Tantipat Chitchanok, Kasetsuwan Ngamjit, Chotikkakamthorn Patraramon, Pongpirul Krit
Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Excellence Center of Cornea and Limbal Stem Cell Transplantation, Department of Ophthalmology, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Front Med (Lausanne). 2022 Jun 10;9:895418. doi: 10.3389/fmed.2022.895418. eCollection 2022.
This study aimed to evaluate the efficacy and safety of bevacizumab eye drops compared with those of an intra-meibomian gland (MG) injection of bevacizumab when performed in conjunction with standard lid hygiene in patients with meibomian gland dysfunction (MGD)-associated posterior blepharitis.
This prospective, open-label, observer-blinded randomized controlled trial included 60 eyes of 30 patients with MGD-associated posterior blepharitis who exhibited lid margin telangiectasia, treated at the Chula Refractive Surgery Center of King Chulalongkorn Memorial Hospital. Patients were randomized to receive lid hygiene plus 0.05% bevacizumab eye drops or a single intra-MG injection of 2.5% bevacizumab. All patients were instructed to perform routine lid hygiene care as demonstrated in an instructional video. Primary outcomes included telangiectasia grading and the lid margin neovascularized area (LMNA). Secondary outcomes included the Ocular Surface Disease Index (OSDI) score, corneal staining, meibum quality, meiboscore, conjunctival redness, fluorescein break-up time (FBUT), lipid layer thickness, treatment compliance, and adverse events. All parameters were evaluated before and 3 months after treatment.
After treatment, there were no significant differences in telangiectasia grade and LMNA between groups (mean difference, -0.14, 95% CI -0.42 to 0.15, = 0.338, -0.1, 95% CI -1.1 to 0.8, = 0.761, respectively); however, the injection group exhibited significant improvements in both telangiectasia grade and LMNA, while, in the eye drop group, only telangiectasia grade showed a significant improvement relative to baseline. The injection group also exhibited significant improvements in corneal staining (mean difference, -0.78, 95% CI -1.29 to -0.27, = 0.003), meiboscores (mean difference, -0.37, 95% CI -0.52 to -0.21, <0.001), and FBUT (mean difference, 1.25, 95% CI 0.21-2.29, = 0.019) compared to the eye drop group. OSDI scores, corneal staining, meibum quality, meiboscores, and conjunctival redness significantly improved relative to baseline in both groups. No local and systemic adverse event was observed at month 3 in both groups.
When performed with regular lid hygiene, intra-MG injection and topical application of bevacizumab are safe and effective for improving lid margin telangiectasia and the signs and symptoms of MGD-associated posterior blepharitis. This therapy may represent an alternative or adjunctive treatment for patients with MGD-associated posterior blepharitis.
本研究旨在评估在睑板腺功能障碍（MGD）相关性睑后炎患者中，与睑板腺内注射贝伐单抗联合标准睑缘清洁相比，贝伐单抗滴眼液的疗效和安全性。
这项前瞻性、开放标签、观察者盲法随机对照试验纳入了30例MGD相关性睑后炎患者的60只眼，这些患者表现出睑缘毛细血管扩张，在朱拉隆功国王纪念医院的朱拉屈光手术中心接受治疗。患者被随机分为接受睑缘清洁加0.05%贝伐单抗滴眼液或单次睑板腺内注射2.5%贝伐单抗。所有患者均按照教学视频所示接受常规睑缘清洁护理指导。主要结局包括毛细血管扩张分级和睑缘新生血管化区域（LMNA）。次要结局包括眼表疾病指数（OSDI）评分、角膜染色、睑脂质量、睑板腺评分、结膜充血、荧光素泪膜破裂时间（FBUT）、脂质层厚度、治疗依从性和不良事件。所有参数在治疗前和治疗后3个月进行评估。
治疗后，两组间毛细血管扩张分级和LMNA无显著差异（平均差异分别为-0.14，95%可信区间-0.42至0.15，P = 0.338；-0.1，95%可信区间-1.1至0.8，P = 0.761）；然而，注射组的毛细血管扩张分级和LMNA均有显著改善，而滴眼液组仅毛细血管扩张分级相对于基线有显著改善。与滴眼液组相比，注射组在角膜染色（平均差异为-0.78，95%可信区间-1.29至-0.27，P = 0.003）、睑板腺评分（平均差异为-0.37，95%可信区间-0.52至-0.21，P <0.001）和FBUT（平均差异为1.25，95%可信区间0.21 - 2.29，P = 0.019）方面也有显著改善。两组的OSDI评分、角膜染色、睑脂质量、睑板腺评分和结膜充血相对于基线均有显著改善。两组在第3个月均未观察到局部和全身不良事件。
在进行常规睑缘清洁时，睑板腺内注射和局部应用贝伐单抗对于改善睑缘毛细血管扩张以及MGD相关性睑后炎的体征和症状是安全有效的。这种治疗方法可能是MGD相关性睑后炎患者的一种替代或辅助治疗方法。
