• 四川大學(xué)華西醫(yī)院皮膚性病科,成都,610041;

目的 　評價外用他克莫司治療異位性皮炎的療效和安全性.
方法 　計算機檢索Cochrane圖書館(2003年第2期)、Cochrane協(xié)作網(wǎng)皮膚病專業(yè)試驗數(shù)據(jù)庫(2003,6)、Medline(1996～2003)、Embase(1984～2003)和中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫(CBM,1978～2003),手工檢索發(fā)表與未發(fā)表的中文文獻及Cochrane Skin Group 8th Annual Meeting記錄,收集所有他克莫司與安慰劑、外用皮質(zhì)類固醇激素制劑的隨機對照試驗,對其逐個進行質(zhì)量評價和Meta-分析.
結(jié)果 　共納入8篇RCT,包括4 122例患者,均為高質(zhì)量研究.對治療有效率的Meta-分析結(jié)果顯示:0.03%他克莫司與安慰劑、1%醋酸氫化可的松、0.1%丁酸氫化可的松比較,OR合并=3.03[95%CI(1.05,8.73),P=0.04];0.1%他克莫司與安慰劑、1%醋酸氫化可的松、0.1%丁酸氫化可的松比較,OR合并=3.84[95%CI(1.43,10.32),P=0.008);0.3%他克莫司與安慰劑比較,OR=3.20[95%CI(1.31,7.79),P=0.01];0.1%-與0.03%他克莫司比較,OR合并=1.40[95%CI(1.13,1.72),P=0.002].所有研究均未發(fā)現(xiàn)嚴(yán)重的副作用.
結(jié)論 　外用他克莫司治療異位性皮炎比安慰劑和1%醋酸氫化可的松有效,而且0.1%他克莫司比0.03%他克莫司有效,但與0.1%丁酸氫化可的松比較尚不能得出肯定結(jié)論.他克莫司對濕疹面積和嚴(yán)重程度指數(shù)積分、頭頸部積分、生活質(zhì)量積分有改善的趨勢,但尚需進行更多的隨機對照試驗才能得出肯定的結(jié)論.

引用本文： 鄧偉,郭在培,劉宏杰. 外用他克莫司治療異位性皮炎的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2004, 04(5): 293-299. doi: 復(fù)制

1. ［1］Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis[J]. Acta Derm Venereol Suppl ( Stockh ) , 1980; 92:44 -47.
2. ［2］Bos JD, Sillevis Smitt JH. Atopic dermatitis [J]. J Eur Acad Dermatol Venereol, 1996; 7 ( 11 ): 101 - 114.
3. ［3］Su JC, Kemp AS, Varigos GA, Nolan TM. Atopic eczema:its impact on the family and financial cost [ J ]. Arch Dis Child, 1997; 76(2): 159 -162.
4. ［4］Fennessy M, Coupland S, Popay J, Naysmith K. The epidemiology and experience of atopic eczema during childhood: a discussion paper on the implications of current knowledge for health care, public health policy and research [J]. J Epidemiol Community Health, 2000; 54(8): 581-589.
5. ［5］Gu H, Yan Y, Chen K, Chen XS, Cao NX, Shao CG, Ye YY. Survey on Atopic Dermatitis in china [J]. Chinese Journal of Dermatology, 2000; 33 (6): 379 - 382.
6. 顧恒,顏艷,陳昆,陳祥生,曹寧校,邵長庚,葉于運.我國特應(yīng)性皮炎流行病學(xué)調(diào)查[J].中華皮膚科雜志,2000;33(6):379～382.
7. ［6］Boguniewicz M, Leung DY. New concepts in atopic dermatitis [J]. Compr Ther, 1996; 22(3): 144-151.
8. ［7］Rudikoff D, Lebwohl. Atopic dermatitis [J]. Lancet, 1998;351(9117): 1 715 -1 721.
9. ［8］Sidbury R, Hanifin JM. Old, new, and emerging therapies for atopic dermatitis [J ]. Dermatol Clin, 2000; 18 ( 1 ): 1 -11.
10. ［9］Degreef H, Dooms-Goossens A. The new corticosteroids:are they effective and safe [J]? Dermatol Clin, 1993; 11(1): 155-160.
11. ［10］Korting HC, Kerscher MJ, Schafer-Korting M. Topical glucocorticoids with improved benefit/risk ratio: do they exist[J]? J Am Acad Dermatol, 1992; 27(1): 87 -92.
12. ［11］Xu XL, Sun JF. Advances on treatment of atopic dermatitis[J]. Chinese Journal of Dermatology, 2003, 36(2): 117 -120.
13. 徐秀蓮,孫建方.特應(yīng)性皮炎的治療進展[J].中華皮膚科雜志,2003,36(2):117～120.
14. ［12］Rajka G, Langeland T. Grading of the Severity of Atopic dermatitis [J]. Acta Derm Venereol Suppl ( Stockh ) , 1989;144: 13 - 14.
15. ［13］Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials [ J ].British Medical Journal, 2001; 323 (7 303 ): 42 - 46.
16. ［14］Boguniewicz M, Fiedler VC, Raimer S, Lawrence ID, Leung DY, Hanifin JM. A randomized, placeto-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children [J]. JAllergy Clin Immunol, 1998; 102 (4 Pt 1 ):637 - 644.
17. ［15］Reitamo S, Van Leent EJ, Ho V, Harper J, Ruzicka T,Kalimo K, Cambazard F, Rustin M, Taieb A, Gratton D,Sauder D, Sharpe G, Smith C, Junger M, de Prost Y. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis [J]. J Allergy Clin Immunol, 2002; 109(3): 539-546.
18. ［16］Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T. Efficacy and safety of tacrolimus ointme compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis[J]. J Allergy Clin Immunol, 2002; 109(3): 547-555.
19. ［17］Ruzicka T, Bieber T, SchopfE, Rubins A, Dobozy A, Bos JD, Jablonska S, Ahmed I, Thestrup-Pedersen K, Daniel F,Finzi A, Reitamo S. A short-term trial of tacrolimus ointment for atopic dermatitis [J]. N Engl J Med, 1997; 337(12):816 -821.
20. ［18］Paller A, Eichenfield LF, Leung DY, Stewart D, Appell M.A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients [J]. J Am Acad Dermatol, 2001; 44 ( 1 Suppl): S47 - 57.
21. ［19］Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E.Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part Ⅰ, efficacy [J]. J Am Acad Dermatol,2001; 44(1 Suppl): S28 -38.
22. ［20］Sorer NA, Fleischer AB Jr, Webster GF, Monroe E, Lawrence I. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients:part Ⅱ, safety[J ]. J Am Acad Dermatol, 2001; 44(1 Suppl): S39-46.
23. ［21］Drake L, Prendergast M, Maher R, Breneman D, Korman N, Satoi Y, Beusterien KM, Lawrence I. The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis [J]. J Am Acad Dermatol, 2001; 44(1 Suppl): S65 -72.
24. ［22］Kang S, Paller A, Soter N, Satoi Y, Rico MJ, Hanifin JM.Safe treatment of head/neck AD with tacrolimus ointment[J]. J Dermatolog Treat, 2003;14(2): 86-94.
25. ［23］Granlund H, Remitz A, Kyllonen H, Lauerma AI, Reitamo S. Treatment of lichenified atopic eczema with tacrolimus ointment [J]. Acta Derm Venereol, 2001; 81(4) :314 -315.
26. ［24］Kang S, Lucky AW, Pariser D, Lawrence I, Hanifin JM.Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children [ J ]. J Am Acad Dermatol, 2001; 44(1 Suppl): S58-64.
  1. 1. ［1］Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis[J]. Acta Derm Venereol Suppl ( Stockh ) , 1980; 92:44 -47.
  2. 2. ［2］Bos JD, Sillevis Smitt JH. Atopic dermatitis [J]. J Eur Acad Dermatol Venereol, 1996; 7 ( 11 ): 101 - 114.
  3. 3. ［3］Su JC, Kemp AS, Varigos GA, Nolan TM. Atopic eczema:its impact on the family and financial cost [ J ]. Arch Dis Child, 1997; 76(2): 159 -162.
  4. 4. ［4］Fennessy M, Coupland S, Popay J, Naysmith K. The epidemiology and experience of atopic eczema during childhood: a discussion paper on the implications of current knowledge for health care, public health policy and research [J]. J Epidemiol Community Health, 2000; 54(8): 581-589.
  5. 5. ［5］Gu H, Yan Y, Chen K, Chen XS, Cao NX, Shao CG, Ye YY. Survey on Atopic Dermatitis in china [J]. Chinese Journal of Dermatology, 2000; 33 (6): 379 - 382.
  6. 6. 顧恒,顏艷,陳昆,陳祥生,曹寧校,邵長庚,葉于運.我國特應(yīng)性皮炎流行病學(xué)調(diào)查[J].中華皮膚科雜志,2000;33(6):379～382.
  7. 7. ［6］Boguniewicz M, Leung DY. New concepts in atopic dermatitis [J]. Compr Ther, 1996; 22(3): 144-151.
  8. 8. ［7］Rudikoff D, Lebwohl. Atopic dermatitis [J]. Lancet, 1998;351(9117): 1 715 -1 721.
  9. 9. ［8］Sidbury R, Hanifin JM. Old, new, and emerging therapies for atopic dermatitis [J ]. Dermatol Clin, 2000; 18 ( 1 ): 1 -11.
  10. 10. ［9］Degreef H, Dooms-Goossens A. The new corticosteroids:are they effective and safe [J]? Dermatol Clin, 1993; 11(1): 155-160.
  11. 11. ［10］Korting HC, Kerscher MJ, Schafer-Korting M. Topical glucocorticoids with improved benefit/risk ratio: do they exist[J]? J Am Acad Dermatol, 1992; 27(1): 87 -92.
  12. 12. ［11］Xu XL, Sun JF. Advances on treatment of atopic dermatitis[J]. Chinese Journal of Dermatology, 2003, 36(2): 117 -120.
  13. 13. 徐秀蓮,孫建方.特應(yīng)性皮炎的治療進展[J].中華皮膚科雜志,2003,36(2):117～120.
  14. 14. ［12］Rajka G, Langeland T. Grading of the Severity of Atopic dermatitis [J]. Acta Derm Venereol Suppl ( Stockh ) , 1989;144: 13 - 14.
  15. 15. ［13］Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials [ J ].British Medical Journal, 2001; 323 (7 303 ): 42 - 46.
  16. 16. ［14］Boguniewicz M, Fiedler VC, Raimer S, Lawrence ID, Leung DY, Hanifin JM. A randomized, placeto-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children [J]. JAllergy Clin Immunol, 1998; 102 (4 Pt 1 ):637 - 644.
  17. 17. ［15］Reitamo S, Van Leent EJ, Ho V, Harper J, Ruzicka T,Kalimo K, Cambazard F, Rustin M, Taieb A, Gratton D,Sauder D, Sharpe G, Smith C, Junger M, de Prost Y. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis [J]. J Allergy Clin Immunol, 2002; 109(3): 539-546.
  18. 18. ［16］Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T. Efficacy and safety of tacrolimus ointme compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis[J]. J Allergy Clin Immunol, 2002; 109(3): 547-555.
  19. 19. ［17］Ruzicka T, Bieber T, SchopfE, Rubins A, Dobozy A, Bos JD, Jablonska S, Ahmed I, Thestrup-Pedersen K, Daniel F,Finzi A, Reitamo S. A short-term trial of tacrolimus ointment for atopic dermatitis [J]. N Engl J Med, 1997; 337(12):816 -821.
  20. 20. ［18］Paller A, Eichenfield LF, Leung DY, Stewart D, Appell M.A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients [J]. J Am Acad Dermatol, 2001; 44 ( 1 Suppl): S47 - 57.
  21. 21. ［19］Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E.Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part Ⅰ, efficacy [J]. J Am Acad Dermatol,2001; 44(1 Suppl): S28 -38.
  22. 22. ［20］Sorer NA, Fleischer AB Jr, Webster GF, Monroe E, Lawrence I. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients:part Ⅱ, safety[J ]. J Am Acad Dermatol, 2001; 44(1 Suppl): S39-46.
  23. 23. ［21］Drake L, Prendergast M, Maher R, Breneman D, Korman N, Satoi Y, Beusterien KM, Lawrence I. The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis [J]. J Am Acad Dermatol, 2001; 44(1 Suppl): S65 -72.
  24. 24. ［22］Kang S, Paller A, Soter N, Satoi Y, Rico MJ, Hanifin JM.Safe treatment of head/neck AD with tacrolimus ointment[J]. J Dermatolog Treat, 2003;14(2): 86-94.
  25. 25. ［23］Granlund H, Remitz A, Kyllonen H, Lauerma AI, Reitamo S. Treatment of lichenified atopic eczema with tacrolimus ointment [J]. Acta Derm Venereol, 2001; 81(4) :314 -315.
  26. 26. ［24］Kang S, Lucky AW, Pariser D, Lawrence I, Hanifin JM.Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children [ J ]. J Am Acad Dermatol, 2001; 44(1 Suppl): S58-64.