 5- PC M2 4,5- DM-3109 M3 4,5- DM-3111 M4 5- PC M5 5- PC M6 DM-3105 M7 SF M8 5- PC M9 DM-3112 M10 DM-3118 M11 DM-3119 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C l C 3 C 3 C C 3 iv
6 M12 DM-3120 M13 - DM-3130 C 3 C 3 C 3 M14 DM-3153 M15 DM-3155 M16 DM-3157 M17 C 3 M-3 M18 M-4 M19 M-7 M20 M-8 M21 M-9 v
7 antidiuretic hormone AD 1 1% V 2 - V 2 - syndrome of inappropriate secretion of antidiuretic hormone SIAD SIAD AD SIAD AD V 2-1
8 ADpg/mL) SIAD msm/kg) AD 2 SIAD Bartter 3 1) 2) 3) 4) 5) 6) SIAD 1 kg ml SIAD 4 80% AD 1 pg/ml SIAD 50% AD 14 SIAD
9 SIAD I II meq/l meq/l msm/kg msm/kg meq/l mg/dl 7. 6 µg/dl III ng/ml/h 3. 5 mg/dl fmol/mg fmol/mg [ ] 1 7 [ ] SIAD AD
10 SIAD 4 1. Guillain-Barre 2. AD 3. AD SIAD 5 (meq/l) JCS Japan Coma Scale JCS I-1 JCS I-3 JCS II JCS III SIAD meq/l 100 meq/l SIAD ,054 SIAD 3,216 3,216 SIAD 469 1, ,400 2,100 4
11 SIAD AD SIAD AD ,317 45,091 18, % 13% 8 10,035 7,665 2,369 SIAD % % % % SIAD 452 1,425 10, SIAD SIAD SIAD 1) 2) 3) kg ml 4 SIAD 14,15,16 10 meq/l/24h meq/l/24h 18 meq/l/48h meq/l/48h 19 SIAD V 2-5
12 20 SIAD camp SIAD SIAD SIAD Bartter SIAD 1967 V 2 - V 2 - V 2 23,24 19 V 2 - V C 3 Cl C 3 C PC in vitro in vivo 6
13 in vitro ) 2) SIAD 129-B*-006P 129-B*-007P C*-004P 30 mg D*-001P SIAD 129-B*-005P C*-001P 129-C*-003P AD 129-C*-001P SIAD 129-C*-003P SIAD SIAD 20 7 *: 新薬承認情報提供時に置き換えた
14 19 SIAD AD 129-C*-002I 5 R(+)- S(-)-S(-)- R(+)- V S(-)- R(+)- in vivo mg 3 8 *: 新薬承認情報提供時に置き換えた
15 (1) V 2-19 V 2 - V 2 - V 2 - V V 2 - V 1a - V 1b - ela V 2 - V 2 - camp V 2 - V 1a - V 2-1/8 V 1b - V 2 - V 2 - M1 M2 M3 M4 M5 V 2 - SIAD 1993 Fujisawa 26 5 mg/kg V 2 - SIAD 2001 SIAD 1 10 mg/kg 2 10 mg/kg V 2 - (2) 30 mg/kg p.o. 1 mg/kg i.v. 30 mg/kg C max 9
16 C max 200 mg/kg p.o C C- 14 C- in vitro 86 in vivo in vitro 1-21 P450 CYP3A4 CYP2C in vitro DA 19 in vitro in vitro
17 mg/kg mg/kg 2000 mg/kg mg/kg 100 mg/kg 100 mg/kg 100 mg/kg 10 mg/kg 30 mg/kg 75 mg/kg 200 mg/kg 75 mg/kg 200 mg/kg 20 mg/kg in vitro in vivo 1 µg/ml 0.5 µg/ml 100 mg/kg 100 mg/kg 200 mg/kg 100 mg/kg 20 mg/kg 40 mg/kg 30 mg AD SIAD 11
18 ) mg 129-A*-003 2) 100 mg 129-B*-001 3) 30 mg mg B* mg/kg/ 1/60 10 mg 60 kg 1/3 3 mg 60 mg 200 mg 100 mg 30 mg mg mg C*-005P (1) SIAD SIAD 129-B*-005P mg 7 3 GCP SIAD (2) AD AD 129-C*-001P 129-A* B* mg *: 新薬承認情報提供時に置き換えた
19 (3) SIAD SIAD 129-C*-003P 129-C*-001P 30 mg AD SIAD (4) AD 129-C*-001P SIAD 129-C*-003P 30mg SIAD SIAD 129-C*-003P 129-C*-001P 129-F*-RS 13 *: 新薬承認情報提供時に置き換えた
20 AD 129-C*-001P SIAD 129-C*-003P (5) mg 129-G* * C E*-001P mg 129-* mg 129-* * *-006 (6) B*-006P 129-B*-007P C*-004P 30 mg D*-001P *: 新薬承認情報提供時に置き換えた
21
22 GCP GCP AD SIAD 30 mg 30 mg 30 mg 30 mg 129-G* mg 129-* M1 M6 M8 M10 M13 M1 M5 M8 M1 M6 M8 M10 M mg 16 *: 新薬承認情報提供時に置き換えた
23 % 30mg 129-*-002 t max t max C- 60mg t max 1.13± t max 129-*-002 t max mg t max 30 mg C max AUC 30 mg AUC AUC AUC C max mg mg C max AUC 48h mg M1 M5 AUC 48h M5 C max 17 *: 新薬承認情報提供時に置き換えた
24 P450 in vitro 3 in vitro M1 M21 30 mg 129-* M1 M6 M8 M10 M13 30 mg * M7 M15 M6 M7 30 mg * mg AUC 24h M4 M6 M7 M9 M10 C max M7 M10 t max M7 t 1/2,z t 1/2,z M6 M6 t 1/2,z 30 mg 129-* mg 30 mg 1 60 mg 2 90 mg 3 C max AUC 18 *: 新薬承認情報提供時に置き換えた
25 C max AUC M6 C max AUC M6 M6 t 1/2,z M6 C max AUC M SIAD SIAD 129-C*-001P 129-C*-003P 129-C*-004P 129-D*-001P CYP3A4 CYP2C mg 129-*-002 t max t max C- 60mg t max 1.13± t max 129-*-002 t max C µg/ml *: 新薬承認情報提供時に置き換えた
26 98.2% M1 M5 M µg/ml 85.1%89.4%87.7%87.2%83.7%95.9% M6 M7 0.1 µg/ml 99.5 % 96.5% M1 M µg/ml M3 0.1 µg/ml 14 C- M1 M6 M7 14 C- 60 mg P450 in vitro R(+)- S(-)- CYP3A4 2C8 M1 M5 M8 CYP3A4 M1 M5 M6 M8 M15 M5 M5 - M4 M17 M8 M5 M17 M15 7 M8 30 mg *-003 M7 M7 M6 in vitro M7 M6 129-*-003 M7 t max in vitro M7 20 *: 新薬承認情報提供時に置き換えた
27 C- 60 mg ± ± ±0.41% ± mg 129-* ±1.84% 14.22±3.31% * * M1 M10 M13 M15 21 *: 新薬承認情報提供時に置き換えた
28 C 3 C 3 C 3 CYP3A4 CYP2C8 CYP3A4 C 3 M5 C 3 CYP3A4 C 3 M13 C 3 CYP3A4 M17 C 3 M4 CYP3A4 C 3 M9 M18 M15 M20 C 3 M8 CYP3A4 M21 M19 C 3 M1 C 3 M11 CYP3A4 C 3 M6 CYP3A4 CYP3A4 C 3 C 3 M10 M2 C 3 M7 C 3 C M16 C 3 M3 C 3 M12 M
29 in vitro CYP CYP1A2 CYP2C9 CYP2C19 CYP2D6 CYP2E1 CYP3A4 R(+) S(-)- R(+)- 10 µm 47.5% 100 µm 17.5% CYP3A4 S(-)- 100 µm 46.6% CYP2D6 10 µm 35.2% 100 µm 5.6% CYP3A4 CYP CYP1A2 CYP2C9 CYP2C19 CYP2D6 CYP2E1 CYP3A4 R(+) S(-)-M1 R(+) S(-)-M5 R(+) S(-)-M4 (4R,5S) (4S,5R)-M2 M8 CYP3A µm 1 µm CYP3A4 10 µm 50% S(-)-M1 38.1% S(-)-M4 46.5% S(-)-M5 39.8%CYP1A2 CYP2C9 CYP2C19 CYP2D6 CYP2E1 1 µm % M1 M7 CYP CYP1A2 CYP2C9 CYP2C19 CYP2D6 CYP3A µm M7 100 µm CYP µm400 µm S- 100 µm 20 µm 50 µm, M7 100 µm CYP IC 50 CYP1A2 CYP2C9 M1 IC µm CYP2C19 M7 IC µm CYP2D6 M4 M5 IC µm CYP3A4 M3 M4 M5 IC µm CYP3A4 129-*-005 CYP3A4 129-*-006 CYP3A4 129-*-005 C max AUC C max AUC 72h M1 M5 M8 M15 AUC C max M2 M3 CYP3A4 23 *: 新薬承認情報提供時に置き換えた
30 CYP3A4 129-*-006 CYP3A4 3MM/DTM in vitro CYP3A A* B* C*-005P G* A* mg 15 mg mg mg B* mg C*-005P 30 mg mg mg mg mg G* mg 4 t max CYP3A4 129-*-005 C max AUC CYP3A4 24 *: 新薬承認情報提供時に置き換えた
31 2.5.4 AD AD 129-C*-001P 129-F*-RS AD AD 30 mg AD *: 新薬承認情報提供時に置き換えた
32 AD cm kg a meq/l msm/kg a meq/ msm/kg
33 C*-001P 1) meq/l 1) * * *: 新薬承認情報提供時に置き換えた
34 C*-001P ) ) ) 4 2 4) 2 4) ) 1) * 2) * 3) * 4)01 5) F*-RS AD 129-C*-001P * 0015* *: 新薬承認情報提供時に置き換えた
35 SIAD AD AD 129-C*-001P AD SIAD SIAD DS national hospital discharged survey SIAD 27 AD Bartter 3 SIAD meq/l a a AD AD (129-C*-001P) AD 124 meq/l ACT TS T 3 T 4 1) 2) 3) 4) 1.6 mg/dl AST GT ALT GPT 2 5) 6) 7) 29 *: 新薬承認情報提供時に置き換えた
36 AD 129-C*-001P meq/l 125 meq/l SIAD 114 meq/l 115 meq/l 124 meq/l 125 meq/l 134 meq/l 135 meq/l 5 AD 129-C*-001P C*-001P 0016* *: 新薬承認情報提供時に置き換えた
37 SIAD 31
38 AD AD 129-C*-001P 16 SIAD 129-C*-003P 12 AD SIAD AD SIAD SIAD mg mg % % % % 3 9.1% % % % 1 0.3% % % 7 2.4% 7 2.4% 32 *: 新薬承認情報提供時に置き換えた
39 SIAD AD 129-C*-001P AD 30 mg SIAD 129-C*-003P AD SIAD 30 mg B*-006P 129-B*-007P mg mg (1) SIAD AD % % 15 AD SIAD % % 8 AD % % AD % % AD SIAD γ % AD SIAD (2) % % % % % % % 33 *: 新薬承認情報提供時に置き換えた
40 10 5.8% % % 9 5.3% 9 5.3% 9 5.3% SIAD % % % % SIAD (1) SIAD SIAD 30 AD 1 (2) C*-004P (1) SIAD AD 16 AD SIAD (2) *: 新薬承認情報提供時に置き換えた
41 (1) SIAD SIAD AD AD SIAD AD 1 AD SIAD 1 6 AD 2 2 AD SIAD AD SIAD - 3 AD 1 1 AD SIAD 1 1 (2) SIAD 30mg 35
42 60mg 1 60mg 15mg SIAD AD SIAD AD AD 129-C*-002I AD BU K Ca 1 7.7ALT GPT a Cl 1 7.1% p AD SIAD 36 *: 新薬承認情報提供時に置き換えた
43 2 20.0AST GT ALT GPT LD γ-GTP a Cl 1 8.3% p % % % % Ca % Cl % % % BU % % 7 5.3% SIAD SIAD 28 3 K AD AD SIAD /159 3 /159 5 /159 γ-gtp 2 /148 2 /158 3 /152 BU 5 /161 5 /146 1 /159 2 /148 K 1 /156 1 /140 1 / AD AD SIAD AD AD SIAD
44 / / % % 66 / % 49 /70 65 / 65 AD AD SIAD % % % % 214 /SIAD % % 37 /SIAD 2 2 / SIAD SIAD / PR QRS ST QT
45 QT PR QRS RR 39
46 SIAD SIAD SIAD Bartter SIAD kg ml 4 SIAD AD EP IP AD SIAD SIAD AD 129-C*-001P 1 kg 20 ml 6 20 ml mg 1 1 AD SIAD AD SIAD 129-C*-003P 12 AD SIAD AD 40 *: 新薬承認情報提供時に置き換えた
47 200 mg mg 7 AD AD SIAD SIAD SIAD AD AD / CYP3A4 CYP3A4 C max AUC CYP3A4 SIAD ALT GT AST GPT 41
48 SIAD PR QRS QT QTc SIAD 14,15,16 10 meq/l/24h meq/l/24h 18 meq/l/48h meq/l/48h 19 AD 129-C*-001P SIAD 129-C*-003P meq/l 5 12 meq/l SIAD 10 mg/kg 30 meq/l (1) meq/l/24hr 42 *: 新薬承認情報提供時に置き換えた
49 Schrier RW, Berl T, Anderson RJ. smotic and nonosmotic control of vasopressin release. Am J Physiol ; 236 : F Zerbe R, Stropes L, Robertson G. Vasopressin function in the syndrome of inappropriate antidiuresis. Annu Rev Med ; 31 : Bartter FC, Schwartz WB. The syndrome of inappropriate secretion of antidiuretic hormone. Am J Med ; 42 : In: 13 ; 2002 : p In: 10 ; 1999 : p55.. In: ; 2000 : p10-4 The research group for population-based cancer registration in japan. Cancer incidence and incidence rates in japan in 1999: estimates based on data from 11 population-based cancer registries. Jpn J Clin ncol ; 34 : Morita T. A statistical study of lung cancer in the annual of pathological autopsy cases in Japan, from 1958 to 1997, with reference to time trends of lung cancer in the world. Jpn J Cancer Res ; 93 : Abe K, Kameya T, Yamaguchi K, Kikuchi K, Adachi I, Tanaka M et al. 35.ormon-Producing Lung Cancers. In: Becker KL, Gazdar AF, editors. The Endocrine Lung in ealth&disease. W.B.SAUDERS CMPAY ; 1984 : p550-1 Seute T, Leffers P, ten Velde GPM, Twijnstra A. eurologic disorders in 432 consecutive patients with small cell lung carcinoma. Cancer ; 100 : ainsworth JD, Workman R, Greco FA. Management of the syndrome of inappropriate antidiuretic hormone secretion in small cell lung cancer. Cancer ; 51 : List AF, ainsworth JD, Davis BW, ande KR, Greco FA, Johnson D. The syndrome of inappropriate secretion of antidiuretic hormone (SIAD) in small-cell lung cancer. J Clin ncol ; 4 : Lockton JA, Thatcher. A retrospective study of thirty-two patients with small-cell bronchogenic carcinoma and inappropriate secretion of antidiuretic hormone. Clin Radiol ; 37 :
50 Kleinschmidt-DeMasters BK, orenberg MD. Rapid correction of hyponatremia causes demyelination: relation to central pontine myelinolysis. Science ; 211 : orenberg MD, Leslie K, Robertson AS. Association between rise in serum sodium and central pontine myelinolysis. Ann eurol ; 11 : Laureno R. Central pontine myelinolysis following rapid correction of hyponatremia. Ann eurol ; 13 : Ellis SJ. Severe hyponatraemia: complications and treatment. QJM ; 88 : Sterns R, Cappuccio JD, Silver SM, Cohen EP. eurologic sequelae after treatment of severe hyponatremia: A multicenter perspective. J Am Soc ephrol ; 4 : Ayus JC, Krothapalli RK, Arieff AI. Treatment of symptomatic hyponatremia and its relation to brain damage. Engl J Med ; 317 : Tanay A, Yust I, Peresecenschi G, Abramov AL, Aviram A. Long-term treatment of the syndrome of inappropriate antidiuretic hormone secretion with phenytoin. Ann Intern Med ; 90 : De Troyer A. Demeclocycline treatment for syndrome of inappropriate antidiuretic hormone secretion. JAMA ; 237 : Forrest J Jr, Cox M, ong C, Morrison G, Bia M, Singer I. Superiority of demeclocycline over lithium in the treatment of chronic syndrome of inappropriate secretion of antidiuretic hormone. Engl J Med ; 298 : Dubb J, Allison, Tatoian D, Blumberg A, Lee K, Stote R. SK&F is antidiuretic in man. Kidney Int. 1987; 31(abstract): 267. Brooks DP, Koster PF, Albrightson-Winslow CR, Stassen FL, uffman WF, Kinter LB. SK&F is a potent antidiuretic hormone antagonist in the rhesus monkey (Macaca mulatta). J Pharmacol Exp Ther. 1988; 245: Yamamura Y, gawa, Yamashita, Chihara T, Miyamoto, akamura S, et al. Characterization of a novel aquaretic agent, PC-31260, as an orally effective, nonpeptide vasopressin V 2 receptor antagonist. Br J Pharmacol ; 105 : Fujisawa G, Ishikawa S, Tsuboi Y, kada K, Saitoh T. Therapeutic efficacy of non-peptide AD antagonist PC in SIAD rats. Kidney Int ; 44 : ational ospital Discharge Survey: 2001 annual summary with detailed diagnosis and procedure data. URL ; 2004 : p
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