体质量影响髋膝关节置换术后口服抗凝药物预防VTE有效性和安全性的Meta分析

Effects of body weight on the efficacy and safety of oral anticoagulants for the prevention of VTE after hip and knee arthroplasty:a meta-analysis

目的系统性评价体质量对新型口服抗凝药(NOACs)、阿司匹林用于全髋关节置换术、全膝关节置换术(以下统称“髋膝关节置换术”)后预防静脉血栓栓塞(VTE)的有效性和安全性的影响,为合理用药提供循证参考。方法计算机检索PubMed、Embase、Cochrane library,收集含有以体质量或体质量指数[BMI 18.5~<25 kg/m^(2)为正常体质量,BMI 25~30 kg/m^(2)为超重,BMI>30 kg/m^(2)为肥胖(其中BMI>40 kg/m^(2)为病态肥胖)]为亚组比较NOACs、阿司匹林和低分子肝素有效性和(或)安全性的随机对照试验(RCT)和非RCT研究。检索时间为建库起至2022年6月30日。筛选文献、提取数据后,采用Cochrane系统评价员手册推荐的偏倚风险评估工具RoB 2.0评价RCT研究的质量,采用纽卡斯尔-渥太华量表评估非RCT研究的质量。采用RevMan 5.4软件进行Meta分析。结果共纳入6篇文献,包含3项系列RCT汇总研究、3项非RCT研究。Meta分析结果显示,在不同BMI亚组中,正常体质量患者[OR=0.63,95%CI(0.26,1.51),P=0.30]、超重患者[OR=0.48,95%CI(0.22,1.04),P=0.06]、肥胖患者[OR=0.70,95%CI(0.40,1.25),P=0.23]使用NOACs在降低主要VTE及VTE相关死亡率方面与依诺肝素比较,差异均无统计学意义。主要出血事件率、主要+临床相关非主要出血事件率方面,NOACs在不同BMI亚组中的安全性与依诺肝素相当(P>0.05)。使用NOACs及阿司匹林的肥胖/病态肥胖患者对比正常/超重患者的总VTE率[OR=1.28,95%CI(0.68,2.40),P=0.45]、症状性VTE及全因死亡率[OR=1.26,95%CI(0.81,1.95),P=0.30]和主要出血事件率[OR=0.79,95%CI(0.58,1.08),P=0.14]比较,差异均无统计学意义。结论体质量对NOACs及阿司匹林预防髋膝关节置换术后VTE有效性和安全性的影响并不显著,支持超重、肥胖患者接受NOACs或阿司匹林预防VTE。

OBJECTIVE To systematically review the effects of body weight on the efficacy and safety of novel oral anticoagulants(NOACs)or aspirin for the prevention of venous thromboembolism(VTE)after total hip arthroplasty and total knee arthroplasty(hereinafter referred to as“hip and knee arthroplasty”).METHODS Retrieved from PubMed,Embase and Cochrane library,randomized controlled trial(RCT)and non-RCT about the effectiveness and/or safety of NOACs,aspirin and lowmolecular heparin by subgrouping according to body weight or body weight index[BMI 18.5-<25 kg/m^(2) as normal body mass,BMI 25-30 kg/m^(2) as overweight,and BMI>30 kg/m^(2) as obesity(of them,BMI>40 kg/m^(2) as morbid obesity)]were collected from the inception to June 30,2022.After literature screening and data extraction,the quality of RCT was evaluated with bias risk assessment tool RoB 2.0 recommended by Cochrane system evaluator manual.The Newcastle-Ottawa scale was used to evaluate the quality of non-RCT.Meta-analysis was performed by using RevMan 5.4 software.RESULTS A total of 6 literatures,containing 3 series of RCT pooled studies and 3 non-RCTs were included.The results of meta-analysis showed that among different BMI subgroups,there was no statistical significance in reducing major VTE and VTE-related mortality of patients with normal body mass patients[OR=0.63,95%CI(0.26,1.51),P=0.30],overweight patients[OR=0.48,95%CI(0.22,1.04),P=0.06]and obese patients[OR=0.70,95%CI(0.40,1.25),P=0.23]by NOACs,compared with enoxaparin.The safety of NOACs was comparable to that of enoxaparin in different BMI subgroups in terms of the incidence of major bleeding events and major+clinically relevant nonmajor bleeding events(P>0.05).There was no statistical significance in the incidences of total VTE[OR=1.28,95%CI(0.68,2.40),P=0.45],symptomatic VTE and all-cause mortality[OR=1.26,95%CI(0.81,1.95),P=0.30]and major bleeding[OR=0.79,95%CI(0.58,1.08),P=0.14]in obese/morbidly obese patients using NOACs and aspirin,compared with normal/overweight patients.CONCLUSIONS The impact of body weight on the efficacy and safety of NOACs and aspirin for the prevention of VTE after hip and knee arthroplasty is not significant,and this study supports that overweight and obese patients receive NOACs or aspirin for VTE prevention.