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

【摘要】 目的 观察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有效性及安全性。方法 采用随机、双盲、安慰剂对照试验，采用简单随机化方法将激素依赖性皮炎患者随机分为治疗组和对照组各32例，治疗组外用重组牛碱性成纤维细胞生长因子，对照组外用其基质，每天2次，连续使用4周。分别于治疗前和治疗1周、2周及4周时进行临床症状及体征评分，同时测定皮损处皮肤角质层含水量、表皮皮脂含量和经皮水分丢失。结果 治疗组31例、对照组30例完成试验。治疗组治疗2周、4周时临床症状及体征评分分别为1.35 ± 0.55、1.00 ± 0.45，明显低于治疗前（2.77 ± 0.43，均P < 0.05），且治疗1周（2.06 ± 0.51）、2周、4周时评分显著低于对照组（分别为2.43 ± 0.57、2.17 ± 0.53、1.93 ± 0.45，均P < 0.05）。与治疗前相比，治疗组治疗4周时皮肤角质层含水量升高，治疗2周、4周时表皮皮脂含量升高，经皮水分丢失减少，差异均有统计学意义（P < 0.05）；与对照组相比，治疗组治疗2周、4周时表皮皮脂含量升高，4周时皮肤角质层含水量升高，经皮水分丢失降低，差异均有统计学意义（P < 0.05）。两组均未出现不良反应。结论 重组牛碱性成纤维细胞生长因子治疗激素依赖性皮炎安全、有效，有助于皮肤屏障功能的修复和重建。

ecombinant bovine basic fibroblast growth factor for the treatment of corticosteroid-dependent dermatitis: a randomized double-blind placebo-controlled trial

Wang Weixia, Li Min, Deng Li′na, Wu Huajuan, Wu Ting, Li Yunfei, Li Xueli Department of Dermatology, Henan Provincial People′s Hospital, Zhengzhou 450003, China Corresponding author: Li Xueli, Email: lixueli0316@139.com 【Abstract】 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.