Topical Tacrolimus For Atopic Dermatitis: A Systematic Review

Objective: To evaluate the efficacy and safety of topical tacrolimus (FK506) for atopic dermatitis.Methods: A systematic review of all the relevant randomized controlled trials (RCTs) was performed according to International Cochrane Collaboration. The electronic databases were searched including Cochrane Skin Group, the Cochrane library, additional electronic search including MEDLINE, EMBASE and Chinese Biology and Medical disc(CBM). References of above searched articles, Chinese Journal of Dermatology, Chinese Journal of Dermatovenerology, Journal of Clinical Dermatology, China Journal of Leprosy and Skin Disease, Journal of Dermatology and Venereology, and Foreign Medical Sciences(Section of dermatology and venereology) were hand searched. The RCT studies meeting the inclusion criteria were selected. Assessing the quality of the collected materials according to thefollowing principles: 1.allocation concealment; 2.follow up and how to deal with them; 3.double blind or trible blind; 4.comparability of each group's baseline;5.the estimate of the effects of the treatments; 6.complete results presentation. And extract data with well-designed form. Jadad scale and degree of randomization allocation concealment were used to evaluate methodological quality of trials. After that, homogeneity, Meta-analysis and sensitivity analysis were used by RevMan4.2. If Meta-analysis can't be done, qualitative descriptions were made.Major results: Eight randomized clinical trials including 4122 patients were included? with all trials of high methodological quality. Meta-analysis of effective rate indicated that comparing 0.03% tacrolimus with vehicle, l%hydrocortisone acetate and 0.1% hydrocortisone butyrate odds ratio was 3.03 (95% confidenceinterval[l.05,8.73],/M).O4) , comparing0.1% tacrolimus with vehicle , l%hydrocortisone acetate and 0.1% hydrocortisone butyrate odds ratio was 3.84 (95% confidence interval[1.43,10.32], /MX006), comparing 0.3% tacrolimus with vehicle odds ratio was 3.20 ( 95% confidence interval[l.31,7.79], P=0.0l) comparing 0.1% as well as 0.03% tacrohmus odds ratio was 1.40 (95% confidence interval[1.13,1.72], P=0.002) . No serious adverse effects were found.Conclusion: Topical tacrolimus for atopic dermatitis is more effective thanvehicle and 1% hydrocortisone acetate. 0.1% tacrolimus is more effective than 0.03% tacrolimus, but it could not be identified compared with 0.1% hydrocortisone butyrate. Tacrolimus had the trend of improving EASI scores, head and neck scores as well as QOL scores, but further and more randomized controlled trials are necessary to draw definite conclusions.