玻璃体内注射雷珠单抗治疗新生血管性年龄相关性黄斑变性与中风风险：一项全国性样本队列研究。

INTRAVITREAL RANIBIZUMAB THERAPY FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION AND THE RISK OF STROKE: A National Sample Cohort Study.

作者信息

Rim Tyler Hyungtaek, Lee Christopher Seungkyu, Lee Sung Chul, Kim Do Wook, Kim Sung Soo

机构信息

*Department of Ophthalmology, National Health Insurance Service Ilsan Hospital; †Department of Ophthalmology, Severance Hospital, Institute of Vision Research, Yonsei University College of Medicine, Seoul, Republic of Korea; ‡Yonsei Healthcare Big Data Based Knowledge Integration System Research Center, Yonsei University College of Medicine, Seoul, Republic of Korea; and §Institute of Convergence Science, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Retina. 2016 Nov;36(11):2166-2174. doi: 10.1097/IAE.0000000000001084.

DOI:10.1097/IAE.0000000000001084

PMID:27341664

Abstract

PURPOSE

To evaluate the risk of stroke after ranibizumab treatment for neovascular age-related macular degeneration.

METHODS

National registry data for 1,025,340 random subjects in the year 2002 were used. The ranibizumab group comprised patients diagnosed with neovascular age-related macular degeneration and treated with ranibizumab between 2009 and 2013 (n = 467). The two types of comparison groups were defined as comorbidity-matched controls (n = 2,330) comprised of randomly selected patients (5 per age-related macular degeneration patient), who were matched to the ranibizumab group according to sociodemographic factors, hypertension, atrial fibrillation, and the Charlson comorbidities index, and sociodemographic-matched controls (n = 2,331) matched according to sociodemographic factors only. Each sampled patient was tracked until 2013. The Cox proportional hazard regression was used.

RESULTS

Stroke occurred in 6.6% of the ranibizumab group versus 7.0% of the comorbidity-matched controls and 6.7% of the sociodemographic-matched controls; these differences were not statistically significant. The overall incidence of stroke was similar for the ranibizumab group versus the comorbidity-matched controls and sociodemographic-matched controls, based on the multivariable Cox regression (hazard ratio = 0.88; 95% confidence interval, 0.60-1.30; hazard ratio = 0.95, 95% confidence interval, 0.64-1.41, respectively).

CONCLUSION

Ranibizumab treatment for neovascular age-related macular degeneration did not increase the overall risk of stroke, compared with comorbidity-matched controls or sociodemographic-matched controls.

摘要

目的

评估雷珠单抗治疗新生血管性年龄相关性黄斑变性后发生中风的风险。

方法

使用2002年1,025,340名随机受试者的国家登记数据。雷珠单抗组包括2009年至2013年间被诊断为新生血管性年龄相关性黄斑变性并接受雷珠单抗治疗的患者（n = 467）。两种比较组定义为共病匹配对照组（n = 2,330），由随机选择的患者组成（每例年龄相关性黄斑变性患者对应5例），这些患者根据社会人口统计学因素、高血压、心房颤动和查尔森共病指数与雷珠单抗组进行匹配，以及仅根据社会人口统计学因素匹配的社会人口统计学匹配对照组（n = 2,331）。对每个抽样患者随访至2013年。采用Cox比例风险回归分析。

结果

雷珠单抗组中风发生率为6.6%，共病匹配对照组为7.0%，社会人口统计学匹配对照组为6.7%；这些差异无统计学意义。基于多变量Cox回归分析，雷珠单抗组与共病匹配对照组和社会人口统计学匹配对照组的中风总发生率相似（风险比分别为0.88；95%置信区间为0.60 - 1.30；风险比为0.95，95%置信区间为0.64 - 1.41）。