50年来我国抗肿瘤药物临床研究的进展

Clinical studies on new anticancer drugs during the past 5 decades in China

自从20世纪50年代肿瘤逐渐成为卫生工作的重点之一,抗肿瘤学新药的研制也随之开始。但由于没有合适的指导原则,在早期发展缓慢而且受到干扰。从80年代以后卫生部药政局制定了新药开发的GCP指导原则,有些有效新药经过临床试验进入市场为患者服务。10年前我国食品药品监督管理局成立以后,近年来每年临床试验的数目超过100项,有些是国际多中心临床研究。我国开发了肿瘤新生血管抑制剂恩度和参一胶囊,从中药提取的有效成分康莱特和β榄香烯等都已经上市。新的靶向药物尼妥珠单抗和埃克替尼正在进行临床试验。在过去50年间我国共开发12项能改善临床实践的新药或新方法,已经给患者带来裨益。通过中西医融合,对肿瘤治疗的个体化"同病异治"和"异病同治"将有我国的贡献。应当优先发展抗肿瘤新药,创新挽救患者。

Since the 50s in the last century, cancer gradually became one of the priorities in public health, and new anticancer drugs have been studied in this field. Due to lack of proper guidelines in the early days, the development of new anticancer drugs was slow and difficult. Only after the mid of 80s, clinical trials were started according to GCP principles designed by the Bureau of Drugs under Ministry of Health. Several effective new anticancer drugs were tested and available in the hospital for cancer patients. Since the establishment of State FoQd and Drug Administration （SFDA） ten years ago, number of clinical trials reached more than 100 every year in recent 5 years, and some of them were global multi-centers trials. We have developed several new drugs such as endostatin （Endostar） and Rg3 as anti-angiogenesis agents, and the active components from Chinese medicinal herbs are also marketed such as Kanglaite and -elemene. New targeted drugs, such as Eketinib and Nimotuzumab, are currently under clinical trial. There are 12 new drugs or approaches developed in China, which have improved the clinical practice and bring benefit to cancer patients in the last 5 decades. Several basic principles of traditional Chinese medicine are integrated into the individualization of clinical oncology practice such as ＂ same disease different treatments＂ and ＂ different diseases same treatment＂. It is concluded that the development of new anticancer drugs should be one of our priorities and innovation in clinical oncology can save life.