狂犬病人免疫球蛋白安全性风险分析

doi:10.19803/j.1672-8629.20250128

摘要/Abstract

摘要： 目的分析狂犬病人免疫球蛋白的安全性风险,为临床合理用药提供参考。方法统计我国国家药品不良反应监测数据库(建库至2023年2月13日)和美国食品药品监督管理局不良事件报告系统（FAERS）数据库（建库至2024年12月31日）中关于狂犬病人免疫球蛋白的不良反应数据,检索狂犬病人免疫球蛋白不良反应国内文献（建库至2024年12月31日）和国外文献（2019年1月1日至2024年12月31日）,分析狂犬病人免疫球蛋白说明书相关资料。结果狂犬病人免疫球蛋白不良反应累及多个系统-器官,临床表现主要有头晕、发热、恶心、胸部不适、皮疹、乏力、瘙痒、过敏性休克等。2023年10月20日,国家药品监督管理局已对狂犬病人免疫球蛋白药品说明书进行统一修订。结论医疗机构应重点关注该药品的过敏性休克、血栓栓塞等严重风险,用药过程中应密切观察,一旦出现过敏反应或其他严重不良反应须立即停药并及时治疗。

关键词: 狂犬病人免疫球蛋白, 药品不良反应, 过敏性休克, 安全, 风险

Abstract: Objective To analyze the safety risks of human rabies immunoglobulin so as to provide a reference for rational clinical use of drugs. Methods Data on adverse reactions caused by human rabies immunoglobulin was retrieved from China’s Adverse Drug Reaction Monitoring Database (collected from inception to February 13, 2023) and FAERS database (collected from inception to December 31, 2024). Domestic literature published from inception to December 31, 2024 and foreign literature published between 2019 and 2024 on cases of adverse drug reactions caused by human rabies immunoglobulin were also retrieved from related databases. Package inserts of the drug were also analyzed. Results Adverse drug reactions of human rabies immunoglobulin involved multiple systems or organs. The clinical manifestations included dizziness, pyrexia, nausea, chest discomfort, rash, hypodynamia, pruritus and anaphylactic shock. The package inserts of human rabies immunoglobulin were upgraded as required by the National Medical Products Administration (NMPA) on October 20, 2023. Conclusion Medical institutions should be alert to such serious risks as anaphylactic shock and thromboembolism associated with this drug. Close observation is essential during medication. In case of allergic reactions or other serious adverse reactions, the drug must be discontinued immediately and quick treatment should be provided.

Key words: Human Rabies Immunoglobulin, Adverse Drug Reactions, Anaphylactic Shock, Safety, Risk

中图分类号:

R954.5

朱会卷, 任经天. 狂犬病人免疫球蛋白安全性风险分析[J]. 中国药物警戒, 2025, 22(7): 786-789.

ZHU Huijuan, REN Jingtian. Safety Risks of Human Rabies Immunoglobulin[J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 786-789.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I7/786

参考文献

[1] ZHOU H, LI Y, CHEN RF, et al.Technical Guideline for Human Rabies Prevention and Control(2016)[J]. Chinese Journal of Epide-miology(中华流行病学杂志), 2016, 37(2): 139-163.
[2] National Disease Control and Prevention Administration. Guidelines for Prevention and Treatment of Rabies Exposure(2023)[EB/OL]. (2023-09-13)[2025-02-26]. https://www.ndcpa.gov.cn/jbkzzx/c100012/common/content/content_1706568784078565376.html.
[3] WHO. Rabies Vaccines: WHO Position Paper-April2018[EB/OL]. (2018-04-19)[2025-02-26]. https://www.who.int/publications/i/item/who-wer9316.
[4] NMPA. National Medical Products Administration Drug Query Module[EB/OL].[2025-02-20]. https://www.nmpa.gov.cn/datasearch/home-index.html#category=yp.
[5] GAO HM, CHANG LM.Progress in Research on Prophylactic Vaccination and Anaphylactic Shock[J]. Chinese Journal of Biologicals(中国生物制品学杂志), 2017, 30(5): 557-560.
[6] ZHANG NH, TANG YP, XIAO Y, et al.Analysis on Adverse Reactions of a Rabies Human Immunoglobulin Product in 3 Consecutive Years[J]. Chinese Journal of Medicinal Guide(中国医药导刊), 2023, 25(2): 210-213.
[7] CHEN XH.Anti-Rabies Immunoglobulin Safety Evaluation of Wuhan Institute of Biological Products[J]. Inner Mongolia Medical Journal(内蒙古医学杂志), 2010, 42(2): 1-2.
[8] JI DY.Analysis of Literatures on ADR Induced by Human Rabies Immunoglobulin[J]. China Pharmacy(中国药房), 2014, 25(18): 1694-1695.
[9] ZHANG XM, LIU HT.Rescue Experience of 6 Cases of Allergic Shock in Children Caused by Human Rabies Immunoglobulin[J]. Chinese Community Doctors(中国社区医师), 2012, 14(302): 165.
[10] WANG B, HOU XC, YI LY, et al.Epidemiological Characteristics and Management of 3216 Rabies Exposed Individuals in Our Hospital from 2013 to 2016[J]. Chinese Journal of Rural Medicine and Pharmacy(中国乡村医药), 2017, 24(17): 69-70.
[11] WANG B, ZUO ZD, YI LY, et al.Experience and Suggestions on the Management and Treatment of 726 Cases of Rabies Exposure in Infants and Young children[J]. Chinese Journal of Rural Medicine and Pharmacy(中国乡村医药), 2021, 28(18): 52-53.
[12] SHI B, LIU Q, HU BB.Analysis and Treatment of Adverse Reactions of Human Rabies Immunoglobulin in 24 Cases[J]. China Journal of Emergency Resuscitation and Disaster Medicine(中国急救复苏与灾害医学杂志), 2019, 14(3): 291-292.
[13] SHEN J, GU HY, ZHANG W.Literature Analysis of 1087 Cases of Adverse Reactions Induced by Different Rabies Immunoglobulin[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(6): 364-368.
[14] YUAN CZ, LIANG HQ.One Case of Report on Allergic Reaction Caused by Injection of Human Rabies Immunoglobulin[J]. Modern Preventive Medicine(现代预防医学), 2005, 32(6): 622.
[15] JIN Y, TANG LW, YU YJ, et al.One Case of Report on Injection Reaction Caused by Human Rabies Immunoglobulin[J]. Chinese Journal of Biologicals(中国生物制品学杂志), 2010, 23(9): 981.
[16] LAI HC, QIU R, LAI HL.One Case of Report on Type I Allergic Reaction Caused by Injection of Human Rabies Immunoglobulin[J]. Science of Travel Medicine(旅行医学科学), 2009, 15(1): 5.
[17] PENG WB.One Case of Hematuria Caused by Intramuscular Injection and Wound Closure of Human Rabies Immunoglobulin[J]. Jiangsu Journal of Preventive Medicine(江苏预防医学), 2008, 19(1): 52.
[18] YU HL, YANG YR.One Case of Allergic Shock Caused by Injection of Human Rabies Immunoglobulin[J]. Journal of Pubic Health and Preventive Medicine(公共卫生与预防医学), 2008, 19(4): 43.
[19] LIN Q.Rescue Experience of Allergic Reaction Caused by Injection of Human Rabies Vaccine and Human Rabies Immunoglobulin[J]. Strait Journal of Preventive Medicine(海峡预防医学杂志), 2009,15(5): 44.
[20] LI CH, KE CX.One Case of Allergic Shock Caused by Injection of Human Rabies Immunoglobulin[J]. National Medical Frontiers of China(中国医疗前沿), 2013, 8(4): 69.
[21] RAVISH SH, NIDHI F, NITU K, et al.Safety and Clinical Efficacy of Human Rabies Immunoglobulin in Post Exposure Prophylaxis for Category III Animal Exposures[J]. Human Vaccines & Immuno-therapeutics, 2022, 18(5): 2081024.
[22] NICHOLAS HP, MICHAL S, NAVEH T, et al.Safety and Efficacy of Rabies Immunoglobulin in Pediatric Patients with Suspected Expo-sure[J]. Human Vaccines & Immunotherapeutics, 2021, 17(7): 2090-2096.
[23] LIU XQ, LI YF, LI JY, et al.Comparing Recombinant Human Rabies Monoclonal Antibody (Ormutivimab) with Human Rabies Immunoglobulin (Hrig) for Postexposure Prophylaxis: a PhaseⅢ, Randomized, Double-Blind, Non-Inferiority Trial[J]. Clinical Trial, 2023, 134: 53-62.
[24] GALEANO KJ, TAY MD, AMADUCCI BS, et al.A Case of a Serum Sickness-Like Reaction after Post Exposure Rabies Prophylaxis[J]. Toxicology, 2023, 65(6): 531-533.
[25] DENG JP, LI SL.Ptosis Caused by Local Injection of Human Rabies Immunoglobulin[J]. Journal of Craniofacial Surgery, 2024, 35(4): e403-e405.
[26] Electronic Medicines Compendium. Human Rabies Immunoglobulin Summary of Product Characteristics[EB/OL]. (2024-04-17)[2025-02-26]. https://www.medicines.org.uk/emc/product/5543/smpc.
[27] NMPA. Announcement of the State Drug Administration on Revision of Human Rabies Immunoglobulin(No.133, 2023)[EB/OL]. (2023-10-20)[2025-02-26]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20231020161236105.html.