外用重组牛碱性成纤维细胞生长因子治疗激素依赖性皮炎的随机、双盲、安慰剂对照观察

Objective To evaluate the safety and efficacy of recombinant bovine basic fibroblast growth factor in the treatment of corticosteroid-dependent dermatitis. Methods A randomized, double-blind, placebo-controlled clinical trial was carried out. By simple randomization, 64 patients with corticosteroid-dependent dermatitis were randomly and equally divided into 2 groups: treatment group topically applying recombinant bovine basic fibroblast growth factor gel twice a day for 4 consecutive weeks, and control group topically applying the gel vehicle twice a day for 4 consecutive weeks. Clinical symptoms and signs were scored before the treatment and after 1-, 2- and 4-week treatment. Meanwhile, the water content of the stratum corneum, skin sebum content and transepidermal water loss (TEWL) of the skin lesions were detected. Results Thirty-one patients in the treatment group and 30 in the control group completed the trial. The clinical symptom and sign scores in the treatment group were significantly lower at week 2 and 4 after starting treatment (1.35 ± 0.55 and 1.00 ± 0.45, respectively) than that before treatment (2.77 ± 0.43, both P < 0.05) , as well as lower at week 1 (2.06 ± 0.51) , 2 and 4 after starting treatment than that in the control group (2.43 ± 0.57, 2.17 ± 0.53, 1.93 ± 0.45, respectively, all P < 0.05) . The treatment group showed significantly increased water content of the stratum corneum at week 4 after starting treatment, significantly increased skin sebum content, but decreased TEWL at week 2 and 4 after starting treatment compared with those before treatment (all P < 0.05) . Compared with the control group, the treatment group showed significantly higher skin sebum content at week 2 and 4 after starting treatment, higher water content of the stratum corneum, but lower TEWL at week 4 after starting treatment (all P < 0.05) . No adverse reactions were observed in either of the 2 groups. Conclusion Recombinant bovine basic fibroblast growth factor is effective and safe for the treatment of corticosteroid-dependent dermatitis, and contributes to repairing and reconstructing the skin barrier function. Key words: Fibroblast growth factor 2; Treatment outcome; Drug toxicity; Corticosteroid-dependent dermatitis; Skin barrier