干眼理疗仪治疗干眼的多中心随机对照研究

Multi-Center Randomized Controlled Clinical Study on the Treatment of Dry Eye Disease with Physiotherapy Device

目的:评估一款干眼理疗仪治疗干眼的临床安全性和有效性。方法:前瞻性、多中心、随机对照临床研究。纳入2018年7—11月在河南省眼科研究所、苏州九龙医院和江南大学附属医院3家符合条件的轻、中度干眼患者,随机分为对照组和试验组。对照组滴0.1%玻璃酸钠滴眼液4次/d,每次1滴,持续治疗4周[(28±5)d]。试验组使用干眼理疗仪1次/d,每次持续时间至少15 min,持续治疗4周[(28±5)d]。分别于治疗前和治疗后1、2和4周对患者的眼表情况进行评估,分析其有效性;于治疗前和治疗后4周对患者的干眼主观症状、泪膜破裂时间(BUT)、SchirmerⅠ试验和角膜荧光素钠染色情况进行评估后计算症征总积分,分析有效率。计量数据比较采用t检验或Wilcoxon秩和检验,构成比及有效率的比较采用卡方检验或Fisher精确概率法。采用非劣效验证,设定非劣效界值为Δ=10%,对照组与试验组治疗有效率之差的95%可信区间下限大于-Δ(-10%),则推断试验组的疗效非劣于对照组。结果:共112例患者纳入研究,其中男41例,女71例;每组各56例;112例中109例患者完成随访。对照组与试验组治疗前右眼与左眼的主观症状总分(右眼:t=0.15,P=0.880;左眼:t=0.19,P=0.850)及症征总积分(右眼:t=0.20,P=0.840;左眼:t=0.43,P=0.670)差异均无统计学意义。治疗4周后,2组症征总积分差异无统计学意义(P>0.05)。对照组治疗有效率为64.8%,试验组治疗有效率为72.7%,2组有效率差异无统计学意义(P>0.05)。对照组出现1例不良事件,试验组出现2例不良事件,差异无统计学意义。结论:干眼理疗仪治疗干眼有效率达72.7%,非劣于0.1%玻璃酸钠滴眼液,且安全性高。

Objective:To evaluate the clinical safety and effectiveness of a dry eye physiotherapy instrument in the treatment of dry eyes.Methods:This was a prospective,multicenter,randomized controlled clinical study.Eligible patients with mild and moderate dry eyes in Henan Institute of Ophthalmology,Suzhou Kowloon Hospital and Affiliated Hospital of Jiangnan University from July to November 2018 were randomly divided into control group and experimental group.The control group were treated with 0.1%sodium hyaluronate eye drops 4 times a day,1 drop each time for 4 weeks(28±5 days).The experimontd group were treated with dry eye physiotherapy instrument once a day for at least 15 minutes for 4 weeks(28±5 days).The ocular surface of patients were evaluated before treatment and 1 week,2 weeks and 4 weeks after treatment,and their effectiveness was analyzed;The subjective symptoms of dry eye,tear film rupture time(BUT),Schirmer I test and corneal fluorescein sodium staining were evaluated before and 4 weeks after treatment.The total symptom score was calculated and the effective rate was analyzed.The measurement data were compared by t-test or Wilcoxon rank sum test,and the constituent ratio and efficiency were compared by Chi square test or Fisher exact probability method.Non inferiority verification method was used to compare the difference between the two groups,and the non inferiority limit was set asΔ=10%,if the lower 95%confidence interval of the difference between the treatment effective rate of the control group and that of the experimental group is greater than-Δ(-10%),it is inferred that the curative effect of the experimental group is not inferior to that of the control group.Results:One hundred and twelve patients were involved,including 41 males and 71 females;and,there was no significant difference in the total score of symptoms and the ocular surface conditions between both eyes of the two groups in the baseline.In the follow-up population,there was no significant difference in ocular surface conditions between the two groups after 1 week,2 weeks and 4 weeks of treatmen(right:t=0.15,P=0.880;left:t=0.19,P=0.850).After 4 weeks of treatment,there was no significant difference in the total score of symptoms between both eyes of the two groups(right:t=0.20,P=0.840;left:t=0.43,P=0.670).The effective rate of the experimontd group was 72.7%,while that of the control group was 64.8%and there was no significant difference between them(P>0.05).There were 2 adverse events in the experimental group and 1 adverse event in the control group,the difference was not statistically significant.Conclusion:The effective rate of eye physiotherapy device is 72.7%in treatment of mild or moderate dry eyes,which is not inferior to 0.1%sodium hyaluronate eye drops,and has high safety.