阿哌沙班治疗和预防癌症相关静脉血栓栓塞症的疗效与安全性的Meta分析

The use of apixaban for treatment and prevention of cancer-associated venous thromboembolism:a meta-analysis research

目的系统评价阿哌沙班治疗和预防癌症相关静脉血栓栓塞症(VTE)的疗效与安全性。方法系统检索PubMed、Cochrane图书馆、Embase等数据库建库至2023年2月关于阿哌沙班治疗或预防癌症相关VTE的随机对照试验。采用Cochrane提供的RevMan 5.4软件进行Meta分析。VTE与出血风险被纳入分析,并根据是否有深静脉血栓形成与肺栓塞进行亚组分析。结果共纳入7项研究进行Meta分析,共3157例患者。结果显示:(1)阿哌沙班治疗癌症相关VTE:阿哌沙班组较对照组VTE的复发减少,差异具有统计学意义(OR=0.52,95%CI:0.35~0.77,P<0.01);与对照组相比,阿哌沙班组不会增加大出血发生率(OR=0.70,95%CI:0.43~1.15,P=0.16)及临床相关的非大出血发生率(OR=0.96,95%CI:0.41~2.23,P=0.93)。(2)阿哌沙班预防癌症相关VTE:阿哌沙班组较对照组VTE发生率降低,差异具有统计学意义(OR=0.35,95%CI:0.19~0.66,P<0.01);与对照组相比,阿哌沙班组不会增加大出血发生率(OR=1.54,95%CI:0.61~3.91,P=0.36)及临床相关的非大出血发生率(OR=0.97,95%CI:0.60~1.57,P=0.90)。亚组分析显示,阿哌沙班组较对照组癌症相关肺栓塞的发生减少,差异具有统计学意义(OR=0.26,95%CI:0.10~0.70,P<0.01),而无论是癌症相关肺栓塞的复发,还是癌症相关深静脉血栓形成的复发和发生(OR=0.57,95%CI:0.32~1.01,P=0.05;OR=0.60,95%CI:0.32~1.10,P=0.10;OR=0.22,95%CI:0.02~2.56,P=0.23),两组差异无统计学意义。结论阿派沙班是安全有效的,可以减少癌症相关VTE的发生,同时不增加出血发生率。

Objective To systematically evaluate the efficacy and safety of apixaban in treating and preventing cancer-related venous thromboembosis(VTE).MethodsPubMed,Cochrane Library and Embase were searched,and the data concerning randomized controlled trials of apixaban in treating or preventing cancer-related VTE were collected until February 2023.Meta-analysis was performed using RevMan5.4,which was provided by Cochrane.VTE and bleeding risk were included in the meta-analysis.Subgroup analysis was carried out according to whether there was deep vein thrombosis(DVT)and pulmonary embolism(PE).ResultsA total of 7 studies with 3157 patients were included in the meta-analysis.The results showed:(1)Apixaban for treating VTE in cancer-related patients:compared with the control group,apixaban reduced the recurrence of VTE,and the difference was statistically significant(OR=0.52,95%CI:0.35-0.77,P=0.001);compared with the control group,apixaban did not increase the incidence of major bleeding(OR=0.70,95%CI:0.43-1.15,P=0.16)and clinically relevant non-major bleeding(OR=0.96,95%CI:0.41-2.23,P=0.93).(2)Apixaban for preventing VTE in cancer-related patients:compared with the control group,apixaban reduced the incidence rate of VTE,and the difference was statistically significant(OR=0.35,95%CI:0.19-0.66,P<0.01);compared with the control group,apixaban did not increase the onset of major bleeding(OR=1.54,95%CI:0.61-3.91,P=0.36)and clinically relevant non-major bleeding(OR=0.97,95%CI:0.60-1.57,P=0.90).By subgroup analysis,it was found that apixaban could reduce the onset of cancer-related PE compared with the control group with significant difference(OR=0.26,95%CI:0.10-0.70,P=0.007).Whether in the recurrence of cancer-related pulmonary embolism or the onset and recurrence of cancer-related VTE,there was no statistically significant difference between two groups(OR=0.57,95%CI:0.32-1.01,P=0.05;OR=0.60,95%CI:0.32-1.10,P=0.10;OR=0.22,95%CI:0.02-2.56,P=0.23).ConclusionApixaban is safe and effective and can reduce the incidence of cancer-related VTE without increasing the incidence of bleeding.