摘要
目的 评价外用他克莫司治疗异位性皮炎的疗效和安全性。 方法 计算机检索Cochrane图书馆 (2 0 0 3年第 2期 )、Cochrane协作网皮肤病专业试验数据库 (2 0 0 3,6 )、Medline(1996～ 2 0 0 3)、Embase(1984～ 2 0 0 3)和中国生物医学文献数据库 (CBM ,1978～ 2 0 0 3) ,手工检索发表与未发表的中文文献及CochraneSkinGroup 8thAnnualMeeting记录 ,收集所有他克莫司与安慰剂、外用皮质类固醇激素制剂的随机对照试验 ,对其逐个进行质量评价和Meta 分析。 结果 共纳入 8篇RCT ,包括 4 12 2例患者 ,均为高质量研究。对治疗有效率的Meta 分析结果显示 :0 0 3%他克莫司与安慰剂、1%醋酸氢化可的松、0 1%丁酸氢化可的松比较 ,OR合并 =3 0 3[95 %CI (1 0 5 ,8 73) ,P =0 0 4 ];0 1%他克莫司与安慰剂、1%醋酸氢化可的松、0 1%丁酸氢化可的松比较 ,OR合并 =3 84 [95 %CI (1 4 3,10 32 ) ,P =0 0 0 8) ;0 3%他克莫司与安慰剂比较 ,OR =3 2 0 [95 %CI (1 31,7 79) ,P =0 0 1\〗 ;0 1%与 0 0 3%他克莫司比较 ,OR合并 =1 4 0 [95 %CI(1 13,1 72 ) ,P =0 0 0 2 ]。所有研究均未发现严重的副作用。 结论 外用他克莫司治疗异位性皮炎比安慰剂和1%醋酸氢化可的松有效 ,而且 0 1%他克莫司比 0 0 3%他克?
Objective To evaluate efficacy and safety of topical tacrolimus(FK506)for atopic dermatitis. Methods Randomized controlled trials (RCTs) were identified from specialized trials registered in Cochrane Skin Group(July, 2003), the Cochrane Library (issue 2, 2003), Medline (19962003), Embase (19842003) and CBM (19782003). We handsearched the published and unpublished data and Cochrane Skin Group 8th Annual Meeting. RCTs comparing tacrolimus with placebo or hormone were included. Data were extracted and evaluated by two reviewers independently. Results Eight randomized controlled trials involving 4 122 patients were included,with all trials of high methodological quality. Meta-analysis indicated that 0.03% tacrolimus was more effective than placebo,1% hydrocortisone acetate and 0.1% hydrocortisone butyrate with odds ratio of 3.03 \[95% CI (1.05, 8.73), [WTBX]P=0.04\], 0.1% tacrolimus was more effective than placebo, 1% hydrocortisone acetate and 0.1% hydrocortisone butyrate with odds ratio of 3.84 \, 0.1% tacrolimus was more effective than placebo, 1% hydrocortisone acetate and 0.1% hydrocortisone butyrate with odds ratio of 3.84 \[95% CI (1.43, 10.32), [WTBX]P=0.008\], 0.3% tacrolimus was more effective than placebo with odds ratio of 3.20 \, 0.3% tacrolimus was more effective than placebo with odds ratio of 3.20 \[95% CI (1.31, 7.79), [WTBX]P=0.01\], the odds ratio of 0.1% tacrolimus vs 0.03% tacrolimus was 1.40 \, the odds ratio of 0.1% tacrolimus vs 0.03% tacrolimus was 1.40 \[95% CI (1.13, 1.72), [WTBX]P=0.002\]. No serious adverse effects were identified. . No serious adverse effects were identified. Conclusion Topical tacrolimus for atopic dermatitis is more effective than placebo and 1% hydrocortisone acetate. 0.1% tacrolimus is more effective than 0.03% tacrolimus. No conclusion could be drawn when tacrolimus is compared with 0.1% hydrocortisone butyrate. Tacrolimus tends to improve EASI scores, head and neck scores as well as HRQL scores, but more randomized controlled trials are necessary to draw definite c
出处
《中国循证医学杂志》
CSCD
2004年第5期293-299,共7页
Chinese Journal of Evidence-based Medicine
