瞼板腺熱脈動系統(tǒng)治療瞼板腺功能障礙的有效性評價
本文選題:瞼板腺功能障礙 + 熱敷 ; 參考:《天津醫(yī)科大學(xué)》2017年碩士論文
【摘要】:目的:本研究通過與傳統(tǒng)熱敷相比較,評估一種瞼板腺熱脈動系統(tǒng)治療瞼板腺功能障礙(Meibomian Gland Dysfunction,MGD)的安全性及臨床療效,并在此基礎(chǔ)上探究淚膜脂質(zhì)層與瞼板腺功能障礙體征的相關(guān)性。方法:本研究為前瞻性、隨機(jī)對照臨床試驗。1.患者選擇:選取2015年9月至2016年9月在天津醫(yī)科大學(xué)眼科醫(yī)院因干眼癥狀就診的患者50人100只眼。納入標(biāo)準(zhǔn):(1)年滿18歲,不論男女或任何種族;(2)眼部主觀癥狀使用SPEED問卷調(diào)查,每只眼睛癥狀得分在6分或更高分;(3)雙眼皆為MGD,評估每一只眼睛的下眼瞼15個腺體,瞼板腺分泌脂質(zhì)評分12分或以下。(4)愿意配合試驗檢測流程,若是分配到對照組,愿意遵守在家熱敷治療;(5)能夠復(fù)診并參與所有研究訪視。排除標(biāo)準(zhǔn):(1)SPEED評分為15分或以上;(2)伴有如下眼部疾病,例如:任何一只眼睛活動性的眼部感染或炎癥;(3)在基線檢查前三個月內(nèi)有眼部手術(shù)或外傷;任何一只眼睛存在可能影響角膜完整性的眼表異常;(4)任何一只眼有影響眼瞼功能的眼瞼異常;(5)系統(tǒng)性疾病導(dǎo)致的干眼,及在研究期間不愿意放棄會導(dǎo)致干眼的系統(tǒng)性藥物治療;(6)基準(zhǔn)檢查前三個月內(nèi)進(jìn)行過淚點(diǎn)塞植入或淚小管成形術(shù)。若在三個月以前進(jìn)行過淚小點(diǎn)栓塞或淚小管成形術(shù)的受試者,在研究期間不允許新的淚小點(diǎn)栓塞或淚小管成形術(shù);(7)基準(zhǔn)檢查前30天內(nèi)參與其他眼科臨床實驗。2.患者分組及隨訪:隨機(jī)均分為兩組:瞼板腺熱脈動治療組(A組)和熱敷治療組(B組)。A組患者在基準(zhǔn)檢查之后接受一次12分鐘的Lipiflow?瞼板腺熱脈動系統(tǒng)(美國Tearscience公司)治療,B組患者接受每日在家使用Eye Giene?Insta-WarmthTM眼罩(美國Eyedetec Medical,Inc公司)熱敷治療15分鐘,每天1次,共2周。治療前和治療后1個月、2個月、3個月所有患者均接受SPEED問卷調(diào)查、裸眼視力(Uncorrected Visual Acuity,UCVA)檢查、非接觸式電腦眼壓檢查、淚膜脂質(zhì)層厚度(Lipid layer thinkness,LLT)、不完全眨眼比例(Partial blink rate,PB)、瞼板腺缺失率檢查、淚液分泌試驗(SchirmerⅠtest,SIT)(無表麻)、淚膜破裂時間(Break-up time,BUT)檢查、角膜熒光素染色(Corneal Fluorescein Staining,CFS)、瞼板腺開口評估器(Meibomian Gland Evaluator,MGE)評估瞼板腺開口和分泌物性狀。3.統(tǒng)計分析:所有記錄數(shù)據(jù)整理后進(jìn)行統(tǒng)計學(xué)處理。采用SPSS 17.0統(tǒng)計學(xué)軟件進(jìn)行統(tǒng)計分析。計量資料以均數(shù)±標(biāo)準(zhǔn)差(`x±s)表示,計數(shù)資料采用χ2檢驗,兩組不同時間點(diǎn)的指標(biāo)比較采用重復(fù)測量方差分析,組內(nèi)治療前與治療后的指標(biāo)比較采用配對t檢驗。同一時間點(diǎn)的組間比較采用獨(dú)立樣本t檢驗。所有的置信區(qū)間被設(shè)置成95%,P0.05為差異有統(tǒng)計學(xué)意義。結(jié)果:1.治療前,兩組在性別、年齡、SPEED問卷評分、UCVA、眼內(nèi)壓(Intra-ocular pressure,IOP)、LLT、PB、瞼板腺缺失率、SIT、BUT、CFS評分、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分等各項指標(biāo)均無統(tǒng)計學(xué)差異(P0.05)。研究期間未發(fā)生任何角膜、眼瞼灼傷等不良事件。2.治療后1個月,A、B兩組除瞼板腺缺失率外的各項指標(biāo)均較治療前有所改善,兩組間SPEED問卷評分、LLT、PB、瞼板腺缺失率、BUT、SIT、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分均無統(tǒng)計學(xué)差異(P0.05);B組的CFS評分明顯優(yōu)于A組,且兩組間差異有統(tǒng)計學(xué)意義(P0.01)。3.治療后2個月,兩組瞼板腺缺失率較治療前均無明顯變化。兩組間LLT、PB、瞼板腺缺失率、SIT、CFS評分均無統(tǒng)計學(xué)差異(P均0.05);A組的BUT、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分均明顯優(yōu)于B組,且兩組間差異均有統(tǒng)計學(xué)意義(P均0.01)。4.治療后3個月,兩組的SPEED問卷評分、BUT及CFS評分均較治療前顯著改善(P均0.01),瞼板腺缺失率無明顯變化(P均0.05)。A組的LLT、PB、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分也均有明顯改善,差異有統(tǒng)計學(xué)意義(P0.01)。B組的LLT、PB、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分雖然較治療前有改善趨勢,但差異無統(tǒng)計學(xué)意義(P均0.05)。兩組間PB、SIT、CFS評分均無統(tǒng)計學(xué)差異(P均0.05);A組的LLT、BUT、瞼板腺開口數(shù)量、瞼板腺分泌物性狀評分均明顯優(yōu)于B組,且組間差異有統(tǒng)計學(xué)意義(P均0.01)。5.治療后的1個月、2個月、3個月兩組的UCVA及IOP均無明顯變化(P均0.05)。6.治療前后淚膜脂質(zhì)層厚度與淚膜破裂時間、瞼板腺開口數(shù)量、正常分泌的瞼板腺數(shù)量及瞼板腺分泌物性狀評分始終呈正相關(guān),P均0.05。結(jié)論:1、瞼板腺熱脈動治療儀治療瞼板腺功能障礙是安全的,治療后3個月研究期間未發(fā)現(xiàn)患者有任何角膜及眼表損害,患者的裸眼視力及眼壓等安全性指標(biāo)無明顯變化。2.瞼板腺熱脈動治療系統(tǒng)治療瞼板腺功能障礙是有效的,它能有效改善MGD患者的干眼癥狀、延長淚膜破裂時間、增加淚膜脂質(zhì)層厚度、降低患者不完全眨眼比例、增加瞼板腺開口數(shù)量及改善瞼板腺分泌物性狀,并能有效改善眼表病變,且通過3個月的隨訪觀察,其治療效果明顯優(yōu)于眼瞼熱敷。并且,在隨訪過程中發(fā)現(xiàn)瞼板腺熱脈動治療組患者的療效在觀察期內(nèi)能夠維持,相比之下,熱敷組患者雖有改善,但其療效維持時間短,容易反復(fù)。3.瞼板腺熱脈動系統(tǒng)治療能有效改善MGD患者的干眼癥狀及體征,但短期內(nèi)并不能改善瞼板腺的萎縮。4.Lipiview?眼表干涉儀測量MGD患者的淚膜脂質(zhì)層厚度與其淚膜破裂時間、瞼板腺開口數(shù)量、正常分泌的瞼板腺數(shù)量及瞼板腺分泌物性狀評分始終呈正相關(guān)。Lipiview?眼表干涉儀對瞼板腺功能障礙的診斷可以起到輔助和指導(dǎo)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.
【學(xué)位授予單位】:天津醫(yī)科大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2017
【分類號】:R777.13
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