国产液脉动系统治疗睑板腺功能障碍的临床应用评价

Clininal evaluation of a novel China original liquid pulsation system for meibomian gland dysfunction

目的评价睑板腺液脉动系统治疗睑板腺功能障碍(MGD)的临床效果及安全性。方法采用非随机对照临床试验设计,纳入2022年2-8月在复旦大学附属眼耳鼻喉科医院确诊为MGD的患者22例44眼,根据患者意愿分为2个组,液脉动治疗组10例MGD患者20眼进行单次12 min的国产睑板腺液脉动系统治疗;强脉冲光(IPL)治疗组12例24眼进行4次IPL和超声眼部熏蒸联合睑板腺人工按摩治疗,治疗间隔3周。各组间年龄等基线特征比较差异均无统计学意义(均P>0.05)。分别于治疗前、治疗后1个月和治疗后3个月进行睑脂评分、泪膜脂质层质量评分、SANDE问卷评分、首次和平均泪膜破裂时间(BUT)测定、角膜荧光素钠染色(CFS)评分、泪河高度(TMH)测定、睑板腺缺失面积评分。结果2个组治疗前后不同时间点泪膜脂质颜色评分和平均BUT比较差异均有统计学意义(H组别=4.39,P=0.036;H时间=6.30,P=0.043.F组别=4.41,P=0.038;F时间=4.08,P=0.049)。液脉动治疗组治疗后1个月和3个月睑脂评分、首次BUT、TMH与治疗前相比均有明显改善,差异均有统计学意义(均P<0.05);而IPL治疗组不同治疗时间睑脂评分、泪膜脂质分布占比、首次BUT、TMH比较,差异均无统计学意义(均P>0.05)。各组治疗后1个月和3个月SANDE问卷、CFS评分均优于治疗前,差异均有统计学意义(均P<0.05)。在安全性评估方面,液脉动治疗组MGD患者未出现任何与仪器有关的不良事件,未报告新出现的不适主诉;各组治疗后CFS染色阳性患者减少,无新发CFS染色阳性患者。结论国产睑板腺液脉动系统治疗MGD 3个月内可有效改善患者泪膜功能及眼表损伤,是一种安全有效的物理治疗手段。

Objective To evaluate the efficacy and safety of a China original liquid pulsation system for the treatment of meibomian gland dysfunction(MGD).Methods A non-randomized controlled clinical trial was conducted.Twenty-two patients(44 eyes)diagnosed with MGD in Eye and ENT Hospital of Fudan University from February to August 2022 were enrolled.The patients were assigned into two groups according to their willingness.Of the 22 patients(44 eyes),10 patients(20 eyes)in single liquid pulsation system group were treated with single liquid pulsation system for 12 minutes,and 12 patients(24 eyes)in intense pulsed light(IPL)group were treated with a course(4 times)of IPL,warm compresses and meibomian gland massage at three-week intervals.There was no difference in age and other baseline clinical indexes between the two groups(all at P<0.05).The meibum grading,quality grading of tear film lipid layer,Symptom Assessment Questionnaire in Dry Eye(SANDE)questionnaire score,first and average tear breakup time(BUT),corneal fluorescein sodium staining(CFS)score,tear meniscus height(TMH),and the area of meibomian gland loss were determined at baseline,1 and 3 months after treatment.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Eye and ENT Hospital of Fudan University(No.2021069).Written informed consent was obtained from each patient before any medical examination.Results Statistically significant group effects and time effects were found in the quality of tear film lipid layer(H group=4.39,P=0.036,H time=6.30,P=0.043)and average BUT(F group=4.41,P=0.038;F time=4.08,P=0.049)in the two groups.The meibum grading,first BUT and TMH 1 and 3 months after treatment were significantly better than before treatment in single liquid pulsation system group(all at P<0.05).Compared with before treatment,there was no significant improvement in the meibum grading,distribution of tear film lipid,first BUT and TMH at 1 and 3 months after treatment in IPL group(all at P>0.05).In both groups,the SANDE and CFS scores 1 and 3 months after treatment were better than those before treatment,showing statistically significance(all at P<0.05).In terms of safety,neither instrument-related adverse events nor extra complaints of discomfort were reported in the single liquid pulsation system group.In both groups,the number of patients with positive CFS staining significantly decreased,and no new cases with positive CFS appeared after treatment.Conclusions This China original liquid pulsation system is a safe and effective physical therapy in improving tear film dysfunction and ocular surface symptoms of MGD patients within 3 months after treatment.