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临床驱动的低剂量直接口服抗凝剂治疗亚洲房颤患者的疗效和安全性:系统评价和荟萃分析。

Efficacy and Safety of Clinically Driven Low-Dose Treatment with Direct Oral Anticoagulants in Asians with Atrial Fibrillation: a Systematic Review and Meta-analysis.

机构信息

Department of Pharmacy and Yonsei Institute of Pharmaceutical Sciences, College of Pharmacy, Yonsei University, 85 Songdogwahak-ro, Yeonsu-gu, Incheon, 21983, Republic of Korea.

Graduate Program of Industrial Pharmaceutical Science, Yonsei University, Incheon, Republic of Korea.

出版信息

Cardiovasc Drugs Ther. 2022 Apr;36(2):333-345. doi: 10.1007/s10557-021-07171-5. Epub 2021 Mar 16.

Abstract

PURPOSE

Although clinically driven low-dose (CDLD) treatment with direct oral anticoagulants (DOACs) is frequently administered to Asian patients with atrial fibrillation, clinical evidence confirming its efficacy remains insufficient. We evaluated the clinical efficacy and safety of CDLD treatment with DOACs compared to on-label dose treatment in Asian patients with atrial fibrillation and assessed the differences in the baseline characteristics between patients receiving these treatments.

METHODS

We searched the MEDLINE, CENTRAL, EMBASE, Web of Science, and Scopus databases for articles from inception through July 2020.

RESULTS

Thirteen studies were included in this meta-analysis. The baseline characteristics of the CDLD group were significantly different from those of the standard dose (STD) and standard low-dose (SLD) groups. The incidences of thromboembolic events (risk ratio [RR] 0.46, 95% confidence interval [CI] 0.29-0.73, p < 0.001) and major bleeding (RR 0.55, 95% CI 0.35-0.87, p = 0.01) in the CDLD group were lower than those in the SLD group; however, they were comparable with those in the STD group. The incidence of a composite endpoint in the CDLD group was not significantly different from that in the STD group but was significantly lower than that in the SLD group (RR 0.50, 95% CI 0.38-0.65, p < 0.001).

CONCLUSION

The clinical outcomes of CDLD treatment showed no difference compared to those of the STD treatment despite the vulnerable baseline characteristics of the CDLD group for thromboembolic and major bleeding events.

摘要

目的

尽管临床上常采用低剂量(CDLD)直接口服抗凝剂(DOACs)治疗亚洲房颤患者,但仍缺乏其疗效的临床证据。我们评估了亚洲房颤患者 CDLD 治疗与 DOACs 标签剂量治疗的临床疗效和安全性,并评估了接受这些治疗的患者基线特征的差异。

方法

我们检索了 MEDLINE、CENTRAL、EMBASE、Web of Science 和 Scopus 数据库,检索时间为建库至 2020 年 7 月。

结果

本荟萃分析共纳入 13 项研究。CDLD 组的基线特征与标准剂量(STD)和标准低剂量(SLD)组有显著差异。CDLD 组血栓栓塞事件(风险比 [RR] 0.46,95%置信区间 [CI] 0.29-0.73,p < 0.001)和大出血(RR 0.55,95% CI 0.35-0.87,p = 0.01)的发生率低于 SLD 组,但与 STD 组相当。CDLD 组复合终点的发生率与 STD 组无显著差异,但明显低于 SLD 组(RR 0.50,95% CI 0.38-0.65,p < 0.001)。

结论

尽管 CDLD 组在血栓栓塞和大出血事件方面的基线特征较为脆弱,但 CDLD 治疗的临床结局与 STD 治疗无差异。

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