角膜疾病患者使用无防腐剂奥布卡因滴眼液的安全性与有效性研究:一项前瞻性单臂临床试验OA
Safety and analgesic efficacy of preservative-free oxybuprocaine hydrochloride eye drops in corneal patients:a prospective,single-arm clinical trial
目的:评估无防腐剂的 0.4%盐酸奥布卡因滴眼液在角膜疾病患者接受需要眼表麻醉的检查项目时的安全性与有效性.通过观察其在健康参与者及轻中度干眼症患者中的应用效果,为临床角膜疾病检查提供参考依据.方法:采用前瞻性单臂临床试验,在 2025 年 1 月—3 月招募于乐山爱尔眼科医院门诊就诊的健康成年人和干眼症患者.研究眼优先选择基线时荧光素钠角膜染色(corneal fuorescein staining,CFS)评分更低眼别,如两眼一致则选取结膜丽丝胺绿染色(conjunctival lissamine green staining,CLGS)评分更低眼别,如 CFS 和 CLGS 一致,则选择荧光素钠泪膜破裂时间(fluorescein tear film break-up time,FBUT)高的眼别,如双眼 CFS、CLGS、FBUT 数值相同则选取右眼.所有参与者将使用无防腐剂 0.4%盐酸奥布卡因滴眼液 1～2 滴.在使用前、使用后 5、20 min 收集研究眼的疼痛评分以及眼表数据(CFS、CLGS、FBUT).本研究主要结局为安全性,次要结局为基线疼痛数字评定量表(numerical rating scale,NRS)评分≥1 分的研究眼滴用盐酸奥布卡因 5、20 min 后 NRS.结果:共纳入 53 例参与者(53 眼),均为汉族,中位年龄 39 岁(四 分 位 数 间 距:32.00～53.00),女性占 54.7%(29/53),其中 17%(9/53)为轻中度干眼症患者.滴用盐酸奥布卡因后研究眼 FBUT、CFS、CLGS 等指标在 5 min 和 20 min 时与基线差异均无统计学意义(P 均>0.05).基线 NRS 评分≥1 分的患者共 20 例,其研究眼 NRS 评分在滴用盐酸奥布卡因后 5 min 和 20 min 下降,与基线比较差异均有统计学意义(P<0.001).结论:无防腐剂 0.4%盐酸奥布卡因滴眼液用于健康参与者或轻中度干眼症患者眼表安全性高,使用者耐受性良好,滴用后 5 min 和 20 min 对有眼表疼痛感觉的患者有镇痛效果,并且在使用期间对参与者角膜、结膜以及泪膜稳定性无明显影响.
Objective:The aim of this study was to evaluate the safety and efficacy of preservative-free 0.4%oxybuprocaine hydrochloride eye drops in patients with corneal conditions undergoing examinations that necessitate ocular surface anesthesia.By observing its application effects in healthy individuals and patients with mild to moderate dry eye(DED),it provides a reference for clinical corneal examinations.Methods:This prospective,single-arm trial enrolled healthy adults and DED patients from the outpatient department of Leshan Aier Eye Hospital between January 2025 and March 2025.The study eye was selected based on the following criteria:First,the eye with a lower fluorescein sodium corneal fluorescein staining(CFS)score at baseline was chosen.If the CFS scores were equal,the eye with the lower conjunctival lissamine green staining(CLGS)score was then selected.In cases where both CFS and CLGS scores were the same,the eye with the higher fluorescein tear film break-up time(FBUT)was picked.If both eyes had identical values,the right eye was designated as the study eye.All participants received 1-2 drops of preservative-free 0.4%oxybuprocaine hydrochloride.Pain scores measured using the numerical rating scale(NRS),and ocular surface parameters(CFS,CLGS,FBUT)were recorded at baseline,5 minutes,and 20 minutes after instillation.The primary endpoint was safety,while the secondary endpoint was NRS scores at 5 and 20 minutes in study eyes with baseline NRS≥1.Results:A total of 53 participants(53 eyes)were included in the study,all of Han ethnicity.The median age of the paticipants was 39 years,with an interquartile range of 32.00-53.00 years,and 54.7%(29/53)were female.Among them,17%(9/53)had mild to moderate DED.No statistically significant differences were found in FBUT,CFS,or CLGS between baseline and post-instillation time points(all P>0.05).Twenty participants with a baseline NRS of≥1 demonstrated statistically significant reductions in NRS scores at 5 and 20 minutes compared to baseline(both P<0.001).Conclusions:Preservative-free 0.4%oxybuprocaine hydrochloride eye drops were well-tolerated and safe for the ocular surface of both healthy individuals and patients with mild to moderate DED.Analgesic efficacy was clearly demonstrated at 5 and 20 minutes after instillation in subjects experiencing ocular surface pain,with no significant adverse effects on corneal/conjunctival integrity or tear film stability.
杨楠;郝更生
乐山爱尔眼科医院,乐山 614099乐山爱尔眼科医院,乐山 614099
医药卫生
盐酸奥布卡因无防腐剂眼表表面麻醉干眼症疼痛数字评定量表
oxybuprocaine hydrochloridepreservative-freeocular surfacesurface anesthesiadry eyenumerical rating scale for pain
《眼科学报》 2026 (7)
526-533,8
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