抗体类抗肿瘤药物药学服务指南

China guideline for pharmaceutical care on anti-tumor antibody-based drugs

抗体药物是采用细胞和基因工程技术为主的抗体工程技术制备而成的药物,在恶性肿瘤治疗中广泛应用。目前上市的抗体类抗肿瘤药物按照药物结构特征可以分为单克隆抗体药物、双特异性抗体药物和抗体偶联药物。截至2022年6月1日,已有39个抗体类抗肿瘤药物在中国获批上市。由于药学特性、体内药效、药物动力学特征不同于传统小分子药物,抗体类抗肿瘤药物在临床应用中具有鲜明特征。为规范合理使用抗体类抗肿瘤药物,中国药师协会肿瘤专科药师分会在国家癌症中心的指导下,联合全国多学科专家,基于临床循证证据、药事管理相关法规和药学服务实践,采用德尔菲法和专家访谈及研讨,制定了抗体类抗肿瘤药物药学服务指南,指南涵盖用药前、用药中和用药后的全程化药学服务体系,为药师进行抗体类抗肿瘤药物的药学服务提供科学依据。

Antibody-based drugs are prepared by cell and genetic engineering technology,which are widely used in the treatment of malignant tumors.According to the structural characteristics,antibody-based drugs currently on the market can be divided into several categories,including monoclonal antibody drugs,bispecific antibody drugs and antibody drug conjugates.Until June 1,2022,39 anti-tumor antibody drugs have been approved in China.Since the pharmaceutical characteristics,in vivo efficacy and pharmacokinetic characteristics of anti-tumor antibody drugs are different from those of traditional small molecule drugs,the pharmaceutical care of anti-tumor antibody drugs in clinical application has distinct features.To regulate pharmaceutical care of these drugs,promote the rational use of antibody drugs in China,this guideline has been made by Cancer Pharmacists Branch of Chinese Pharmacists Association,with the guidance of the National Cancer Center.We used the Delphi method and expert interview and discussion,to build the key problems.The contents in this guideline are based on clinical evidence,domestic pharmaceutical management regulations and pharmaceutical care practice.This guideline covers the whole process of pharmaceutical care system,includes the using of before,during and after drug administration.It provides a scientific basis for pharmacists to carry out pharmaceutical care for this kind of drugs.