冯诚诚,张正丰,罗春梅
利伐沙班与间歇充气加压泵联合弹力袜法两种方案对病人凝血功能的影响
冯诚诚,张正丰,罗春梅
[目的]比较利伐沙班和间歇充气加压泵联合弹力袜预防腰椎融合术后静脉血栓栓塞症对病人凝血功能的影响。[方法]将我院2014年3月—9月行腰椎融合术后病人158例随机分为A组(n=85)、B组(n=73),A组从术后12 h开始连续7 d口服利伐沙班,每日10 mg;B组术后当天至术后7 d采用间歇充气加压装置,每次30 min,每日2次,术后当天至术后7 d采用双下肢长腿弹力袜。两组均于术后7 d停止预防措施。术前及术后7 d检测凝血六项[凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、抗凝血酶(AT)、D-二聚体、凝血酶时间(TT)、纤维蛋白原(FIB)],行双下肢血管超声检查,术后观察记录48 h引流量、注意有无出血并发症、下肢肿胀等静脉血栓栓塞症(VTE)征象。[结果]两组病人术后7 d内均无VTE发生、无出血并发症;术后两组间48 h引流量、PT、APTT、AT比较差异均无统计学意义(P>0.05);A组、B组术后7 d D-二聚体分别比术前增加了3.6倍、7.4倍,组间及组内比较差异均有统计学意义(P<0.05);A组、B组术后7 d FIB分别比术前增加了51.8%、49.9%,术后7 d组间比较差异无统计学意义(P>0.05),术后7 d与术前比较差异均有统计学意义(P<0.05);A组TT时间术后7 d比术前降低了9.4%,B组术后7 d与术前比较无变化,术后7 d组间比较差异无统计学意义(P>0.05)。[结论]利伐沙班与间歇充气加压泵联合弹力袜两种方法预防VTE效果相当,利伐沙班应用后对病人PT、APTT、AT、FIB等凝血功能的影响小,临床观察无出血并发症,未增加出血风险,在D-二聚体水平控制上具有显著优势。
凝血功能;腰椎融合术;利伐沙班;间歇充气加压泵;弹力袜
腰椎融合术后病人卧床休息使其血液呈高黏滞性和高凝状态,易发生静脉血栓栓塞症(venous thromboembolism,VTE)。VTE包括下肢深静脉血栓(DVT)和肺栓塞(PE),严重者可导致病人残疾和死亡,发病率为2%左右[1]。目前,临床上采用间歇充气加压泵、弹力袜法等物理预防措施或抗凝药物来预防VTE的发生[2-3]。间歇充气加压泵联合弹力袜法是通过按摩腿部肌肉,促进下肢静脉血液回流来预防血栓发生的物理方法,因其经济、方便、无出血并发症、易被病人及家属接受而被广泛应用于临床中[4]。利伐沙班(Rivaroxaban)是一种预防静脉血栓药,预防外科手术后血栓效果显著。利伐沙班预防腰椎术后VTE的发生在国内已被报道,其疗效与低分子肝素相当[5],但它的使用是否会增加出血风险仍是临床关心的核心问题。本研究比较口服利伐沙班与间歇充气加压泵联合弹力袜法两种方案对病人凝血功能的影响,以期对腰椎融合术后的抗凝治疗提供依据。
1.1临床资料将2014年3月—9月在我院行腰椎融合术的病例分为两组,单号手术病人为A组(利伐沙班组,n=85),双号手术病人为B组(间歇充气加压泵联合弹力袜组,n=73)。纳入标准:①年龄≥40岁;②术前双下肢静脉超声显示无血栓形成;③术前3个月内未口服抗凝药物;④术后用药除A组使用利伐沙班抗凝药物外均未使用其他抗凝药;⑤术后无活动性出血或高危出血倾向者;⑥无使用利伐沙班、间歇充气加压泵、弹力袜禁忌证;⑦无VTE病史。两组术者为同一组医师,纳入对象均知情同意并签署同意书。本研究得到本院伦理委员会批准,并接受其监督、指导。
1.2方法
1.2.1A组①从术后12 h开始连续7 d口服利伐沙班(德国拜耳制药有限公司,规格:每片10 mg,批号:BXG9601),每日10 mg。②基础预防措施:2 h翻身1次;每次深呼吸15 min,每日2次;每组咳嗽运动5次,每日2组;髋膝关节伸屈活动每次4 min,踝关节伸屈活动每次4 min,每组30次,每日2组,术后当天开始至术后1个月;术后选择清淡低脂食品,每日饮水量>1 500 mL;避免下肢静脉穿刺,预防静脉炎的发生;静脉穿刺时观察有无回血差或采血后出现血液过快凝集现象;尽量保持大便通畅、心情舒畅。
1.2.2B组术后当天至术后7 d采用间歇充气加压装置,每次30 min,每日2次;术后当天至术后7 d采用双下肢长腿弹力袜。基础预防措施与A组相同。
1.3观察指标入院后第1天及术后7 d清晨采血,检测凝血六项[凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、抗凝血酶(AT)、D-二聚体、凝血酶时间(TT)、纤维蛋白原(FIB)];入院后第1天及术后7 d 行双下肢血管彩色超声;分别记录两组病人术中出血量、术后卧床时间;观察、记录术后48 h引流量,观察其他出血并发症(如有无伤口血肿、黏膜出血、凝血时间延长、其他脏器出血)。术后每天量腿围,观察下肢是否肿胀、有无Homans征、疼痛、浅静脉曲张等VTE征象。
2.1两组一般情况比较(见表1)
表1 两组病人一般资料比较
2.2两组病人术后7 d各项指标比较两组病人术后7 d内均无下肢肿胀等VTE征象发生,术后7 d行双下肢血管彩超检测均无DVT发生,A组1例右侧腘静脉流速缓慢、1例左侧大隐静脉轻度曲张;B组1例双侧股静脉血流缓慢,但上述3例病人凝血六项检测均无异常。两组病人术后均无出血并发症发生。两组病人术后48 h引流量比较见表2。
表2 两组病人术后48 h引流量比较 mL
2.3两组病人术前、术后7 d凝血六项比较(见表3)
表3 两组病人术前、术后7 d凝血六项比较
A组和B组术后7 d D-二聚体分别比术前增加了3.6倍、7.4倍,组间及组内比较差异均有统计学意义(P<0.05);A组TT术后7 d比术前降低了9.4%,B组术后7 d与术前比较无明显变化;A组、B组术后7 d FIB分别比术前增加了51.8%、49.9%,与术前比较差异均有统计学意义(P<0.05)。
2.4两组病人术前和术后7 d D-二聚体水平比较B组病人术后7 d D-二聚体为4 305.3 μg/L±3 129.6 μg/L,显著高于A组。A组病人术后7 d D-二聚体超过4 305.3 μg/L的仅有7例(8.2%),其中最高的为8.44 mg/L;B组病人术后7 d D-二聚体超过4 305.3 μg/L的有25例(34.2%),最高的为16.77 mg/L。
凝血功能异常是VTE、出血等潜在危险并发症发生的信号,病人PT、APTT、AT、TT值降低,D-二聚体值升高,说明血液高凝,容易发生VTE;PT、APTT、AT、TT值升高,说明有出血的风险[6-8]。腰椎融合术后病人卧床、制动导致下肢深静脉腔内血流瘀滞,处于高凝状态,进而增加了发生VTE的风险[9-10]。目前,临床使用利伐沙班、间歇充气加压泵、梯度弹力袜等预防措施收到了良好的效果,但利伐沙班是否会对病人凝血功能产生大的影响是临床使用的主要顾虑[11-12]。抗凝药的应用是双刃剑,既可以改变病人血液高凝状态而预防VTE,又有可能会带来出血风险,特别是外科术后病人[13-14]。本研究通过对在我院行腰椎融合术后158例病人进行前瞻性研究,应用利伐沙班的A组病人和应用间歇充气加压泵联合弹力袜的B组病人术后7 d均无VTE、出血并发症、凝血功能障碍发生,说明利伐沙班预防VTE效果与间歇充气加压泵联合弹力袜相当,同时并未增加病人的出血风险。具体表现在:两组病人术后7 d PT、APTT、AT与术前比较并无发生明显变化,组间比较也无明显变化。在TT时间检测中,仅A组术后7 d比术前及B组术后7 d降低了9%左右;FIB A组、B组术后7 d分别比术前增加了51.8%、49.9%,组间术后7 d比较差异无统计学意义。在D-二聚体检测中,A组术后7 d D-二聚体比术前增加了3.6倍,B组术后7 d D-二聚体比术前增加了7.4倍,组间比较差异有统计学意义,说明服用利伐沙班能有效降低腰椎术后引发的D-二聚体增加。A组、B组病人中,术后7 d D-二聚体水平超过4 305.3 μg/L的人数分别为7例和25例,但他们均未发生下肢肿胀和DVT,虽然D-二聚体水平增高使血栓发生的风险增大,但还是不宜通过检测D-二聚体水平来预测腰椎术后DVT的发生,这与孙云波等[15]的报道相似。
综上所述,利伐沙班和间歇充气加压泵联合弹力袜这两种方案均能有效预防腰椎融合术后病人VTE的发生,且经观察使用利伐沙班并未增加出血风险。同时利伐沙班在控制D-二聚体水平上具有一定优势。
[1]Arpaia G,Bavera PM,Caputo D,etal.Risk of deep venous thrombosis (DVT) in bedridden or wheelchair-bound multiple sclerosis patients:a prospective study[J].Thrombosis Research,2010,125(4):315-317.
[2]龚小玲,岳莎莉,潘玉然.分级加压弹力袜与间歇充气加压泵联合应用预防重症患者深静脉血栓形成的研究[J].护理学报,2012,19(7A):57-59.
[3]Chen HL,Wang XD.Heparin for venous thromboembolism prophylaxis in patients with acute spinal cord injury:a systematic review and meta-analysis[J].Spinal Cord,2013,51(8):596-602.
[4]Epstein NE.Efficacy of pneumatic compression stocking prophylaxis in the prevention of deep venous thrombosis and pulmonary embolism following 139 lumbar laminectomies with instrumented fusions[J].Journal of Spinal Disorders & Techniques,2006,19(1):28-31.
[5]张剑锋,刘建青,沈炳华,等.利伐沙班与低分子肝素预防腰椎手术后下肢深静脉血栓的疗效对比[J].中国新药与临床杂志,2014,33(3):211-214.
[6]刘碧翠,杨华,余新华.长期卧床患者凝血状况及血液流变学研究[J].疑难病杂志,2012,11(3):199-201.
[7]Saito T,Takenaka M,Miyai I,etal.Coagulation and fibrinolysis disorder in muscular dystrophy[J].Muscle & Nerve,2001,24(3):399-402.
[8]Niemi TT,Pitkanen M,Syrjala M,etal.Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty[J].Acta Anaesthesiologica Scandinavica,2000,44(4):457-464.
[9]Arachchillage DR,Efthymiou M,Mackie IJ,etal.Rivaroxaban and warfarin achieve effective anticoagulation,as assessed by inhibition of TG and in-vivo markers of coagulation activation,in patients with venous thromboembolism[J].Thrombosis Research,2015,135(2):388-393.
[10] Halim TA,Chhabra HS,Arora M,etal.Pharmacological prophylaxis for deep vein thrombosis in acute spinal cord injury:an Indian perspective[J].Spinal Cord,2014,52(7):547-550.
[11] Okuda Y,Kitajima T,Egawa H,etal.A combination of heparin and an intermittent pneumatic compression device may be more effective to prevent deep-vein thrombosis in the lower extremities after laparoscopic cholecystectomy[J].Surgical Endoscopy,2002,16(5):781-784.
[12] Douxfils J,Mullier F,Loosen C,etal.Assessment of the impact of rivaroxaban on coagulation assays:laboratory recommendations for the monitoring of rivaroxaban and review of the literature[J].Thrombosis Research,2012,130(6):956-966.
[13] 黄侣,甘文魁.腰椎后路手术后利伐沙班与低分子肝素钙抗凝效果的比较[J].广西医科大学学报,2014,31(3):490-492.
[14] 于熙,吕国义,田毅,等.乌司他丁持续输注联合利伐沙班对骨科大手术患者凝血功能的影响[J].天津医药,2013,41(7):692-695.
[15] 孙云波,王磊,神兴勤,等.D-二聚体异常患者人工全膝关节置换术后利伐沙班药物抗凝的安全性和有效性分析[J].中国修复重建外科杂志,2014,28(8):955-959.
(本文编辑张建华)
Influence of two different methods of Rivaroxaban and intermittent pneumatic compression pump combined with elastic socks on coagulation function of patients
Feng Chengcheng,Zhang Zhengfeng,Luo Chunmei
(Xinqiao Hospital of Third Military Medical University of PLA,Chongqing 400037 China)
Objective:The aim was to compare effects of Rivaroxaban and intermittent pneumatic compression pump combined with elastic socks on the coagulation function of patients with venous thromboembolism after lumbar fusion operation.Methods:A total of 158 patients after lumbar fusion operation in our hospital from March 2014 to September 2014 were randomly divided into group A(n=85) and group B(n=73),Patients in group A were taken orally Rivaroxaban for 7 days continuously,12 h after surgery 10 mg per day.Patients in group B were used intermittent pneumatic compression device,30 min each time,2 times a day,from the first postoperative day to postoperative 7 days.And double lower limbs long legs elastic socks were used.Preventive measure of all patients were stopped at 7 d after operation.Coagulation six items prothrombin time(PT),activated partial thromboplastin time(APTT),antithrombin(at),D-dimer,thrombin time(TT),fibrinogen(FIB) were detected on before operation and postoperative 7 days.Double lower limb blood vessel ultrasound examination were dene.After operation,we should observe and record 48 h drainage,pay attention to bleeding complications,lower limb swelling and other venous thromboembolism(VTE) signs.Results:No VTE and no bleeding complications occurred 7 d after operation in two groups.There were no significant differences in 48 h drainage,PT,APTT and AT between the two groups.In group A and group B,D-dimer on postoperative 7 days were increased 3.6 times and 7.4 timesthanthat of before operation.And there was statistically significant difference between two groups and within groups(P<0.05).In group B and group A,FIB were increased by 49.9% and 51.8% respectively.There was no significant difference between two groups on postoperative 7 days(P>0.05).There were statistically significant differences between the postoperative 7 days and before operation(P<0.05).TT on postoperative 7 days was lower than that of before operation 9.4% in group A.There was no change between postoperative 7 days and before operation in group B.There was no significant difference within groups on postoperative 7 days(P>0.05).Conclusion:Effect of preventing VTE of two methods of Rivaroxaban and intermittent pneumatic compression pump combined with elastic socks is quiter the same.After application of Rivaroxaban,effect of PT,APTT,AT,FIB and other blood coagulation function of patients are small.Clinical observation was without bleeding complications and no increase risk of bleeding.And it has a significant advantage in the D-dimer level control.
coagulation function;lumbar fusion operation;Rivaroxaban;intermittent pneumatic pressure pump;elastic socks
2012年第三军医大学新桥医院临床护理科研基金资助课题,编号:201208.
冯诚诚,护师,本科,单位:400037,中国人民解放军第三军医大学新桥医院;张正丰、罗春梅(通讯作者)单位:400037,中国人民解放军第三军医大学新桥医院。
引用信息冯诚诚,张正丰,罗春梅.利伐沙班与间歇充气加压泵联合弹力袜法两种方案对病人凝血功能的影响[J].护理研究,2016,30(9C):3352-3355.
R473.6
A
10.3969/j.issn.1009-6493.2016.27.009
1009-6493(2016)09C-3352-04
2015-10-14;
2016-07-31)