Sharp Dianne M, Lai Susannah, Markey Caroline M
Retina specialists, Parnell, New Zealand.
Clin Exp Ophthalmol. 2007 Jan-Feb;35(1):24-31. doi: 10.1111/j.1442-9071.2007.01394.x.
To assess the efficacy and safety of photodynamic therapy (PDT) for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and other conditions by analysing visual acuity changes.
A retrospective review of patients treated with PDT was conducted. CNV was confirmed on fluorescein angiography. Visual acuity outcomes were recorded at 3-monthly intervals to a maximum of 48 months. The primary outcome measure was the proportion of patients avoiding moderate visual loss (losing less than three lines of visual acuity relative to baseline) at 12 months.
A total of 343 patients receiving PDT were followed up for a mean of 14.9 months. Two hundred and eighty-five (83%) patients presented with CNV due to AMD and 58 patients (17%) due to other causes. Seventy per cent of patients with CNV secondary to AMD avoided moderate visual loss at both 12 and 24 months. Secondary outcomes (including mean change in visual acuity, proportion of patients with stable or improved vision and proportion of patients with severe vision loss) also compared favourably with the Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Investigation. Of patients with CNV secondary to causes other than AMD, 76% avoided moderate visual loss at both 12 and 24 months. The safety profile identified one severe adverse reaction, with development of a serous pigment epithelial detachment and subsequent rip.
The results of this present retrospective, open-label, clinical practice study in New Zealand are consistent with the findings of multicentre randomized, placebo-controlled trials and confirm the treatment benefit of PDT in a clinical setting.
通过分析视力变化,评估光动力疗法(PDT)治疗年龄相关性黄斑变性(AMD)及其他病症继发脉络膜新生血管(CNV)的疗效和安全性。
对接受PDT治疗的患者进行回顾性研究。通过荧光素血管造影确认CNV。每3个月记录一次视力结果,最长记录48个月。主要观察指标是12个月时避免中度视力丧失(相对于基线视力下降少于3行)的患者比例。
共有343例接受PDT治疗的患者接受了平均14.9个月的随访。285例(83%)患者的CNV由AMD引起,58例(17%)由其他原因引起。继发于AMD的CNV患者中有70%在12个月和24个月时均避免了中度视力丧失。次要观察指标(包括平均视力变化、视力稳定或改善的患者比例以及严重视力丧失的患者比例)与光动力疗法治疗年龄相关性黄斑变性(TAP)研究相比也具有优势。继发于AMD以外原因引起的CNV患者中,76%在12个月和24个月时均避免了中度视力丧失。安全性分析发现了1例严重不良反应,即发生浆液性色素上皮脱离并随后出现裂孔。
新西兰这项回顾性、开放标签的临床实践研究结果与多中心随机、安慰剂对照试验的结果一致,并证实了PDT在临床环境中的治疗益处。