重组牛bFGF凝胶治疗中度干眼的多中心随机双盲平行对照临床试验  

Efficacy of a recombinant bovine basic fibroblast growth factor gel for the treatment of moderate dry eye:a multicenter randomized double-blind parallel controlled clinical trial

作　　者：黄彩虹[1] 刘祖国 张明昌[3] 孙旭光 徐建江[5] 梁凌毅[6] 林祥 王家松 田磊 吴甦潜 刘艳 钟桃玲 Huang Caihong;Liu Zuguo;Zhang Mingchang;Sun Xuguang;Xu Jianjiang;Liang Lingyi;Lin Xiang;Wang Jiasong;Tian Lei;Wu Suqian;Liu Yan;Zhong Taoling(Eye Institute of Xiamen University,Fujian Provincial Key Laboratory of Ophthalmology and Visual Science,Fujian Engineering and Research Center of Eye Regenerative Medicine,Xiamen 361002,China;Department of Ophthalmology,Xiang′an Hospital and Xiamen Eye Center Affiliated to Xiamen University,Eye Institute of Xiamen University,Fujian Provincial Key Laboratory of Ophthalmology and Visual Science,Fujian Engineering and Research Center of Eye Regenerative Medicine,Xiamen 361102,China;Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430022,China;Beijing Tongren Eye Center,Beijing Tongren Hospital,Capital Medical University,Beijing Institute of Ophthalmology,Beijing Key Laboratory of Ophthalmology and Vision Science,Beijing 100730,China;Eye&ENT Hospital of Fudan University,Shanghai 361016,China;Zhongshan Ophthalmic Centre,Sun Yat-sen University,Guangzhou 510060,China;National Institute for Data Science in Health and Medicine,Xiamen University,Xiamen 361005,China)

机构地区：[1]厦门大学眼科研究所福建省眼科与视觉科学重点实验室福建省眼再生医学工程研究中心,厦门361002 [2]厦门大学附属翔安医院眼科及厦门眼科中心,厦门大学眼科研究所,福建省眼科与视觉科学重点实验室,福建省眼再生医学工程研究中心,厦门361102 [3]华中科技大学同济医学院附属协和医院,430022 [4]首都医科大学附属北京同仁医院北京同仁眼科中心,北京市眼科研究所,北京市眼科学与视觉科学重点实验室,100730 [5]复旦大学附属眼耳鼻喉科医院,上海361016 [6]中山大学中山眼科中心,广州510060 [7]厦门大学健康医疗大数据国家研究院,厦门361005

出　　处：《中华眼科杂志》2021年第12期930-938,共9页Chinese Journal of Ophthalmology

基　　金：国家自然科学基金(81900825);国家重点研发计划(2018YFA0107304)。

摘　　要：目的比较重组牛碱性成纤维细胞生长因子(rb-bFGF)凝胶和凝胶基质治疗中度干眼的临床疗效。方法随机、双盲、平行对照的临床试验研究。纳入2015年8月至2019年4月在厦门大学眼科研究所及厦门大学附属厦门眼科中心、华中科技大学同济医学院附属协和医院、首都医科大学附属北京同仁医院、复旦大学附属眼耳鼻喉科医院和中山大学中山眼科中心5个单位符合条件的中度干眼患者, 采用动态随机化将患者分为试验组和对照组。试验组和对照组分别给予rb-bFGF凝胶和凝胶基质治疗4周。分别于治疗前和治疗后2、4周对患者的干眼症状进行评分, 并进行泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠt)和角膜荧光素钠染色等检查, 在治疗前和治疗后第4周行结膜印迹细胞学检查, 并观察用药后的药物刺激性。定量资料的比较采用t检验、威尔科克森符号秩检验或曼-惠特尼U检验;计数资料的比较采用χ2检验。结果共100例患者纳入研究, 84例患者完成随访, 其中男性25例, 女性59例;年龄(43±14)岁;试验组和对照组各42例。治疗后2、4周, 试验组干眼症状总评分分别为(7.17±3.60)、(5.95±3.25)分, 对照组分别为(7.01±3.25)、(6.32±3.85)分, 均明显低于治疗前试验组的(9.48±3.88)分(t=6.226, 6.563)和对照组的(9.15±3.58)分(t=4.693, 4.726), 差异有统计学意义(P<0.05)。治疗后2、4周, 试验组BUT分别为4.00(2.40, 5.00)、4.64(3.00, 5.00)s, 较治疗前的3.72(2.00, 4.39)s均明显延长(Z=-2.485, -3.152;P<0.05);治疗后2周, 对照组BUT为4.41(2.79, 5.12)s, 较治疗前的3.89(2.09, 4.25)s差异无统计学意义(Z=-1.953, P>0.05);治疗后4周, 对照组BUT为 5.21(3.00, 5.02)s, 较治疗前明显延长(Z=-2.485, P<0.05)。治疗后2、4周, 试验组SⅠt结果分别为 7.31(3.75, 10.00)、8.50(4.00, 11.00)mm, 较治疗前的6.69(2.00, 8.13)mm均明显增多, 差异有统计学意义(Z=-2.031, -2.236;P<0.05);治疗后2�Objective To compare the clinical efficacy of a recombinant bovine basic fibroblast growth factor(rb-bFGF)gel and a gel matrix in the treatment of moderate dry eye.Methods It was a prospective random double-blind controlled study.One hundred patients diagnosed as moderate dry eye in Eye Institute and Affiliated Xiamen Eye Center of Xiamen University,Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Beijing Tongren Hospital,Capital Medical University,Eye&ENT Hospital of Fudan University and Zhongshan Ophthalmic Center from August 2015 to April 2019 were divided into two groups:experimental group and control group.Two groups of patients were allocated to receive either a rb-bFGF gel or a gel matrix 4 times per day for 4 weeks.Subjective symptoms,break-up time of the tear film(BUT),SchirmerⅠtest(SⅠt)and corneal fluorescein sodium staining were assessed at baseline,2 and 4 weeks after treatment.Bulbar impression cytology was evaluated at baseline and 4 weeks after treatment.Irritation of the rb-bFGF gel and the gel matrix was estimated after treatment.T test,Wilcoxon signed-rank test or Mann-Whitney U test was used for quantitative data,and Chi-square test was used for enumerative data.Results Eighty-four subjects were included for statistical analyses after the exclusion of 16 subjects who were lost for followup,with an age of 43±14 years.There were 42 cases in the experimental group and the control group,respectively.There was no statistically significant difference between the two groups in demographic baseline characteristics before treatment(P>0.05).The total score of subjective symptoms was 7.17±3.60 and 5.95±3.25 at 2 and 4 weeks after therapy in the experimental group,which were lower than 9.48±3.88 before treatment(t=6.226,6.563;both P<0.05);in the control group,it was 7.01±3.25 and 6.32±3.85 at 2 and 4 weeks after treatment,with a significant reduction in comparison with that before treatment(9.15±3.58;t=4.693,4.726;both P<0.05).The median(lower

关 键 词：干眼综合征 成纤维细胞生长因子2 润眼液 随机对照试验(主题) 多中心研究 双盲法 

分 类 号：R777.34[医药卫生—眼科]