新型硬性角膜接触镜润滑液安全性和有效性评价  

Safety and effectiveness evaluation of a new rigid contact lens lubricant

作　　者：侯晶晶 刘东伟[1] 伍晓艳[2] 付志英 陶黎明[1] HOU Jingjing;LIU Dongwei;WU Xiaoyan;FU Zhiying;TAO Liming(Department of Ophthalmology,the Second Affiliated Hospital of Anhui Medical University,Hefei 230061,China;Department of Maternal Child and Adolescent Health of Anhui Medical University,Hefei 230032,China;Kangshi Eye Hospital of Anhui Medical University,Hefei 230088,China)

机构地区：[1]安徽医科大学第二附属医院眼科,安徽合肥230601 [2]安徽医科大学儿少卫生与妇幼保健学系,安徽合肥230032 [3]安徽医科大学康视眼科医院,安徽合肥230088

出　　处：《安徽医学》2023年第1期13-16,共4页Anhui Medical Journal

基　　金：安徽省重点研究与开发计划立项(编号:2022j11020013)。

摘　　要：目的评价一种国产新型硬性角膜接触镜润滑液的安全性和有效性。方法选择2020年11月至2021年6月在安徽医科大学第二附属医院眼科门诊接受硬性角膜接触镜验配的近视患者为研究对象,共82例164只眼,使用计算机程序法随机分为试验组和对照组,每组41例82眼,试验组使用新型硬性角膜接触镜润滑液,对照组使用博士伦硬性角膜接触镜润滑液。观察并记录患者戴镜前、戴镜1周、1个月、3个月的检查结果,包括矫正视力、主观症状、泪膜破裂时间(BUT)、角膜荧光素染色评分、结膜充血情况。结果两组患者矫正视力≥1.0的比例在戴镜1周、1个月、3个月差异均无统计学意义(P>0.05),主观症状评分的差异也无统计学意义(P>0.05),两组润滑液的有效性指标差异无统计学意义;两组患者在各时间点的BUT、角膜荧光素染色评分、结膜充血情况的差异均无统计学意义(P>0.05),两组润滑液的安全性指标差异无统计学意义。结论国产新型硬性角膜接触镜润滑液的临床应用安全有效。Objective To evaluate the safety and effectiveness of a new domestic rigid contact lens lubricant.Methods A total of 82 patients(164 eyes)with myopia who received rigid corneal contact lens fitting were enrolled from the Ophthalmology Clinic of the Second Affiliated Hospital of Anhui Medical University from December 2020 to June 2021.The patients were randomly divided into two groups,with 41 patients(82 eyes)in each group.The experimental group used the new rigid contact lens lubricant,and the control group used Bausch&Lomb rigid gas-permeable contact lens lubricant.The results of patients before and after 1 week,1 month and 3 months wearing were observed and recorded,including corrected vision,subjective symptom,break-up time(BUT),fluorescein staining of corneal and conjunctival congestion.Results There was no significant difference in the proportion of corrected vision≥1.0 on 1 week,1 month and 3 months(P>0.05);meanwhile,there was no significant difference in subjective symptom scores between the two groups(P>0.05).There was no significant difference in the effectiveness between the two groups.There was no significant difference in tear break-up time,fluorescein staining of corneal,and conjunctival congestion between the two groups at each time point(P>0.05).There was no significant difference in the safety between the two groups.Conclusions The new domestic rigid contact lens lubricant is safe and effective in clinical application.

关 键 词：硬性透气角膜接触镜 屈光不正 透明质酸纳 

分 类 号：R988.1[医药卫生—药品]