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A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy.

Abstract：

OBJECTIVE:To determine the efficacy of a combination of 5-fluorouracil and low-molecular-weight heparin (LMWH) to improve the outcome of surgery for established proliferative vitreoretinopathy (PVR). DESIGN:Double-masked, prospective, randomized, placebo-controlled clinical trial. SETTING:Three tertiary-referral teaching hospital vitreoretinal surgical units. PATIENTS:One hundred fifty-seven patients with established PVR (grade C, anterior or posterior) undergoing vitrectomy surgery. INTERVENTION:All patients underwent vitreoretinal surgery and silicone oil exchange with or without membrane peeling and/or retinectomy. Patients were randomly allocated to perioperative infusion with or without 5-fluorouracil (200 microg/ml) and LMWH (5 IU/ml) in Hartmann's solution for 1 hour. OUTCOME MEASURES:The primary outcome measure was defined as posterior retinal reattachment after removal of silicone oil without any reoperations at 6 months. Secondary outcome measures recorded were posterior retinal reattachment, localized/tractional retinal detachment, visual acuity, macular pucker, hypotony, glaucoma, keratopathy, and cataract. Removal of silicone oil and reoperations were also recorded. RESULTS:Overall, at 6 months 84% of patients had full retinal reattachment and 94% had stable posterior retinal reattachment. There was no significant difference in success in the primary outcome measure (56%, treatment group; 51%, placebo group; P = 0.59) or in secondary outcome measures or rates of complications. Secondary macular pucker occurred less often in the treatment group (6% vs. 17% at 6 months, P = 0.068). CONCLUSIONS:A perioperative infusion of combined 5-fluorouracil and LMWH does not significantly increase the success rate of vitreoretinal surgery for established PVR.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Charteris DG,Aylward GW,Wong D,Groenewald C,Asaria RH,Bunce C,PVR Study Group.

doi

10.1016/j.ophtha.2004.05.036

subject

Has Abstract

pub_date

2004-12-01 00:00:00

pages

2240-5

issue

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(04)00977-7

journal_volume

111

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy.