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1.天津医科大学第二医院药学部,天津 300211
2.天津医科大学第二医院血管外科,天津 300211
Received:20 November 2024,
Revised:07 April 2025,
Accepted:07 April 2025,
Published:30 May 2025
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王华玉,上官可可,王莹等.阿哌沙班预防和治疗肿瘤相关静脉血栓栓塞症的快速卫生技术评估 Δ[J].中国药房,2025,36(10):1260-1265.
WANG Huayu,SHANGGUAN Keke,WANG Ying,et al.Apixaban for the prevention and treatment of cancer-associated venous thromboembolism: a rapid health technology assessment[J].ZHONGGUO YAOFANG,2025,36(10):1260-1265.
王华玉,上官可可,王莹等.阿哌沙班预防和治疗肿瘤相关静脉血栓栓塞症的快速卫生技术评估 Δ[J].中国药房,2025,36(10):1260-1265. DOI: 10.6039/j.issn.1001-0408.2025.10.19.
WANG Huayu,SHANGGUAN Keke,WANG Ying,et al.Apixaban for the prevention and treatment of cancer-associated venous thromboembolism: a rapid health technology assessment[J].ZHONGGUO YAOFANG,2025,36(10):1260-1265. DOI: 10.6039/j.issn.1001-0408.2025.10.19.
目的
2
评价阿哌沙班预防和治疗肿瘤相关静脉血栓栓塞症(CA-VTE)的有效性、安全性和经济性,为临床用药提供循证依据。
方法
2
检索PubMed、the Cochrane Library、中国知网、万方数据、维普网及卫生技术评估(HTA)相关网站,收集阿哌沙班预防和治疗CA-VTE的系统评价/Meta分析、药物经济学研究和HTA报告。经资料提取、质量评价后,对纳入研究的结果进行描述性分析。
结果
2
共纳入23篇文献,包括16篇系统评价/Meta分析和7篇药物经济学研究。有效性方面,与安慰剂比较,预防性应用阿哌沙班可显著降低门诊成年肿瘤患者的静脉血栓栓塞症(VTE)发生率(
P
<0.05);与低分子肝素(LMWH)、利伐沙班和华法林患者的VTE发生率比较,差异均无统计学意义(
P
>0.05),但阿哌沙班排名最优。与使用华法林比较,阿哌沙班可显著降低CA-VTE患者的VTE复发率(
P
<0.05);与使用LMWH、利伐沙班、艾多沙班和达比加群患者的VTE复发率、深静脉血栓形成复发率和肺栓塞复发率比较,差异均无统计学意义(
P
>0.05)。安全性方面,与安慰剂比较,预防性应用阿哌沙班的接受化疗门诊成年肿瘤患者的大出血发生率更高(
P
<0.05),与使用LMWH、利伐沙班和华法林患者的大出血发生率比较,差异均无统计学意义(
P
>0.05),但阿哌沙班排名最优。使用阿哌沙班与达肝素的CA-VTE患者的大出血发生率、全因死亡率比较,差异均无统计学意义(
P
>0.05),但使用阿哌沙班患者的临床相关非大出血(CRNMB)发生率更高(
P
<0.05)。与艾多沙班比较,使用阿哌沙班患者的大出血发生率显著降低(
P
<0.05),但CRNMB发生率、临床相关出血发生率和全因死亡率比较,差异均无统计学意义(
P
>0.05)。与利伐沙班、华法林和达比加群比较,使用阿哌沙班患者的大出血发生率、CRNMB发生率、临床相关出血发生率和全因死亡率比较,差异均无统计学意义(
P
>0.05)。经济性方面,我国研究表明,阿哌沙班预防CA-VTE具有经济性;国外研究表明,阿哌沙班预防和治疗CA-VTE具有经济性。
结论
2
阿哌沙班预防和治疗CA-VTE具有良好的有效性、安全性和经济性。
OBJECTIVE
2
To evaluate the efficacy, safety and cost-effectiveness of apixaban in the prevention and treatment of cancer-associated venous thromboembolism (CA-VTE), and provide evidence-based reference for clinical treatment.
METHODS
2
Retrieved from PubMed, the Cochrane Library, CNKI, Wanfang, VIP database and other websites of health technology assessment (HTA), systematic review/meta-analysis, pharmacoeconomic studies and HTA reports of apixaban in the prevention and treatment of CA-VTE were collected. After data extraction and quality evaluation, the results of the included study were analyzed descriptively.
RESULTS
2
A total of 23 literatures were included, involving 16 systematic review/meta-analysis and 7 pharmacoeconomic studies. In terms of efficacy, compared with placebo, prophylactic use of apixaban could significantly reduce the incidence of venous thromboembolism (VTE) in outpatient adult cancer patients receiving chemotherapy (
P
<0.05). Compared with low-molecular weight heparin (LMWH), rivaroxaban and warfarin, there were no statistically significant differences in the incidence of VTE for apixaban (
P
>0.05); nevertheless, apixaban was ranked as the most preferable choice. For the treatment of patients with CA-VTE, compared with warfarin, apixaban could significantly reduce the recurrence rate of VTE (
P
<0.05). While compared with patients treated with LMWH, rivaroxaban, edoxaban and dabigatran, there were no statistically significant differences in the recurrence rates of VTE, deep venous thrombosis and pulmona
ry embolism among patients using apixaban (
P
>0.05). In terms of safety, compared with placebo, prophylactic use of apixaban showed a higher occurrence of major bleeding in outpatient adult cancer patients receiving chemotherapy (
P
<0.05), while compared with patients treated with LMWH, rivaroxaban, and warfarin, there were no statistically significant differences in the incidence of major bleeding among patients using apixaban (
P
>0.05); despite this, apixaban was ranked as the most favorable option. For the treatment of patients with CA-VTE, compared with dalteparin, the incidence of major bleeding and all-cause mortality of apixaban were similar (
P
>0.05), while the incidence of clinically relevant non-major bleeding (CRNMB) was higher (
P
<0.05). Compared with edoxaban, the incidence of major bleeding of apixaban was reduced significantly (
P
<0.05), while there was no significant difference in the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (
P
>0.05). Compared with rivaroxaban, warfarin and dabigatran, there were no significant differences in the incidence of major bleeding, the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (
P
>0.05). In terms of cost-effectiveness, the researches in China showed that apixaban was cost-effective in preventing CA-VTE; foreign studies showed that apixaban was cost-effective in preventing and treating CA-VTE.
CONCLUSIONS
2
Apixaban is effective, safe and cost-effective in the prevention and treatment of CA-VTE.
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