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半剂量维替泊芬光动力疗法治疗急性中心性浆液性脉络膜视网膜病变:一项随机对照试验的一年结果

Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial.

作者信息

Chan Wai-Man, Lai Timothy Y Y, Lai Ricky Y K, Liu David T L, Lam Dennis S C

机构信息

Department of Ophthalmology & Visual Science, The Chinese University of Hong Kong, Kowloon, Hong Kong, China.

出版信息

Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.

DOI:10.1016/j.ophtha.2008.04.014
PMID:18538401
Abstract

OBJECTIVE

To evaluate the efficacy of photodynamic therapy (PDT) with half-dose verteporfin for treating acute central serous chorioretinopathy (CSC).

DESIGN

Prospective, double-masked, placebo-controlled, randomized clinical trial.

PARTICIPANTS AND CONTROLS

Sixty-three eyes of 63 patients with acute symptomatic CSC of 3 months' duration or less were recruited. Forty-three eyes were randomized to indocyanine green angiography (ICGA)-guided PDT with half-dose (3 mg/m(2)) verteporfin and 21 eyes were randomized to placebo.

INTERVENTION

Patients in the verteporfin group received an infusion of half-dose verteporfin over 8 minutes, followed by ICGA-guided PDT 10 minutes from the start of infusion. Laser was applied for 83 seconds covering the choroidal abnormalities observed in ICGA, with a maximum laser spot size of 4500 mum.

MAIN OUTCOME MEASURES

The primary outcome measure was the proportion of eyes with absence of subretinal fluid at the macula at 12 months. Secondary outcome measures included changes in mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA), subjective symptoms, optical coherence tomography (OCT) results, central foveal thickness (CFT), and angiographic findings during the 12-month study period.

RESULTS

Thirty-nine patients in the verteporfin group and 19 patients in the placebo group completed 12 months of follow-up. Thirty-seven (94.9%) eyes in the verteporfin group compared with 11 (57.9%) eyes in the placebo group showed absence of subretinal fluid at the macula at 12 months (P = 0.001). The mean logMAR BCVA at 12 months was significantly better in the verteporfin group compared with the placebo group: -0.05 and 0.05, respectively (P = 0.008). All 39 (100%) verteporfin-treated eyes had stable or improved vision, compared with 15 (78.9%) eyes in the placebo group (P = 0.009). The mean OCT CFT for the verteporfin group also was significantly lower compared with the placebo group at 12 months (P = 0.001). No ocular or systemic adverse event was encountered in the study.

CONCLUSIONS

Photodynamic therapy with half-dose verteporfin is effective in treating acute symptomatic CSC, resulting in a higher proportion of patients with absence of exudative macular detachment and better visual acuity compared with placebo.

摘要

目的

评估半剂量维替泊芬光动力疗法(PDT)治疗急性中心性浆液性脉络膜视网膜病变(CSC)的疗效。

设计

前瞻性、双盲、安慰剂对照、随机临床试验。

参与者与对照组

招募了63例病程在3个月及以内的急性症状性CSC患者的63只眼。43只眼随机接受吲哚菁绿血管造影(ICGA)引导下的半剂量(3mg/m²)维替泊芬PDT治疗,21只眼随机接受安慰剂治疗。

干预

维替泊芬组患者在8分钟内静脉输注半剂量维替泊芬,从输注开始10分钟后进行ICGA引导下的PDT。激光照射83秒,覆盖ICGA中观察到的脉络膜异常,最大激光光斑尺寸为4500μm。

主要观察指标

主要观察指标是12个月时黄斑区视网膜下液消失的眼的比例。次要观察指标包括在12个月研究期内最小分辨角对数(logMAR)最佳矫正视力(BCVA)、主观症状、光学相干断层扫描(OCT)结果、中心凹厚度(CFT)和血管造影结果的变化。

结果

维替泊芬组39例患者和安慰剂组19例患者完成了12个月的随访。维替泊芬组37只眼(94.9%)在12个月时黄斑区视网膜下液消失,而安慰剂组为11只眼(57.9%)(P = 0.001)。维替泊芬组12个月时的平均logMAR BCVA显著优于安慰剂组:分别为-0.05和0.05(P = 0.008)。所有39只(100%)接受维替泊芬治疗的眼视力稳定或改善,而安慰剂组为15只眼(78.9%)(P = 0.009)。维替泊芬组12个月时的平均OCT CFT也显著低于安慰剂组(P = 0.001)。研究中未遇到眼部或全身不良事件。

结论

半剂量维替泊芬光动力疗法治疗急性症状性CSC有效,与安慰剂相比,渗出性黄斑脱离消失的患者比例更高,视力更好。

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