背景:小儿孔源性视网膜脱离(PRRD)是复杂的,很少发生,通常与创伤或先天性异常有关。儿童通常不认识或报告视网膜脱离的症状。因此,在介绍时,PRRD通常是晚期的,通常伴有黄斑病变,增生性玻璃体视网膜病变(PVR),慢性持续时间,视力差。因为5-FU和LMWH在PVR工艺的不同方面都是有效的,据认为,预防PVR的联合方法将是有利的。
方法:在知情同意后,在前瞻性随机试验中,14岁以下高危PRRD儿童接受了平坦部玻璃体切除术和巩膜扣硅油注射治疗,分为2组.A组接受术中输注5-FU(200µg/ml)和LMWH(5IU/ml),B组输注生理盐水。主要结果是12周内发生复发性PRRD,次要结局是PVR的发生,最佳矫正视力(BCVA),12周内二次手术的次数和时间。
结果:该研究包括41例患者的42只眼,A组21例,B组21例,PRRD的持续时间A组为0.5~7个月,B组为0.25~5个月,B组为33%,A组为19%(p=0.292)。A组PRRD复发的平均发生时间为9.5±5周,而B组为2.86±2.41周(p=0.042)。B组中更多的患者最终获得更晚期的PVR(p=0.038),BCVA仅在所有病例术前均为手部运动(HM),与B组的光感(PL)-0.1Snellen相比,A组改善至HM-0.3Snellen(p=0.035),任何二次手术均无差异,但A组时间为9.71±3.73周,比B组时间晚4.0±2.83周(p=0.042).
结论:这项研究得出结论,在高风险PRRD中使用5-FU和LMWH组合导致术后PVR的发生率较低,PRRD复发较晚,最终BCVA较好。
背景:注册:clinicaltrials.govPRSNCT06166914初始发布日期4/12/2023。唯一协议ID:9,163,209日期21/10/2021。追溯登记。
BACKGROUND: Pediatric rhegmatogenous retinal detachments (PRRDs) are complex, rare occurrences and are often related to trauma or congenital abnormalities. Children often do not recognize or report symptoms of retinal detachment. Thus at presentation, PRRD is typically advanced often with macular involvement, proliferative vitreoretinopathy (PVR), chronic duration, and poor visual acuity. Because 5-FU and LMWH are effective in different aspects in the PVR process, it was believed that a syngergistic approach to the prevention of PVR would be advantageous.
METHODS: After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized
trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.
RESULTS: The
study included 42 eyes of 41 patients, 21 in group A and 21 in group B, the duration of PRRD ranged from 0.5 to 7 months in group A and 0.25-5 months in group B.The rate of recurrent PRRD was higher in group B 33% compared to 19% in group A (p = 0.292). The mean timing of occurrence of recurrent PRRD was 9.5 ± 5 weeks in group A compared to 2.86 ± 2.41 weeks in group B (p = 0.042), more patients in group B ended up with more advanced PVR (p = 0.038), BCVA was hand movement (HM) only in all cases preoperatively and improved to HM-0.3 Snellen in group A compared to light perception (PL)-0.1Snellen in group B (p = 0.035), there was no difference in any of secondary procedures but with later timing in group A 9.71 ± 3.73 weeks than in group B 4.0 ± 2.83 weeks (p = 0.042).
CONCLUSIONS: This
study concluded that the use of the 5-FU and LMWH combination in high risk PRRD resulted in lower rate of postoperative PVR, later recurrence of PRRD and better final BCVA.
BACKGROUND: Registry: clinicaltrials.gov PRS NCT06166914 date of initial release 4/12/2023. Unique Protocol ID: 9,163,209 date 21/10/2021. Retrospectively registered.