目的:探讨利伐沙班与血塞通注射液联合使用预防脊柱术后下肢深静脉血栓(DVT)形成的效果及对患者凝血功能、血流变学指标及其它血生化指标的影响。方法:选取本院脊柱外科接受脊柱手术治疗的患者105例,并随机分为治疗组、对照组1和对照组2...目的:探讨利伐沙班与血塞通注射液联合使用预防脊柱术后下肢深静脉血栓(DVT)形成的效果及对患者凝血功能、血流变学指标及其它血生化指标的影响。方法:选取本院脊柱外科接受脊柱手术治疗的患者105例,并随机分为治疗组、对照组1和对照组2,各35例。对照组1术后给予血塞通注射液治疗,对照组2术后给予利伐沙班治疗,治疗组给予血塞通联合利伐沙班治疗。检测并比较3组患者凝血功能、血流变学指标、其他血生化指标的变化;评估并比较3组患者术后5 d DVT发生情况。结果:治疗后3组凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)均较治疗前显著延长,纤维蛋白原(FIB)水平较治疗前显著降低(P<0.05或P<0.01),且组间差异有统计学意义(P<0.05或P<0.01);治疗后3组全血粘度、血浆粘度、红细胞比容、红细胞刚性指数均较治疗前显著下降,红细胞变形指数较治疗前显著升高(P<0.05或P<0.01),且组间差异具有统计学意义(P<0.05或P<0.01);治疗后3组血小板计数(PLT)、血管内皮素(ET)水平均较治疗前显著升高,D-二聚体(D-D)水平较治疗前显著降低(P<0.01),且组间差异具有统计学意义(P<0.05或P<0.01)。血红蛋白(Hb)治疗前后及组间比较差异无统计学意义(P>0.05);治疗组术后DVT发生率为2.86%显著低于对照组1的14.28%和对照组2的11.42%(P<0.05)。结论:利伐沙班联合血塞通注射液可明显改善血流变学及其它血生化指标水平,进而有效预防脊柱创伤术后DVT形成,安全有效。展开更多
AIM: Pharmacokinetic and pharmacodynamic profiles of Xuesaitong injection in cerebral ischemic patients are investigated in order to optimize dosage regimen of multiple constituent TCM in clinic. METHODS: 63 patients ...AIM: Pharmacokinetic and pharmacodynamic profiles of Xuesaitong injection in cerebral ischemic patients are investigated in order to optimize dosage regimen of multiple constituent TCM in clinic. METHODS: 63 patients were studied in our protocol. Enumeration and measurement data of all patients were collected during our experiment. Blood samples were collected for two times at different time after intravenous infusion Xuesaitong injection at the dosage of 800 mg/kg for two weeks. Concentration of Xuesaitong injection in plasma, prothrombin time(PT), thrombin time(TT), activated partial thromboplastin time(APTT)and fibrinogen(Fib) were determined. NONMEM and SAAMⅡ were employed for the simulation of PPK parameters and time-course fitting of Xuesaitong injection in cerebral ischemic patients. RESULTS: Population pharmacokinetic (PPK) parameters of Xuesaitong injection obtained as follow: CL1: 1.5 L·h-1·kg-1, CL2: 13.0 L·h-1·kg-1, k10: 0.1136/h, k12: 0.9848/h, k21: 0.2057/h. Inter-individual variability were 36.3%, 17.8%, 1.0% and 60.3%. Residual variability was 8.67%. Age, stature, gender of patients showed no correlation with the prolong ratio of PT(PT%), TT(TT%), APTT(APTT%) and inhibit ratio of Fib(Fib%) whereas dosage (weight), infusion ratio and concentration of Xuesaitong injection in plasma were marked correlation to PT%, TT%, APTT% and Fib%. Correlation coefficient between dosage, infusion ratio, plasma concentration to PT%, TT%, APTT% and Fib% were 0.598, 0.551, 0.590, 0.505; 0.204, 0.401, 0.348, 0.403 and 0.560, 0.436, 0.593, 0.351, respectively. P value was less than 0.01 or 0.05. Best pharmacological effect obtained when Xuesaitong injection was administered as follow: Dosage was of 12.0-17.0 mg/kg, infusion ratio was of 10.0-18.0 mg/min and plasma concentration was of 25.0-35.0 μg/mL. Time course of Xuesaitong injection in cerebral ischemic patients was successfully predicted and simulated results suggested that better effects were obtained at the dosage of 800-1 200 mg/d than 200-400 mg/d. AUC 800-1 200 mg/d over the concentration range of 15-40 μg/mL in plasma was 32.99-77.33 mg·L-1·h when the infusion ratio of Xuesaitong injection was 10-14 mg/min whereas nothing or little at the dosage of 200-400 mg/d. CONCLUSION: Multiple constituent TCM population pharmacokinetic and pharmacodynamic profiles are successfully evaluated in cerebral ischemic patients. It gives us some information for the dosage regimen optimization in clinic for increasing therapeutic effect and reducing toxic reaction of multiple constituent TCM.展开更多
文摘目的:探讨利伐沙班与血塞通注射液联合使用预防脊柱术后下肢深静脉血栓(DVT)形成的效果及对患者凝血功能、血流变学指标及其它血生化指标的影响。方法:选取本院脊柱外科接受脊柱手术治疗的患者105例,并随机分为治疗组、对照组1和对照组2,各35例。对照组1术后给予血塞通注射液治疗,对照组2术后给予利伐沙班治疗,治疗组给予血塞通联合利伐沙班治疗。检测并比较3组患者凝血功能、血流变学指标、其他血生化指标的变化;评估并比较3组患者术后5 d DVT发生情况。结果:治疗后3组凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)均较治疗前显著延长,纤维蛋白原(FIB)水平较治疗前显著降低(P<0.05或P<0.01),且组间差异有统计学意义(P<0.05或P<0.01);治疗后3组全血粘度、血浆粘度、红细胞比容、红细胞刚性指数均较治疗前显著下降,红细胞变形指数较治疗前显著升高(P<0.05或P<0.01),且组间差异具有统计学意义(P<0.05或P<0.01);治疗后3组血小板计数(PLT)、血管内皮素(ET)水平均较治疗前显著升高,D-二聚体(D-D)水平较治疗前显著降低(P<0.01),且组间差异具有统计学意义(P<0.05或P<0.01)。血红蛋白(Hb)治疗前后及组间比较差异无统计学意义(P>0.05);治疗组术后DVT发生率为2.86%显著低于对照组1的14.28%和对照组2的11.42%(P<0.05)。结论:利伐沙班联合血塞通注射液可明显改善血流变学及其它血生化指标水平,进而有效预防脊柱创伤术后DVT形成,安全有效。
文摘AIM: Pharmacokinetic and pharmacodynamic profiles of Xuesaitong injection in cerebral ischemic patients are investigated in order to optimize dosage regimen of multiple constituent TCM in clinic. METHODS: 63 patients were studied in our protocol. Enumeration and measurement data of all patients were collected during our experiment. Blood samples were collected for two times at different time after intravenous infusion Xuesaitong injection at the dosage of 800 mg/kg for two weeks. Concentration of Xuesaitong injection in plasma, prothrombin time(PT), thrombin time(TT), activated partial thromboplastin time(APTT)and fibrinogen(Fib) were determined. NONMEM and SAAMⅡ were employed for the simulation of PPK parameters and time-course fitting of Xuesaitong injection in cerebral ischemic patients. RESULTS: Population pharmacokinetic (PPK) parameters of Xuesaitong injection obtained as follow: CL1: 1.5 L·h-1·kg-1, CL2: 13.0 L·h-1·kg-1, k10: 0.1136/h, k12: 0.9848/h, k21: 0.2057/h. Inter-individual variability were 36.3%, 17.8%, 1.0% and 60.3%. Residual variability was 8.67%. Age, stature, gender of patients showed no correlation with the prolong ratio of PT(PT%), TT(TT%), APTT(APTT%) and inhibit ratio of Fib(Fib%) whereas dosage (weight), infusion ratio and concentration of Xuesaitong injection in plasma were marked correlation to PT%, TT%, APTT% and Fib%. Correlation coefficient between dosage, infusion ratio, plasma concentration to PT%, TT%, APTT% and Fib% were 0.598, 0.551, 0.590, 0.505; 0.204, 0.401, 0.348, 0.403 and 0.560, 0.436, 0.593, 0.351, respectively. P value was less than 0.01 or 0.05. Best pharmacological effect obtained when Xuesaitong injection was administered as follow: Dosage was of 12.0-17.0 mg/kg, infusion ratio was of 10.0-18.0 mg/min and plasma concentration was of 25.0-35.0 μg/mL. Time course of Xuesaitong injection in cerebral ischemic patients was successfully predicted and simulated results suggested that better effects were obtained at the dosage of 800-1 200 mg/d than 200-400 mg/d. AUC 800-1 200 mg/d over the concentration range of 15-40 μg/mL in plasma was 32.99-77.33 mg·L-1·h when the infusion ratio of Xuesaitong injection was 10-14 mg/min whereas nothing or little at the dosage of 200-400 mg/d. CONCLUSION: Multiple constituent TCM population pharmacokinetic and pharmacodynamic profiles are successfully evaluated in cerebral ischemic patients. It gives us some information for the dosage regimen optimization in clinic for increasing therapeutic effect and reducing toxic reaction of multiple constituent TCM.
