放射性药物的研究现状与前景展望
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摘要
放射性药物是指用于临床诊断或治疗的放射性核素制剂或者其标记化合物,主要包括诊断用放射性药物和治疗用放射性药物两类。随着SPECT、PET/PET-CT普及,以99mTc、18F、68Ga为代表的诊断用放射性药物研发近年来得到了迅速发展;治疗用放射性药物近年来由于其呈现出的良好经济效益和研发潜力也日益得到重视,然而我国目前对放射性药物的研发投入及相关政策法规体系与美国、欧盟相比仍存在较大差距。本文论述了当今国内外放射性药物的研究现状和我国放射性药物的发展概况,并就存在问题和发展前景进行展望。
Radiopharmaceuticals refers to radionuclides for clinical diagnosis or treatment, or labeled compounds,mainly including the radiological drugs for diagnosis and radiological drugs for treatment. With the popularity of SPECT/PET/PET-CT, the research and development of diagnostic radiotherapy drugs represented by99 mTc,18 F and68 Ga have developed rapidly in recent years. In recent years, more and more attention has been paid to the research and development of therapeutic radiotherapy drugs due to their good economic benefits and research and development potential. However, there is still a big gap between China and the United States and the European Union in terms of research and development investment in radioactive drugs and relevant policies and regulations. In this paper, the present situation of radiopharmaceutical research at home and abroad and the general situation of radiopharmaceutical development in China are discussed.
Radiopharmaceuticals refers to radionuclides for clinical diagnosis or treatment, or labeled compounds,mainly including the radiological drugs for diagnosis and radiological drugs for treatment. With the popularity of SPECT/PET/PET-CT, the research and development of diagnostic radiotherapy drugs represented by99 mTc,18 F and68 Ga have developed rapidly in recent years. In recent years, more and more attention has been paid to the research and development of therapeutic radiotherapy drugs due to their good economic benefits and research and development potential. However, there is still a big gap between China and the United States and the European Union in terms of research and development investment in radioactive drugs and relevant policies and regulations. In this paper, the present situation of radiopharmaceutical research at home and abroad and the general situation of radiopharmaceutical development in China are discussed.
引文
[1]贾红梅,刘伯里.中国放射性药物的现状与展望.同位素[J].2011, 24(3):129-139.
[2] Czarniecki M, Mena E, Lindenberg L, et al. Keeping up with the prostate-specific membrane antigens(PSMAs):an introduction to anewclassofpositron emission tomography(PET)imagingagents[J].Translational Andrology and Urology, 2018, 7(5):831-843.
[3]王正,徐建锋,蔡玉婷,等.中国放射性药物的现状及发展趋势[J].中国食品药品监管, 2018,7(2):44-49.
[4] Morigi JJ,Stricker PD,van Leeuwen PJ, et al. Prospective comparison of18F-fluoromethylcholine versus68Ga-PSMA PET/CT in prostate cancer patients who have rising PSA after curative treatment and are being considered for targeted therapy[J]. Journal of Nuclear Medicine, 2015, 56(8):1185-1190.
[5] Afshar-Oromieh A, Hetzheim H, Kratochwil C, et al. The novel theranostic PSMA-ligand PSMA-617 in the diagnosis of prostate cancer by PET/CT:biodistribution in humans, radiation dosimetry and first evaluation of tumor lesions[J]. Journal of Nuclear Medicine,2015, 34(115):161-199.
[6] Giesel F L, Hadaschik B, Cardinale J, et al. F-18 labelled PSMA-1007:biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients[J]. European journal of nuclear medicine and molecular imaging, 2017, 44(4):678-688.
[7] Liu F, Liu T, Xu X, et al. Design, Synthesis, and Biological Evaluation of68Ga-DOTA-PA1 for Lung Cancer:A Novel PET Tracer for Multiple Somatostatin Receptor Imaging[J]. Molecular pharmaceutics,2018, 15(2):619-628.
[8] Hofman M S, Violet J, Hicks R J, et al.[177Lu]-PSMA-617radionuclidetreatmentinpatientswith metastatic castration-resistant prostate cancer(Lu PSMA trial):a single-centre, single-arm, phase 2study[J]. The Lancet Oncology, 2018, 19(6):825-833.
[9] Kratochwil C, Bruchertseifer F, Rathke H, et al. Targeted Alpha Therapy of m CRPC with225Actinium-PSMA-617:Swimmer-Plot analysis suggests efficacy regarding duration of tumor-control[J].Journal of Nuclear Medicine, 2018, 14(117):203-239.
[10]姜典卓.放射性药品国家标准现状及2015年版《中国药典》中主要增修订内容介绍[J].中国药学杂志, 2015, 50(20):1770-1772.
[11]叶军,张友干.《临床用药须知》放射性药物中存在的问题[J].中国药事, 2015, 7(2):198-200.
[12]田怡,杨悦,田丽娟.美国FDA药品风险沟通的发展与启示[J].中国药物警戒, 2016, 13(1):24-27.
[13]魏芬芳,孙宇昕,陈健刚,等.日本药物临床试验审查机制概况及对我国的启示[J].中国药物警戒, 2017, 14(3):169-175.
[14]光红梅,王庆利. EMA对放射性诊断药品的非临床评价要求介绍[J].中国新药杂志,2018, 27(28):2111-2113.
[15]张锦明,田嘉禾.国内正电子放射性药物发展现状简介[J].同位素, 2006, 19(4):240-245.
[16]顾慰萍,朱霖.中国放射性药物发展战略研究[J]. 2006, 3(15):68-71.
[2] Czarniecki M, Mena E, Lindenberg L, et al. Keeping up with the prostate-specific membrane antigens(PSMAs):an introduction to anewclassofpositron emission tomography(PET)imagingagents[J].Translational Andrology and Urology, 2018, 7(5):831-843.
[3]王正,徐建锋,蔡玉婷,等.中国放射性药物的现状及发展趋势[J].中国食品药品监管, 2018,7(2):44-49.
[4] Morigi JJ,Stricker PD,van Leeuwen PJ, et al. Prospective comparison of18F-fluoromethylcholine versus68Ga-PSMA PET/CT in prostate cancer patients who have rising PSA after curative treatment and are being considered for targeted therapy[J]. Journal of Nuclear Medicine, 2015, 56(8):1185-1190.
[5] Afshar-Oromieh A, Hetzheim H, Kratochwil C, et al. The novel theranostic PSMA-ligand PSMA-617 in the diagnosis of prostate cancer by PET/CT:biodistribution in humans, radiation dosimetry and first evaluation of tumor lesions[J]. Journal of Nuclear Medicine,2015, 34(115):161-199.
[6] Giesel F L, Hadaschik B, Cardinale J, et al. F-18 labelled PSMA-1007:biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients[J]. European journal of nuclear medicine and molecular imaging, 2017, 44(4):678-688.
[7] Liu F, Liu T, Xu X, et al. Design, Synthesis, and Biological Evaluation of68Ga-DOTA-PA1 for Lung Cancer:A Novel PET Tracer for Multiple Somatostatin Receptor Imaging[J]. Molecular pharmaceutics,2018, 15(2):619-628.
[8] Hofman M S, Violet J, Hicks R J, et al.[177Lu]-PSMA-617radionuclidetreatmentinpatientswith metastatic castration-resistant prostate cancer(Lu PSMA trial):a single-centre, single-arm, phase 2study[J]. The Lancet Oncology, 2018, 19(6):825-833.
[9] Kratochwil C, Bruchertseifer F, Rathke H, et al. Targeted Alpha Therapy of m CRPC with225Actinium-PSMA-617:Swimmer-Plot analysis suggests efficacy regarding duration of tumor-control[J].Journal of Nuclear Medicine, 2018, 14(117):203-239.
[10]姜典卓.放射性药品国家标准现状及2015年版《中国药典》中主要增修订内容介绍[J].中国药学杂志, 2015, 50(20):1770-1772.
[11]叶军,张友干.《临床用药须知》放射性药物中存在的问题[J].中国药事, 2015, 7(2):198-200.
[12]田怡,杨悦,田丽娟.美国FDA药品风险沟通的发展与启示[J].中国药物警戒, 2016, 13(1):24-27.
[13]魏芬芳,孙宇昕,陈健刚,等.日本药物临床试验审查机制概况及对我国的启示[J].中国药物警戒, 2017, 14(3):169-175.
[14]光红梅,王庆利. EMA对放射性诊断药品的非临床评价要求介绍[J].中国新药杂志,2018, 27(28):2111-2113.
[15]张锦明,田嘉禾.国内正电子放射性药物发展现状简介[J].同位素, 2006, 19(4):240-245.
[16]顾慰萍,朱霖.中国放射性药物发展战略研究[J]. 2006, 3(15):68-71.
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