Kasetsuwan Ngamjit, Reinprayoon Usanee, Satitpitakul Vannarut
Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.
We assessed the efficacy and tolerability of topical bevacizumab 0.05% when used as an adjunctive therapy after excision of primary pterygia.
This randomized double-masked study included 22 patients (22 eyes) with primary pterygia who underwent pterygium surgery with the use of the bare sclera technique. After pterygium excision, 22 patients were randomized to receive the topical bevacizumab 0.05% (12 eyes) or the placebo (10 eyes) with the use of the block of four randomization method. Topical bevacizumab and placebo were applied in the respective groups 4 times daily for 3 months. Follow-up evaluations for recurrence by slit-lamp photography were conducted once monthly. Ocular and systemic adverse events were assessed every 2 weeks during the 3 months of treatment. The slit-lamp photographs were masked and analyzed. The primary and secondary outcomes were the differences in the pterygial recurrence rates between the groups and adverse events at 3 months, respectively. Corneal recurrence was defined as recurrent fibrovascular tissue invading the cornea; conjunctival recurrence was defined as either recurrent vessels or fibrous tissue in the excised area without corneal invasion.
All 22 patients completed follow-up at 3 months after the start of the trial medications. After 3 months of treatment, 1 patient (8.33%) and 3 patients (30.00%) from the bevacizumab and placebo groups, respectively, had a corneal recurrence. No significant (P = 0.293) differences were found between the groups as determined by Fisher's exact test. However, conjunctival and corneal recurrences were found in 4 (33.33%) and 9 (90.00%) patients, respectively, in the bevacizumab and placebo groups, a difference that reached significance (P = 0.01). No significant adverse events developed.
Topical bevacizumab, as an adjunctive treatment after pterygium excision, was well tolerated. The trend for recurrence was lower in the topical bevacizumab group. ClinicalTrials.gov identifier: NCT01311960.
我们评估了0.05%的局部用贝伐单抗作为原发性翼状胬肉切除术后辅助治疗的疗效和耐受性。
这项随机双盲研究纳入了22例（22只眼）原发性翼状胬肉患者，他们接受了使用裸巩膜技术的翼状胬肉手术。翼状胬肉切除术后，22例患者采用随机分组法分为4组，分别接受0.05%的局部用贝伐单抗（12只眼）或安慰剂（10只眼）。局部用贝伐单抗和安慰剂分别在各自组中每天应用4次，持续3个月。每月通过裂隙灯摄影进行一次复发情况的随访评估。在治疗的3个月期间，每2周评估一次眼部和全身不良事件。裂隙灯照片进行了遮蔽和分析。主要和次要结局分别是两组之间翼状胬肉复发率的差异以及3个月时的不良事件。角膜复发定义为复发的纤维血管组织侵入角膜；结膜复发定义为切除区域出现复发血管或纤维组织但未侵入角膜。
所有22例患者在开始试验用药3个月后均完成随访。治疗3个月后，贝伐单抗组和安慰剂组分别有1例（8.33%）和3例（30.00%）出现角膜复发。Fisher精确检验显示两组之间无显著差异（P = 0.293）。然而，贝伐单抗组和安慰剂组分别有4例（33.33%）和9例（90.00%）出现结膜和角膜复发，差异具有统计学意义（P = 0.01）。未出现显著不良事件。
局部用贝伐单抗作为翼状胬肉切除术后的辅助治疗，耐受性良好。局部用贝伐单抗组的复发趋势较低。ClinicalTrials.gov标识符：NCT01311960。
