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  

Clinical trial of rivaroxaban tablets combined with dextran 40 and amino acids injection in the treatment of acute lower extremity deep vein thrombosis

作　　者：左江伟 杨雄 曾保尧 ZUO Jiang-wei;YANG Xiong;ZENG Bao-yao(Department of Cardiovascular Thoracic Surgery, The Second Nanning People' s Hospital, Third filiated Hospital of Guangxi Medical University, Nanning 530031, Guangxi Zhuang Autonomous Region, China)

机构地区：[1]南宁市第二人民医院/广西医科大学第三附属医院胸心血管外科

出　　处：《中国临床药理学杂志》2019年第13期1323-1325,1329,共4页The Chinese Journal of Clinical Pharmacology

基　　金：广西壮族自治区卫生厅科研课题基金资助项目(Z2013167)

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 dextran 40 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 ) mPa·s, the plasma viscosity were (1. 41 ±0. 31) and (1. 37 ± 0. 33) mPa· 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 ta

关 键 词：利伐沙班片 低分子右旋糖酐氨基酸注射液 低分子肝素注射液 深静脉血栓 安全性评价 

分 类 号：R972[医药卫生—药品]