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随机临床试验:玻璃体腔内注射阿瓦斯汀与光动力疗法和玻璃体腔内曲安奈德比较:长期结果。

Randomised clinical trial of intravitreal Avastin vs photodynamic therapy and intravitreal triamcinolone: long-term results.

机构信息

Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.

出版信息

Eye (Lond). 2009 Dec;23(12):2223-7. doi: 10.1038/eye.2008.423.

DOI:10.1038/eye.2008.423
PMID:19169239
Abstract

PURPOSE

To compare 1-year functional and anatomic outcomes of intravitreal bevacizumab (IVB) and photodynamic therapy plus intravitreal triamcinolone (PDT+IVTA) combination in patients with neovascular age-related macular degeneration (AMD).

METHODS

In this prospective, randomised, controlled clinical trial, 28 patients were included. All patients were randomised 1 : 1 to 0.04 ml/1 mg of IVB or PDT plus same day 0.1 ml/4 mg IVTA (PDT+IVTA). Follow-up examinations were performed in monthly intervals in IVB group and every 3 months in PDT+IVTA group. Main outcomes were change in mean visual acuity (VA), mean central retinal thickness (CRT) and the mean number of treatments.

RESULTS

At month 12, mean VA improved to a 1.5-line gain in IVB group, and lost three letters in PDT+IVTA group (P=0.02). Mean CRT was reduced from 357 microm at baseline to 244 microm at month 12 in IVB group and from 326 microm to 254 microm, respectively, in PDT+IVTA group (P=0.8). The mean number of treatments was 6.8 in the IVB group vs 1.9 in the PDT+IVTA group. No significant local or systemic safety concerns were detected during follow-up time.

CONCLUSIONS

Patients treated with IVB showed a significant better VA outcome compared with the PDT+IVTA group despite the fact that both modalities showed equal potency in reducing CRT during a 12-month period.

摘要

目的

比较玻璃体内注射贝伐单抗(IVB)和光动力疗法联合玻璃体内曲安奈德(PDT+IVTA)联合治疗年龄相关性黄斑变性(AMD)的 1 年功能和解剖学结果。

方法

在这项前瞻性、随机、对照的临床试验中,纳入了 28 例患者。所有患者均以 1:1 的比例随机分为 0.04ml/1mg IVB 或 PDT 加当天 0.1ml/4mg IVTA(PDT+IVTA)组。IVB 组每月进行一次随访检查,PDT+IVTA 组每 3 个月进行一次。主要结局是平均视力(VA)、平均中心视网膜厚度(CRT)和平均治疗次数的变化。

结果

在第 12 个月,IVB 组的平均 VA 提高了 1.5 行,而 PDT+IVTA 组则下降了 3 个字母(P=0.02)。IVB 组从基线时的 357μm降至第 12 个月时的 244μm,而 PDT+IVTA 组从 326μm降至 254μm(P=0.8)。IVB 组的平均治疗次数为 6.8 次,而 PDT+IVTA 组为 1.9 次。在随访期间,未发现明显的局部或全身安全性问题。

结论

尽管两种治疗方法在 12 个月内降低 CRT 的效果相当,但接受 IVB 治疗的患者 VA 结果明显优于 PDT+IVTA 组。

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