B Ingelheim公司正计划于明年第一季度在日本提出Pradaxa(dabigatran)用于房颤病人卒中预防的批准申请。涉及全球18,000例病人比较这种口服直接凝血酶抑制剂与华法林的RE—LY研究预计于今年晚些时候出结果,而第一次申请将于2009年...B Ingelheim公司正计划于明年第一季度在日本提出Pradaxa(dabigatran)用于房颤病人卒中预防的批准申请。涉及全球18,000例病人比较这种口服直接凝血酶抑制剂与华法林的RE—LY研究预计于今年晚些时候出结果,而第一次申请将于2009年底提出。在日本有326例病人参与了RE—LY研究,其治疗方案与全球其他参与者相同。这个产品也在日本等待批准用于全膝置换术后静脉血栓形成(VTE)事件预防。展开更多
Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. T...Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. The complexity of the pharmacokinetic and pharmacodynamics profile of warfarin makes it a challenge to use during treatment. Its manufacturing characteristics play a key role in its dosage. The aim of this study is to examine and evaluate the effect of two different warfarin regimens in Chinese patients. A cross-sectional study design was adopted. Medical records of all patients (n = 368) who received warfarin therapy in cardio-thoracic surgery wards between Sep. 2008 and Dec. 2009 were reviewed. Details of antithrombotic results of international normalized ratio (INR) monitoring were obtained. Statistical analysis was performed to assess factors predictive of INR therapeutic range at patients' discharge time according to different warfarin regimens (2.5 mg in China and 3.0 mg in USA). The patients' mean age was (48.23~12.96) years. The percentage of patients within the INR therapeutic range in the group treated with 2.5 mg warfarin (35.17%) was much lower than that in group treated with 3.0 mg warfarin (47.72%). Therefore, a significance difference was observed (P = 0.032〈0.05). In this study, statistical values have shown that most of the patients were related to medical case requesting INR target range of 1.8-2.2 and 2.0-2.5, respectively. There was a statistically significant difference between the two groups. The study showed that the 2.5 mg-warfarin regimen was less suitable than the 3.0 mg-warfarin regimen. Medication regimen should be simplified as much as possible, especially during different treatment period.展开更多
文摘Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. The complexity of the pharmacokinetic and pharmacodynamics profile of warfarin makes it a challenge to use during treatment. Its manufacturing characteristics play a key role in its dosage. The aim of this study is to examine and evaluate the effect of two different warfarin regimens in Chinese patients. A cross-sectional study design was adopted. Medical records of all patients (n = 368) who received warfarin therapy in cardio-thoracic surgery wards between Sep. 2008 and Dec. 2009 were reviewed. Details of antithrombotic results of international normalized ratio (INR) monitoring were obtained. Statistical analysis was performed to assess factors predictive of INR therapeutic range at patients' discharge time according to different warfarin regimens (2.5 mg in China and 3.0 mg in USA). The patients' mean age was (48.23~12.96) years. The percentage of patients within the INR therapeutic range in the group treated with 2.5 mg warfarin (35.17%) was much lower than that in group treated with 3.0 mg warfarin (47.72%). Therefore, a significance difference was observed (P = 0.032〈0.05). In this study, statistical values have shown that most of the patients were related to medical case requesting INR target range of 1.8-2.2 and 2.0-2.5, respectively. There was a statistically significant difference between the two groups. The study showed that the 2.5 mg-warfarin regimen was less suitable than the 3.0 mg-warfarin regimen. Medication regimen should be simplified as much as possible, especially during different treatment period.