1. Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology-drug disposition, action and therapy in infants and children. N Engl J
Med 2003; 349: 1157-1167.
2. 越前宏俊，図解薬理学. 病態生理から考える薬の効くメカニズムと治療戦略 第2版. 医学書院 2008: 5.
3. 厚生労働省. 内服薬処方せんの記載方法のあり方に関する検討会報告書. 平成22年１ 月 (http://www.mhlw.go.jp/shingi/2010/01/s0129-4.html, accessed on
Oct. 4, 2011).
4. Heimann G. Enteral absorption and bioavailability in children in relation to age. Eur J Clin Pharmaocol 1980; 18: 43-50.
5. Huang NN, High RH. Comparison of serum levels following the adminsitariton of oral and paranteral preparations of penicillin to infants and children of
various age groups. J Pediatr 1953; 42: 657-658.
6. Lin JH, Yamazaki M. Role of P-glycoprotein in pharmacokinetics: clinical implications. Clin Pharmacokinet 2003; 42: 59-98.
7. Masuda S, Uemoto S, Goto M, et al. Tacrolimus therapy according to mucosal MDR1 levels in small-bowel transplant recipients. Clin Pharmacol Ther
2004; 75: 352-361.
8. Maples HD, James LP, Stowe CD. Special pharmacokinetis and pharmacodynamic considerations in children. In: Burton ME, Shaw LM, Schentag
JJ and Evans WE eds. Applied Pharmacokinetics & Pharmacodynamics, 4th ed. Philadelphia, Lippincott Wiliams & Wilkins 2004: 213-259.
9. Siber GR, Echeverria P, Smith AL, et al. Pharmacokinetics of gentamicin in children and adults. J Infect Dis 1975; 132: 647-651.
10. Stevens JC, et al. Developmental expression of the major human hepatic CYP3A enzymes. J Pharmacol Exp Ther 2003; 307: 573-582.
11. de Wildt SN, Kearns GI, LeederJS, et al. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet 1999; 37: 485-505.
12. Koukouritaki SB, Manro JR, Marsh SA, et al. Developmental expression of human hepatic CYP2C9 and CYP2C19. J Pharmacol Exp Ther 2004;
308: 965-974.
13. Kraus DM, Fischer JH, Reitz SJ, et al. Alterations in theophylline metabolism during the first year of life. Clin Pharmacol Ther 1993; 54: 351-359.
14. Blake MJ, Gaedigk A, Pearce RE, et al. Ontogeny of dextromethorphan O-and N-demethylation in the first year of life. Clin Pharmacol Ther 2007;
81: 510-516.
15. Yong WS, Lietman PS. Chloramphenicol glucuronyl transferase: assay, ontogeny, and inducibility. J Pharmacol Exp Ther 1978; 204: 203-211.
16. Miyagi S, Collier AC. Pediatric development of glucuronidation: the ontogeny of hepatic UGT1A4. Drug Metab Dispos 2007; 35: 1587-1591.
17. Soars MG, et al. In vitro analysis of human drug glucuronidation and prediction of in vivo metabolic clearance. J Pharmacol Exp Ther 2002; 301:
382-390.
18. Choonara IA, et al. Morphine metabolism in children. Br J Clin Pharmacol 1989; 28: 599-604.
19. Kanamori M, Takahashi H, Echizen H. Developmental changes in the liver weight-and body weight-normalized clearance of theophylline, phenytoin
and cyclosporine in children. Int J Clin Pharmacol Ther 2002; 40: 485-492.
20. Blanco JG, Harrison PL, Evans WE, et al. Human cytochrome P450 maximal activities in pediatric versus adult liver. Drug Metab Dispos 2000; 28:
379-382.
21. Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children.
Clin Pharmacokinet 2006; 45: 931-956.
22. Brion LP, Fleischman AR, Schwartz GJ. Gentamicin interval in newborn infants as determined by renal function and postconceptional age. Pediatr
Nephrol 1991; 5: 675-679.
23. Sullivan JE, Witte MK, Yamashita TS, et al. Pharmacokinetics of bumetanide in critically ill infants. Clin Pharmacol Ther 1996; 60: 405-413.
24. Takahashi H, Ishikawa S, Nomoto S, et al. Developmental changes in pharmacokinetics and pharmacodynamics of warfarin enantiomers in Japanese
children. Clin Pharmacol Ther 2000; 68: 541-555.
25. Peters F, Geisthovel F, Breckwoldt M. Serum prolactin levels in women with excessive milk production. Normalization by transitory prolactin inhibition.
Acta Endocrinol (Copenh) 1985; 109: 463-466.
26. Harenberg J, Leber G, Zimmermann R, et al. Prevention of thromboembolism with low-molecular weight heparin in pregnancy. Geburtshilfe Frauenheilkd
1987; 47: 15-18.
27. Ito S, et al. Xenobiotic transporter expression and function in the human mammary gland. Adv Drug Deliv Rev 2003; 55: 653-665.
28. Jonker JW, et al. The breast cancer resistance protein BCRP (ABCG2) concentrates drugs and cartinogenic xenotoxins into milk. Nat Med 2005; 11:
127-129.
29. Pittard WB III, Glazier H. Procainamide excretion in human milk. J Pediatr 1983; 102: 631-633.
30. Koren G, et al. Pharmacogenetics of morphine poisoning in a breastfed neonate of a codein-prescribed mother. LANCET 2006; 368: 704.
31. Redman CWG, et al. The excretion of enalapril and enalaprilat in human breast milk. Eur J Clin Pharmacol 1990; 38: 99.
32. Friis-Hansen B. Water distribution in the foetus and newborn infant. Acta Paediatr Scand 1983; Suppl 305: 7-11.
33. Pacifici GM, et al. Effects of development, aging, and renal and hepatic insufficiency as well as hemodialysis on the plasma concentrations of albumin
and α1-acid glycoprotein : implications for binding of drugs. Ther Drug Monit 1986; 8: 259-263.
34. Devlin RG, Fleiss PM. Captopril in human blood and breast milk.J Clin Pharmacol 198; 21: 110-113.
35. Smith MT, Livingstone I, Hooper WD, et al. Propranolol, propranolol glucuronide, and naphthoxylactic acid in breast milk and plasma. Ther Drug Monit
1983; 5: 87-93.
36. Ehrenkranz RA, Ackerman BA, Hulse JD. Nifedipine transfer into human milk. J Pediatr 1989; 114: 478-480.
37. Liedholm H, Melander A, Bitzen PO, et al. Accumulation of atenolol and metoprolol in human breast milk. Eur J Clin Pharmacol 1981; 20: 229-231.
38. O’Hare MF, Murnaghan GA, Russell CJ, et al. Sotalol as a hypotensive agent in pregnancy. Br J Obstet Gynaecol 1980; 87: 814-820.
39. Taddio A, Oskamp M, Ito S, et al. Is nifedipine use during labour and breast-feeding safe for the neonate? Clin Invest Med 1996; 19 (4 Suppl): S11.
40. Bartels P, Hanff L, Mathot R, et al. Nicardipine in preeclamptic patients: placental transfer and disposition in breast milk. BJOG 2006; 114: 230-233.
41. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk. Clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988; 14: 217-240.
42. Leitz F, Bariletto S, Gural R, et al. Secretion of labetalol in breast milk of lactating women. Fed Proc 1983; 42: 378.
43. Boutroy MJ, Bianchetti G, Dubruc C, et al. To nurse when receiving acebutolol: is it dangerous for the neonate? Eur J Clin Pharmacol 1986; 30:
737-739.
44. Ito S, et al. A novel index for expressing exposure of the infant to drug in breast milk. Br J Clin Pharmacol 1994; 38: 99-102.
45. Ito S. Drug therapy for breast-feeding women. N Eng J Med 2000; 343: 118-126.
46. Moretti ME, Ito S, Koren G. Therapeutic drug monitoring in the lactating patient. Reprod Toxicol 1995; 9: 580-581.
47. American Academy of Pediatrics. Policy Statement Breastfeeding and the Use of Human Milk. 2005; Pediatrics 115: 496-506.
48. 厚生労働省.「 授乳・離乳の支援ガイド」の策定について. http://www.mhlw.go.jp/shingi/2007/03/s0314-17.html
49. 日本小児科学会栄養委員会. 若手医師に伝えたい母乳の話. 日小誌 2007; 111: 922-941.
50. Gideon Koren. Maternal-Fetal Toxicology 2nd. (Gideon Koren). MARCEL DEKKER, INC. 1994: 1-7.
51. 加藤隆一. 臨床薬物動態学. 南江堂: 257-259.
52. Syme MR, Paxton JW, Keelan JA. Drug transfer and Metabolism by the Human Placenta. Clin Pharmacokinet 2004; 43: 487-514.
53. Gedeon C, Koren G. Designing Pregnancy Centered Medications: Drugs Which Do Not Cross the Human Placenta. Placenta 2006; 27: 861-868.
54. 松永民秀，丸山昌孝，大森栄．胎児におけるシトクロムP450 の発現 2008; 56: 7-16.
55. 林昌洋，佐藤孝道，北川浩明．妊娠と薬 第2版．じほう: 7-11.
56. Shotan A, Widerhorn J, Hurst A, et al. Risks of angiotensin converting enzyme inhibition during pregnancy: experimental and clinical evidence,
potential mechanisms, and recommendations for use. Am J Med 1994; 96: 451-456.
57. Buttar HS. An overview of the influence of ACE inhibitors on fetal placental circulation and perinatal development. Mol Cell Biochem 1997; 176 (1-2):
61-71.
58. Quan A. Fetopathy associated with exposure to angiotensin converting enzyme inhibitors and angiotensin receptor antagonists. Early Hum Dev
2006; 82: 23-28.
59. Boubred F, Vendemmia M, Garcia-Meric P, et al. Effects of maternally administered drugs on the fetal and neonatal kidney. Drug Saf 2006; 29:
397-419.
60. Mastrobattista JM. Angiotensin converting enzyme inhibitors in pregnancy. Semin Perinatol 1997; 21: 124-134.
61. Saji H, Yamanaka M, Hagiwara A, et al. Losartan and fetal toxic effects. Lancet 2001; 357: 363.
62. Lambot M-A, Vermeylen D, Noel J-C. Angiotensin-IIreceptor inhibitors in pregnancy. Lancet 2001; 357: 1619-1620.
63. Martinovic J, Benachi A, Laurent N, et al. Fetal toxic effects and angiotensin-II-receptor antagonists. Lancet 2001; 358: 241-242.
64. Schaefer C. Angiotensin II-receptor-antagonists: further evidence of fetotoxicity but not teratogenicity. Birth Defects Res Part A Clin Mol Teratol
2003; 67: 591-594.
65. Alwan S, Polifka JE, Friedman JM. Angiotensin II receptor antagonist treatment during pregnancy. Birth Defects Res A Clin Mol Teratol 2005; 73:
123-130.
66. 瀬口春道，他監訳．ムーア人体発生学 第7版: 315-316.
67. 海野信也．出生前小児科学，五十嵐隆編. 小児科学 第9版. 文光堂: 115-136.
68. 若槻明彦. 羊水の生理学的意義. 産科と婦人科 2011; 78: 1185-1187.
69. Gideon Koren. Maternal-Fetal Toxicology 2nd. (Gideon Koren). MARCEL DEKKER, INC. 1994: 302.
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2. 越前宏俊，図解薬理学. 病態生理から考える薬の効くメカニズムと治療戦略 第2版. 医学書院 2008: 5.
3. 厚生労働省. 内服薬処方せんの記載方法のあり方に関する検討会報告書. 平成22年１ 月 (http://www.mhlw.go.jp/shingi/2010/01/s0129-4.html, accessed on
Oct. 4, 2011).
4. Heimann G. Enteral absorption and bioavailability in children in relation to age. Eur J Clin Pharmaocol 1980; 18: 43-50.
5. Huang NN, High RH. Comparison of serum levels following the adminsitariton of oral and paranteral preparations of penicillin to infants and children of
various age groups. J Pediatr 1953; 42: 657-658.
6. Lin JH, Yamazaki M. Role of P-glycoprotein in pharmacokinetics: clinical implications. Clin Pharmacokinet 2003; 42: 59-98.
7. Masuda S, Uemoto S, Goto M, et al. Tacrolimus therapy according to mucosal MDR1 levels in small-bowel transplant recipients. Clin Pharmacol Ther
2004; 75: 352-361.
8. Maples HD, James LP, Stowe CD. Special pharmacokinetis and pharmacodynamic considerations in children. In: Burton ME, Shaw LM, Schentag
JJ and Evans WE eds. Applied Pharmacokinetics & Pharmacodynamics, 4th ed. Philadelphia, Lippincott Wiliams & Wilkins 2004: 213-259.
9. Siber GR, Echeverria P, Smith AL, et al. Pharmacokinetics of gentamicin in children and adults. J Infect Dis 1975; 132: 647-651.
10. Stevens JC, et al. Developmental expression of the major human hepatic CYP3A enzymes. J Pharmacol Exp Ther 2003; 307: 573-582.
11. de Wildt SN, Kearns GI, LeederJS, et al. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet 1999; 37: 485-505.
12. Koukouritaki SB, Manro JR, Marsh SA, et al. Developmental expression of human hepatic CYP2C9 and CYP2C19. J Pharmacol Exp Ther 2004;
308: 965-974.
13. Kraus DM, Fischer JH, Reitz SJ, et al. Alterations in theophylline metabolism during the first year of life. Clin Pharmacol Ther 1993; 54: 351-359.
14. Blake MJ, Gaedigk A, Pearce RE, et al. Ontogeny of dextromethorphan O-and N-demethylation in the first year of life. Clin Pharmacol Ther 2007;
81: 510-516.
15. Yong WS, Lietman PS. Chloramphenicol glucuronyl transferase: assay, ontogeny, and inducibility. J Pharmacol Exp Ther 1978; 204: 203-211.
16. Miyagi S, Collier AC. Pediatric development of glucuronidation: the ontogeny of hepatic UGT1A4. Drug Metab Dispos 2007; 35: 1587-1591.
17. Soars MG, et al. In vitro analysis of human drug glucuronidation and prediction of in vivo metabolic clearance. J Pharmacol Exp Ther 2002; 301:
382-390.
18. Choonara IA, et al. Morphine metabolism in children. Br J Clin Pharmacol 1989; 28: 599-604.
19. Kanamori M, Takahashi H, Echizen H. Developmental changes in the liver weight-and body weight-normalized clearance of theophylline, phenytoin
and cyclosporine in children. Int J Clin Pharmacol Ther 2002; 40: 485-492.
20. Blanco JG, Harrison PL, Evans WE, et al. Human cytochrome P450 maximal activities in pediatric versus adult liver. Drug Metab Dispos 2000; 28:
379-382.
21. Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children.
Clin Pharmacokinet 2006; 45: 931-956.
22. Brion LP, Fleischman AR, Schwartz GJ. Gentamicin interval in newborn infants as determined by renal function and postconceptional age. Pediatr
Nephrol 1991; 5: 675-679.
23. Sullivan JE, Witte MK, Yamashita TS, et al. Pharmacokinetics of bumetanide in critically ill infants. Clin Pharmacol Ther 1996; 60: 405-413.
24. Takahashi H, Ishikawa S, Nomoto S, et al. Developmental changes in pharmacokinetics and pharmacodynamics of warfarin enantiomers in Japanese
children. Clin Pharmacol Ther 2000; 68: 541-555.
25. Peters F, Geisthovel F, Breckwoldt M. Serum prolactin levels in women with excessive milk production. Normalization by transitory prolactin inhibition.
Acta Endocrinol (Copenh) 1985; 109: 463-466.
26. Harenberg J, Leber G, Zimmermann R, et al. Prevention of thromboembolism with low-molecular weight heparin in pregnancy. Geburtshilfe Frauenheilkd
1987; 47: 15-18.
27. Ito S, et al. Xenobiotic transporter expression and function in the human mammary gland. Adv Drug Deliv Rev 2003; 55: 653-665.
28. Jonker JW, et al. The breast cancer resistance protein BCRP (ABCG2) concentrates drugs and cartinogenic xenotoxins into milk. Nat Med 2005; 11:
127-129.
29. Pittard WB III, Glazier H. Procainamide excretion in human milk. J Pediatr 1983; 102: 631-633.
30. Koren G, et al. Pharmacogenetics of morphine poisoning in a breastfed neonate of a codein-prescribed mother. LANCET 2006; 368: 704.
31. Redman CWG, et al. The excretion of enalapril and enalaprilat in human breast milk. Eur J Clin Pharmacol 1990; 38: 99.
32. Friis-Hansen B. Water distribution in the foetus and newborn infant. Acta Paediatr Scand 1983; Suppl 305: 7-11.
33. Pacifici GM, et al. Effects of development, aging, and renal and hepatic insufficiency as well as hemodialysis on the plasma concentrations of albumin
and α1-acid glycoprotein : implications for binding of drugs. Ther Drug Monit 1986; 8: 259-263.
34. Devlin RG, Fleiss PM. Captopril in human blood and breast milk.J Clin Pharmacol 198; 21: 110-113.
35. Smith MT, Livingstone I, Hooper WD, et al. Propranolol, propranolol glucuronide, and naphthoxylactic acid in breast milk and plasma. Ther Drug Monit
1983; 5: 87-93.
36. Ehrenkranz RA, Ackerman BA, Hulse JD. Nifedipine transfer into human milk. J Pediatr 1989; 114: 478-480.
37. Liedholm H, Melander A, Bitzen PO, et al. Accumulation of atenolol and metoprolol in human breast milk. Eur J Clin Pharmacol 1981; 20: 229-231.
38. O’Hare MF, Murnaghan GA, Russell CJ, et al. Sotalol as a hypotensive agent in pregnancy. Br J Obstet Gynaecol 1980; 87: 814-820.
39. Taddio A, Oskamp M, Ito S, et al. Is nifedipine use during labour and breast-feeding safe for the neonate? Clin Invest Med 1996; 19 (4 Suppl): S11.
40. Bartels P, Hanff L, Mathot R, et al. Nicardipine in preeclamptic patients: placental transfer and disposition in breast milk. BJOG 2006; 114: 230-233.
41. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk. Clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988; 14: 217-240.
42. Leitz F, Bariletto S, Gural R, et al. Secretion of labetalol in breast milk of lactating women. Fed Proc 1983; 42: 378.
43. Boutroy MJ, Bianchetti G, Dubruc C, et al. To nurse when receiving acebutolol: is it dangerous for the neonate? Eur J Clin Pharmacol 1986; 30:
737-739.
44. Ito S, et al. A novel index for expressing exposure of the infant to drug in breast milk. Br J Clin Pharmacol 1994; 38: 99-102.
45. Ito S. Drug therapy for breast-feeding women. N Eng J Med 2000; 343: 118-126.
46. Moretti ME, Ito S, Koren G. Therapeutic drug monitoring in the lactating patient. Reprod Toxicol 1995; 9: 580-581.
47. American Academy of Pediatrics. Policy Statement Breastfeeding and the Use of Human Milk. 2005; Pediatrics 115: 496-506.
48. 厚生労働省.「 授乳・離乳の支援ガイド」の策定について. http://www.mhlw.go.jp/shingi/2007/03/s0314-17.html
49. 日本小児科学会栄養委員会. 若手医師に伝えたい母乳の話. 日小誌 2007; 111: 922-941.
50. Gideon Koren. Maternal-Fetal Toxicology 2nd. (Gideon Koren). MARCEL DEKKER, INC. 1994: 1-7.
51. 加藤隆一. 臨床薬物動態学. 南江堂: 257-259.
52. Syme MR, Paxton JW, Keelan JA. Drug transfer and Metabolism by the Human Placenta. Clin Pharmacokinet 2004; 43: 487-514.
53. Gedeon C, Koren G. Designing Pregnancy Centered Medications: Drugs Which Do Not Cross the Human Placenta. Placenta 2006; 27: 861-868.
54. 松永民秀，丸山昌孝，大森栄．胎児におけるシトクロムP450 の発現 2008; 56: 7-16.
55. 林昌洋，佐藤孝道，北川浩明．妊娠と薬 第2版．じほう: 7-11.
56. Shotan A, Widerhorn J, Hurst A, et al. Risks of angiotensin converting enzyme inhibition during pregnancy: experimental and clinical evidence,
potential mechanisms, and recommendations for use. Am J Med 1994; 96: 451-456.
57. Buttar HS. An overview of the influence of ACE inhibitors on fetal placental circulation and perinatal development. Mol Cell Biochem 1997; 176 (1-2):
61-71.
58. Quan A. Fetopathy associated with exposure to angiotensin converting enzyme inhibitors and angiotensin receptor antagonists. Early Hum Dev
2006; 82: 23-28.
59. Boubred F, Vendemmia M, Garcia-Meric P, et al. Effects of maternally administered drugs on the fetal and neonatal kidney. Drug Saf 2006; 29:
397-419.
60. Mastrobattista JM. Angiotensin converting enzyme inhibitors in pregnancy. Semin Perinatol 1997; 21: 124-134.
61. Saji H, Yamanaka M, Hagiwara A, et al. Losartan and fetal toxic effects. Lancet 2001; 357: 363.
62. Lambot M-A, Vermeylen D, Noel J-C. Angiotensin-IIreceptor inhibitors in pregnancy. Lancet 2001; 357: 1619-1620.
63. Martinovic J, Benachi A, Laurent N, et al. Fetal toxic effects and angiotensin-II-receptor antagonists. Lancet 2001; 358: 241-242.
64. Schaefer C. Angiotensin II-receptor-antagonists: further evidence of fetotoxicity but not teratogenicity. Birth Defects Res Part A Clin Mol Teratol
2003; 67: 591-594.
65. Alwan S, Polifka JE, Friedman JM. Angiotensin II receptor antagonist treatment during pregnancy. Birth Defects Res A Clin Mol Teratol 2005; 73:
123-130.
66. 瀬口春道，他監訳．ムーア人体発生学 第7版: 315-316.
67. 海野信也．出生前小児科学，五十嵐隆編. 小児科学 第9版. 文光堂: 115-136.
68. 若槻明彦. 羊水の生理学的意義. 産科と婦人科 2011; 78: 1185-1187.
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文献
小児期心疾患における薬物療法ガイドライン
Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases （ JCS2012）
Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases （ JCS2012）