中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
2015年
9期
693-695
,共3页
利伐沙班%依诺肝素%骨科大手术%深静脉血栓%安全性
利伐沙班%依諾肝素%骨科大手術%深靜脈血栓%安全性
리벌사반%의낙간소%골과대수술%심정맥혈전%안전성
rivaroxaban%enoxaparin%major orthopedic surgery%deep vein thrombosis%safety
目的：评价利伐沙班与依诺肝素预防骨科大手术后深静脉血栓形成的疗效及安全性。方法入选骨科大手术患者212例，分为利伐沙班组102例（试验组）和依诺肝素组110例（对照组）。试验组术后6 h口服利伐沙班10 mg· d－1，连续28 d。对照组术前12 h及术后皮下注射依诺肝素0.4 mL，qd，连续10 d。记录2组患者围手术期输血、次要出血、血肿等并发症及术后随访6个月深静脉血栓发生情况，分析2组患者深静脉血栓形成及出血风险有无差别，记录术前和术后1周血流动力学指标。结果术后随访6个月，试验组发生深静脉血栓者3例（2.9％），对照组2例（1.8％），2组患者深静脉血栓发生风险差别无统计学意义（P＞0.05）。2组患者术后凝血指标差异无统计学意义（P＞0.05）。试验组术后输血8例，次要出血3例，伤口渗血2例，血肿4例，伤口感染1例；对照组术后输血11例，次要出血5例，伤口渗血3例，血肿5例，伤口感染1例，2组患者不良反应发生率差异均无统计学意义（ P＞0.05）。结论利伐沙班与依诺肝素预防骨科大手术后深静脉血栓形成及安全性无明显差异。
目的：評價利伐沙班與依諾肝素預防骨科大手術後深靜脈血栓形成的療效及安全性。方法入選骨科大手術患者212例，分為利伐沙班組102例（試驗組）和依諾肝素組110例（對照組）。試驗組術後6 h口服利伐沙班10 mg· d－1，連續28 d。對照組術前12 h及術後皮下註射依諾肝素0.4 mL，qd，連續10 d。記錄2組患者圍手術期輸血、次要齣血、血腫等併髮癥及術後隨訪6箇月深靜脈血栓髮生情況，分析2組患者深靜脈血栓形成及齣血風險有無差彆，記錄術前和術後1週血流動力學指標。結果術後隨訪6箇月，試驗組髮生深靜脈血栓者3例（2.9％），對照組2例（1.8％），2組患者深靜脈血栓髮生風險差彆無統計學意義（P＞0.05）。2組患者術後凝血指標差異無統計學意義（P＞0.05）。試驗組術後輸血8例，次要齣血3例，傷口滲血2例，血腫4例，傷口感染1例；對照組術後輸血11例，次要齣血5例，傷口滲血3例，血腫5例，傷口感染1例，2組患者不良反應髮生率差異均無統計學意義（ P＞0.05）。結論利伐沙班與依諾肝素預防骨科大手術後深靜脈血栓形成及安全性無明顯差異。
목적：평개리벌사반여의낙간소예방골과대수술후심정맥혈전형성적료효급안전성。방법입선골과대수술환자212례，분위리벌사반조102례（시험조）화의낙간소조110례（대조조）。시험조술후6 h구복리벌사반10 mg· d－1，련속28 d。대조조술전12 h급술후피하주사의낙간소0.4 mL，qd，련속10 d。기록2조환자위수술기수혈、차요출혈、혈종등병발증급술후수방6개월심정맥혈전발생정황，분석2조환자심정맥혈전형성급출혈풍험유무차별，기록술전화술후1주혈류동역학지표。결과술후수방6개월，시험조발생심정맥혈전자3례（2.9％），대조조2례（1.8％），2조환자심정맥혈전발생풍험차별무통계학의의（P＞0.05）。2조환자술후응혈지표차이무통계학의의（P＞0.05）。시험조술후수혈8례，차요출혈3례，상구삼혈2례，혈종4례，상구감염1례；대조조술후수혈11례，차요출혈5례，상구삼혈3례，혈종5례，상구감염1례，2조환자불량반응발생솔차이균무통계학의의（ P＞0.05）。결론리벌사반여의낙간소예방골과대수술후심정맥혈전형성급안전성무명현차이。
Objective To evaluate the efficacy and safety of rivaroxaban versus enoxaparin in prevention of deep vein thrombosis after major orthopedic surgery.Methods A total of 212 patients who accepted major orthopedic surgery and received rivaroxaban or enoxaparin in prevention of deep vein thrombosis were recruited in this study.Of the included 212 subjects, 102 patients( experiment group) received rivaro-xaban 10 mg· d-1 orally 6 h after surgery for 28 days and 110 patients ( control group ) received enoxaparin 0.4 mL 12 h before surgery and after surgery for 10 days.The risk of developing deep vein thrombosis within 6 months, perioperative blood transfusion, secondary bleeding and hematoma were compared between the two groups.Results In the period of 6 moths follow-up, 3 (2.9%) and 2 cases (1.8%) of deep vein thrombosis were found in the experiment and control group, respec-tively, but without statistical difference ( P>0.05 ).And no significant difference in coagulation index were recorded between the two groups ( P>0.05).There were 8 cases of blood transfusion, 3 cases of seconda-ry bleeding, 2 cases of wound bleeding, 4 cases of hematoma and 1 case of wound infection in experiment group.And 11 cases of blood transfusion, 5 cases of secondary bleeding, 3 cases of wound bleeding, 5 cases of hematoma and 1 case of wound infection in control group were found.The risk of developing anticoagulation between the two groups was not statistically different ( P>0.05 ).Conclusion Rivaroxaban and enoxaparin in prevention of deep vein thrombosis after major orthopedic surgery has similar clinical efficacy and safety.
