陆敏 孙淑娟 李向花

[摘要]目的：探討重组牛碱性成纤维细胞生长因子（Recombinant bovine basic fibroblast growth factor，rb-bFGF）凝胶对玫瑰痤疮皮肤损伤的修复作用及安全性分析。方法：本研究为随机、单盲、安慰剂对照研究，一共纳入了128例玫瑰痤疮患者，随机分为治疗组（n=65）和对照组（n=63）。两组患者均接受硫酸羟氯喹（HCQ）治疗，0.2克/次，2 次/天。治疗组在此基础上局部应用rbFGF凝胶治疗（300IU/cm2），8周为1个疗程;对照组采用凝胶载体。分别在治疗前和治疗4周、8周、停药4周时对红斑、毛细血管扩张、丘疹、脓疱等客观体征及潮红、干燥、灼热、瘙痒等主观症状进行评分，并且测定治疗前后的经皮水分丢失值、角质层含水量及表皮皮脂含量。结果：治疗组，治疗4周、8周及停药4周时的客观体征和主观症状评分分别为2.06±0.51，1.35±0.55和1.00±0.45，较对照组的2.43±0.57，2.17±0.53和1.93±0.45明显降低;与对照组相比，治疗组经治疗后的表皮皮脂含量及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）;治疗4周、8周及停药4周时，治疗组患者的总有效率明显高于对照组（分别为56.63%vs.28.84%，85.11% vs.40.81%，96.56% vs.55.82%），两组均未出现不良反应。结论：rbFGF凝胶对于玫瑰痤疮皮肤损伤的修复有确切的治疗效果，且安全性较高，值得临床推广。

[关键词]玫瑰痤疮;重组牛碱性成纤维细胞生长因子;临床疗效;修复作用;安全性

[中图分类号]R758.73+4    [文献标志码]A    [文章编号]1008-6455（2021）07-0071-04

Study and Analysis of the Effectiveness and Safety of Recombinant Bovine Basic Fibroblast Growth Factor Gel in Repairing Rosacea Skin Damage

LU Min1， SUN Shu-juan2， LI Xiang-hua3

[1.Department of Dermatology， Beijing Fengtai District Maternal and Child Health and Family Planning Service Center （Beijing Fengtai District Maternal and Child Health Hospital）， Beijing 100069，China; 2. Department of Dermatology， Air Force Characteristic Medical Center，Beijing 100000，China; 3. Department of Dermatology， Ningxia Hui Autonomous Region People's Hospital， Yinchuan 750001， Ningxia，China]

Abstract： Objective  To investigate the repair effect and safety analysis of recombinant bovine basic fibroblast growth factor （rb-bFGF） gel on rosacea skin damage. Methods This study is a randomized， single-blind， placebo-controlled study. A total of 128 patients with rosacea were enrolled and randomly divided into treatment group （n=65） and control group （n=63）. Both groups of patients received hydroxychloroquine sulfate （HCQ）， 0.2g/time， 2 times/d. On this basis， the treatment group used topical rbFGF gel treatment （300IU/cm2）， 8 weeks as a course of treatment; the control group used gel carrier. Score the objective signs of erythema， telangiectasia， papules， pustules， and subjective symptoms such as flushing， dryness， burning， and itching before treatment， 4 weeks， 8 weeks， and 4 weeks after treatment. Transdermal water loss value， stratum corneum water content， epidermal sebum content. Results  The objective signs and subjective symptom scores of the treatment group were 2.06±0.51， 1.35±0.55， and 1.00±0.45 at 4 weeks， 8 weeks of treatment， and 4 weeks of discontinuation， respectively， compared with 2.43±0.57， 2.17±0.53 and 2.17±0.53 of the control group 1.93±0.45 is significantly reduced. Compared with the control group， the epidermal sebum content and stratum corneum water content of the treatment group increased after treatment， and the transdermal water loss decreased， and the difference was statistically significant （P<0.05）. At 4 weeks， 8 weeks and 4 weeks of treatment， the total effective rate of patients in the treatment group was significantly higher than that of the control group （56.63% vs. 28.84%， 85.11% vs.40.81%， 96.56% vs. 55.82%）. There were no adverse reactions in the two groups. Conclusion  rbFGF gel has a definite therapeutic effect on the repair of rosacea skin damage， and it is safe and worthy of promotion.

Key words： rosacea; recombinant bovine basic fibroblast growth factor; clinical efficacy; repair effect; security

玫瑰痤疮（Rosacea）是一种常见的慢性炎症性皮肤病，影响面部皮肤的血管和毛囊皮脂腺。主要症状包括阵发性潮红、持久性红斑、丘疹、脓疱和毛细血管扩张，长期病程严重者可能发展成暗红色斑块或鼻部肥厚、增生[1]。根据美国玫瑰痤疮专家委员会的推荐，按照病变的严重程度和症状，玫瑰痤疮可以分为四种类型：红斑毛细血管扩张型、丘疹脓疱型、肥大增生型及眼型[2]。现有研究对于玫瑰痤疮的发病机理缺乏清晰的认识，可能与微生物感染、天然免疫、神经免疫、血管舒缩功能异常、皮肤屏障功能障碍及部分遗传因素相关[3]。……