CAJ | 학술논문

背景近视性准分子激光角膜原位磨镶术(LASIK)后需局部使用糖皮质激素滴眼液已成为共识,具有良好抗炎效果且不良反应小的糖皮质激素滴眼液有利于术后角膜上皮的快速修复.目的评估质量分数0.5％氯替泼诺滴眼液在LASIK术后的临床应用效果.方法采用前瞻性随机对照研究设计.本研究经中山大学中山眼科中心伦理委员会批准,所有患者纳入前均充分了解本研究的内容并签署知情同意书.112例224眼纳入研究,其中共97例194眼完成随访.双眼接受近视性LASIK的患者以随机数字表法分为0.5％氯替泼诺滴眼液点眼组(试验组)54例108眼和对照组43例86眼,两组患者年龄及术前等效球镜度差异均无统计学意义(P＞0.05).两组的基础治疗方法一致.试验组从术后第1天开始局部点用0.5％氯替泼诺滴眼液,每日4次,共1周,对照组以同样的方法点用妥布霉素地塞米松滴眼液.分别于术后1d、1周、1个月对2个组患者的主观症状进行评分,并行裸眼视力、最佳矫正视力(BCVA)、眼压、中央角膜厚度、角膜荧光素染色检查,同时观查术眼的术中和术后并发症情况,以评价0.5％氯替泼诺滴眼液点眼的安全性.结果在随访过程中,未观察到与药物相关的全身和眼部严重并发症.术后1d、1周和1个月,试验组和对照组主观症状评分(包括眼痛、异物感、视物模糊评分)比较,差异均无统计学意义(P＞0.05).术后1周,试验组和对照组校正后的实际眼压分别为(16.27±3.31)mmHg和(17.49±4.48)mmHg,差异有统计学意义(t=-2.113,P=0.036)；术后1个月,试验组和对照组校正后的实际眼压分别为(15.01±3.22)mmHg和(15.30±4.17)mmHg,差异无统计学意义(t=-0.532,P=0.595).术后1d,试验组发生轻度弥漫性层间角膜炎(DLK)者7眼,对照组为5眼,差异无统计学意义(x2 =0.153,P=0.926),术后1周和1个月两组中均未发现DLK.术后1d、1周和1个月两组间的角膜荧光素染色评分差异均无统计学意义(Z=-0.566,P=0.571；Z=-0.689,P=0.491；Z=-1.628,P=0.103).结论 0.5％氯替泼诺滴眼液用于LASIK术后可以有效控制术后炎症反应和DLK,并且减少了传统糖皮质激素升高眼压的风险. 揹景近視性準分子激光角膜原位磨鑲術(LASIK)後需跼部使用糖皮質激素滴眼液已成為共識,具有良好抗炎效果且不良反應小的糖皮質激素滴眼液有利于術後角膜上皮的快速脩複.目的評估質量分數0.5％氯替潑諾滴眼液在LASIK術後的臨床應用效果.方法採用前瞻性隨機對照研究設計.本研究經中山大學中山眼科中心倫理委員會批準,所有患者納入前均充分瞭解本研究的內容併籤署知情同意書.112例224眼納入研究,其中共97例194眼完成隨訪.雙眼接受近視性LASIK的患者以隨機數字錶法分為0.5％氯替潑諾滴眼液點眼組(試驗組)54例108眼和對照組43例86眼,兩組患者年齡及術前等效毬鏡度差異均無統計學意義(P＞0.05).兩組的基礎治療方法一緻.試驗組從術後第1天開始跼部點用0.5％氯替潑諾滴眼液,每日4次,共1週,對照組以同樣的方法點用妥佈黴素地塞米鬆滴眼液.分彆于術後1d、1週、1箇月對2箇組患者的主觀癥狀進行評分,併行裸眼視力、最佳矯正視力(BCVA)、眼壓、中央角膜厚度、角膜熒光素染色檢查,同時觀查術眼的術中和術後併髮癥情況,以評價0.5％氯替潑諾滴眼液點眼的安全性.結果在隨訪過程中,未觀察到與藥物相關的全身和眼部嚴重併髮癥.術後1d、1週和1箇月,試驗組和對照組主觀癥狀評分(包括眼痛、異物感、視物模糊評分)比較,差異均無統計學意義(P＞0.05).術後1週,試驗組和對照組校正後的實際眼壓分彆為(16.27±3.31)mmHg和(17.49±4.48)mmHg,差異有統計學意義(t=-2.113,P=0.036)；術後1箇月,試驗組和對照組校正後的實際眼壓分彆為(15.01±3.22)mmHg和(15.30±4.17)mmHg,差異無統計學意義(t=-0.532,P=0.595).術後1d,試驗組髮生輕度瀰漫性層間角膜炎(DLK)者7眼,對照組為5眼,差異無統計學意義(x2 =0.153,P=0.926),術後1週和1箇月兩組中均未髮現DLK.術後1d、1週和1箇月兩組間的角膜熒光素染色評分差異均無統計學意義(Z=-0.566,P=0.571；Z=-0.689,P=0.491；Z=-1.628,P=0.103).結論 0.5％氯替潑諾滴眼液用于LASIK術後可以有效控製術後炎癥反應和DLK,併且減少瞭傳統糖皮質激素升高眼壓的風險.
배경 근시성준분자격광각막원위마양술(LASIK)후수국부사용당피질격소적안액이성위공식,구유량호항염효과차불량반응소적당피질격소적안액유리우술후각막상피적쾌속수복.목적 평고질량분수0.5％록체발낙적안액재LASIK술후적림상응용효과.방법 채용전첨성수궤대조연구설계.본연구경중산대학중산안과중심윤리위원회비준,소유환자납입전균충분료해본연구적내용병첨서지정동의서.112례224안납입연구,기중공97례194안완성수방.쌍안접수근시성LASIK적환자이수궤수자표법분위0.5％록체발낙적안액점안조(시험조)54례108안화대조조43례86안,량조환자년령급술전등효구경도차이균무통계학의의(P＞0.05).량조적기출치료방법일치.시험조종술후제1천개시국부점용0.5％록체발낙적안액,매일4차,공1주,대조조이동양적방법점용타포매소지새미송적안액.분별우술후1d、1주、1개월대2개조환자적주관증상진행평분,병행라안시력、최가교정시력(BCVA)、안압、중앙각막후도、각막형광소염색검사,동시관사술안적술중화술후병발증정황,이평개0.5％록체발낙적안액점안적안전성.결과 재수방과정중,미관찰도여약물상관적전신화안부엄중병발증.술후1d、1주화1개월,시험조화대조조주관증상평분(포괄안통、이물감、시물모호평분)비교,차이균무통계학의의(P＞0.05).술후1주,시험조화대조조교정후적실제안압분별위(16.27±3.31)mmHg화(17.49±4.48)mmHg,차이유통계학의의(t=-2.113,P=0.036)；술후1개월,시험조화대조조교정후적실제안압분별위(15.01±3.22)mmHg화(15.30±4.17)mmHg,차이무통계학의의(t=-0.532,P=0.595).술후1d,시험조발생경도미만성층간각막염(DLK)자7안,대조조위5안,차이무통계학의의(x2 =0.153,P=0.926),술후1주화1개월량조중균미발현DLK.술후1d、1주화1개월량조간적각막형광소염색평분차이균무통계학의의(Z=-0.566,P=0.571；Z=-0.689,P=0.491；Z=-1.628,P=0.103).결론 0.5％록체발낙적안액용우LASIK술후가이유효공제술후염증반응화DLK,병차감소료전통당피질격소승고안압적풍험.
Background It has become a consensus about the necessity of topical administration of corticosteroid eye solutions after myopic laser-assisted in situ keratomileusis(LASIK).The glucocorticoid eye drops with good anti-inflammatory effect and less adverse effects is helpful for the repair of corneal epithelium following LASIK.Objective This study was to evaluate the clinical effects of 0.5％ loteprednol etabonate eye drops after LASIK.Methods A prospective randomized-controlled study was designed.One hundred and twelve myopia patients(224 eyes)who had received LASIK were included in this study and randomly divided into two groups,and 97 patients finished the follow-up,including 108 eyes of 54 patients in the 0.5％ ioteprednol etabonate eye drops treatment group and 86 eyes of 43 patients in the control group.0.5％ loteprednol etabonate eye drops or dexamethasone/tobramycin eye drops were administered topically to the treatment group and control group,respectively 4 times daily from postoperative day 1 through day 7 following LASIK in addition to regular basic treatment.The follow-up was performed 1 day,1 week and 1 month after LASIK.Subjective symptoms including eye pain,foreign body sensation and blurring were scored,and uncorrected visual acuity(UCVA),best corrected visual acuity(BCVA),intraocular pressure(IOP),central corneal thickness,corneal fluorescein staining and diffuse laminar keratitis(DLK)were evaluated and compared between the two groups 1 day,1 week,and 1 month after LASIK.This clinical trial was approved by the Ethic Commission of Zhongshan Ophthalmic Center,and written informed consent was obtained from each patient before the trial.Results No drug-related ocular and systemic adverse events were found in the treatment group throughout the follow-up duration.There was no significant difference in the subjective symptom score after 1 day,1 week and 1 month(P＞0.05).At 1 week post-LASIK,the corrected actual IOP was (16.27±3.31)mmHg in the treatment group and(17.49±4.48)mmHg in the control group,with a statistically significant difference between them(t =-2.113,P =0.036).However,there was no statistically significant difference in IOP between the treatment group(15.01±3.22)mmHg and the control group(15.30±4.17)mmHg at 1 month post-LASIK(t=-0.532,P=0.595).Mild diffuse lamellar keratitis developed in 7 eyes in the treatment group and 5 eyes in the control group without a significant difference on the first day after LASIK(x2 =0.153,P =0.926).The scores of corneal fluorescein staining were not statistically different between the two groups at 1 day,1 week and 1 month postoperative(Z=-0.566,P=0.571 ;Z=-0.689,P=0.491 ;Z=-1.628,P=0.103).Conclusions 0.5％ loteprednol etabonate eye drops could effectively inhibit postoperative inflammation and low the incidence of DLK.It can lessen the risk of IOP elevation in comparison with traditional steroid eye drops.