冠状动脉初发病变患者冠状动脉支架植入术后西罗莫司的全身暴露情况：Supralimus-Core®药代动力学研究。
Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core® pharmacokinetic study.
作者信息
Thakkar Ashok S, Abhyankar Atul D, Dani Sameer I, Banker Darshan N, Singh Parvinder I, Parmar Sanjay A, Mehta Anita A
机构信息
Sahajanand Medical Technologies Pvt. Ltd., 'Sahajanand Estate', Vakharia Wadi, Surat - 395004, India.
出版信息
Indian Heart J. 2012 May-Jun;64(3):273-9. doi: 10.1016/S0019-4832(12)60086-8.
OBJECTIVES
This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting coronary stents.
METHODS
Twenty patients with coronary artery disease (CAD) were treated with 1, 2, or 3 a newly designed metallic stents. Blood samples were drawn at 14 time points to determine the pharmacokinetic of sirolimus. Whole blood concentrations of sirolimus were determined by using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method.
RESULTS
Minimal measurable blood levels were detectable at 7 days. Across all dose levels, individual T(max) values ranged from 1.00 hour and 12.00 hours; individual C(max) ranged from 0.73 ng/mL and 4.13 ng/mL.
CONCLUSION
This study confirms the limited exposure of the systemic circulation of the eluted drug with the use of the Supralimus-Core® Sirolimus-Eluting Coronary Stent System (Sahajanand Medical Technologies Pvt. Ltd., Surat, India). In this study, sirolimus concentration in systemic circulation is to be safe, well-tolerated and short-lived.
目的
本研究旨在评估西罗莫司洗脱冠状动脉支架的全身药物释放及分布情况。
方法
20例冠心病患者接受了1个、2个或3个新设计的金属支架治疗。在14个时间点采集血样以测定西罗莫司的药代动力学。采用灵敏且经过验证的高效液相色谱串联质谱法测定西罗莫司的全血浓度。
结果
在第7天可检测到最低可测血药浓度。在所有剂量水平下，个体的达峰时间（T(max)）值范围为1.00小时至12.00小时；个体的血药峰浓度（C(max)）范围为0.73纳克/毫升至4.13纳克/毫升。
结论
本研究证实，使用Supralimus-Core®西罗莫司洗脱冠状动脉支架系统（印度苏拉特市萨哈贾南德医疗技术有限公司）时，洗脱药物在体循环中的暴露有限。在本研究中，体循环中西罗莫司的浓度安全、耐受性良好且持续时间短。
Zotero 插件