CAJ | 학술논문

目的探讨低分子肝素依诺肝素用于普通外科手术后预防深静脉血栓形成( DVT)和肺栓塞(PE)的有效性和安全性.方法以随机双盲方法,将2006年1月至2011年6月本院收住的1 928例外科手术患者根据术后抗凝与否分为观察组和对照组.观察组960例,给予依诺肝素干预(方案:手术前12h皮下注射依诺肝素40 mg,术后12h再注射40 mg,以后每日注射40 mg 1次,连续7 d)；对照组968例不予干预.观察两组患者DVT、PE以及出血事件的发生情况.结果 ①两组患者性别、年龄、体质指数、危险因素(包括肥胖、静脉血栓病史、静脉曲张、慢性阻塞性肺疾病史、慢性心功能不全病史、激素治疗史)以及手术类型比较差异均无统计学意义.对照组36.5％为非恶性肿瘤手术,63.5％为恶性肿瘤手术,手术时间2.3h；观察组分别为35.6％、64.4％和2.2h,两组比较差异均无统计学意义(均P＞0.05).②在住院期间,对照组968例患者中发生DVT 59例(6.1％)、PE 14例(1.4％),其中非致死性PE 8例(0.8％)、致死性PE 6例(0.6％),致死性PE占该组PE的42.8％；观察组960例中发生DVT 28例(2.9％)、PE 3例(0.3％),其中非致死性PE 2例(0.2％)、致死性PE 1例(0.1％),致死性PE占该组PE的33.3％,均较对照组下降(P＜0.05或P＜0.01).在随访期间,对照组DVT增加了14例(1.4％),致死性PE增加了1例(0.1％)；观察组DVT增加了2例(0.2％),与对照组差异有统计学意义(P＜0.01),非致死性PE增加了1例(0.1％).③出血事件比较:住院期间,对照组有少量出血30例(3.1％),严重出血8例(0.8％),而观察组少量出血33例(3.4％),严重出血9例(0.9％),两组无明显差异(均P＞0.05)；停药后及出院随访期间两组出血事件比较差异无统计学意义.结论依诺肝素用于外科术后患者预防性治疗可以降低DVT和PE的发生率,且安全,不会增加出血的风险.
목적 탐토저분자간소의낙간소용우보통외과수술후예방심정맥혈전형성( DVT)화폐전새(PE)적유효성화안전성.방법 이수궤쌍맹방법,장2006년1월지2011년6월본원수주적1 928예외과수술환자근거술후항응여부분위관찰조화대조조.관찰조960례,급여의낙간소간예(방안:수술전12h피하주사의낙간소40 mg,술후12h재주사40 mg,이후매일주사40 mg 1차,련속7 d)；대조조968례불여간예.관찰량조환자DVT、PE이급출혈사건적발생정황.결과 ①량조환자성별、년령、체질지수、위험인소(포괄비반、정맥혈전병사、정맥곡장、만성조새성폐질병사、만성심공능불전병사、격소치료사)이급수술류형비교차이균무통계학의의.대조조36.5％위비악성종류수술,63.5％위악성종류수술,수술시간2.3h；관찰조분별위35.6％、64.4％화2.2h,량조비교차이균무통계학의의(균P＞0.05).②재주원기간,대조조968례환자중발생DVT 59례(6.1％)、PE 14례(1.4％),기중비치사성PE 8례(0.8％)、치사성PE 6례(0.6％),치사성PE점해조PE적42.8％；관찰조960례중발생DVT 28례(2.9％)、PE 3례(0.3％),기중비치사성PE 2례(0.2％)、치사성PE 1례(0.1％),치사성PE점해조PE적33.3％,균교대조조하강(P＜0.05혹P＜0.01).재수방기간,대조조DVT증가료14례(1.4％),치사성PE증가료1례(0.1％)；관찰조DVT증가료2례(0.2％),여대조조차이유통계학의의(P＜0.01),비치사성PE증가료1례(0.1％).③출혈사건비교:주원기간,대조조유소량출혈30례(3.1％),엄중출혈8례(0.8％),이관찰조소량출혈33례(3.4％),엄중출혈9례(0.9％),량조무명현차이(균P＞0.05)；정약후급출원수방기간량조출혈사건비교차이무통계학의의.결론 의낙간소용우외과술후환자예방성치료가이강저DVT화PE적발생솔,차안전,불회증가출혈적풍험.
Objective To evaluate the efficacy and safety of the administration of enoxaparin,a low molecular weight heparin (LMWH),in the prevention of post surgical deep vein thrombosis (DVT) and pulmonary embolism (PE).Methods 1 928 patients hospitalized for general surgery were randomly divided into:(① test group (n=960) to receive enoxaparin (40 mg,s.c.,12 hours before and after surgery,then once daily for 7 consecutive days); ② control group (n=968) without intervention.The incidence of DVT,PE and bleeding were recorded for statistical analysis during hospitalization and a 2 months follow-up after discharge.Results ① No significant difference was found between the two groups in age,sex,average body mass index,type of surgery,and DVT/PE risk factors (obesity,varicose veins,and history of:venous thrombosis,chronic obstructive pulmonary disease,chronic heart failure,and hormone therapy).The percentage of non-malignant/malignant tumor surgery were 36.5％/63.5％ (average operation time 2.3 hours) in control group and 35.6％/64.4％ (2.2 hours) in test group (both P＞0.05).② During the hospitalization period,59 eases (incidence =6.1 ％) of DVT and 14 cases (incidence =1.4 ％ ) of PE (among them 6 were fetal,42.8％ of all PE cases) were found in the control group,while 28 cases of DVT (2.9％) and 3 cases (0.3％) of PE (1 fetal,33.3％ of all PE cases) were found in test group.The incidence of DVT,PE (total),and PE (fetal) were significant lower in test group (P＜ 0.05 or P＜ 0.01).During the follow-up,14 more cases of DVT (1.4％) and 1 more case (0.1％ ) of PE (a fetal) were found in the control group,and 2 more DVT cases (0.2％) in test group,with the DVT incidence in test group significantly lower (P＜0.01).(③ During the enoxaparin administration,30 cases (3.1 ％) minor bleeding and 8 cases (0.8％) major bleeding were found in the control group,while 33 cases (3.4％) minor bleeding events and 9 cases (0.9％) major bleeding events were found in the test group.The results in the two groups were not significantly different in either type of bleeding events (both P＞0.05).Also no significant difference was found in the bleeding events after the ending of enoxaparin administration and during the follow-up.Conclusion Enoxaparin may reduce the incidence of DVT and PE in patients undergoing general surgery without increased risk of bleeding.