睑板腺热脉动系统治疗睑板腺功能障碍的有效性评价

发布时间：2018-05-11 09:43

本文选题：睑板腺功能障碍 + 热敷　；参考：《天津医科大学》2017年硕士论文

【摘要】：目的:本研究通过与传统热敷相比较,评估一种睑板腺热脉动系统治疗睑板腺功能障碍(Meibomian Gland Dysfunction,MGD)的安全性及临床疗效,并在此基础上探究泪膜脂质层与睑板腺功能障碍体征的相关性。方法:本研究为前瞻性、随机对照临床试验。1.患者选择:选取2015年9月至2016年9月在天津医科大学眼科医院因干眼症状就诊的患者50人100只眼。纳入标准:(1)年满18岁,不论男女或任何种族;(2)眼部主观症状使用SPEED问卷调查,每只眼睛症状得分在6分或更高分;(3)双眼皆为MGD,评估每一只眼睛的下眼睑15个腺体,睑板腺分泌脂质评分12分或以下。(4)愿意配合试验检测流程,若是分配到对照组,愿意遵守在家热敷治疗;(5)能够复诊并参与所有研究访视。排除标准:(1)SPEED评分为15分或以上;(2)伴有如下眼部疾病,例如:任何一只眼睛活动性的眼部感染或炎症;(3)在基线检查前三个月内有眼部手术或外伤;任何一只眼睛存在可能影响角膜完整性的眼表异常;(4)任何一只眼有影响眼睑功能的眼睑异常;(5)系统性疾病导致的干眼,及在研究期间不愿意放弃会导致干眼的系统性药物治疗;(6)基准检查前三个月内进行过泪点塞植入或泪小管成形术。若在三个月以前进行过泪小点栓塞或泪小管成形术的受试者,在研究期间不允许新的泪小点栓塞或泪小管成形术;(7)基准检查前30天内参与其他眼科临床实验。2.患者分组及随访:随机均分为两组:睑板腺热脉动治疗组(A组)和热敷治疗组(B组)。A组患者在基准检查之后接受一次12分钟的Lipiflow?睑板腺热脉动系统(美国Tearscience公司)治疗,B组患者接受每日在家使用Eye Giene?Insta-WarmthTM眼罩(美国Eyedetec Medical,Inc公司)热敷治疗15分钟,每天1次,共2周。治疗前和治疗后1个月、2个月、3个月所有患者均接受SPEED问卷调查、裸眼视力(Uncorrected Visual Acuity,UCVA)检查、非接触式电脑眼压检查、泪膜脂质层厚度(Lipid layer thinkness,LLT)、不完全眨眼比例(Partial blink rate,PB)、睑板腺缺失率检查、泪液分泌试验(SchirmerⅠtest,SIT)(无表麻)、泪膜破裂时间(Break-up time,BUT)检查、角膜荧光素染色(Corneal Fluorescein Staining,CFS)、睑板腺开口评估器(Meibomian Gland Evaluator,MGE)评估睑板腺开口和分泌物性状。3.统计分析:所有记录数据整理后进行统计学处理。采用SPSS 17.0统计学软件进行统计分析。计量资料以均数±标准差(`x±s)表示,计数资料采用χ2检验,两组不同时间点的指标比较采用重复测量方差分析,组内治疗前与治疗后的指标比较采用配对t检验。同一时间点的组间比较采用独立样本t检验。所有的置信区间被设置成95%,P0.05为差异有统计学意义。结果:1.治疗前,两组在性别、年龄、SPEED问卷评分、UCVA、眼内压(Intra-ocular pressure,IOP)、LLT、PB、睑板腺缺失率、SIT、BUT、CFS评分、睑板腺开口数量、睑板腺分泌物性状评分等各项指标均无统计学差异(P0.05)。研究期间未发生任何角膜、眼睑灼伤等不良事件。2.治疗后1个月,A、B两组除睑板腺缺失率外的各项指标均较治疗前有所改善,两组间SPEED问卷评分、LLT、PB、睑板腺缺失率、BUT、SIT、睑板腺开口数量、睑板腺分泌物性状评分均无统计学差异(P0.05);B组的CFS评分明显优于A组,且两组间差异有统计学意义(P0.01)。3.治疗后2个月,两组睑板腺缺失率较治疗前均无明显变化。两组间LLT、PB、睑板腺缺失率、SIT、CFS评分均无统计学差异(P均0.05);A组的BUT、睑板腺开口数量、睑板腺分泌物性状评分均明显优于B组,且两组间差异均有统计学意义(P均0.01)。4.治疗后3个月,两组的SPEED问卷评分、BUT及CFS评分均较治疗前显著改善(P均0.01),睑板腺缺失率无明显变化(P均0.05)。A组的LLT、PB、睑板腺开口数量、睑板腺分泌物性状评分也均有明显改善,差异有统计学意义(P0.01)。B组的LLT、PB、睑板腺开口数量、睑板腺分泌物性状评分虽然较治疗前有改善趋势,但差异无统计学意义(P均0.05)。两组间PB、SIT、CFS评分均无统计学差异(P均0.05);A组的LLT、BUT、睑板腺开口数量、睑板腺分泌物性状评分均明显优于B组,且组间差异有统计学意义(P均0.01)。5.治疗后的1个月、2个月、3个月两组的UCVA及IOP均无明显变化(P均0.05)。6.治疗前后泪膜脂质层厚度与泪膜破裂时间、睑板腺开口数量、正常分泌的睑板腺数量及睑板腺分泌物性状评分始终呈正相关,P均0.05。结论:1、睑板腺热脉动治疗仪治疗睑板腺功能障碍是安全的,治疗后3个月研究期间未发现患者有任何角膜及眼表损害,患者的裸眼视力及眼压等安全性指标无明显变化。2.睑板腺热脉动治疗系统治疗睑板腺功能障碍是有效的,它能有效改善MGD患者的干眼症状、延长泪膜破裂时间、增加泪膜脂质层厚度、降低患者不完全眨眼比例、增加睑板腺开口数量及改善睑板腺分泌物性状,并能有效改善眼表病变,且通过3个月的随访观察,其治疗效果明显优于眼睑热敷。并且,在随访过程中发现睑板腺热脉动治疗组患者的疗效在观察期内能够维持,相比之下,热敷组患者虽有改善,但其疗效维持时间短,容易反复。3.睑板腺热脉动系统治疗能有效改善MGD患者的干眼症状及体征,但短期内并不能改善睑板腺的萎缩。4.Lipiview?眼表干涉仪测量MGD患者的泪膜脂质层厚度与其泪膜破裂时间、睑板腺开口数量、正常分泌的睑板腺数量及睑板腺分泌物性状评分始终呈正相关。Lipiview?眼表干涉仪对睑板腺功能障碍的诊断可以起到辅助和指导作用。
[Abstract]:Objective: To evaluate the safety and clinical efficacy of a system of Meibomian Gland Dysfunction (MGD) for the treatment of tarsal gland dysfunction (MGD) by comparing with the traditional hot compress, and to explore the correlation between the lipid layer of the tear film and the signs of the dysfunctional gland dysfunction. Selection of.1. patients in bed test: 100 eyes of 50 patients who were diagnosed with dry eye symptoms in Ophthalmological Hospital Affiliated to Tianjin Medical University from September 2015 to September 2016. (1) 18 years old, regardless of men and women or any race; (2) the subjective symptoms of the eyes were investigated with a SPEED questionnaire, each eye symptom score was 6 or higher, and (3) both eyes were MGD, 15 glands in the lower eyelids of each eye were assessed, and the palpebral gland secreted a lipid score of 12 or less. (4) willing to cooperate with the test process, if assigned to the control group, willing to comply with the home hot compress treatment; (5) can be reviewed and participated in all research visits. (1) the SPEED score was 15 points or more; (2) the following eye diseases, such as Any eye infection or inflammation in one eye; (3) eye surgery or trauma within three months before the baseline examination; any eye may have eye surface abnormalities that may affect the integrity of the cornea; (4) any eye with eyelid abnormalities affecting eyelid function; (5) dry eyes caused by systemic disease, and unwillingness to set up during the study. Systematic drug treatment for dry eyes; (6) tacral plug implantation or canaliculoplasty within three months before the baseline examination. Patients who had undergone teardrop embolization or lacrimal canaliculoplasty three months ago did not allow new lacrimal punctum embolism or lacrimal canaliculoplasty during the study; (7) participation within 30 days prior to the baseline examination. Group and follow-up of.2. patients in other clinical trials: two groups were randomly divided into two groups: the eyelid glandular fever pulsation treatment group (group A) and the hot compress group (group B).A patients received a 12 minute Lipiflow after the baseline examination, the eyelid glandular fever pulsation system (American Tearscience Department), and the B group received Eye Giene Insta-W daily at home. ArmthTM eye mask (American Eyedetec Medical, Inc company) hot compress for 15 minutes, 1 times a day for 2 weeks. All patients before and after treatment and 1 months, 2 months, 3 months received SPEED questionnaire survey, naked eye vision (Uncorrected Visual Acuity, UCVA) examination, non-contact computerized intraocular pressure examination, tear film lipid thickness (Lipid layer thinkness, thinkness, thinkness, thinkness, Lipid layer thinkness, Lipid layer thinkness, Lipid layer thinkness, thinkness, Lipid layer thinkness, thinkness, Lipid layer thinkness ), Partial blink rate (PB), examination of tarsal gland loss rate, tear secretion test (Schirmer I test, SIT), tear film rupture time (Break-up time, BUT), cornea fluorescein staining (Corneal Fluorescein), palpalate gland opening evaluator to evaluate the palpalate gland opening Statistical analysis of.3. and secretion traits: all recorded data were processed and statistically analyzed. Statistical analysis was carried out by SPSS 17 statistics software. The measurement data were represented by mean + standard deviation (`x + s). The count data were tested by chi 2, and the two groups of different time points were compared with the repeated measurements of variance analysis, before and after treatment in the group. The later index was compared by paired t test. Independent sample t test was used for the same time point. All confidence intervals were set to 95%, P0.05 was statistically significant. Results: before 1., two groups were in sex, age, SPEED questionnaire, UCVA, Intra-ocular pressure, IOP, LLT, PB, loss of eyelid gland, SIT, BUT There was no statistical difference between the CFS score, the number of blepharo gland opening and the character score of the exudate of the palpebral gland (P0.05). During the study, 1 months after the treatment of adverse events such as cornea and eyelid burns, all the indexes except the loss rate of the palpebral gland in the two groups were better than those before the treatment, and the two groups of SPEED scores, LLT, PB, were all improved. The loss rate of the eyelid gland, BUT, SIT, the number of eyelid gland opening, and the score of the eyelid gland secretion were not statistically significant (P0.05), and the CFS score in the group B was obviously superior to that of the A group, and the difference between the two groups was statistically significant (P0.01).3. treatment for 2 months, and the two groups had no significant changes in the loss rate of the eyelid gland gland compared with those before the treatment. The two groups were LLT, PB, the loss rate of the eyelid glandular glands, SIT, C There was no statistical difference in FS score (P 0.05). The BUT of A group, the number of eyelid glandular openings, and the score of eyelid gland secretion were obviously superior to those in the B group, and the difference between the two groups was statistically significant (P 0.01).4. after the treatment, and the SPEED questionnaire score of the two groups was significantly improved (P 0.01), and the loss rate of the eyelid gland was not obvious. Changes (P 0.05).A group LLT, PB, the number of eyelid glandular openings, the eyelid gland secretion character score also improved significantly, the difference was statistically significant (P0.01).B group LLT, PB, the number of eyelid glandular opening, the eyelid gland secretion character score improved although compared with before treatment, but the difference was not statistically significant (P is 0.05). Two groups PB, SIT, CFS evaluation There was no statistical difference (P 0.05), and the number of LLT, BUT, meibomian gland opening and tarsal gland secretion in group A were significantly better than those in group B, and there was a significant difference between the groups (P all) and 1 months after.5. treatment, 2 months and 3 months of two groups had no obvious changes in UCVA and IOP (P 0.05).6. before and after the treatment of tear film thickness and tear film rupture There was a positive correlation between the number of tarsal gland openings, the number of normal secretory glands and the character score of the exudate gland secretion. P 0.05. conclusion: 1, the eyelid glandular fever pulsation therapy instrument is safe for the treatment of tarsal gland dysfunction. After 3 months of treatment, the patients have no corneal and ocular surface damage, and the patients' naked eye vision and the visual acuity of the patients are not found. There is no obvious change in the safety index of intraocular pressure (IOP)..2. is effective in the treatment of tarsal gland dysfunction. It can effectively improve the dry eye symptoms of MGD patients, prolong tear film rupture time, increase the thickness of tear film lipid layer, reduce the proportion of incomplete blink of the eyes, increase the number of opening of the eyelid gland and improve the exudation of the eyelid plate gland After 3 months of follow-up observation, the treatment effect was obviously better than that of the eyelid hot compress. In the follow-up process, the curative effect of the blepharospasm treatment group was maintained during the observation period. In contrast, the patients in the hot compress group were improved, but the duration of the treatment was shorter and the.3. palpebral plate was easy to be repeated. The treatment of adenosine pulsation system can effectively improve the dry eye symptoms and signs of MGD patients. But in the short term, the atrophy of the eyelid gland can not be improved by.4.Lipiview? The ocular surface interferometer is used to measure the thickness of tear film in MGD patients with tear film rupture time, the number of opening of the eyelid gland, the number of normal secretory glands and the character score of the eyelid gland secretion. .Lipiview? Ocular surface interferometer can play an auxiliary and guiding role in the diagnosis of meibomian gland dysfunction.

【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R777.13

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