Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Burapha University, Chonburi, Thailand.
Division of Pharmaceutical care, Department of Pharmacy, Banphaeo General Hospital, Samut Sakhon, Thailand.
Medicine (Baltimore). 2022 Sep 9;101(36):e30388. doi: 10.1097/MD.0000000000030388.
Patients who had mechanical heart valves and an international normalized ratio (INR) of >5.0 should be managed by temporary cessation of vitamin K antagonist. This study aimed to investigate the safety of low-dose vitamin K1 in patients with mechanical heart valves who have supratherapeutic INR.
CINAHL, Cochran Library, Clinical trial.gov, OpenGrey, PubMed, ScienceDirect, and Scopus were systematically searched from the inception up to October 2021 without language restriction. Studies comparing the safety of low-dose vitamin K1 treatment in patients with placebo or other anticoagulant reversal agents were included. We used a random-effect model for the meta-analysis. Publication bias was determined by a funnel plot with subsequent Begg's test and Egger's test.
From 7529 retrieved studies, 3 randomized control trials were included in the meta-analysis. Pooled data demonstrated that low-dose vitamin K was not associated with thromboembolism rate (risk ratio [RR] = 0.94; 95% CI: 0.19-4.55) major bleeding rate (RR = 0.58; 95% CI: 0.07-4.82), and minor bleeding rate (RR = 0.60; 95% CI: 0.07-5.09). Subgroup and sensitivity analysis demonstrated the nonsignificant effect of low-dose vitamin K on the risk of thromboembolism. Publication bias was not apparent, according to Begg's test and Egger's test (P = .090 and 0.134, respectively).
The current evidence does not support the role of low-dose vitamin K as a trigger of thromboembolism in supratherapeutic INR patients with mechanical heart valves. Nevertheless, more well-designed studies with larger sample sizes are required to justify this research question.
国际标准化比值（INR）>5.0 的机械心脏瓣膜患者应通过暂时停止使用维生素 K 拮抗剂进行管理。本研究旨在调查低剂量维生素 K1 治疗 INR 高于治疗范围的机械心脏瓣膜患者的安全性。
系统检索了 CINAHL、Cochrane 图书馆、Clinicaltrial.gov、OpenGrey、PubMed、ScienceDirect 和 Scopus，检索时间从建库至 2021 年 10 月，无语言限制。纳入比较低剂量维生素 K1 治疗与安慰剂或其他抗凝逆转剂安全性的研究。Meta 分析采用随机效应模型。通过漏斗图和随后的 Begg 检验和 Egger 检验来确定发表偏倚。
从 7529 篇检索到的研究中，有 3 项随机对照试验纳入了 Meta 分析。汇总数据表明，低剂量维生素 K 与血栓栓塞发生率（风险比 [RR] = 0.94；95%CI：0.19-4.55）、大出血发生率（RR = 0.58；95%CI：0.07-4.82）和小出血发生率（RR = 0.60；95%CI：0.07-5.09）均无相关性。亚组和敏感性分析表明，低剂量维生素 K 对血栓栓塞风险无显著影响。根据 Begg 检验和 Egger 检验，未发现发表偏倚（P =.090 和 0.134）。
目前的证据不支持低剂量维生素 K 作为机械心脏瓣膜 INR 高于治疗范围患者血栓栓塞的触发因素。然而，需要更多设计良好、样本量更大的研究来证实这一研究问题。
