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年龄相关性黄斑变性治疗比较试验结果将如何影响临床护理。

How the comparison of age-related macular degeneration treatments trial results will impact clinical care.

机构信息

Bascom Palmer Eye Institute, Miami, Florida, USA.

出版信息

Am J Ophthalmol. 2011 Oct;152(4):509-14. doi: 10.1016/j.ajo.2011.07.004.

Abstract

PURPOSE

To provide a perspective on the impact of the Comparison of Age-related Macular Degeneration Treatments Trial (CATT) on future clinical practices.

DESIGN

Interpretation of trial outcomes relative to clinical use of neovascular age-related macular degeneration (AMD) treatments, assessment of the influence of study design and execution on results, and review of unanalyzed safety data in the online supplement.

METHODS

Expert opinion.

RESULTS

The CATT study supports the selection of either ranibizumab or bevacizumab for treatment of AMD based on factors other than efficacy, such as cost, because monthly administration of bevacizumab was noninferior to the reference treatment of monthly ranibizumab in improving visual acuity at 1 year. Visual acuity results for bevacizumab as needed were inconclusive for noninferiority relative to monthly administration of either drug. The secondary outcome of decrease in thickness at the foveal center as measured by time-domain optical coherence tomography significantly favored the monthly ranibizumab group vs the bevacizumab-as-needed group but is more difficult to interpret as it did not correlate with visual acuity and is less appropriate for a noninferiority design. Bevacizumab groups had a statistically higher observed risk of serious adverse events; however, scrutiny of the online supplements shows similar numbers of cardiac and neurologic events in bevacizumab and ranibizumab users. Information regarding fellow eye treatment with anti-VEGF agents was not given.

CONCLUSIONS

CATT provides the first level I evidence for bevacizumab in a large number of patients with neovascular AMD. The trial supports use of either drug as primary therapy and suggests that modification of monthly dosing regimens is feasible. A difference in cardiovascular safety between the 2 drugs was not apparent on inspection of the supplementary safety data.

摘要

目的

提供一个视角,探讨年龄相关性黄斑变性治疗比较试验(CATT)对未来临床实践的影响。

设计

相对于新生血管性年龄相关性黄斑变性(AMD)治疗的临床应用,解释试验结果;评估研究设计和实施对结果的影响;以及审查在线补充中的未分析安全性数据。

方法

专家意见。

结果

CATT 研究支持根据成本等因素而不是疗效来选择雷珠单抗或贝伐单抗治疗 AMD,因为贝伐单抗每月给药在改善视力方面与每月雷珠单抗的参考治疗非劣效,而每月贝伐单抗给药在改善视力方面则不明确。在需要时用贝伐单抗进行治疗的次要终点(通过时域光学相干断层扫描测量的中心凹厚度减少)明显倾向于每月雷珠单抗组而非每月贝伐单抗组,但由于它与视力没有相关性,并且不太适合非劣效性设计,因此更难解释。贝伐单抗组观察到的严重不良事件风险统计学上较高;然而,仔细审查在线补充材料表明,贝伐单抗和雷珠单抗使用者的心脏和神经系统事件数量相似。关于用抗 VEGF 药物治疗对侧眼的信息没有提供。

结论

CATT 为大量患有新生血管性 AMD 的患者提供了贝伐单抗的首个一级证据。该试验支持将这两种药物用作一线治疗,并表明修改每月剂量方案是可行的。对补充安全性数据的检查表明,两种药物之间的心血管安全性差异不明显。

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