背景:玻璃体腔注射地塞米松和抗血管内皮生长因子(抗VEGF)药物彻底改变了眼部疾病的管理和良好的眼部安全性,但很少有研究比较其全身不良事件(SAE).本研究通过使用真实世界数据调查了玻璃体内地塞米松和抗VEGF的SAE。
方法:这项回顾性队列研究来源于台湾最大的多机构数据库的医疗记录。纳入2014年至2019年接受玻璃体内地塞米松(n=137)或抗VEGF(n=10,345)的患者。进行倾向评分匹配以达到两组间的均一性。使用Fine-Gray模型计算子分布风险比(SHR)和95%置信区间(CI)。比较1年随访后的全身和眼部临床事件和全身生物标志物。
结果:两组均表现出相当的主要心脏不良事件风险(SHR1.57,95%CI0.29-8.55),心力衰竭(SHR0.62,95%CI0.07-5.33),大出血(SHR0.23,95%CI0.03-1.77),全因入院(SHR0.73,95%CI0.41-1.30),和全因死亡(SHR2.11,95%CI0.35-12.71)。收缩压和舒张压的纵向变化没有显着差异,糖化血红蛋白,低密度脂蛋白,估计肾小球滤过率,或组间丙氨酸转氨酶。两组的白内障手术发生率相似。尽管地塞米松组的抗青光眼药物使用率相对较高,青光眼手术的发生率没有明显升高.
结论:在我们的研究中,玻璃体腔注射地塞米松和抗VEGF药物具有相当的全身安全性。两种药物都代表有效和安全的眼部疾病疗法。
BACKGROUND: Intravitreal dexamethasone and anti-vascular endothelial growth factor (anti-VEGF) medications have revolutionized ocular disease management and favorable ocular safety profiles, but few studies have compared their systemic adverse events (SAEs). This study investigated the SAEs of intravitreal dexamethasone and anti-VEGFs by using real-world data.
METHODS: This retrospective cohort study sourced medical records from the largest multi-institutional database in Taiwan. Patients who received intravitreal dexamethasone (n = 137) or anti-VEGFs (n = 10,345) between 2014 and 2019 were enrolled. Propensity score matching was performed to achieve homogeneity between the two groups. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (CIs) were calculated using the Fine-Gray model. Systemic as well as ocular clinical events and systemic biomarkers after 1-year follow-up were compared.
RESULTS: Both groups demonstrated comparable risks of major cardiac adverse events (SHR 1.57, 95% CI 0.29-8.55), heart failure (SHR 0.62, 95% CI 0.07-5.33), major bleeding (SHR 0.23, 95% CI 0.03-1.77), all-cause admission (SHR 0.73, 95% CI 0.41-1.30), and all-cause death (SHR 2.11, 95% CI 0.35-12.71). There were no significant differences in longitudinal changes in systolic and diastolic blood pressure, glycated hemoglobin, low-density lipoprotein, estimated glomerular filtration rate, or alanine aminotransferase between the groups. Both groups had a similar incidence of cataract surgery. Although the dexamethasone group exhibited a relatively high prevalence of antiglaucomatous medication use, there was not a significantly higher incidence of glaucoma surgery.
CONCLUSIONS: Intravitreal dexamethasone and anti-VEGF medications had comparable systemic safety profiles in our study. Both drugs represent efficacious and safe therapies for ocular diseases.