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年龄相关性黄斑变性、抗血管内皮生长因子药物与短期死亡率:一项药物上市后安全性和监测研究。

Age-related macular degeneration, anti-vascular endothelial growth factor agents, and short-term mortality: a postmarketing medication safety and surveillance study.

机构信息

VA Center of Excellence on Implementing Evidence Based Practice, Regenstrief Institute, Inc, Department of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN 46202, USA.

出版信息

Retina. 2011 Jun;31(6):1036-42. doi: 10.1097/IAE.0b013e31821dc66f.

DOI:10.1097/IAE.0b013e31821dc66f
PMID:21836410
Abstract

PURPOSE

To compare short-term (1 year) survival of subjects treated for exudative age-related macular degeneration (AMD) with those with AMD who received no treatment.

METHODS

This was a case-control study. Beneficiaries of the Veterans Health Administration aged ≥55 years with a diagnosis of AMD in fiscal years 2007-2009 were included in this study. Veterans Health Administration clinical and pharmacy data sets were linked with a national Veterans Health Administration mortality registry. Anti-vascular endothelial growth factor exposure was identified through pharmacy records, coupled to procedure code for intravitreous injection and diagnosis code of exudative AMD. Control group consisted of patients with coded diagnosis of dry AMD and no pharmacy claims for case-defining medications. Cox proportional hazard model was adjusted for age, gender, number of injections, and ocular and medical comorbidities. The main outcome measure was hazard of death according to medication exposure.

RESULTS

A total of 3,210 patients received intravitreous injections for exudative AMD. There were 117,364 nonexposed patients with dry AMD. Twelve-month all-cause mortality in the exposed and control groups were 3.9% and 4.5%, respectively. When adjusted for age, gender, and ocular and medical comorbidities, the death hazard was 0.89 (95% confidence interval, 0.74-1.06). The risk of all-cause mortality was similar for patients receiving bevacizumab and ranibizumab.

CONCLUSION

Twelve-month all-cause mortality in a population of predominately men with exudative AMD and a high prevalence of medical comorbidities was unaffected by exposure to therapeutic levels of vitreous bevacizumab and ranibizumab. Commonly used anti-vascular endothelial growth factor agents for exudative AMD do not adversely impact short-term survival in men.

摘要

目的

比较接受渗出性年龄相关性黄斑变性(AMD)治疗的患者与未接受治疗的 AMD 患者的短期(1 年)生存率。

方法

这是一项病例对照研究。本研究纳入了 2007 年至 2009 年财政年度 Veterans Health Administration 中年龄≥55 岁且诊断为 AMD 的患者。将 Veterans Health Administration 的临床和药房数据集与全国 Veterans Health Administration 死亡率登记处进行了关联。通过药房记录识别血管内皮生长因子抑制剂的使用情况,并与玻璃体腔内注射程序代码和渗出性 AMD 的诊断代码相结合。对照组由编码诊断为干性 AMD 且无病例定义药物药房用药记录的患者组成。Cox 比例风险模型根据年龄、性别、注射次数以及眼部和医学合并症进行了调整。主要观察指标是根据药物暴露情况评估死亡风险。

结果

共有 3210 名患者接受了治疗渗出性 AMD 的玻璃体腔内注射。有 117364 名未暴露于药物的患者患有干性 AMD。暴露组和对照组的 12 个月全因死亡率分别为 3.9%和 4.5%。在校正年龄、性别以及眼部和医学合并症后,死亡风险比为 0.89(95%置信区间,0.74-1.06)。接受贝伐单抗和雷珠单抗治疗的患者全因死亡风险相似。

结论

在男性为主、患有渗出性 AMD 且合并症高发的人群中,玻璃体内应用贝伐单抗和雷珠单抗的治疗剂量并未影响 12 个月全因死亡率。常用于治疗渗出性 AMD 的血管内皮生长因子抑制剂不会对男性的短期生存产生不利影响。

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