Prophylactic Intraoperative Adjuvant Therapy with 5-Fluorouracil and Low Molecular Weight Heparin for the Prevention of Proliferative Vitreoretinopathy (PVR) in High-risk Patients with Primary Rhegmatogenous Retinal Detachment.

增殖性玻璃体视网膜病变(PVR)是孔源性视网膜脱离(RRD)术后失败的主要原因。纤维血管瘢痕会导致继发性视网膜脱离，这往往需要多次广泛的手术才能实现重新附着。尽管PVR的手术治疗取得了进展，但视力预后很差，许多患者在法律上是失明的。虽然已经进行了几项使用化疗药物的研究，但到目前为止还没有标准的治疗方法来预防PVR。两个独立的试验在手术中使用5-氟尿嘧啶(5-FU)加低分子肝素(LMWH)玻璃体内输注，一次用于高危患者，一次用于未选择的患者。在高危患者中，5-FU+LMWH使PVR的发生率降低了50%，而在未选择的患者中则没有。Cochrane-Collaboration的一项审查导致了在高危患者中使用5-FU+LMWH进行临床随机试验的建议。我们已经建立了非侵入性激光耀斑光度法作为一种新的工具，用于快速和准确地评估PVR重新脱离的风险。通过用这种方法选择高危患者，我们计划在安慰剂对照、随机、双盲试验中，在术中使用玻璃体内5-FU+低分子肝素作为预防性治疗。我们的目标是减少治疗组PVR的发生率。5-FU+低分子肝素可作为预防PVR、降低视网膜脱离致盲率的首个有效的预防性标准治疗。激光耀斑光度测定法将把治疗限制在高危人群。

Proliferative vitreoretinopathy (PVR) is the major cause for postoperative failure after surgery for rhegmatogenous retinal detachment (RRD). Fibrovascular scars lead to secondary retinal detachments, which often require multiple extensive operations to achieve re-attachment. Despite advances in the surgical management of PVR, the visual prognosis is poor and many patients become legally blind. Although several studies using chemotherapeutic agents have been undertaken, so far there is no standard therapy to prevent PVR. Two independent trials used an intravitreal infusion with 5-Fluorouracil (5-FU) plus low molecular weight heparin (LMWH) during surgery once in high-risk patients and once in unselected patients. In high-risk patients 5-FU + LMWH reduced PVR rates by 50%, while in unselected patients it did not. A review of the COCHRANE-collaboration led to the recommendation to conduct a clinical randomized trial using 5-FU + LMWH in high-risk patients. We have established non-invasive laser flare photometry as a novel tool for fast and precise estimation of the risk for PVR re-detachments. By selecting high-risk patients with this method we plan to use intraoperative intravitreal 5-FU + LMWH as a prophylactic therapy in a placebo controlled, randomized, double blind trial. We aim to reduce the incidence of PVR in the treatment group. 5-FU + LMWH would be the first effective prophylactic standard treatment to prevent PVR and decrease the incidence of blindness in patients with retinal detachments. Laser flare photometry would limit the treatment to those at high risk.