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Discussion of standardized assessment and emergency treatment for hypersensitivity reactions in early clinical trials of anti-tumor monoclonal antibody drugs
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Ying-ying FANG, Long LIU, Yin-juan LI, Xing-he WANG
Chinese Journal of New Drugs | 2021, 30(24) : 2295 - 2299
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收藏切换
Chinese Journal of New Drugs | 2021, 30(24): 2295-2299
Discussion of standardized assessment and emergency treatment for hypersensitivity reactions in early clinical trials of anti-tumor monoclonal antibody drugs
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Ying-ying FANG, Long LIU, Yin-juan LI, Xing-he WANG
Affiliations
  • Phase Ⅰ Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
Published: 2021-12-30
Outline
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Objective:

To explore the roles of standardized judgement, risk assessment and emergency treatment of hypersensitivity reactions (HSRs) of anti-tumor monoclonal antibody drugs.

Methods:

The literature of anti-tumor drugs, monoclonal antibodies and HSRs was retrieved from China National Knowledge Infrastructure (CNKI) and PubMed from January 1, 2010 to October 1, 2021. The definition and classification of HSRs, risk factors and novel treatment were analyzed.

Results:

A total of 63 pieces of literature were included, of which 22.1% did not clearly define the type of HSRs. The frequencies of infusion reactions of Fully Human Mab and Humanized Mab were reported to be 56.7% and 43.1%, respectively. The frequency of reported HSRs in intravenous drugs was significantly higher than that in subcutaneous ones (88.5% vs 11.5%); the frequency of HSRs reported in patients was significantly higher than that in healthy subjects (58.7% vs 20.2%).

Conclusion:

The terminology of HSRs needs to be standardized. The degree of risk could be related to the drug characteristic, the method of administration, and the population of medication. The treatment of acute HSRs needs to be standardized, systematized and individualized. Rapid drug desensitization (RDD) might be novel and beneficial treatment for tumor patients.

anti-tumor drugs  /  monoclonal antibodies  /  early clinical trials  /  hypersensitivity reactions  /  standardized judgement  /  risk assessment  /  standardized emergency treatment
方莹莹, 刘龙, 李银娟, 王兴河. 抗肿瘤单克隆抗体早期临床试验中超敏反应规范化处置策略探讨. 中国新药杂志, 2021 , 30 (24) : 2295 -2299 .
Ying-ying FANG, Long LIU, Yin-juan LI, Xing-he WANG. Discussion of standardized assessment and emergency treatment for hypersensitivity reactions in early clinical trials of anti-tumor monoclonal antibody drugs[J]. Chinese Journal of New Drugs, 2021 , 30 (24) : 2295 -2299 .
Year 2021 volume 30 Issue 24
29
8
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  • Online Date:2026-10-28
  • Published:2021-12-30
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  • Accepted:2021-10-30
Affiliations
    Phase Ⅰ Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
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表12种不同金属材料的力学参数
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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