Protocol of Interventional Treatment for Hepatocellular Carcinoma

To establish a reasonable protocol for interventional treatment ofhcpatocellular carcinoma (HCC). Methods: The data of 1000 HCC patients treated by different kinds ofinterventional treatments were reviewed with their results of biochemistry, imaging, pathology andsurvival rate evaluated. The values as well as the pros and cons of these various kinds ofinterventional treatments were compared in order to find an optimal protocol. Results:Segmental-transcatheter oil chemoembolization (S-TOCE) could more effectively eradicate the tumoryet inflicting less damage on the noncancerous hepatic tissue and giving much higher survival ratethan the conventional transcatheter oil chemoembolization (C-TOCE). Precutaneous ethanol injection(PEI) in combination with chemoembolization could eliminate the residual tumor and significantlyincrease the survival rate without damaging the noncancerous hepatic tissue. The living quality orsurvival rate could be improved by choosing different ways of interventional treatments to cut downthe complications. Conclusion: The selection of different interventional treatments should bo doneaccording to the size and type of HCC. Active management is indicated for different complicationspresenting along with HCC.

FDA“抗体偶联药物的考虑”供企业用的指导原则草案介绍

美国食品药品监督管理局(FDA)于2022年2月发布了“抗体偶联药物的考虑”供企业用的指导原则草案,旨在帮助企业和其他参与者开发细胞毒性小分子药物(有效载荷)的抗体偶联药物(ADC)。该指导原则阐述了FDA目前对ADC临床药理学开发方案的建议,包括生物分析方法、给药方案、剂量和暴露反应分析、内在因素、QTc评估、免疫原性和药物-药物相互作用。ADC主要用于治疗肿瘤,又是当前国内药物研发的热点。中国目前还没有类似的指导原则,详细介绍FDA的该指导原则,期望有助于国内对这类新药的研发与监管。