利伐沙班片联合低分子右旋糖酐氨基酸注射液治疗下肢急性周围型深静脉血栓的临床研究
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摘要
目的比较利伐沙班片与低分子肝素钠注射液分别联合低分子右旋糖酐氨基酸注射液治疗下肢急性周围型深静脉血栓的临床疗效及安全性。方法将112例下肢急性周围型深静脉血栓患者随机分为对照组和试验组,每组56例。对照组予以低分子右旋糖酐氨基酸注射液每次500 m L,qd,静脉滴注+低分子肝素钠注射液每次0. 4 m L,bid,皮下注射;试验组予以低分子右旋糖酐氨基酸注射液每次500 m L,qd,静脉滴注+利伐沙班片每次15 mg,bid,口服。2组患者均治疗10 d。比较2组患者的临床疗效、患侧肢体肿胀程度与疼痛程度,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92. 86%(52例/56例)和96. 43%(54例/56例),差异无统计学意义(P> 0. 05)。治疗后,试验组和对照组的肿胀程度分别为(0. 87±0. 45)和(0. 96±0. 47) cm,疼痛评分分别为(2. 19±0. 69)和(2. 35±0. 62)分,全血黏度分别为(9. 85±2. 94)和(9. 67±2. 91) m Pa·s,血浆黏度分别为(1. 41±0. 31)和(1. 37±0. 33) m Pa·s,血细胞比容分别为(56. 52±5. 21)%和(55. 49±5. 04)%,差异均无统计学意义(均P> 0. 05)。试验组发生的药物不良反应有恶心呕吐和牙龈出血,对照组发生的药物不良反应有恶心呕吐、牙龈出血和转氨酶轻微升高。试验组和对照组的总药物不良反应发生率分别为3. 57%和5. 36%,差异无统计学意义(P> 0. 05)。结论利伐沙班片联合低分子右旋糖酐氨基酸注射液与低分子肝素钠注射液联合低分子右旋糖酐氨基酸注射液治疗下肢急性周围型深静脉血栓的临床疗效与安全性相仿。
Objective To compare the clinical efficacy and safety of rivaroxaban tablets combined with dextran 40 and amino acids injection and low molecular weight heparin sodium injection combined with dextran40 and amino acids injection in the treatment of acute lower extremity deep vein thrombosis. Methods A total of 112 patients with acute lower extremity deep vein thrombosis were randomly divided into control and treatment groups with 56 cases per group. Control group was given dextran 40 and amino acids injection 500 mL per time,qd,intravenous drip+ low molecular weight heparin sodium injection 0. 4 mL per time,bid,subcutaneous injection. Treatment group received dextran 40 and amino acids injection 500 mL per time,qd,intravenous drip + rivaroxaban 15 mg per time,bid,orally. Two groups were treated for 10 days. The clinical efficacy,degree of limb swelling,pain scores and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 92. 86%( 52 cases/56 cases) and 96. 43%( 54 cases/56 cases) without significant difference( P > 0. 05). After treatment,the main indexes of treatment and control groups were compared:the swelling degree were( 0. 87 ± 0. 45) and( 0. 96 ± 0. 47) cm,the pain scores were( 2. 19 ± 0. 69) and( 2. 35 ± 0. 62),the blood viscosity were( 9. 85 ± 2. 94) and( 9. 67 ± 2. 91) m Pa ·s,the plasma viscosity were( 1. 41 ± 0. 31) and( 1. 37 ± 0. 33) m Pa·s,the hematocrit were( 56. 52 ± 5. 21) % and( 55. 49 ± 5. 04) %. The differences were not statistically significant( all P > 0. 05). The adverse drug reactions of treatment group were nausea,vomiting and gingival bleeding,while those in the control group were nausea and vomiting,gingival bleeding and slight elevation of transaminase. The total incidences of adverse drug reactions in treatment and control groups were 3. 57% and 5. 36% without significant difference( P > 0. 05). Conclusion The clinical efficacy and safety of rivaroxaban tablets combined with dextran 40 and amino acids injection in the treatment of acute lower extremity deep vein thrombosis are the same as those of low molecular weight heparin sodium injection combined with dextran 40 and amino acids injection.
Objective To compare the clinical efficacy and safety of rivaroxaban tablets combined with dextran 40 and amino acids injection and low molecular weight heparin sodium injection combined with dextran40 and amino acids injection in the treatment of acute lower extremity deep vein thrombosis. Methods A total of 112 patients with acute lower extremity deep vein thrombosis were randomly divided into control and treatment groups with 56 cases per group. Control group was given dextran 40 and amino acids injection 500 mL per time,qd,intravenous drip+ low molecular weight heparin sodium injection 0. 4 mL per time,bid,subcutaneous injection. Treatment group received dextran 40 and amino acids injection 500 mL per time,qd,intravenous drip + rivaroxaban 15 mg per time,bid,orally. Two groups were treated for 10 days. The clinical efficacy,degree of limb swelling,pain scores and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 92. 86%( 52 cases/56 cases) and 96. 43%( 54 cases/56 cases) without significant difference( P > 0. 05). After treatment,the main indexes of treatment and control groups were compared:the swelling degree were( 0. 87 ± 0. 45) and( 0. 96 ± 0. 47) cm,the pain scores were( 2. 19 ± 0. 69) and( 2. 35 ± 0. 62),the blood viscosity were( 9. 85 ± 2. 94) and( 9. 67 ± 2. 91) m Pa ·s,the plasma viscosity were( 1. 41 ± 0. 31) and( 1. 37 ± 0. 33) m Pa·s,the hematocrit were( 56. 52 ± 5. 21) % and( 55. 49 ± 5. 04) %. The differences were not statistically significant( all P > 0. 05). The adverse drug reactions of treatment group were nausea,vomiting and gingival bleeding,while those in the control group were nausea and vomiting,gingival bleeding and slight elevation of transaminase. The total incidences of adverse drug reactions in treatment and control groups were 3. 57% and 5. 36% without significant difference( P > 0. 05). Conclusion The clinical efficacy and safety of rivaroxaban tablets combined with dextran 40 and amino acids injection in the treatment of acute lower extremity deep vein thrombosis are the same as those of low molecular weight heparin sodium injection combined with dextran 40 and amino acids injection.
引文
[1]YAMADA S M,TOMITA Y,MURAKAMI H,et al.Deep vein thrombosis in the lower extremities in comatose elderly patients with acute neurological diseases[J].Yonsei Med J,2016,57(2):388-392.
[2]KUZNETSOV M R,SAPELKIN S V,BOLDIN B V,et al.Recanalization of lower-limb deep veins as an index of efficacy of treatment for acute venous thrombosis[J].Angiol Sosud Khir,2016,22(3):82-88.
[3]林伟,汪海,林建锋,等.低分子肝素对急性冠状动脉综合征患者的抗Xa活性的影响[J].中国临床药理学杂志,2017,33(12):1088-1090.
[4]吴怀球,张卫东,彭敏恋,等.利伐沙班在急性中危肺血栓栓塞合并下肢深静脉血栓患者治疗中的作用[J].实用医学杂志,2017,25(22):3802-3806.
[5]李晓强,王深明.深静脉血栓形成的诊断和治疗指南(第二版)[J].中国血管外科杂志(电子版),2013,5(1):23-26.
[6]李红伟.介入溶栓联合抗凝治疗急性下肢深静脉血栓的临床疗效观察[J].实用医学影像杂志,2018,19(6):546-547.
[7]付郁,马迎新,范春辉,等.评价彩色多普勒超声在急性下肢深静脉血栓溶栓效果中的监测价值[J].影像研究与医学应用,2019,3(1):174-175.
[8]DELOUGHERY TG,AUERBACH M.Is low molecular weight iron dextran really the most risky iron-unconvincing data from an unconvincing study[J].Am J Hematol,2016,91(5):451-452.
[9]邓林伟.低分子肝素对关节置换术患者术中血液流变学及凝血的影响[J].中外医疗,2015,34(22):17-18.
[10]李瑶,李红斌.低分子肝素钠在腹部外科手术后预防下肢深静脉血栓形成的效果观察[J].中国当代医药,2014,21(21):52-53.
[11]BAUERSACHS R,KOITABASHI N.Overview of current evidence on the impact of the initial high dose of the direct factor Xa inhibitor rivaroxaban on thrombus resolution in the treatment of venous thromboembolism[J].Int Heart J,2017,58(1):124-125.
[12]侯训凯,林永杰,石恩东,等.低分子肝素与利伐沙班预防脊柱外科手术后下肢深静脉血栓的疗效和安全性比较[J].中国药房,2015,36(30):4221-4223.
[13]汤继军,李强.利伐沙班联合低分子右旋糖酐治疗下肢急性周围型深静脉血栓的临床评价[J].世界临床药物,2017,9(8):554-558.
[2]KUZNETSOV M R,SAPELKIN S V,BOLDIN B V,et al.Recanalization of lower-limb deep veins as an index of efficacy of treatment for acute venous thrombosis[J].Angiol Sosud Khir,2016,22(3):82-88.
[3]林伟,汪海,林建锋,等.低分子肝素对急性冠状动脉综合征患者的抗Xa活性的影响[J].中国临床药理学杂志,2017,33(12):1088-1090.
[4]吴怀球,张卫东,彭敏恋,等.利伐沙班在急性中危肺血栓栓塞合并下肢深静脉血栓患者治疗中的作用[J].实用医学杂志,2017,25(22):3802-3806.
[5]李晓强,王深明.深静脉血栓形成的诊断和治疗指南(第二版)[J].中国血管外科杂志(电子版),2013,5(1):23-26.
[6]李红伟.介入溶栓联合抗凝治疗急性下肢深静脉血栓的临床疗效观察[J].实用医学影像杂志,2018,19(6):546-547.
[7]付郁,马迎新,范春辉,等.评价彩色多普勒超声在急性下肢深静脉血栓溶栓效果中的监测价值[J].影像研究与医学应用,2019,3(1):174-175.
[8]DELOUGHERY TG,AUERBACH M.Is low molecular weight iron dextran really the most risky iron-unconvincing data from an unconvincing study[J].Am J Hematol,2016,91(5):451-452.
[9]邓林伟.低分子肝素对关节置换术患者术中血液流变学及凝血的影响[J].中外医疗,2015,34(22):17-18.
[10]李瑶,李红斌.低分子肝素钠在腹部外科手术后预防下肢深静脉血栓形成的效果观察[J].中国当代医药,2014,21(21):52-53.
[11]BAUERSACHS R,KOITABASHI N.Overview of current evidence on the impact of the initial high dose of the direct factor Xa inhibitor rivaroxaban on thrombus resolution in the treatment of venous thromboembolism[J].Int Heart J,2017,58(1):124-125.
[12]侯训凯,林永杰,石恩东,等.低分子肝素与利伐沙班预防脊柱外科手术后下肢深静脉血栓的疗效和安全性比较[J].中国药房,2015,36(30):4221-4223.
[13]汤继军,李强.利伐沙班联合低分子右旋糖酐治疗下肢急性周围型深静脉血栓的临床评价[J].世界临床药物,2017,9(8):554-558.
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