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

doi:10.3760/cma.j.issn.0412-4030.2018.03.014

摘要/Abstract

摘要： 【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。

关键词: 成纤维细胞生长因子2, 治疗结果, 药物毒性, 激素依赖性皮炎, 皮肤屏障

Abstract: 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.

Key words: Fibroblast growth factor 2, Treatment outcome, Drug toxicity, Corticosteroid?dependent dermatitis, Skin barrier

王伟霞李敏邓丽娜吴华娟毋婷李云飞李雪莉. 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[J]. 中华皮肤科杂志, 2018, 51(3): 217-220.

参考文献 13

［1］	吴琰瑜, 王学民. 外用糖皮质激素对皮肤屏障系统的影响［J］.国际皮肤性病学杂志, 2011,37（5）:289⁃291. doi: 10.3760/cma.j.issn.1673⁃4173.2011.05.009.<br />
［2］	Shibata M, Katsuyama M, Onodera T, et al. Glucocorticoids enhance Toll⁃like receptor 2 in human keratino⁃cytes stimulated with Propionibacterium acnes or proinflammatory cytokines［J］. J Invest Dermatol, 2009,129（2）:375⁃382. doi: 10.1038/jid.2008.237.<br />
［3］	Drummond PD, Su D. Endothelial and axon reflex vasodilatation to acetylcholine in rosacea⁃affected skin［J］. Arch Dermatol Res, 2012,304（2）:133⁃137. doi: 10.1007/s00403⁃011⁃1177⁃1.<br />
［4］	Whitfeld M, Gunasingam N, Leow LJ, et al. Staphylococcus epidermidis: a possible role in the pustules of rosacea［J］. J Am Acad Dermatol, 2011,64（1）:49⁃52. doi: 10.1016/j.jaad.2009.12. 036.<br />
［5］	常远. 他克莫司软膏联合重组牛碱性成纤维细胞生长因子凝胶治疗面部激素依赖性皮炎的疗效观察［J］. 中国医药指南, 2015,13（13）:84⁃85.<br />
［6］	王娟. 强脉冲光540 nm联合重组牛碱性成纤维细胞生长因子治疗面部毛细血管扩张症的临床疗效［J］. 中华医学美学美容杂志, 2010,16（4）:220⁃223. doi: 10.3760/cma.j.issn.1671⁃0290. 2010.04.002.<br />
［7］	中国医师协会皮肤科分会美容专业组. 激素依赖性皮炎诊治指南［J］. 临床皮肤科杂志, 2009,38（8）:549⁃550. doi: 10.3969/j.issn.1000⁃4963.2009.08.038.<br />
［8］	蒋献, 冀然, 陆华, 等. 理肤泉舒缓喷雾对女性颜面再发性皮炎辅助治疗作用的随机对照研究［J］. 四川大学学报（医学版）, 2008,39（2）:343⁃344. doi: 10.3969/j.issn.1672⁃173X.2008.02.051.<br />
［9］	Schoepe S, Schäcke H, May E, et al. Glucocorticoid therapy⁃induced skin atrophy［J］. Exp Dermatol, 2006,15（6）:406⁃420. doi: 10.1111/j.0906⁃6705.2006.00435.x.<br />
［10］	何黎. 皮肤屏障与相关皮肤病［J］. 中华皮肤科杂志, 2012,45（6）:455⁃457. doi: 10.3760/cma.j.issn.0412⁃4030.2012.06.031.<br />
［11］	周镜桂, 谢思田, 张明君, 等. 碱性成纤维细胞生长因子在活性全层皮肤构建中的作用［J］. 汕头大学医学院学报, 2014,27（2）:84⁃85. doi: 10.13401/j.cnki.jsumc.2014.02.001.<br />
［12］	Matsumine H. Treatment of skin avulsion injuries with basic fibroblast growth factor［J/OL］. Plast Reconstr Surg Glob Open, 2015,3（4）:e371［2017⁃11⁃06］. http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC4422202&blobtype=pdf. doi: 10.1097/ GOX.0000000000000341.<br />
［13］	卫秀洋. 碱性成纤维细胞生长因子在组织修复的研究进展［J］.中国矫形外科杂志, 2011,19（13）:1108⁃1110. doi: 10.3977/j.issn.1005⁃8478.2011.13.13.<br />

[1]	梁源刘玲玲王珊赵作涛马琳向欣顾恒陈崑王华易红陈谨萍张金桃姚志荣郭一峰陈戟程颖朱学骏. 0.03%他克莫司软膏长期间歇维持治疗儿童特应性皮炎的多中心随机对照临床研究[J]. 中华皮肤科杂志, 2019, 52(8): 519-524.
[2]	雷杰豪樊奇敏陈荣许爱娥. 白癜风患者窄谱中波紫外线治疗效果与光疗反应的关系及相关因素分析[J]. 中华皮肤科杂志, 2019, 52(4): 259-262.
[3]	翟寒月宋益兴. 585 nm脉冲染料激光治疗儿童传染性软疣的临床观察[J]. 中华皮肤科杂志, 2019, 52(3): 195-197.
[4]	王刚. 皮肤科生物制剂的主要不良反应及对策[J]. 中华皮肤科杂志, 2019, 52(2): 77-80.
[5]	向睿宇冯素英. 疫苗相关的皮肤不良反应[J]. 中华皮肤科杂志, 2019, 52(2): 128-131.
[6]	关欣张春雷. 英夫利西单抗长疗程治疗中重度寻常性银屑病的疗效评价[J]. 中华皮肤科杂志, 2019, 52(2): 86-89.
[7]	张南王莲刘莲张自晖蒋献. 特应性皮炎相关细胞因子对皮肤屏障的影响[J]. 中华皮肤科杂志, 2019, 52(1): 46-49.
[8]	张静薛峤范文葛魏梅王玲赵军丁浩陶晓瑜. 联用糖皮质激素治疗老年头面部带状疱疹的疗效[J]. 中华皮肤科杂志, 2018, 51(9): 670-672.
[9]	秦蓓刘全忠. 阿奇霉素与多西环素治疗生殖道沙眼衣原体感染疗效的Meta分析[J]. 中华皮肤科杂志, 2018, 51(9): 691-695.
[10]	肖媛媛徐子刚徐哲向欣刘盈马琳杨舟. 长春新碱联合糖皮质激素治疗11例婴儿期Kasabach-Merritt综合征[J]. 中华皮肤科杂志, 2018, 51(8): 601-603.
[11]	黄骏许爱娥. 反射式共聚焦显微镜和皮肤镜在评估黑变病综合疗法效果中的应用[J]. 中华皮肤科杂志, 2018, 51(6): 440-442.
[12]	黄丹鞠梅常宝珠陈旭张小华朱艳周亚男许南陈崑顾恒. 51例女童尖锐湿疣临床分析[J]. 中华皮肤科杂志, 2018, 51(5): 363-365.
[13]	丁冬梅杨莉李燕杨舒云杨建婷何黎. 含青刺果油和马齿苋的舒敏保湿特护霜修复敏感性皮肤的屏障功能评估[J]. 中华皮肤科杂志, 2018, 51(4): 313-315.
[14]	黄骏胡文婷章玲玲许爱娥. 复方甘草酸苷注射液治疗黄褐斑疗效评估[J]. 中华皮肤科杂志, 2018, 51(4): 299-301.
[15]	韩锋张静候彦丽王晓鹏安金刚王小闯李满祥王岗. 单纯单次血浆置换疗法治疗17例中毒性表皮坏死松解症临床观察[J]. 中华皮肤科杂志, 2018, 51(12): 896-898.