CAJ | 학술논문

目的评估利伐沙班预防腰椎手术后静脉血栓栓塞的有效性及安全性。方法自2009年8月至2011年12月，1321例接受腰椎手术治疗，975例符合试验设计需求者入选本次试验。根据骨科手术的静脉血栓栓塞症危险分度将入选患者分为4组：低危组，中危组，高危组，极高危组。每组患者随机分为利伐沙班组、低分子肝素组、物理治疗组。分别采用利伐沙班、低分子肝素钠及物理性措施进行术后下肢深静脉血栓的预防，比较三组术后安全终点事件（出血性事件）和疗效终点事件（静脉血栓形成）的发生情况。比较安全终点事件和疗效终点事件组间分布情况。结果血栓事件发生率比较，利伐沙班组与低分子肝素钠组比较无统计学差异，两组明显小于物理预防组（ P＜0.05）。疗效终点组间分布比较：低危组、中危组：主要疗效终点、主要的次要疗效终点和其他疗效终点三组之间比较无统计学差异。高危组、极高危组：主要疗效终点、主要的次要疗效终点和其他疗效终点三组比较有统计学差异，利伐沙班组小于低分子肝素组，低分子肝素组小于物理预防组（ P＜0.05）。出血事件发生率利伐沙班组和低分子肝素组比较无统计学差异，但两组同物理预防组比较出血事件发生率高于物理预防组（ P＜0.05）。安全终点组间分布比较：低危组、中危组：严重出血和非严重出血三组间比较无统计学差异，但利伐沙班和低分子肝素组较物理预防组有明显增高趋势。高危组、极高危组：严重出血和非严重出血三组比较无统计学差异。结论利伐沙班作为新型的口服抗凝药物，与低分子肝素钠相比服用方便、抗凝效果可靠，能明显减少腰椎术后血栓事件发生。利伐沙班可增加血栓低危和中危风险人群出血事件发生，与物理预防相比不增加血栓高危和极高危人群出血风险。建议对于血栓低危和中危人群应用物理预防下肢深静脉血栓，对于血栓高危和极高危人群应用利伐沙班和低分子肝素预防下肢深静脉血栓。但是，由于脊柱解剖部位的差异，脊髓神经和马尾神经对外在压迫的耐受程度不同，利伐沙班能否广泛应用于颈、胸椎术后的抗凝尚需慎重，还需要大宗的多中心、随机、双盲的临床试验进行验证。目的評估利伐沙班預防腰椎手術後靜脈血栓栓塞的有效性及安全性。方法自2009年8月至2011年12月，1321例接受腰椎手術治療，975例符閤試驗設計需求者入選本次試驗。根據骨科手術的靜脈血栓栓塞癥危險分度將入選患者分為4組：低危組，中危組，高危組，極高危組。每組患者隨機分為利伐沙班組、低分子肝素組、物理治療組。分彆採用利伐沙班、低分子肝素鈉及物理性措施進行術後下肢深靜脈血栓的預防，比較三組術後安全終點事件（齣血性事件）和療效終點事件（靜脈血栓形成）的髮生情況。比較安全終點事件和療效終點事件組間分佈情況。結果血栓事件髮生率比較，利伐沙班組與低分子肝素鈉組比較無統計學差異，兩組明顯小于物理預防組（ P＜0.05）。療效終點組間分佈比較：低危組、中危組：主要療效終點、主要的次要療效終點和其他療效終點三組之間比較無統計學差異。高危組、極高危組：主要療效終點、主要的次要療效終點和其他療效終點三組比較有統計學差異，利伐沙班組小于低分子肝素組，低分子肝素組小于物理預防組（ P＜0.05）。齣血事件髮生率利伐沙班組和低分子肝素組比較無統計學差異，但兩組同物理預防組比較齣血事件髮生率高于物理預防組（ P＜0.05）。安全終點組間分佈比較：低危組、中危組：嚴重齣血和非嚴重齣血三組間比較無統計學差異，但利伐沙班和低分子肝素組較物理預防組有明顯增高趨勢。高危組、極高危組：嚴重齣血和非嚴重齣血三組比較無統計學差異。結論利伐沙班作為新型的口服抗凝藥物，與低分子肝素鈉相比服用方便、抗凝效果可靠，能明顯減少腰椎術後血栓事件髮生。利伐沙班可增加血栓低危和中危風險人群齣血事件髮生，與物理預防相比不增加血栓高危和極高危人群齣血風險。建議對于血栓低危和中危人群應用物理預防下肢深靜脈血栓，對于血栓高危和極高危人群應用利伐沙班和低分子肝素預防下肢深靜脈血栓。但是，由于脊柱解剖部位的差異，脊髓神經和馬尾神經對外在壓迫的耐受程度不同，利伐沙班能否廣汎應用于頸、胸椎術後的抗凝尚需慎重，還需要大宗的多中心、隨機、雙盲的臨床試驗進行驗證。
목적평고리벌사반예방요추수술후정맥혈전전새적유효성급안전성。방법자2009년8월지2011년12월，1321례접수요추수술치료，975례부합시험설계수구자입선본차시험。근거골과수술적정맥혈전전새증위험분도장입선환자분위4조：저위조，중위조，고위조，겁고위조。매조환자수궤분위리벌사반조、저분자간소조、물리치료조。분별채용리벌사반、저분자간소납급물이성조시진행술후하지심정맥혈전적예방，비교삼조술후안전종점사건（출혈성사건）화료효종점사건（정맥혈전형성）적발생정황。비교안전종점사건화료효종점사건조간분포정황。결과혈전사건발생솔비교，리벌사반조여저분자간소납조비교무통계학차이，량조명현소우물리예방조（ P＜0.05）。료효종점조간분포비교：저위조、중위조：주요료효종점、주요적차요료효종점화기타료효종점삼조지간비교무통계학차이。고위조、겁고위조：주요료효종점、주요적차요료효종점화기타료효종점삼조비교유통계학차이，리벌사반조소우저분자간소조，저분자간소조소우물리예방조（ P＜0.05）。출혈사건발생솔리벌사반조화저분자간소조비교무통계학차이，단량조동물리예방조비교출혈사건발생솔고우물리예방조（ P＜0.05）。안전종점조간분포비교：저위조、중위조：엄중출혈화비엄중출혈삼조간비교무통계학차이，단리벌사반화저분자간소조교물리예방조유명현증고추세。고위조、겁고위조：엄중출혈화비엄중출혈삼조비교무통계학차이。결론리벌사반작위신형적구복항응약물，여저분자간소납상비복용방편、항응효과가고，능명현감소요추술후혈전사건발생。리벌사반가증가혈전저위화중위풍험인군출혈사건발생，여물리예방상비불증가혈전고위화겁고위인군출혈풍험。건의대우혈전저위화중위인군응용물리예방하지심정맥혈전，대우혈전고위화겁고위인군응용리벌사반화저분자간소예방하지심정맥혈전。단시，유우척주해부부위적차이，척수신경화마미신경대외재압박적내수정도불동，리벌사반능부엄범응용우경、흉추술후적항응상수신중，환수요대종적다중심、수궤、쌍맹적림상시험진행험증。
Objective To explore the effectiveness and safety of Rivaroxaban in preventing deep veinthrombosis after lumbar spinal surgery.Methods 1321 patients received lumbar surgery in our hospital from Aug .2009 to Dec.2011,975/1321 were analysed.All of the 975 cases were divided into 4 groups based on the risk level ofvenous thrombosis:low risk,intermediate risk,high risk,and extrahigh risk.All the patients were divided into 3groups [Rivaroxaban group, Low-molecular-weight heparin (LMWH) group and physical treatment group ], andaccepted different methods in preventing VTE .Bleeding affairs and deep vein thrombosis affairs (efficacy endpoints)were recorded and analysed.Results Analysis showed the incidences in vein thrombosis affairs had no differrencebetween LMWH group and Rivaroxaban group;and PSCD made the highest rate.Deep vein thrombosis affairs(efficacy endpoints):there were no difference between low risk,intermediate risk groups on primary,secondary andother efficacy endpoints;there were difference between high risk,and extrahigh risk groups on primary,secondary andother efficacy endpoints.Bleeding affairs:there were no difference between Rivaroxaban group and LMWH group ;but PSCD made a lower incidence.Safety endpoints:there were no difference between low risk ,intermediate risk groups inbad bleeding affairs;the same thing occurred between high risk,and extrahigh risk groups.But compared to PSCDgroup,the Rivaroxaban group,LMWH group showed a increasing bleeding incidence .Conclusions Compared withLMWH regimens,oral rivaroxaban reduces the composite of symptomatic DVT after lumbar surgery ,with no increasein bleeding.But rivaroxaban made a increasing bleeding in low risk ,intermediate risk groups compared to PSCD,thesame thing were not obseverd in high risk,and extrahigh risk groups.So,rivaroxaban were recommended for low risk,intermediate risk groups,and LMWH were still the first choice for high risk,and extrahigh risk groups.However,inconsideration of tolerance to hematoma compression ,Rivaroxaban for cervical, thoracic surgery should be moretested.