非维生素K拮抗剂口服抗凝药（NOACs）与华法林治疗深静脉血栓形成（DVT）的比较安全性和疗效：一项荟萃分析。
Comparative Safety and Efficacy of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Deep Vein Thrombosis (DVT) Treatment: A Meta-analysis.
作者信息
Hao Manwei, Wang Zhongchao, Gao Han, Gao Haicheng, Cheng Zhihua
机构信息
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Jilin University, Changchun City, Jilin Province, P.R. China.
Basic Medical Department, Changchun Medical College, Changchun City, Jilin Province, P.R. China.
出版信息
Cardiovasc Drugs Ther. 2024 Dec 27. doi: 10.1007/s10557-024-07654-1.
PURPOSE
This meta-analysis aimed to conduct a systematic evaluation of the comparative efficacy and safety of new oral anticoagulants (NOACs) versus warfarin for the treatment of deep venous thrombosis (DVT).
METHODS
A systematic computerized search of databases including PubMed, Medline, Web of Science, Embase, Cochrane Library, and www.
CLINICALTRIALS
gov . was performed to gather research on the efficacy and safety of NOACs versus warfarin in the treatment of DVT, encompassing all records from the inception of each database through September 2024. The discrete data were presented as odds ratios (ORs) with their corresponding 95% confidence intervals (CIs), and the meta-analysis was executed utilizing the Review Manager 5.4.1 and Stata 16 softwares.
RESULTS
A comprehensive analysis of 16 studies encompassing 10,084 patients was conducted, with 6704 individuals in the experimental group receiving NOACs and 3380 in the control group treated with warfarin. The findings are as follows: (1) NOACs demonstrated enhanced treatment efficacy over warfarin, particularly in achieving vascular patency (OR = 1.57, 95% CI (1.09, 2.24), P = 0.01). (2) Regarding the incidence of major bleeding events (OR = 0.65, 95% CI (0.54, 0.78), P < 0.00001), other clinical adverse events-including pulmonary embolism, mortality, stroke, myocardial infarction and recurrent thrombosis (OR = 0.77, 95% CI (0.67, 0.88), P = 0.0002), and post-thrombotic syndrome (PTS) (OR = 0.62, 95% CI (0.47, 0.80), P = 0.0003); NOACs offered improved safety profiles in comparison to warfarin. Furthermore, subgroup analysis revealed that the preventive efficacy of NOACs against PTS improves with longer follow-up periods (P = 0.02).
CONCLUSION
NOACs have demonstrated superior efficacy and safety profiles in the treatment of DVT compared to traditional warfarin anticoagulant therapy.
CLINICAL TRIAL REGISTRATION
This project did not involve any clinical data collection; the data utilized were derived from articles published in PubMed.
目的
本荟萃分析旨在对新型口服抗凝剂（NOACs）与华法林治疗深静脉血栓形成（DVT）的疗效和安全性进行系统评价。
方法
通过计算机系统检索包括PubMed、Medline、Web of Science、Embase、Cochrane图书馆和www.CLINICALTRIALS.gov在内的数据库，以收集关于NOACs与华法林治疗DVT疗效和安全性的研究，涵盖各数据库自创建至2024年9月的所有记录。离散数据以比值比（OR）及其相应的95%置信区间（CI）表示，并使用Review Manager 5.4.1和Stata 16软件进行荟萃分析。
结果
对16项研究进行了全面分析，涉及10084例患者，其中实验组6704例接受NOACs治疗，对照组3380例接受华法林治疗。结果如下：（1）NOACs在治疗效果上优于华法林，尤其是在实现血管通畅方面（OR = 1.57，95%CI（1.09，2.24），P = 0.01）。（2）在主要出血事件发生率方面（OR = 0.65，95%CI（0.54，0.78），P < 0.00001），以及其他临床不良事件——包括肺栓塞、死亡率、中风、心肌梗死和复发性血栓形成（OR = 0.77，95%CI（0.67，0.88），P = 0.0002）和血栓后综合征（PTS）（OR = 0.62，95%CI（0.47，0.80），P = 0.0003）；与华法林相比，NOACs的安全性更好。此外，亚组分析显示，NOACs预防PTS的疗效随随访时间延长而提高（P = 0.02）。
结论
与传统华法林抗凝治疗相比，NOACs在治疗DVT方面已显示出更好的疗效和安全性。
临床试验注册
本项目未涉及任何临床数据收集；所使用的数据来自PubMed上发表的文章。
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