茵陈五苓糖浆联合人血白蛋白治疗新生儿高胆红素血症的临床研究

目的 探讨茵陈五苓糖浆联合人血白蛋白治疗新生儿高胆红素血症的临床疗效.方法 选取2019年4月—2021年4月在南阳市中心医院治疗的98例高胆红素血症患儿,随机分为对照组(49例)和治疗组(49例).对照组静脉滴注人血白蛋白,10 g加入5％葡萄糖注射液100 mL,1次/d.治疗组患者在对照组基础上口服茵陈五苓糖浆,...

Clinical study on Yinchen Wuling Syrup combined with human albumin in treatment of neonatal hyperbilirubinemia

Objective To summarize and analyze the collection of peripheral blood samples from phase I clinical trials of antitumor drugs, and to provide the basis for the formulation of relevant policy standards. Methods A cross-sectional survey was conducted on the amount of blood collected in Phase I clinical trials involving the declaration of human genetic resources in the Cancer Hospital of the Chinese Academy of Medical Sciences. The distribution and influencing factors of total blood collection, safety blood collection and research blood collection were compared. Results A total of 26 clinical trials were included. The median volume of total blood collection was 312 mL, ranging from 148 to 479 mL, and the median volume of safety blood collection was 212 mL, ranging from 76 to 373 mL, the median volume of research blood collection was 87 mL, ranging from 0 to 193 mL, and the median proportion of blood collected in the first two cycles was 30.5%, ranging from 9.4% to 59.5%. The total blood collection volume of most projects is controlled within a reasonable range. The antibody-drug conjugate (ADC) drugs, small molecular target drugs and the First-in-human trials have more blood samples. Conclusion The collection of peripheral blood samples in phase I clinical trials of new antitumor drugs should have a clear scientific basis and limit the total amount to a reasonable range. At the same time, it is suggested to optimize the biological sample management of clinical trials by following the principles of unified standards, reasonable design, limiting the total amount, fully informing and paying attention to communication.