直接抗凝剂与传统抗凝剂治疗癌症相关血栓形成的比较：观察性研究与随机临床试验的汇总及交互分析
Direct versus conventional anticoagulants for treatment of cancer associated thrombosis: a pooled and interaction analysis between observational studies and randomized clinical trials.
作者信息
Gu Zhi-Chun, Yan Yi-Dan, Yang Sheng-Yan, Shen Long, Kong Ling-Cong, Zhang Chi, Wei An-Hua, Li Zheng, Wang Xin-Hua, Lin Hou-Wen
机构信息
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.
Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.
出版信息
Ann Transl Med. 2020 Feb;8(4):95. doi: 10.21037/atm.2019.12.152.
BACKGROUND
There are emerging observational studies (OSs) to assess real-world comparative effectiveness and safety of direct oral anticoagulants (DOACs) in cancer associated thrombosis (CAT). We conducted a pooled and interaction analysis to compare the treatment effect estimates of DOACs between OSs and randomized controlled trials (RCTs).
METHODS
We systematically searched PUBMED, EMBASE and Cochrane Library for OSs and RCTs that reported recurrent venous thromboembolism (VTE) and/or major bleeding events in CAT patients receiving DOACs and conventional anticoagulants [warfarin or low molecular-weight heparins (LMWHs)]. Relative risks (RRs) for OSs and RCTs were calculated using random-effects models separately, and interaction analyses were afterward applied to assess the comparability between OSs and RCTs.
RESULTS
Baseline characteristic was comparable between identified 10 OSs (35,142 patients) and 8 RCTs (2,602 patients). Overall, no significant difference of treatment effect estimates between OSs and RCTs was detected (P: 0.42 for recurrent VTE; P: 0.38 for major bleeding). DOACs significantly decreased the risk of recurrent VTE compared with conventional anticoagulants in CAT patients (RR: 0.74, 95% CI: 0.63-0.86, I: 0% for OSs; RR: 0.65, 95% CI: 0.49-0.86; I: 0% for RCTs), without increasing major bleeding risk (RR: 0.90, 95% CI: 0.76-1.07, I: 24.0% for OSs; RR: 1.17, 95% CI: 0.72-1.88, I: 26.2% for RCTs). Whereas, increased risk of gastrointestinal bleeding (GIB) was found with DOACs versus conventional anticoagulants in CAT patients (RR: 2.77, 95% CI: 1.35-5.68, I: 0% for RCTs). Analyses of subgroups, based on comparators and follow-up duration, did not significantly affect results.
CONCLUSIONS
In this study, effectiveness and safety of DOACs versus conventional anticoagulants in CAT from OSs are in agreement with those from RCTs, confirming a low risk of recurrent VTE and similar risk of major bleeding in CAT patients receiving DOACs.
背景
有一些新出现的观察性研究（OS）来评估直接口服抗凝剂（DOAC）在癌症相关血栓形成（CAT）中的真实世界比较疗效和安全性。我们进行了一项汇总和交互分析，以比较OS和随机对照试验（RCT）中DOAC的治疗效果估计值。
方法
我们系统检索了PUBMED、EMBASE和Cochrane图书馆，以查找报告接受DOAC和传统抗凝剂[华法林或低分子肝素（LMWH）]的CAT患者复发性静脉血栓栓塞（VTE）和/或大出血事件的OS和RCT。分别使用随机效应模型计算OS和RCT的相对风险（RR），随后进行交互分析以评估OS和RCT之间的可比性。
结果
在纳入的10项OS（35142例患者）和8项RCT（2602例患者）之间，基线特征具有可比性。总体而言，未检测到OS和RCT之间治疗效果估计值的显著差异（复发性VTE的P值为0.42；大出血的P值为0.38）。与传统抗凝剂相比，DOAC显著降低了CAT患者复发性VTE的风险（OS的RR：0.74，95%CI：0.63 - 0.86，I²：0%；RCT的RR：0.65，95%CI：0.49 - 0.86；I²：0%），且未增加大出血风险（OS的RR：0.90，95%CI：0.76 - 1.07，I²：24.0%；RCT的RR：1.17，95%CI：0.72 - 1.88，I²：26.2%）。然而，与传统抗凝剂相比，DOAC在CAT患者中导致胃肠道出血（GIB）风险增加（RCT的RR：2.77，95%CI：1.35 - 5.68，I²：0%）。基于对照和随访持续时间的亚组分析未显著影响结果。
结论
在本研究中，OS中DOAC与传统抗凝剂在CAT中的疗效和安全性与RCT一致，证实接受DOAC的CAT患者复发性VTE风险低且大出血风险相似。
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