加热型理疗镜治疗睑板腺功能障碍的有效性及安全性临床评价

Clinical evaluation of the efficacy and safety of heating physiotherapy goggles in the treatment of meibomian gland dysfunction

目的评价加热型理疗镜治疗睑板腺功能障碍(MGD)的有效性和安全性。方法采用随机对照研究方法,收集2021年7月至2022年1月于温州医科大学附属眼视光医院就诊的MGD患者44例,根据信封法将患者随机分为理疗镜组和热毛巾组,每组22例(各失访1例,最终各纳入21例),分别进行加热型理疗镜和热毛巾热敷治疗。对检查者设单盲,选取双眼中体征较重眼的数据进行分析。分别于治疗前和治疗2周、4周通过眼表疾病指数(OSDI)、眼表综合分析仪测量泪河高度(TMH)、裂隙灯显微镜检查评估荧光素泪膜破裂时间(FBUT)、角膜荧光素染色评分(CFS)、睑缘充血评分、睑板腺功能评分以观察治疗的有效性;通过测量视力、眼压及裂隙灯显微镜检查以观察其安全性。结果治疗前后不同时间点OSDI评分比较差异有统计学意义(F时间=16.528,P<0.001),其中热毛巾组治疗2周OSDI评分为(30.46±17.31)分,与治疗前的(35.43±18.22)分比较,差异无统计学意义(P=0.405);理疗镜组治疗2周OSDI评分为(26.27±16.47)分,明显低于治疗前的(39.24±17.96)分,差异有统计学意义(P=0.001)。理疗镜组治疗4周睑缘充血评分为0.0(1.0,2.0)分,明显低于热毛巾组的2.0(1.0,3.0)分,差异有统计学意义(Waldχ^(2)=11.444,P=0.001)。理疗镜组治疗2周、4周的睑板腺开口状态评分均为1.0(0.0,1.0)分,低于热毛巾组的2.0(1.0,3.0)分和2.0(1.0,2.5)分,差异均有统计学意义(Waldχ^(2)=15.082、23.172,均P<0.001)。理疗镜组治疗2周、4周的睑板腺分泌物性状评分分别为1.0(0.5,2.0)分和1.0(0.0,1.5)分,分别低于热毛巾组的2.0(1.0,2.0)分和2.0(1.0,2.5)分,差异均有统计学意义(Waldχ^(2)=4.638、9.395,均P<0.05)。理疗镜组治疗2周、4周的上睑板腺排出能力评分均为2.0(1.0,2.0)分,低于热毛巾组的3.0(2.0,3.0)分和2.0(2.0,2.5)分,差异均有统计学意义(Waldχ^(2)=6.489、11.562,均P<0.05)。理疗镜组治疗4周下睑板腺排出能力评分为1.0(0.5,2.0)分,明显低于热毛巾组的2.0(2.0,3.0)分,差异有统计学意义(Waldχ^(2)=24.085,P<0.001)。理疗镜组治疗2周、4周的FBUT分别为3.00(1.75,3.50)s和3.00(2.00,4.00)s,明显长于热毛巾组的1.00(0.75,2.00)s和2.00(1.00,3.00)s,差异均有统计学意义(Waldχ^(2)=8.576、8.539,均P<0.05)。治疗前后不同时间点TMH比较差异有统计学意义(F时间=8.874,P<0.001),其中热毛巾组治疗4周TMH为(0.24±0.09)mm,明显高于治疗前的(0.18±0.05)mm,差异有统计学意义(P<0.05);理疗镜组治疗4周TMH为(0.23±0.09)mm,明显高于治疗前的(0.17±0.05)mm,差异有统计学意义(P<0.05)。治疗前后不同时间点CFS评分比较差异有统计学意义(Waldχ^(2)时间=10.116,P=0.006),其中热毛巾组治疗前后CFS评分比较差异无统计学意义(Waldχ^(2)=1.781,P=0.410);理疗镜组治疗2周、4周CFS评分分别为0.0(0.0,1.5)分、0.0(0.0,0.0)分,明显低于治疗前的0.0(0.0,4.0)分,差异均有统计学意义(均P<0.05)。理疗镜组治疗2周、4周的视力(LogMAR)分别为0.10(0.00,0.22)和0.10(0.00,0.22),明显优于治疗前的0.10(0.00,0.40),差异均有统计学意义(均P<0.05);2个组治疗前后不同时间点眼压比较差异均无统计学意义(F组别=0.432,P=0.515;F时间=0.329,P=0.721)。随访期内2个组均未出现严重不良事件。结论与热毛巾治疗方法相比,使用加热型理疗镜治疗能更迅速改善MGD患者眼部不适症状和睑板腺功能及状态,是治疗MGD安全、有效的手段。

Objective To evaluate the efficacy and safety of heating physiotherapy goggles in the treatment of meibomian gland dysfunction(MGD).Methods A randomized controlled study was performed.Forty-four MGD patients were recruited in Wenzhou Medical University Eye Hospital from July 2021 to January 2022.Two patients were lost to follow-up.The patients were randomly divided into experimental group treated with heating physiotherapy goggles and control group treated with hot towels according to the random envelope method,with 21 patients(21 eyes)in each group.Throughout the study,the examiner was blinded.The data of the worse eye were analyzed.At baseline,2 weeks and 4 weeks after treatment,the Ocular Surface Disease Index(OSDI),tear meniscus height(TMH),fluorescein breakup time(FBUT),corneal fluorescein staining score(CFS),lid margin hyperemia score and meibomian gland function scores were measured to evaluate the efficacy;visual acuity,intraocular pressure and slit lamp microscopy were examined to assess the safety.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Wenzhou Medical University Eye Hospital(No.2021-177-K-153-01).Results There were significant differences in OSDI scores between before and after treatment(F time=16.528,P<0.001).No significant difference was found in OSDI scores between 30.46±17.31 at 2 weeks after treatment and 35.43±18.22 before treatment in control group(P=0.405).The OSDI score at 2 weeks after treatment was 26.27±16.47,which was significantly lower than 39.24±17.96 before treatment in experimental group(P=0.001).The eyelid margin hyperemia score was 0.0(1.0,2.0)at 4 weeks after treatment in experimental group,which was significantly lower than 2.0(1.0,3.0)in control group(Waldχ^(2)=11.444,P=0.001).The morphologic scores of meibomian gland orifices at 2 and 4 weeks after treatment were both 1.0(0.0,1.0)in experimental group,which were significantly lower than 2.0(1.0,3.0)and 2.0(1.0,2.5)in control group(Waldχ^(2)=15.082,23.172;both at P<0.001).The scores of meibum quality at 2 and 4 weeks after treatment were 1.0(0.5,2.0)and 1.0(0.0,1.5)in experimental group,which were significantly lower than 2.0(1.0,2.0)and 2.0(1.0,2.5)in control group(Waldχ^(2)=4.638,9.395;both at P<0.05).The scores of upper meibomian gland expressibility at 2 and 4 weeks after treatment were both 2.0(1.0,2.0)in experimental group,which were significantly lower than 3.0(2.0,3.0)and 2.0(2.0,2.5)in control group(Waldχ^(2)=6.489,11.562;both at P<0.05).The score of lower meibomian gland expressibility at 4 weeks after treatment in experimental group was 1.0(0.5,2.0),which was significantly lower than 2.0(2.0,3.0)in control group(Waldχ^(2)=24.085,P<0.001).The FBUT at 2 and 4 weeks after treatment were 3.00(1.75,3.50)and 3.00(2.00,4.00)seconds in experimental group,which were significantly longer than 1.00(0.75,2.00)and 2.00(1.00,3.00)seconds in control group(Waldχ^(2)=8.576,8.539;both at P<0.05).There were significant differences in TMH among different time points(F time=8.874,P<0.001).In control group,the TMH at 4 weeks after treatment was(0.24±0.09)mm,which was significantly higher than(0.18±0.05)mm before treatment(P<0.05).In experimental group,the TMH at 4 weeks after treatment was(0.23±0.09)mm,which was significantly higher than(0.17±0.05)mm before treatment(P<0.05).Significant differences were found in CFS score among different time points(Waldχ^(2)time=10.116,P=0.006).There was no statistically significant differences in CFS score between before and after treatment in control group(Waldχ^(2)=1.781,P=0.410).In experimental group,the CFS scores at 2 and 4 weeks after treatment were 0.0(0.0,1.5)and 0.0(0.0,0.0),which were significantly decreased in comparison with 0.00(0.00,4.00)before treatment(both at P<0.05).In experimental group,the visual acuity converted to the logarithm of the minimum angle of resolution at 2 and 4 weeks after treatment were 0.10(0.00,0.22)and 0.10(0.00,0.22),which was significantly better than 0.10(0.00,0.40)before treatment(both at P<0.05).There was no significant change in intraocular pressure at different time points between the two groups(F group=0.432,P=0.515;F time=0.329,P=0.721).No serious adverse effects occurred in both groups during the follow-up period.Conclusions Compared with hot towel therapy,the use of heating physiotherapy goggles can relieve ocular discomfort of MGD patients more rapidly and improve the function and status of the meibomian gland more significantly.Heating physiotherapy goggles can treat MGD safely and effectively.