Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.
School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.
Eye (Lond). 2020 Feb;34(2):408-414. doi: 10.1038/s41433-019-0596-7. Epub 2019 Sep 25.
To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.
评估康柏西普多次结膜下注射治疗翼状胬肉术后患者的安全性和有效性。
本研究为前瞻性随机对照临床试验,共纳入 96 例(96 只眼)有复发倾向的翼状胬肉患者,术后第 5 天随机分为康柏西普组和 5-氟尿嘧啶组。所有患者在术后第 5 天(基线)、第 2 周和第 4 周时分别接受 3 次结膜下注射康柏西普(0.2ml)或 5-氟尿嘧啶(0.2ml)。记录并分析翼状胬肉形态、颜色强度、复发和并发症情况,分别在第 1 次注射前、第 1 天、第 1 周、第 1 个月、第 3 个月和第 6 个月进行评估。此外,无患者脱落。
在第 3 次注射后第 1 天、第 1 周、第 1 个月、第 3 个月和第 6 个月,两组间的颜色强度差异有统计学意义(p=0.001、0.002、0.000、0.000 和 0.002),康柏西普组的眼睛颜色较 5-氟尿嘧啶组更浅。在第 3 次注射后 6 个月,两组间在翼状胬肉形态(p=0.006)和复发(p=0.002)方面存在显著差异,康柏西普组的情况好于 5-氟尿嘧啶组。此外,康柏西普组未发生角膜擦伤,明显少于 5-氟尿嘧啶组(17/48;p=0.000)。两组间在结膜下出血(p=0.789)和持续性上皮缺损(p=0.078)方面无显著差异。
康柏西普多次结膜下注射作为翼状胬肉手术后的辅助治疗方法,安全、有效且患者耐受性良好。