CAJ | 학술논문

目的探讨成人膝部原发性骨肿瘤术后静脉血栓栓塞(VTE)的发生率及应用利伐沙班预防VTE的有效性及安全性.方法本研究为前瞻、随机、阴性对照的单中心临床研究.符合入选标准且完成研究的膝部原发性骨肿瘤患者被随机分入两组.试验组(利伐沙班)50例:术后24 h内开始服用利伐沙班,每天10 mg至术后第14天；对照组(空白对照)50例:术后不采取任何药物抗凝措施.结果有效性指标:试验组术后发生深静脉血栓(DVT)6例,发生率为12％；对照组15例,发生率为30％,两组间的DVT发生率差异有统计学意义(P＜0.05).两组中均无肺栓塞(PE)和死亡事件发生.安全性指标:试验组总的出血事件3例(6％),其中大出血1例,非大出血2例.对照组总的出血事件2例(4％),其中大出血0例,非大出血2例.出血事件发生率差异无统计学意义(P＞0.05).试验组总的不良反应发生率为6％(3/50).试验组平均引流量高于对照组,但两组平均引流时间的差异无统计学意义.而且试验室检查利伐沙班对凝血系统指标的数值几乎无影响.结论利伐沙班可以有效预防成人膝部原发性骨肿瘤术后VTE的发生,安全性良好,不良反应率低.
목적 탐토성인슬부원발성골종류술후정맥혈전전새(VTE)적발생솔급응용리벌사반예방VTE적유효성급안전성.방법 본연구위전첨、수궤、음성대조적단중심림상연구.부합입선표준차완성연구적슬부원발성골종류환자피수궤분입량조.시험조(리벌사반)50례:술후24 h내개시복용리벌사반,매천10 mg지술후제14천；대조조(공백대조)50례:술후불채취임하약물항응조시.결과 유효성지표:시험조술후발생심정맥혈전(DVT)6례,발생솔위12％；대조조15례,발생솔위30％,량조간적DVT발생솔차이유통계학의의(P＜0.05).량조중균무폐전새(PE)화사망사건발생.안전성지표:시험조총적출혈사건3례(6％),기중대출혈1례,비대출혈2례.대조조총적출혈사건2례(4％),기중대출혈0례,비대출혈2례.출혈사건발생솔차이무통계학의의(P＞0.05).시험조총적불량반응발생솔위6％(3/50).시험조평균인류량고우대조조,단량조평균인류시간적차이무통계학의의.이차시험실검사리벌사반대응혈계통지표적수치궤호무영향.결론 리벌사반가이유효예방성인슬부원발성골종류술후VTE적발생,안전성량호,불량반응솔저.
Objective To explore the incidence of postoperative venous thromboemolism (VTE) in adult patients with primary bone tumor undergoing knee operation and evaluate its efficacy and safety in the prevention of VTE.Methods For this prospective,randomized and negative-control single-center trial,a total of 100 eligible patients were selected and randomly divided into observation and control groups.Observation group (rivaroxaban):the first rivaroxaban tablet was taken in the first 24 hours after operation.Rivaroxaban was administered daily every 24 hours up to Day 14.Control group:no anticoagulant was taken postoperatively.Results Efficacy indictors:6 cases of DVT (an incidence of 12％) occurred in the observation group versus 15 (30％) in the control group.Significant statistical difference existed between two groups (P ＜ 0.05).Furthermore,neither pulmonary embolism nor death was found in either group,Safety indicators:a total of 3 bleeding (1 major and 2 non-major) cases occurred in observation group versus a total of 2 bleeding (no major and 2 non-major) cases in control group.No significant statistical difference existed in bleeding events (P ＞ 0.05).The total incidence of adverse effect was 6％ (3/50) in the observation group.The drainage volume of the observation group was a little more than that of the control group.But no significant statistical difference existed in drainage duration (P ＞ 0.05).And there was almost no change in the coagulation system by laboratory examination after oral administration.Conclusion With an excellent safety profile and a low incidence of adverse effects,Rivaroxaban is effective and safe in the prevention of VTE in adult patients with primary bone tumor undergoing knee operation.