低分子肝素预防外科术后患者的肺栓塞

Enoxaparin for the prevention of post-surgical pulmonary embolism

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1928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40mg，术后12h再注射40mg，以后每日注射40mg1次，连续7d）；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DVT59例（6．1％）、PE14例（1．4％），其中非致死性PE8例（0．8％）、致死性PE6例（0．6％），致死性PE占该组PE的42．8％；观察组960例中发生DVT28例（2．9％）、PE3例（0．3％），其中非致死性PE2例（0．2％）、致死性PE1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。

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 cases （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.