复方野菊花眼贴在治疗轻中度干眼中的临床价值  

A multicenter,randomized,double-masked,placebo-controlled trial of compound wild chrysanthemum eye masks for mild and moderate dry eye

作　　者：吴洁丽 刘祖国 金明[2] 刘静[3] 李莹[4] 毕宏生[5] 解孝锋[5] 张铭连 石慧君 高学敏 李磊[7] 黄彩虹 Wu Jieli;Liu Zuguo;Jin Ming;Liu Jing;Li Ying;Bi Hongsheng;Xie Xiaofeng;Zhang Minglian;Shi Huijun;Gao Xuemin;Li Lei;Huang Caihong(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,Xiamen 361102,China;China-Japan Friendship Hospital,Beijing 100069,China;Wangjing Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100069,China;Department of Ophthalmology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital,Jinan 250004,China;Hebei Eye Hospital,Xingtai 050011,China;Pharmaceutical Research and Evaluation Technology Center of Chinese Association of Traditional Chinese Medicine,Beijing 100700,China)

机构地区：[1]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,361102 [2]中日友好医院,北京100069 [3]中国中医科学院望京医院,北京100069 [4]中国医学科学院,北京协和医学院,北京协和医院眼科,100730 [5]山东中医药大学附属眼科医院,济南250004 [6]河北省眼科医院,邢台050011 [7]中国中药协会药物研究评价技术中心,北京100700

出　　处：《中华眼科杂志》2021年第8期601-607,共7页Chinese Journal of Ophthalmology

摘　　要：目的探讨局部使用复方野菊花眼贴治疗轻中度干眼的临床效果与安全性。方法前瞻性多中心、随机、双盲、安慰剂平行对照研究。受试者为自2019年4月至9月就诊于厦门大学附属厦门眼科中心、中日友好医院、北京协和医院、中国中医科学院望京医院、山东中医药大学附属眼科医院和河北省眼科医院6家三级甲等医院的中老年轻中度干眼患者。采用计算机区组随机方法将纳入者按1∶1的比例随机分为试验组和对照组,分别采用复方野菊花眼贴及模拟剂眼贴进行治疗。在治疗前和治疗后1、2周记录并观察患者的干眼相关症状、泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠt)及角膜荧光素钠染色评分,记录治疗过程中的不良事件及不良反应。定量资料的比较采用t检验或Wilcoxon秩和检验,若考虑协变量的影响则采用协方差分析;计数资料的比较采用卡方检验或Fisher确切概率法。结果本研究共纳入符合入选标准的干眼患者120例,排除脱落且未用药的8例后,最终进入统计分析的受试者共有112例,其中男性32例,女性80例,年龄(54.26±7.44)岁(41~75岁)。试验组与对照组各56例(56只眼),各基线指标具有可比性。治疗前和治疗后1、2周,试验组干眼症状总评分分别为14.50(10.00,19.00)、9.00(5.00,14.00)、7.00(4.00,10.00)分,对照组分别为14.00(9.00,22.50)、12.00(6.00,20.00)、10.00(3.50,17.00)分;治疗1周后与治疗前相比,差异均有统计学意义(t=9.16,S=398.00;P<0.01);治疗2周后与治疗前总评分的差异均有统计学意义(S=681.00,575.50;P<0.05);试验组治疗后干眼症状总评分均低于对照组(Z=3.27,2.81;P<0.05)。治疗后1周,试验组BUT为(5.71±2.31)s,较治疗前的(5.06±2.00s)s明显延长(S=208.50,P<0.05),而对照组与治疗前相比差异无统计学意义(S=150.00,P>0.05);治疗2周后两组BUT与治疗前相比差异均有统计学意义(S=407.00,t=3.07;P<0.01)。治疗1周后,两组S�Objective To investigate the clinical efficacy and safety of compound wild chrysanthemum eye masks for mild and moderate dry eye.Methods In this double-masked,multicenter,placebo-controlled,randomized trial,middle-aged and elderly patients with mild and moderate dry eye were enrolled from six hospitals(Xiamen Eye Center of Xiamen University,China-Japan Friendship Hospital,Peking Union Medical College Hospital,Wangjing Hospital of China Academy of Chinese Medical Sciences,Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine and Hebei Eye Hospital).The patients were assigned to the compound wild chrysanthemum eye mask group and the eye mask simulator group based on the random number table.Subjective symptoms of dry eye,visual acuity,break-up time(BUT),SchirmerⅠtest,and corneal fluorescent staining were evaluated in all patients before treatment and at 1 and 2 weeks after treatment.All adverse reactions during the treatment and follow-up were recorded.Results A total of 120 patients were enrolled.Among them,112 subjects were included for statistical analyses after the exclusion of 8 subjects who were lost for follow-up or had an adverse event,with an age of(54.26±7.44)years.All the indicators were equally comparable between the two groups.Before treatment and at 1 and 2 weeks after treatment,the median(lower quartile,upper quartile)of total score of questionnaires in the eye mask group was 14.50(10.00,19.00),9.00(5.00,14.00)and 7.00(4.00,10.00),respectively,and that in the control group was 14.00(9.00,22.50),12.00(6.00,20.00)and 10.00(3.50,17.00),respectively.The score decreased significantly in both groups after 1 week(t=9.1604,S=398.00;P<0.01)and 2 weeks(S=681.00,575.50;P<0.05)of treatment.The total score of questionnaires in the eye mask group was significantly lower than that in the control group(Z=3.27,2.81;P<0.05)after treatment.After 1 week of treatment,the average BUT of the eye mask group was(5.71±2.31)s,which was significantly longer than that before treatment(5.06±2.00)s(S=2

关 键 词：干眼综合征 菊花 复方合剂 经皮贴片 

分 类 号：R276.7[医药卫生—中医五官科学]