馮誠誠，張正豐，羅春梅

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利伐沙班與間歇充氣加壓泵聯(lián)合彈力襪法兩種方案對病人凝血功能的影響

馮誠誠，張正豐，羅春梅

[目的]比較利伐沙班和間歇充氣加壓泵聯(lián)合彈力襪預(yù)防腰椎融合術(shù)后靜脈血栓栓塞癥對病人凝血功能的影響。[方法]將我院2014年3月—9月行腰椎融合術(shù)后病人158例隨機(jī)分為A組(n=85)、B組(n=73)，A組從術(shù)后12 h開始連續(xù)7 d口服利伐沙班,每日10 mg；B組術(shù)后當(dāng)天至術(shù)后7 d采用間歇充氣加壓裝置，每次30 min，每日2次，術(shù)后當(dāng)天至術(shù)后7 d采用雙下肢長腿彈力襪。兩組均于術(shù)后7 d停止預(yù)防措施。術(shù)前及術(shù)后7 d檢測凝血六項[凝血酶原時間(PT)、活化部分凝血活酶時間(APTT)、抗凝血酶(AT)、D-二聚體、凝血酶時間(TT)、纖維蛋白原(FIB)],行雙下肢血管超聲檢查，術(shù)后觀察記錄48 h引流量、注意有無出血并發(fā)癥、下肢腫脹等靜脈血栓栓塞癥(VTE)征象。[結(jié)果]兩組病人術(shù)后7 d內(nèi)均無VTE發(fā)生、無出血并發(fā)癥；術(shù)后兩組間48 h引流量、PT、APTT、AT比較差異均無統(tǒng)計學(xué)意義(P>0.05)；A組、B組術(shù)后7 d D-二聚體分別比術(shù)前增加了3.6倍、7.4倍，組間及組內(nèi)比較差異均有統(tǒng)計學(xué)意義(P<0.05)；A組、B組術(shù)后7 d FIB分別比術(shù)前增加了51.8%、49.9%，術(shù)后7 d組間比較差異無統(tǒng)計學(xué)意義(P>0.05)，術(shù)后7 d與術(shù)前比較差異均有統(tǒng)計學(xué)意義(P<0.05)；A組TT時間術(shù)后7 d比術(shù)前降低了9.4%，B組術(shù)后7 d與術(shù)前比較無變化，術(shù)后7 d組間比較差異無統(tǒng)計學(xué)意義(P>0.05)。[結(jié)論]利伐沙班與間歇充氣加壓泵聯(lián)合彈力襪兩種方法預(yù)防VTE效果相當(dāng)，利伐沙班應(yīng)用后對病人PT、APTT、AT、FIB等凝血功能的影響小，臨床觀察無出血并發(fā)癥，未增加出血風(fēng)險，在D-二聚體水平控制上具有顯著優(yōu)勢。

凝血功能；腰椎融合術(shù)；利伐沙班；間歇充氣加壓泵；彈力襪

腰椎融合術(shù)后病人臥床休息使其血液呈高黏滯性和高凝狀態(tài)，易發(fā)生靜脈血栓栓塞癥(venous thromboembolism,VTE)。VTE包括下肢深靜脈血栓(DVT)和肺栓塞(PE)，嚴(yán)重者可導(dǎo)致病人殘疾和死亡，發(fā)病率為2%左右[1]。目前，臨床上采用間歇充氣加壓泵、彈力襪法等物理預(yù)防措施或抗凝藥物來預(yù)防VTE的發(fā)生[2-3]。間歇充氣加壓泵聯(lián)合彈力襪法是通過按摩腿部肌肉，促進(jìn)下肢靜脈血液回流來預(yù)防血栓發(fā)生的物理方法，因其經(jīng)濟(jì)、方便、無出血并發(fā)癥、易被病人及家屬接受而被廣泛應(yīng)用于臨床中[4]。利伐沙班(Rivaroxaban)是一種預(yù)防靜脈血栓藥，預(yù)防外科手術(shù)后血栓效果顯著。利伐沙班預(yù)防腰椎術(shù)后VTE的發(fā)生在國內(nèi)已被報道，其療效與低分子肝素相當(dāng)[5]，但它的使用是否會增加出血風(fēng)險仍是臨床關(guān)心的核心問題。本研究比較口服利伐沙班與間歇充氣加壓泵聯(lián)合彈力襪法兩種方案對病人凝血功能的影響，以期對腰椎融合術(shù)后的抗凝治療提供依據(jù)。

1　資料與方法

1.1臨床資料將2014年3月—9月在我院行腰椎融合術(shù)的病例分為兩組，單號手術(shù)病人為A組(利伐沙班組，n=85)，雙號手術(shù)病人為B組(間歇充氣加壓泵聯(lián)合彈力襪組,n=73)。納入標(biāo)準(zhǔn)：①年齡≥40歲；②術(shù)前雙下肢靜脈超聲顯示無血栓形成；③術(shù)前3個月內(nèi)未口服抗凝藥物；④術(shù)后用藥除A組使用利伐沙班抗凝藥物外均未使用其他抗凝藥；⑤術(shù)后無活動性出血或高危出血傾向者；⑥無使用利伐沙班、間歇充氣加壓泵、彈力襪禁忌證；⑦無VTE病史。兩組術(shù)者為同一組醫(yī)師，納入對象均知情同意并簽署同意書。本研究得到本院倫理委員會批準(zhǔn)，并接受其監(jiān)督、指導(dǎo)。

1.2方法

1.2.1A組①從術(shù)后12 h開始連續(xù)7 d口服利伐沙班(德國拜耳制藥有限公司，規(guī)格:每片10 mg，批號：BXG9601)，每日10 mg。②基礎(chǔ)預(yù)防措施：2 h翻身1次；每次深呼吸15 min，每日2次；每組咳嗽運(yùn)動5次，每日2組；髖膝關(guān)節(jié)伸屈活動每次4 min，踝關(guān)節(jié)伸屈活動每次4 min，每組30次，每日2組，術(shù)后當(dāng)天開始至術(shù)后1個月；術(shù)后選擇清淡低脂食品，每日飲水量>1 500 mL；避免下肢靜脈穿刺，預(yù)防靜脈炎的發(fā)生；靜脈穿刺時觀察有無回血差或采血后出現(xiàn)血液過快凝集現(xiàn)象；盡量保持大便通暢、心情舒暢。

1.2.2B組術(shù)后當(dāng)天至術(shù)后7 d采用間歇充氣加壓裝置，每次30 min，每日2次；術(shù)后當(dāng)天至術(shù)后7 d采用雙下肢長腿彈力襪?；A(chǔ)預(yù)防措施與A組相同。

1.3觀察指標(biāo)入院后第1天及術(shù)后7 d清晨采血，檢測凝血六項[凝血酶原時間(PT)、活化部分凝血活酶時間(APTT)、抗凝血酶(AT)、D-二聚體、凝血酶時間(TT)、纖維蛋白原(FIB)]；入院后第1天及術(shù)后7 d 行雙下肢血管彩色超聲；分別記錄兩組病人術(shù)中出血量、術(shù)后臥床時間；觀察、記錄術(shù)后48 h引流量，觀察其他出血并發(fā)癥(如有無傷口血腫、黏膜出血、凝血時間延長、其他臟器出血)。術(shù)后每天量腿圍，觀察下肢是否腫脹、有無Homans征、疼痛、淺靜脈曲張等VTE征象。

2　結(jié)果

2.1兩組一般情況比較(見表1)

表1　兩組病人一般資料比較

2.2兩組病人術(shù)后7 d各項指標(biāo)比較兩組病人術(shù)后7 d內(nèi)均無下肢腫脹等VTE征象發(fā)生，術(shù)后7 d行雙下肢血管彩超檢測均無DVT發(fā)生，A組1例右側(cè)腘靜脈流速緩慢、1例左側(cè)大隱靜脈輕度曲張；B組1例雙側(cè)股靜脈血流緩慢，但上述3例病人凝血六項檢測均無異常。兩組病人術(shù)后均無出血并發(fā)癥發(fā)生。兩組病人術(shù)后48 h引流量比較見表2。

表2　兩組病人術(shù)后48 h引流量比較　mL

2.3兩組病人術(shù)前、術(shù)后7 d凝血六項比較(見表3)

表3　兩組病人術(shù)前、術(shù)后7 d凝血六項比較

A組和B組術(shù)后7 d D-二聚體分別比術(shù)前增加了3.6倍、7.4倍，組間及組內(nèi)比較差異均有統(tǒng)計學(xué)意義(P<0.05)；A組TT術(shù)后7 d比術(shù)前降低了9.4%，B組術(shù)后7 d與術(shù)前比較無明顯變化；A組、B組術(shù)后7 d FIB分別比術(shù)前增加了51.8%、49.9%，與術(shù)前比較差異均有統(tǒng)計學(xué)意義(P<0.05)。

2.4兩組病人術(shù)前和術(shù)后7 d D-二聚體水平比較B組病人術(shù)后7 d D-二聚體為4 305.3 μg/L±3 129.6 μg/L，顯著高于A組。A組病人術(shù)后7 d D-二聚體超過4 305.3 μg/L的僅有7例(8.2%)，其中最高的為8.44 mg/L；B組病人術(shù)后7 d D-二聚體超過4 305.3 μg/L的有25例(34.2%)，最高的為16.77 mg/L。

3　討論

凝血功能異常是VTE、出血等潛在危險并發(fā)癥發(fā)生的信號，病人PT、APTT、AT、TT值降低，D-二聚體值升高，說明血液高凝，容易發(fā)生VTE；PT、APTT、AT、TT值升高，說明有出血的風(fēng)險[6-8]。腰椎融合術(shù)后病人臥床、制動導(dǎo)致下肢深靜脈腔內(nèi)血流瘀滯，處于高凝狀態(tài)，進(jìn)而增加了發(fā)生VTE的風(fēng)險[9-10]。目前，臨床使用利伐沙班、間歇充氣加壓泵、梯度彈力襪等預(yù)防措施收到了良好的效果，但利伐沙班是否會對病人凝血功能產(chǎn)生大的影響是臨床使用的主要顧慮[11-12]。抗凝藥的應(yīng)用是雙刃劍，既可以改變病人血液高凝狀態(tài)而預(yù)防VTE，又有可能會帶來出血風(fēng)險，特別是外科術(shù)后病人[13-14]。本研究通過對在我院行腰椎融合術(shù)后158例病人進(jìn)行前瞻性研究，應(yīng)用利伐沙班的A組病人和應(yīng)用間歇充氣加壓泵聯(lián)合彈力襪的B組病人術(shù)后7 d均無VTE、出血并發(fā)癥、凝血功能障礙發(fā)生，說明利伐沙班預(yù)防VTE效果與間歇充氣加壓泵聯(lián)合彈力襪相當(dāng)，同時并未增加病人的出血風(fēng)險。具體表現(xiàn)在：兩組病人術(shù)后7 d PT、APTT、AT與術(shù)前比較并無發(fā)生明顯變化，組間比較也無明顯變化。在TT時間檢測中，僅A組術(shù)后7 d比術(shù)前及B組術(shù)后7 d降低了9%左右；FIB A組、B組術(shù)后7 d分別比術(shù)前增加了51.8%、49.9%，組間術(shù)后7 d比較差異無統(tǒng)計學(xué)意義。在D-二聚體檢測中，A組術(shù)后7 d D-二聚體比術(shù)前增加了3.6倍，B組術(shù)后7 d D-二聚體比術(shù)前增加了7.4倍，組間比較差異有統(tǒng)計學(xué)意義，說明服用利伐沙班能有效降低腰椎術(shù)后引發(fā)的D-二聚體增加。A組、B組病人中，術(shù)后7 d D-二聚體水平超過4 305.3 μg/L的人數(shù)分別為7例和25例，但他們均未發(fā)生下肢腫脹和DVT，雖然D-二聚體水平增高使血栓發(fā)生的風(fēng)險增大，但還是不宜通過檢測D-二聚體水平來預(yù)測腰椎術(shù)后DVT的發(fā)生，這與孫云波等[15]的報道相似。

綜上所述，利伐沙班和間歇充氣加壓泵聯(lián)合彈力襪這兩種方案均能有效預(yù)防腰椎融合術(shù)后病人VTE的發(fā)生，且經(jīng)觀察使用利伐沙班并未增加出血風(fēng)險。同時利伐沙班在控制D-二聚體水平上具有一定優(yōu)勢。

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(本文編輯張建華)

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年第三軍醫(yī)大學(xué)新橋醫(yī)院臨床護(hù)理科研基金資助課題，編號：201208.

馮誠誠，護(hù)師，本科，單位：400037，中國人民解放軍第三軍醫(yī)大學(xué)新橋醫(yī)院；張正豐、羅春梅(通訊作者)單位：400037，中國人民解放軍第三軍醫(yī)大學(xué)新橋醫(yī)院。

引用信息馮誠誠，張正豐，羅春梅.利伐沙班與間歇充氣加壓泵聯(lián)合彈力襪法兩種方案對病人凝血功能的影響[J].護(hù)理研究，2016，30(9C)：3352-3355.

R473.6

A

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2015-10-14；

2016-07-31)