CAJ | 학술논문

目的：探讨留置针在麻醉新药Ⅰ期临床药代动力学试验中采集成年健康受试者静脉血标本的可行性。方法对30例健康受试者，随机分为10，20，30 mg/kg 3个剂量组，在单次静脉给药前后以留置针采集血样标本，法斯特秒表计时，根据采血量计算采血速率。结果按照试验设计，顺利完成30例健康受试者共660次血样采集。结论留置针采血，可以满足麻醉新药临床药代动力学试验定时定量大量血标本采集的要求。
목적：탐토류치침재마취신약Ⅰ기림상약대동역학시험중채집성년건강수시자정맥혈표본적가행성。방법대30례건강수시자，수궤분위10，20，30 mg/kg 3개제량조，재단차정맥급약전후이류치침채집혈양표본，법사특초표계시，근거채혈량계산채혈속솔。결과안조시험설계，순리완성30례건강수시자공660차혈양채집。결론류치침채혈，가이만족마취신약림상약대동역학시험정시정량대량혈표본채집적요구。
Objective To explore the feasibility of indwelling needle for collecting venous blood specimens from adult healthy volun-teers in the phase Ⅰclinical pharmacokinetics trials of anesthetic new drugs. Methods 30 healthy subjects were randomly divided into 10 mg/kg, 20 mg/kg, 30 mg/kg dose groups. The indwelling needle was adopted to collect venous blood specimens before and after sin-gle intravenous administration with Fast stopwatch for timing. The collecting blood speed was calculated by the amount collecting blood sample. Results According to the experimental design, 660 times of blood sample collection in 30 healthy subjects were smoothly com-pleted. Conclusion The indwelling needle for blood sampling can meet the requirement of timing, quantitative and a large number of blood sample collection in clinical pharmacokinetic trials of anesthetic drugs.