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基因型指导的华法林剂量在中国人群中的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and Safety of Genotype-Guided Warfarin Dosing in the Chinese Population: A Meta-analysis of Randomized Controlled Trials.

机构信息

Department of Cardiology, The First Affiliated Hospital, Jinan University, Guangzhou, China.

出版信息

J Cardiovasc Pharmacol. 2019 Mar;73(3):127-135. doi: 10.1097/FJC.0000000000000656.

Abstract

AIMS

To evaluate the efficacy and safety of using genetic information to guide warfarin dosing in the Chinese population.

METHODS

This meta-analysis was conducted among the published, randomized, controlled trials (RCTs) in the Chinese population comparing genotype-guided warfarin dosing (PG group) with clinical or standard warfarin dosing (STD group). RCTs published on or before January 2018 were identified using the PubMed, Embase, Cochrane Library, CNKI, Chinese VIP database, and Chinese Wanfang database.

RESULT

Intotal, 2137 participants from 14 RCTs were included in the meta-analysis. Primary analysis showed that both bleeding events [odds ratio (OR) = 0.24; 95% confidence interval (CI), 0.11-0.52; P = 0.0003] and adverse events (OR = 0.60; 95% CI, 0.43-0.83; P = 0.002) were significantly lower in the genotype-guided group than in the clinical or standard group. The percentage of patients who received a warfarin-stable therapeutic dose during follow-up was increased in the genotype-guided group compared with the percentage in the clinical or standard group (OR = 2.68; 95% CI, 1.82-3.95; P < 0.00001). In the genotype-guided group, the time to a stable therapeutic dose (mean difference = -7.98; 95% CI, -9.08 to -6.87; P < 0.00001) and the time to the first target value (mean difference = -1.87; 95% CI, -3.41 to -0.32; P = 0.02) were shortened compared with those of the clinical or standard group, but there was no difference for international normalized ratio >4, between the 2 groups (OR = 0.42; 95% CI, 0.14-1.25; P = 0.12).

CONCLUSIONS

Genotype-guided warfarin-dosing algorithms could improve the efficacy and safety of warfarin anticoagulation in the Chinese population.

摘要

目的

评估在中国人群中使用遗传信息指导华法林剂量的疗效和安全性。

方法

本荟萃分析纳入了在中国人群中比较基因指导华法林剂量(PG 组)与临床或标准华法林剂量(STD 组)的已发表的随机对照试验(RCT)。使用 PubMed、Embase、Cochrane 图书馆、CNKI、中国维普数据库和中国万方数据库检索了截至 2018 年 1 月的 RCT。

结果

共纳入了 14 项 RCT 的 2137 名参与者进行荟萃分析。主要分析显示,PG 组的出血事件(比值比[OR] = 0.24;95%置信区间[CI],0.11-0.52;P = 0.0003)和不良事件(OR = 0.60;95%CI,0.43-0.83;P = 0.002)发生率均显著低于 STD 组。与 STD 组相比,PG 组在随访期间接受华法林稳定治疗剂量的患者比例更高(OR = 2.68;95%CI,1.82-3.95;P < 0.00001)。PG 组达到稳定治疗剂量的时间(平均差值 = -7.98;95%CI,-9.08 至-6.87;P < 0.00001)和达到第一个目标值的时间(平均差值 = -1.87;95%CI,-3.41 至-0.32;P = 0.02)均短于 STD 组,但两组间国际标准化比值(INR)>4 的差异无统计学意义(OR = 0.42;95%CI,0.14-1.25;P = 0.12)。

结论

基因指导华法林剂量算法可提高中国人群华法林抗凝的疗效和安全性。

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