在印度情况下玻璃体内注射贝伐单抗(阿瓦斯汀)安全性概况的真实世界证据。
Real-world evidence of safety profile of intravitreal bevacizumab (Avastin) in an Indian scenario.
作者信息
Jain Prashant, Sheth Jay, Anantharaman Giridhar, Gopalakrishnan Mahesh
机构信息
Department of Vitreoretina, Giridhar Eye Institute, Kochi, Kerala, India.
出版信息
Indian J Ophthalmol. 2017 Jul;65(7):596-602. doi: 10.4103/ijo.IJO_992_16.
PURPOSE
The purpose of this study was to evaluate the safety profile of intravitreal bevacizumab (Avastin) as an off-label pharmacotherapeutic agent for various ocular conditions.
METHODS
Retrospective analysis was carried out on 3806 injections of 1761 patients that were administered with intravitreal bevacizumab injection at a tertiary eye care center in India. The injections were administered on a pro re nata basis for various indications such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
RESULTS
The mean age of the patients was 61.8 ± 11.59 years. A total of 59.2% of the patients were men and 40.8% women. The most common indications for which the injection was administered were DME (27.5%), AMD (26%), and branch RVO (12.3%). Among the ocular side effects, endophthalmitis was seen in three eyes (0.08%), retinal breaks in none of the eyes whereas 35 eyes had a rise in intraocular pressure (IOP) >21 mmHg (0.9%). Preexisting glaucoma was present in four eyes while remaining 31 eyes did not have any history of glaucoma. IOP rise was significantly more in eyes with preexisting glaucoma as compared to nonglaucomatous eyes (P = 0.04). No systemic adverse events were noted in our study population.
CONCLUSION
Our study provides real-world evidence regarding the safety profile of intravitreal bevacizumab (Avastin). These data suggest that bevacizumab is a safe and economical pharmacotherapeutic agent that can be administered for a variety of ocular disorders. Analyzing the safety of bevacizumab is necessary for a developing country like India as the majority of the population cannot afford the costly ranibizumab as compared to bevacizumab for ocular healthcare.
目的
本研究旨在评估玻璃体内注射贝伐单抗(阿瓦斯汀)作为多种眼部疾病的非标签药物治疗剂的安全性。
方法
对印度一家三级眼科护理中心1761例患者的3806次玻璃体内注射贝伐单抗进行回顾性分析。这些注射是根据不同适应症(如年龄相关性黄斑变性(AMD)、糖尿病性黄斑水肿(DME)和视网膜静脉阻塞(RVO))按需进行的。
结果
患者的平均年龄为61.8±11.59岁。患者中男性占59.2%,女性占40.8%。注射的最常见适应症为DME(27.5%)、AMD(26%)和分支RVO(12.3%)。在眼部副作用中,三只眼发生了眼内炎(0.08%),未发现视网膜裂孔,而35只眼眼压升高>21 mmHg(0.9%)。四只眼存在原发性青光眼,其余31只眼无青光眼病史。与非青光眼眼相比,原发性青光眼眼的眼压升高明显更多(P = 0.04)。在我们的研究人群中未观察到全身不良事件。
结论
我们的研究提供了关于玻璃体内注射贝伐单抗(阿瓦斯汀)安全性的真实世界证据。这些数据表明,贝伐单抗是一种安全且经济的药物治疗剂,可用于多种眼部疾病。对于像印度这样的发展中国家来说,分析贝伐单抗的安全性是必要的,因为与贝伐单抗相比,大多数人负担不起昂贵的雷珠单抗用于眼部治疗。