三种含药眼贴治疗蠕形螨睑缘炎的疗效和安全性评价:一项多中心双盲随机对照临床试验  

Efficacy and safety evaluation of three medicated eye patches in Demodex blepharitis:a multicenter,doubleblind,randomized controlled clinical trial

作　　者：王莎莎 蒋炎 黄洁 杨珍 龙俊君 费新峰 刘焰[6] 李颖[3] 李兰[4] 陈吉利 Wang Shasha;Jiang Yan;Huang Jie;Yang Zhen;Long Junjun;Fei Xinfeng;Liu Yan;Li Ying;Li Lan;Chen Jili(Department of Ophthalmology,Shanghai Jing'an District Shibei Hospital,Shanghai 200443,China;Department of Ophthalmology,Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital,Shanghai 201999,China;Department of Ophthalmology,The Fourth Hospital of Xi'an City,Xi'an 710005,China;Department of Ophthalmology,The First People's Hospital of Kunming,Kunming 650200,China;Department of Ophthalmology,The Fourth People's Hospital of Shanghai,Shanghai 200081,China;Department of Ophthalmology,The First People's Hospital Affiliated to Shanghai Jiaotong University,Shanghai 200080,China)

机构地区：[1]上海市静安区市北医院眼科,上海200443 [2]上海市宝山区中西医结合医院眼科,上海201999 [3]陕西省西安市第四医院眼科,西安710005 [4]云南省昆明市第一人民医院眼科,昆明650200 [5]上海市第四人民医院眼科,上海200081 [6]上海交通大学附属第一人民医院眼科,上海200080

出　　处：《中华实验眼科杂志》2023年第5期450-456,共7页Chinese Journal Of Experimental Ophthalmology

基　　金：上海市卫生健康委员会科研项目(20204Y0039);上海市静安区卫生科研课题项目(2020QN05)。

摘　　要：目的评价并比较不同含药眼贴治疗蠕形螨睑缘炎临床疗效及安全性。方法采用多中心双盲随机平行对照临床试验方法,于2021年7月至2022年12月分别在上海静安区市北医院眼科、西安市第四医院眼科、昆明第一人民医院眼科招募蠕形螨睑缘炎患者140例280眼,用随机数字表将患眼随机分为茶树精油组、秋葵精油组、基液对照组和甲硝唑组,采用双盲法分别用含20%茶树精油、1%秋葵精油、制备基液、2%甲硝唑的眼贴贴敷眼部28 d,评估治疗前及治疗第14天和第28天患者睑缘蠕形螨计数;采用眼表疾病指数量表(OSDI)对眼表症状进行评分;裂隙灯显微镜下对睑缘充血程度、睫毛根部袖套样分泌物进行评分。依据上述综合评分计算治疗有效率,并观察受试者不良反应情况。结果所有受试者均完成治疗和随访,失访率为0%。各组治疗14和28 d受试眼睑缘蠕形螨计数较治疗前均明显减少(均P<0.05)。治疗28 d,茶树精油组、秋葵精油组和甲硝唑组蠕形螨数量明显低于基液对照组,差异均有统计学意义(均P<0.05)。茶树精油组、秋葵精油组和甲硝唑组治疗14和28 d时受试眼OSDI评分、睑缘充血评分和袖套样分泌物评分均明显低于治疗前,差异有统计学意义(均P<0.05)。治疗28 d,茶树精油组、秋葵精油组和甲硝唑组治疗有效率分别为71.4%、71.4%和62.9%,明显高于基液对照组的25.7%。治疗及随访期间未发现严重的局部及全身不良反应。结论含茶树精油、秋葵精油、甲硝唑眼贴治疗蠕形螨睑缘炎效果显著,可有效改善睑缘生物环境,消除睑缘相关炎症反应。Objective To evaluate and compare the clinical efficacy and safety of three different medicated eye patches in the treatment of Demodex blepharitis.Methods A multicenter,randomized,double-blind,parallel-controlled clinical trial was conducted.A total of 140 patients(280 eyes)with Demodex blepharitis were recruited in Shanghai Jing'an District Shibei Hospital,Xi'an Fourth Hospital and Kunming First People's Hospital from July 2021 to December 2022.The affected eyes were randomly divided into tea tree oil group,okra oil group,basal fluid control group and metronidazole group by the random number table method.Eye patches containing 20%tea tree oil,1%okra oil,prepared base solution and 2%metronidazole were applied to the eyes for 28 days by the double-blind method.The count of Demodex was evaluated before treatment and on days 14 and 28 of treatment.Ocular surface symptoms were scored according to Ocular Surface Disease Index(OSDI).The degree of congestion at the eyelid margin and cylindrical dandruff at the root of eyelashes were scored under a slit lamp microscope.The effective rate was calculated according to the comprehensive scores above,and the adverse reactions of the subjects were observed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Shanghai Jing'an District Shibei Hospital(No.YL-20200320-05).All the subjects were informed of the significance,purpose and method of the study.Written informed consent was obtained from each subject before any medical examination.Results All subjects completed the treatment and follow-up,and the loss to follow-up rate was 0%.After 14 and 28 days of treatment,the Demodex count was significantly decreased in all groups compared with before treatment(all at P<0.05).After 28 days of treatment,the number of Demodex in tea tree oil group,okra oil group and metronidazole group were significantly lower than that in basal fluid control group,with statistically significant differences(all at P<0.05).The OSDI score,palpebral m

关 键 词：睑缘炎 蠕形螨 疗效 安全性 多中心随机对照临床研究 含药眼贴 

分 类 号：R777.11[医药卫生—眼科]