新型抗肿瘤药的临床综合评价

Clinical comprehensive evaluation of antineoplastic drugs

新型抗肿瘤药逐渐成为癌症治疗药物发展的主要趋势。目前大量创新药、仿制药上市,需要科学化、同质化、规范化地对新型抗肿瘤药品进行综合评判。药品临床综合评价可以多维度评估新型抗肿瘤药的实际临床应用价值,对药品保障和临床应用有重要参考意义。本文检索了评估新型抗肿瘤药的临床综合评价及卫生技术评估报告,对现有的综合评价文献进行总结。共纳入22篇新型抗肿瘤药相关的评价报告,均为中文文献。其中18篇为快速卫生技术评估报告(rHTA),4篇题为临床综合评价,涉及最多的癌种为非小细胞肺癌(10篇,45.5%),涉及的22种评价药品中埃克替尼被提及最多次(3篇,13.6%)。主要评估维度为安全性、有效性、经济性。临床综合评价报告公开数量少,形式各异;rHTA报告形式较为统一。总体文献数量偏少,评价药品较为分散,涉及的癌种分布不均衡,且一部分经济性评价缺乏中国地区数据。未来尚需更多完整的临床综合评价或HTA报告补充更多维度证据,全面促进我国新型抗肿瘤药临床综合评价的发展。

Novel antineoplastic drugs have become the leading trend in cancer research.As more and more of these drugs rush into the market,a scientific,consistent,and standardized drug evaluation framework for novel antineoplastic drugs is deemed necessary.A clinical comprehensive evaluation assesses the practical value of the drugs in multiple dimensions,which serves as an important reference for the decision-making in drug formulary change,procurement,and clinical use.This article summarizes the current literature about clinical comprehensive evaluation and health technology assessment reports of novel antineoplastic drugs.A total of 22 published articles were included(all written in Chinese),among which 18 were termed“rapid health technology assessment”(rHTA)and the other 4 were entitled“clinical comprehensive evaluation”.Non-small cell lung cancer(10 articles,45.5%)and icotinib(3 articles,13.6%)were discussed most often.Safety,effectiveness,and economical values were the main dimensions of evaluation.Overall,clinical comprehensive evaluation reports are not wellpublished.The format and dimensions of evaluation of the currently available literature with“clinical comprehensive evaluation”in their title are far from consistent compared to the rHTA reports.The drugs under evaluation and the types of cancer involved are scattered in addition to the lack of pharmacoeconomic data in China.In the future,full evaluations with all of the dimensions are highly encouraged and needed to improve the quality and promote the development of clinical comprehensive evaluation of novel antineoplastic drugs in China.