Objective  To analyze the domestic antibody drug safety and risk research status, the latest research hotspots and frontiers in the current ten years.

Methods  CiteSpace 6.2.R2 software was used to analyze all literature related to the safety and risk of antibody drugs in CNKI, WanFang data and Vip database from 2012 to 2022.

Results  A total of 2 773 pieces of literature were obtained from the three databases, which were imported into CiteSpace after deduplication, and finally, 1 870 pieces were included in the analysis. In the past decade, the number of articles published in the field of antibody drugs safety and risk research has remained at about 100 articles per year from 2012 to 2019, since 2020, the number of articles published has started to increase, and the annual number of articles published has increased to around 300 articles from 2021 to 2022. The network graph of domestic institutional cooperation showed that there was a lack of cooperation among the research institutions of antibody drug safety and risk research, mainly due to the fact that hospitals were conducting research in this field, and the types of research subjects were relatively single. The author collaboration network graph showed that the core teams in this research field, such as Li Bo, Yang Yanwei, and Lin Zhi, had the closest collaboration, while there was less collaboration among high-yield authors, additionally, some experts and scholars conducted research on their own as individuals or small groups, the research focused on adverse reactions, safety, bevacizumab, Rituximab, Meta-analysis, etc.

Conclusion  In the past decade, domestic research has mainly focused on the clinical efficacy and safety of antibody drugs, with few scholars exploring the risk of antibody drugs, therefore, in the future, it is necessary to pay attention to the research on the risks of antibody drugs.

1.李敏, 吴日伟. 国内外单抗药物市场概述[J]. 中国生物工程杂志, 2017, 37(3): 106-114. [Li M, Wu RW. Overview of monoclonal antibody market at home and abroad[J]. China Biotechnology, 2017, 37(3): 106-114.] DOI: 10.13523/j.cb. 2017031.

2.甄永苏. 抗体药物与肿瘤靶向治疗[J]. 医学研究杂志, 2007, 36(2): 1-2. [Zhen YS. Antibody drugs and tumor targeting therapy[J]. Journal of Medical Research, 2007, 36(2): 1-2.] DOI: 10.3969/j.issn.1673-548X.2007.02.001.

3.杨懿祺, 张志高, 游小龙, 等. 抗体药物的发展与应用[J]. 生物技术进展, 2022, 12(3): 358-365. [Yang YQ, Zhang ZG, You XL, et al. Development and application of antibody drugs[J]. Current Biotechnology, 2022, 12(3): 358-365.] DOI: 10.19586/j.2095-2341.2021.0173.

4.杨高松, 马东杰. 呼吸道传染病治疗中抗体药物的研发进展[J]. 生物技术进展, 2020, 10(5): 441-447. [Yang GS, Ma DJ. Progress in the development of antibody drugs for the treatment of respiratory infectious diseases[J]. Current Biotechnology, 2020, 10(5): 441-447.] DOI: 10.19586/j.2095-2341.2020.0026.

5.李锋. 我国抗体药物产业分析和展望[J]. 生物产业技术, 2017, (2): 68-71. [Li F. Analysis and prospect of antibody drug industry in China[J]. Biotechnology & Business, 2017, (2): 68-71.] DOI: 10.3969/j.issn.1674- 0319.2017.02.009.

6.夏凡, 丁肖梁, 缪丽燕. 抗体药物的药学监护[J]. 中国医院药学杂志, 2020, 40(14): 1577-1581. [Xia  F, Ding  XL, Miao LY. Pharmaceutical care of antibody drugs[J]. Chinese Journal of Hospital Pharmacy, 2020, 40(14): 1577-1581.] DOI: 10.13286/j.1001-5213.2020.14.15.

7.陈悦, 陈超美, 刘则渊, 等. CiteSpace知识图谱的方法论功能[J]. 科学学研究, 2015, 33(2): 242-253. [Chen  Y, Chen CM, Liu ZY, et al. The methodological function of CiteSpace knowledge graph[J]. Studies in Science of Science, 2015, 33(2): 242-253.] DOI: 10.16192/j.cnki. 1003-2053.2015.02.009.

8.周衍平, 尹意, 陈会英. 基于CiteSpace的我国专利合作网络研究的知识图谱分析[J]. 山东科技大学学报(社会科学版), 2022, 24(6): 55-66. [Zhou YP, Yin  Y, Chen HY. Knowledge graph analysis of Chinese patent cooperation network based on CiteSpace[J]. Journal of Shandong University of Sciences & Technology (Social Science), 2022, 24(6): 55-66.] DOI: 10.16452/j.cnki.sdkjsk.2022.06.011.

9.汪传雷, 杨东祥, 陈欣, 等. 数字经济背景下数字孪生研究现状、热点与前沿—基于CiteSpace的可视化分析[J]. 西安航空学院学报, 2022, 40(6): 9-21. [Wang  CL, Yang DX, Chen X, et al. Current status, hot spots and frontiers of digital twin research in the context of digital economy: visualization analysis based on CiteSpace[J]. Journal of Xi'an Aeronautical University, 2022, 40(6): 9-21.] DOI: 10.3969/j.issn.1008-9233.2022.06.003.

10.齐虹, 闫静璇. 基于知识图谱的我国信息行为研究态势分析[J]. 现代情报, 2018, 38(5): 131-139. [Qi  H, Yan  JX. Situation analysis of information behavior research in China based on knowledge graph[J]. Modern Information, 2018, 38(5): 131-139.] DOI: 10.3969/j.issn.1008-0821. 2018.05.021.

11.栾春娟, 赵呈刚. 基于SCI的基因操作技术国际前沿分析[J]. 技术与创新管理, 2009, 30(1): 11-13. [Luan CJ, Zhao CG. International frontier analysis of gene manipulation technology based on SCI[J]. Technology and Innovation Management, 2009, 30(1): 11-13.] DOI: 10.3969/j.issn.1672-7312.2009.01.004.

12.宋府霖. 环境治理研究的发展脉络、热点主题与前沿趋势—基于CiteSpace的图谱量化分析[J]. 上海管理科学, 2022, 44(1): 75-79. [Song FL. Development context, hot topics and frontier trends of environmental governance research: quantitative analysis based on CiteSpace[J]. Shanghai Management Science, 2022, 44(1): 75-79.] DOI: 10.3969/j.issn.1005-9679.2022.01.021.

13.Shoji T, Eto H, Sato T, et al. A new therapeutic strategy for recurrent ovarian cancer―bevacizumab beyond progressive disease[J]. Healthcare, 2019, 7(3): 109. DOI: 10.3390/healthcare7030109.

14.李婷婷, 施维, 刘爱群. 新型抗体药物在肝细胞癌免疫治疗中的研究进展[J]. 生命科学, 2023, 35(4): 448-462. [Li TT, Shi W, Liu AQ. Research progress of novel antibody drugs in immunotherapy of hepatocellular carcinoma[J]. Life Sci, 2023, 35(4): 448-462.] DOI: 10.13376/j.cbls/2023053.

15.Paolo T, Roberto CP, Chiara C, et al. Antibody-drug conjugates: smart chemotherapy delivery across tumor histologies[J]. CA Cancer J Clin, 2022, 72(2): 165-182. DOI: 10.3322/caac.21705.

16.Chen C, Chen Y, Horowitz M, et al. Towards an explanatory and computational theory of scientific discovery[J]. J Informetr, 2009, 3(3): 191-209. DOI: 10.1016/j.joi.2009. 03.004.

17.李梦颖, 王峻霞, 蒋蓉. 美国生物药上市后风险管理及对我国的启示[J]. 中国药房, 2021, 32(7): 776-781. [Li  MY, Wang JX, Jiang R. Post-marketing risk management of biologic drugs in the united states and its implications for China[J]. China Pharmacy, 2021, 32(7): 776-781.] DOI: 10.6039/j.issn.1001-0408.2021.07.02.

18.卢茜. 单克隆抗体靶向治疗肿瘤策略及安全性[J]. 中国研究型医院, 2021, 8(4): 64-68. [Lu X. Strategy and safety of monoclonal antibody targeted therapy for tumor[J]. Journal of Chinese Research Hospitals, 2021, 8(4): 64-68.] DOI: 10.19450/j.cnki.jcrh.2021.04.016.

19.Maritaz C, Metz C, Baba-Hamed N, et al. Cetuximab-induced aseptic meningitis: case report and review of a rare adverse event[J]. BMC Cancer, 2016, 16: 384. DOI: 10.1186/s12885-016-2434-7.

20.Pallin DJ, Baugh CW, Postow MA, et al. Immune-related adverse events in cancer patients[J]. Acad Emerg Med, 2018, 25(7): 819-827. DOI: 10.1111/acem.13443.

21.陈玉磊, 林锦锦, 郑培义, 等. 新冠病毒中和单克隆抗体及纳米抗体研究进展[J]. 生物工程学报, 2022, 38(9): 3173-3193. [Chen YL, Lin JJ, Zheng PY, et al. Research progress of neutralizing monoclonal antibodies and nano-antibodies against novel coronavirus[J]. Chinese Journal of Biotechnology, 2022, 38(9): 3173-3193.] DOI: 10.13345/j.cjb.220328.

22.任晓蕾, 詹轶秋, 张春燕, 等. 免疫检查点抑制剂安全性研究及不良反应防治[J]. 中国药学杂志, 2022, 57(21): 1855-1859. [Ren XL, Zhan YQ, Zhang CY, et al. Safety of immune checkpoint inhibitors and prevention and treatment of adverse reactions[J]. Chinese Journal of Pharmaceutical Sciences, 2022, 57(21): 1855-1859.] DOI: 10.11669/cpj.2022.21.012.

23.Morgado M, Plácido A, Morgado S, et al. Management of the adverse effects of immune checkpoint inhibitors[J]. Vaccines (Basel), 2020, 8(4): 575. DOI: 10.3390/vaccines 8040575.

24.中华医学会肿瘤学分会乳腺肿瘤学组. 中国乳腺癌靶向治疗药物安全性管理专家共识[J]. 中国癌症杂志, 2019, 29(12): 993-1006. DOI: 10.19401/j.cnki.1007- 3639.2019.12.013.

25.Curigliano G, Cardinale D, Suter T, et al. Cardiovascular toxicity induced by chemotherapy, targeted agents and radiotherapy: ESMO clinical practice guidelines[J]. Ann Oncol, 2012, Suppl 7: vii155-66. DOI: 10.1093/annonc/mds293.

26.Usmani SZ, Garfall AL, van de Donk NWCJ, et al. Teclistamab, a B-cell maturation antigen×CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study[J]. Lancet, 2021, 398(10301): 665-674. DOI: 10.1016/S0140-6736(21)01338-6.

27.Uy GL, Aldoss I, Foster MC, et al. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia[J]. Blood, 2021, 137(6): 751-762. DOI: 10.1182/blood.2020007732.