印度人口中心脏支架相关的报道不良事件的回顾性研究
Sandeep Mewada1, Shatrunajay Shukla2, Maneesh Soni2,3
1Faculty of Pharmacy, VNS Group of Institutions, Bhopal, India.
Expert review of medical devices
|January 19, 2025
概括
印度心脏支架的不良事件 (AE) 很常见,剖析是最常见的. 虽然大多数AE是严重的,但死亡很少发生,尽管男性和老年患者面临更高的风险.
科学领域:
- 心血管医学 心血管医学
- 医疗器械安全 医疗器械安全
- 公共卫生 公共卫生
背景情况:
- 冠状动脉疾病是全球主要的健康问题,特别是在印度.
- 心脏支架对于治疗这种疾病至关重要.
- 了解与心脏支架相关的不良事件对于患者的安全至关重要.
研究的目的:
- 调查印度人口中与心脏支架相关的不良事件的频率和特征.
- 分析来自国家物质监测计划的数据,以确定心脏支架AE的趋势.
主要方法:
- 从2020-2022年开始,从印度国家协调中心-物质监测计划 (NCC-MvPI) 系统地收集数据.
- 分析了来自10,542个医疗器械事件的更大数据库中的2,075个与心脏支架相关的不良事件报告.
- 数据的清理,分离和统计分析,以确定常见的AE和患者人口统计.
主要成果:
- 93%与心脏支架相关的副作用被归类为严重.
- 最常见的严重副作用包括剖析,胸痛,血栓形成和呼吸困难.
- 虽然只有5%的报告导致死亡,但男性和老年患者患上AE的发病率更高.
结论:
- 这项研究强调,需要进一步研究心脏支架AEs的根本原因.
- 制定有效的策略来缓解这些不良事件是优先考虑的.
- 未来的研究应该评估患者的长期结果,以评估各种心脏支架类型的安全性和有效性.
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