与口服抗凝剂相关的自发内出血风险的共同数据模型
Noah Hong1, Yeh-Hee Ko2, Jeong Hyun Park3
1Department of Neurosurgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, Republic of Korea.
概括
这项研究在现实环境中调查了与口服抗凝剂相关的自发性内出血 (sICH),发现非维生素K对抗剂口服抗凝剂 (NOAC) 的SICH风险低于华法林. 高血压和糖尿病是显著的危险因素.
科学领域:
- 临床药理学 临床药理学
- 神经学 神经学
- 现实世界的证据.
背景情况:
- 自发性内出血 (sICH) 是口服抗凝治疗的严重并发症.
- 与抗凝剂相关的SICH的发病率正在增加,需要进行真实世界的风险评估.
- 现有的研究可能无法完全捕捉不同患者群体中sICH的复杂性.
研究的目的:
- 调查与口服抗凝剂相关的SICH的发生率和危险因素.
- 为了比较华法林和非维生素K对抗剂口服抗凝剂 (NOACs) 之间的SICH风险.
- 评估一个共同的数据模型 (CDM) 对sICH临床研究的实用性.
主要方法:
- 使用了观察医学结果伙伴关系 (OMOP) 共同数据模型 (CDM).
- 分析了12821名服用口服抗凝剂 (华法林或NOACs) 的患者的数据.
- 进行了多变量分析,以确定SICH的重大风险因素.
主要成果:
- sICH发生在华法林使用者的0.5%和NOAC使用者的0.2%.
- 华法林使用,高血压,糖尿病,脑瘤和较短的抗凝剂持续时间是SICH的重要危险因素.
- 在这项单一机构研究中,NOACs与华法林相比,SICH的风险较低.
结论:
- 在现实环境中,NOACs似乎比华法林有较低的SICH风险.
- 高血压,糖尿病和脑瘤是口服抗凝药患者sICH的重要危险因素.
- 使用CDM用于多中心数据集的临床研究可以为SICH风险提供更强大的洞察力.
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