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利伐沙班联合尿激酶治疗急性肺栓塞患者的临床研究

Clinical trial of rivaroxaban combined with urokinase in the treatment of patients with acute pulmonary embolism

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【作者】 崔潇文于新明刘兵张永杰

【Author】 CUI Xiao-wen;YU Xin-ming;LIU Bing;ZHANG Yong-jie;Vascular Surgery Department,Zibo Central Hospital;Department Vascular Surgery,of Laoshan Hospital,Affiliated Hospital of Qingdao University;

【通讯作者】 张永杰;

【机构】 淄博市中心医院血管外科青岛大学附属医院崂山院区血管外科

【摘要】 目的 探究利伐沙班与低分子肝素分别联合尿激酶治疗急性肺栓塞对凝血功能及心功能的影响。方法 将急性肺栓塞患者按随机数字表法分为对照组和试验组,对照组给予注射用尿激酶4 400 U·kg-1,治疗2 d+低分子肝素注射液5 000 U,q12h,皮下注射;试验组给予尿激酶(方法同对照组)+利伐沙班片,每次20 mg,qd,口服。2组患者均治疗3个月。比较2组临床疗效、生命体征、血气分析指标、凝血功能、心功能,以及药物不良反应发生情况。结果 试验过程中共脱落2例,最终试验组和对照组分别纳入35例。试验组的总有效率为91.43%(32例/35例),对照组的总有效率为71.43%(25例/35例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的心率分别为(70.27±9.48)和(77.93±10.26)time·min-1,呼吸频率分别为(18.46±2.84)和(20.15±2.93)time·min-1,氧分压(PaO2)分别为(78.91±5.33)和(70.79±4.61)mmHg,纤维蛋白原(FIB)分别为(4.26±0.74)和(6.41±1.05)g·L-1,凝血酶时间(TT)分别为(15.49±1.47)和(13.96±1.24)s,凝血酶原时间(PT)分别为(21.18±2.19)和(18.27±1.91)s,活化部分凝血活酶时间(APTT)分别为(35.42±3.27)和(31.64±2.89)s,右心室收缩末期容积(RVESVⅠ)分别为(38.06±5.46)和(43.47±5.72)mL·m-2,右心室舒张末期容积(RVEDVⅠ)分别为(78.41±6.37)和(82.75±7.08)mL·m-2,心肌肌钙蛋白Ⅰ(cTnⅠ)分别为(0.89±0.14)和(1.23±0.29)μg·L-1,N-末端脑钠肽前体(NT-proBNP)分别为(155.94±26.08)和(237.32±41.35)pg·mL-1,试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。治疗过程中,试验组发生的药物不良反应有恶心呕吐、皮肤黏膜出血、牙龈出血;对照组发生的药物不良反应有皮肤黏膜出血、牙龈出血,试验组和对照组的药物不良反应发生率分别为14.29%和11.43%,差异无统计学意义(P>0.05)。结论 与低分子肝素联合尿激酶比较,利伐沙班联合尿激酶治疗急性肺栓塞的疗效更好,可有效改善患者凝血功能及心功能,且安全性良好。

【Abstract】 Objective To compare the effects of rivaroxaban or low molecular weight heparin combined with urokinase on coagulation function and cardiac function in treating acute pulmonary embolism.Methods The patients with acute pulmonary embolism were divided into control group and treatment group according to the random number table method.The control group received an injection of urokinase,4 400U·kg-1,twice a day for 2 days+low molecular weight heparin 5 000 U,subcutaneously injected every 12 hours.The treatment group received urokinase (same method as the control group)+rivaroxaban tablets 20 mg,orally administered once a day.Patients in two groups were treated for 3 months.The clinical efficacy,vital signs,blood gas analysis indexes,coagulation function,cardiac function and adverse drug reactions were compared between the two groups.Results A total of 2 cases were lost during the trial,and finally 35cases were included in the treatment group and the control group,respectively.The total effective rate of the treatment group was 91.43%(32 cases/35 cases),and the total effective rate of the control group was 71.43%(25 cases/35cases),the difference was statistically significant (P<0.05).After treatment,the heart rates of the treatment group and the control group were (70.27±9.48) and (77.93±10.26) time·min-1;the respiratory rates were(18.46±2.84) and (20.15±2.93) time·min-1;the oxygen partial pressure (PaO2) were (78.91±5.33) and(70.79±4.61) mm Hg;and the fibrinogen (FIB) were (4.26±0.74) and (6.41±1.05) g·L-1,respectively;the thrombin time (TT) were (15.49±1.47) and (13.96±1.24) s;prothrombin time (PT) were (21.18±2.19)and (18.27±1.91) s;activated partial thromboplastin time (APTT) were (35.42±3.27) and (31.64±2.89) s;right ventricular end-systolic volume (RVESVI) were (38.06±5.46) and (43.47±5.72) m L·m-2;the right ventricular end-diastolic volume (RVEDV I) was (78.41±6.37) and (82.75±7.08) m L·m-2;cardiac troponin I (cTnI) was (0.89±0.14) and (1.23±0.29)μg·L-1;and N-terminal pro-brain natriuretic peptide(NT-proBNP) was (155.94±26.08) and (237.32±41.35) pg·m L-1,respectively.The above indexes in the treatment group were significantly different from those in the control group (all P<0.05).During the treatment,the adverse drug reactions in the treatment group included nausea and vomiting,skin mucosal bleeding,and gingival bleeding.The adverse drug reactions in the control group were skin mucosal bleeding and gingival bleeding.The incidence of adverse drug reactions in the treatment group and the control group was 14.29%and 11.43%,respectively,and the difference was not statistically significant (P>0.05).Conclusion Compared with low molecular weight heparin combined with urokinase,rivaroxaban combined with urokinase has better efficacy in the treatment of acute pulmonary embolism,and the latter one can more effectively improve coagulation function and cardiac function with better safety.

  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2023年18期
  • 【分类号】R563.5
  • 【下载频次】23
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