Zhonghua yi xue za zhi · 2012
[Evaluation of efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in adult patients with primary bone tumor undergoing knee operation].
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Tang Ben-qiang, Guo Wei, Yang Rong-li, Tang Xiao-dong, Yan Tai-qiang, Tang Shun
Аннотация
OBJECTIVE: To explore the incidence of postoperative venous thromboembolism (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.
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.