アトピー性皮膚炎 九州大学医学部皮膚科学教室TOPへ
研究分担者 佐伯秀久 東京慈恵会医科大学皮膚科講師
要旨 はじめに 目的 方法 結果 考察 結論 参考文献
タクロリムス外用療法評価表一覧
評価表の見方
評価法の見方
参考文献
1) Nakagawa H, et al: Tacrolimus ointment for atopic dermatitis. Lancet 344:883, 1994.
2) Aoyama H, et al: Successful treatment of resistant facial lesions of atopic dermatitis with 0.1% FK506 ointment. Br J Dermatol 133:494-496, 1995.
3) Alaiti S, et al: Tacrolimus (FK506) ointment for atopic dermatitis: a phase I study in adults and children. J Am Acad Dermatol. 38:69-76, 1998.
4) FK506 軟膏研究会:アトピー性皮膚炎に対するFK506軟膏の濃度設定に関する後期第II相試験(その2). 西日皮膚59:427-435, 1997.
5) Ruzicka T et alA short-term trial of tacrolimus ointment for atopic dermatitis. N Engl J Med 337:816-21, 1997.
6) 石橋康正ほか:アトピー性皮膚炎に対するFK506軟膏剤の前期第II相試験成績. 臨床医薬14:2293-2311, 1998.
7) Hanifin JM, et al: Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. J Am Acad Dermatol 44:S28-38, 2001.
8) Drake L, et al:The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis. J Am Acad Dermatol 44:S65-72, 2001
9) FK506 軟膏研究会: FK506 軟膏第III相比較試験-アトピー性皮膚炎(顔面・頚部)に対するプロピオン酸アルクロメタゾン軟膏との群間比較試験-. 皮膚科紀要 92:277-288, 1997.
10) FK506 軟膏研究会: FK506 軟膏第III相比較試験-アトピー性皮膚炎(躯幹・四肢)に対する吉草酸ベタメタゾン軟膏との群間比較試験-. 西日本皮膚科 59:870-879, 1997.
11) Reitamo S, et al: Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis.J Allergy Clin Immunol 109:547-55, 2002.
12) Reitamo S, et al: Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. Arch Dermatol 136:999-1006, 2000.
13) FK506 軟膏研究会:アトピー性皮膚炎に対するFK506 (タクロリムス)軟膏の長期観察試験-2年間の成績-. 臨床医薬17:705-726, 2001.
14) Sugiura H, et al: Long-term efficacy of tacrolimus ointment for recalcitrant facial erythema resistant to topical corticosteroids in adult patients with atopic dermatitis. Arch Dermatol 136:1062-1063, 2000.
15) Boguniewicz M, et al: A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. J Allergy Clin Immunol 102:637-44, 1998.
16) Kang S, et al: Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol 44:S58-64, 2001.
17) Paller A, et al: A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol. 44:S47-57, 2001.
18) Reitamo S, et al: Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 109:539-46, 2002.
19) 大槻マミ太郎ほか: FK506 (タクロリムス) 軟膏の小児におけるアトピー性皮膚炎に対する第III相試験-軟膏基剤を対照とした二重盲検群間比較試験-. 臨床医薬 19:569-595, 2003.
20) 川島 眞ほか: FK506 (タクロリムス) 軟膏の小児アトピー性皮膚炎患者に対する長期観察試験. 臨床医薬 19:597-636, 2003.
21) Patel RR, et al: The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis. Arch Dermatol 139: 1184-1186, 2003.
22) Soter NA, et al: Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. J Am Acad Dermatol. 44:S39-46, 2001.
23) Reitamo S, et al: Tacrolimus ointment does not affect collagen synthesis: Results of a single-center randomized trial. J Invest Dermatol 111: 396-8, 1998.
24) Fleischer AB Jr, et al: Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections. J Am Acad Dermatol 47: 562-570, 2002.
25) 大槻マミ太郎ほか:小児アトピー性皮膚炎に対する FK506(タクロリムス)軟膏長期使用時の安全性および有効性の検討 二重盲検群間比較試験後の継続試験.臨床医薬21: 335-60, 2005.
26) 窪田泰夫ほか:成人アトピー性皮膚炎患者の躯幹・四肢病変に対するタクロリムス軟膏とステロイド軟膏との併用連続療法の有用性.西日皮65: 175-82, 2003.
27) 飯田晴康ほか:アトピー性皮膚炎に対するステロイド外用剤とタクロリムス軟膏のSequential療法.日皮アレルギー12 20-5, 2004.
28) 古賀哲也ほか:成人型アトピー性皮膚炎に伴う難治性顔面紅斑に対するタクロリムス軟膏とトシル酸スプラタストの併用効果検討.西日皮65: 375-80, 2003.
29) 大谷稔男ほか:顔面のアトピー性皮膚炎治療における抗アレルギー薬の有用性 顔面の皮疹に対するタクロリムス軟膏の減量維持効果.皮膚の科学3 316-22, 2004.
30) Garside R, et al: The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation. Health Technol Assess 9: 1-230, 2005.
31) El-Batawy MM, et al: Topical calcineurin inhibitors in atopic dermatitis: a systematic review and meta-analysis. J Dermatol Sci 54: 76-87, 2009.
32) Iskedjian M, et al: Topical calcineurin inhibitors in the treatment of atopic dermatitis: a meta-analysis of current evidence. Am J Clin Dermatol 5: 267-79, 2004.
33) Ashcroft DM, et al: Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomized controlled trials. BMJ 330: 516, 2005.
34) Miyachi Y, et al: Suplatast/tacrolimus combination therapy for refractory facial erythema in adult patients with atopic dermatitis: a meta-analysis study. Allegol Int 56: 269-75, 2007.
35) Yan J, et al: Meta-analysis of tacrolimus ointment for atopic dermatitis in pediatric patients. Pediatr Dermatol 25: 117-20, 2008.
36) Chapman MS, et al: US Tacrolimus Ointment Study Group Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis. J Am Acad Dermatol 53: S177-85, 2005.
37) Hanifin JM, et al; US Tacrolimus Ointment Study Group: Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. J Am Acad Dermatol 53: S186-94, 2005.
38) Schachner LA, et al; US Tacrolimus Ointment Study Group: Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients: results from a randomized, double-blind, vehicle-controlled study. Pediatrics 116: e334-42, 2005.
39) Remitz A, et al; European Tacrolimus Ointment Study Group: Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Acta Derm Venereol 87: 54-61, 2007.
40) Reitamo S, et al; European Tacrolimus Ointment Study Group: Long-term treatment with 0.1% tacrolimus ointment in adults with atopic dermatitis: results of a two-year, multicentre, non-comparative study. Acta Derm Venereol 87: 406-12, 2007.
41) Reitamo S, et al: A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol 159 :942-51, 2008.
42) Tan J, et al: Safety and efficacy of tacrolimus ointment 0.1% (Protopic) in atopic dermatitis: a Canadian open-label multicenter study. J Cutan Med Surg 8: 213-9, 2004.
43) Won CH, et al: A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea. J Dermatolog Treat 15: 30-4, 2004.
44) Paller AS, et al; Tacrolimus Ointment Study Group: Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol 52: 810-22, 2005.
45) Fleischer AB Jr, et al; US/Canada tacrolimus ointment study group: Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat 18: 151-7, 2007.
46) Reitamo S, et al; European Tacrolimus Ointment Study Group: A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol 152: 1282-9, 2005.
47) Reitamo S, et al; European Tacrolimus Ointment Group: 0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial. Br J Dermatol 150: 554-62, 2004.
48) Xhauflaire-Uhoda E, et al: Comparative effect of tacrolimus and betamethasone valerate on the passive sustainable hydration of the stratum corneum in atopic dermatitis. Dermatology 214: 328-32, 2007.
49) Furue M, et al: Dosage and adverse effects of topical tacrolimus and steroids in daily management of atopic dermatitis. J Dermatol 31: 277-83, 2004.
50) Nakahara T, et al: Intermittent topical corticosteroid/tacrolimus sequential therapy improves lichenification and chronic papules more efficiently than intermittent topical corticosteroid/emollient sequential therapy in patients with atopic dermatitis. J Dermatol 31: 524-8, 2004.
51) Hebert AA, et al: Desoximetasone 0.25% and tacrolimus 0.1% ointments versus tacrolimus alone in the treatment of atopic dermatitis. Cutis 78: 357-63, 2006.
52) Kubota Y, et al: Effect of sequential applications of topical tacrolimus and topical corticosteroids in the treatment of pediatric atopic dermatitis: an open-label pilot study. J Am Acad Dermatol 60: 212-7, 2009.
53) Wollenberg A, et al; European Tacrolimus Ointment Study Group: Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy 63: 742-50, 2008.
54) Breneman D, et al; Tacrolimus Ointment Study Group: Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol 58: 990-9, 2008.
55) Thaçi D, et al: Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol 159: 1348-56, 2008.
56) Wollenberg A, et al: Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol 159: 1322-30, 2008.
57) Harper J, et al: A multicenter study of the pharmacokinetics of tacrolimus ointment after first and repeated application to children with atopic dermatitis. J Invest Dermatol 124: 695-9, 2005.
58) Rubins A, et al: Pharmacokinetics of 0.1% tacrolimus ointment after first and repeated application to adults with moderate to severe atopic dermatitis. J Invest Dermatol 125: 68-71, 2005.
59) Krueger GG, et al: Pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adult and pediatric patients with moderate to severe atopic dermatitis. J Drugs Dermatol 6: 185-93, 2007.
60) Naylor M, et al: Non-melanoma skin cancer in patients with atopic dermatitis treated with topical tacrolimus. J Dermatolog Treat 16: 149-53, 2005.
61) Margolis DJ, et al: Lack of association between exposure to topical calcineurin inhibitors and skin cancer in adults. Dermatology 214: 289-95, 2007.
62) Arellano FM, et al: Risk of lymphoma following exposure to calcineurin inhibitors and topical steroids in patients with atopic dermatitis. J Invest Dermatol 127: 808-16, 2007.
63) Park CW, et al: Tacrolimus reduces staphylococcal colonization on the skin in Korean atopic dermatitis patients. Drugs Exp Clin Res 31: 77-87, 2005.
64) Hashizume H, et al: Comparable risk of herpes simplex virus infection between topical treatments with tacrolimus and corticosteroids in adults with atopic dermatitis. Br J Dermatol 154: 1204-6, 2006.
65) Freeman AK, et al: Tacrolimus ointment in the treatment of eyelid dermatitis. Cutis 73: 267-71, 2004.
66) Nivenius E, et al: Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis. Eye 21: 968-75, 2007.
67) Kawashima M; QOL Research Forum for Patients with Atopic Dermatitis: Quality of life in patients with atopic dermatitis: impact of tacrolimus ointment. Int J Dermatol 45: 731-6, 2006.
68) Kondo Y, et al: Short-term efficacy of tacrolimus ointment and impact on quality of life. Pediatr Int 5: 385-9, 2009.
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九州大学医学部皮膚科学教室TOPへ