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年龄相关性黄斑变性患者单剂量或重复剂量玻璃体内注射贝伐单抗后发生心肌梗死和中风的风险

Risk of Myocardial Infarction and Stroke With Single or Repeated Doses of Intravitreal Bevacizumab in Age-Related Macular Degeneration.

作者信息

Etminan Mahyar, Maberley David A, Babiuk David W, Carleton Bruce C

机构信息

Pharmaceutical Outcomes Programme, British Columbia Children Hospital, Vancouver, Canada; Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver, Canada.

Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, Canada.

出版信息

Am J Ophthalmol. 2016 Mar;163:53-58. doi: 10.1016/j.ajo.2015.11.030. Epub 2015 Dec 15.

DOI:10.1016/j.ajo.2015.11.030
PMID:26701272
Abstract

PURPOSE

To examine the risk of myocardial infarction and stroke with single and repeated doses of intravitreal bevacizumab in wet age-related macular degeneration (AMD).

DESIGN

Nested case-control study and retrospective cohort study.

METHODS

setting: Two patient cohorts from British Columbia, Canada.

STUDY POPULATION

Patients with wet AMD.

INTERVENTION

For the cohort study, patients who received the first intravitreal bevacizumab; for the nested case-control study, repeated injections of intravitreal bevacizumab.

MAIN OUTCOME MEASURES

Myocardial infarction for the retrospective cohort study; myocardial infarction and stroke for the nested case-control study.

RESULTS

In the cohort analysis, there were 2564 AMD subjects not on a vascular endothelial growth factor (VEGF) inhibitor and 5644 subjects receiving intravitreal bevacizumab. The rate of myocardial infarction (MI) among bevacizumab users was 11/1000 person-years, compared to 14.9/1000 person-years in nonusers. The adjusted rate ratio (RR) for MI was 0.70 (95% confidence interval [CI]: 0.50-1.00) and 0.74 (0.46-1.20) for the propensity score-adjusted analysis. In the nested case-control analysis there were 7452 new users of VEGF inhibitors, within which there were 313 cases of MI with 3130 matched controls. The adjusted RR for MI among those receiving 3 or more injections compared to those receiving fewer than 3 was 0.71 (95% CI: 0.41-1.22). Also in the nested case-control analysis, the adjusted RR for stroke was 0.81 (95% CI: 0.39-1.65) for those receiving ≥4 injections vs those receiving fewer than 4 injections.

CONCLUSION

Single or repeated doses of intravitreal bevacizumab were not shown to increase the risk of myocardial infarction or stroke in patients with wet AMD.

摘要

目的

探讨在湿性年龄相关性黄斑变性(AMD)患者中,单次及重复玻璃体内注射贝伐单抗后发生心肌梗死和中风的风险。

设计

巢式病例对照研究和回顾性队列研究。

方法

研究地点:来自加拿大不列颠哥伦比亚省的两个患者队列。

研究人群

湿性AMD患者。

干预措施

队列研究中,接受首次玻璃体内注射贝伐单抗的患者;巢式病例对照研究中,重复玻璃体内注射贝伐单抗的患者。

主要观察指标

回顾性队列研究中的心肌梗死;巢式病例对照研究中的心肌梗死和中风。

结果

在队列分析中,有2564例未使用血管内皮生长因子(VEGF)抑制剂的AMD患者和5644例接受玻璃体内注射贝伐单抗的患者。贝伐单抗使用者中心肌梗死(MI)发生率为11/1000人年,未使用者为14.9/1000人年。倾向评分调整分析中,MI的调整率比(RR)为0.70(95%置信区间[CI]:0.50 - 1.00),倾向评分调整分析中为0.74(0.46 - 1.20)。在巢式病例对照分析中,有7452名新使用VEGF抑制剂的患者,其中有313例MI病例和3130例匹配对照。接受3次或更多次注射的患者与接受少于3次注射的患者相比,MI的调整RR为0.71(95%CI:0.41 - 1.22)。同样在巢式病例对照分析中,接受≥4次注射的患者与接受少于4次注射的患者相比,中风的调整RR为0.81(95%CI:0.39 - 1.65)。

结论

在湿性AMD患者中,单次或重复剂量的玻璃体内注射贝伐单抗未显示会增加心肌梗死或中风的风险。

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