Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing

LIU Hong; BAI Yu; WANG Xiaoyang; ZHANG Wensi; ZHANG Benjing; ZHANG Yanhua

doi:10.6039/j.issn.1001-0408.2024.21.15

您当前的位置：

首页 >

文章列表页 >

Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing

更新时间：2024-11-08

- Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing
- ZHONGGUO YAOFANG Vol. 35, Issue 21, Pages: 2663-2667(2024)
- 作者机构：
  
  1.北京大学肿瘤医院暨北京市肿瘤防治研究所药剂科/恶性肿瘤发病机制及转化研究教育部重点实验室，北京　100142
  2.北京市药品不良反应监测中心，北京　101117
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.21.15
  CLC： R969.3;R979.1
- Published：15 November 2024，
  
  Received：15 April 2024，
  
  Revised：21 October 2024，
- 稿件说明：
移动端阅览
刘红,白羽,王啸洋等.2018－2023年北京市注射用曲妥珠单抗不良反应统计分析 ^Δ[J].中国药房,2024,35(21):2663-2667.

LIU Hong,BAI Yu,WANG Xiaoyang,et al.Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing[J].ZHONGGUO YAOFANG,2024,35(21):2663-2667.
刘红,白羽,王啸洋等.2018－2023年北京市注射用曲妥珠单抗不良反应统计分析 ^Δ[J].中国药房,2024,35(21):2663-2667. DOI： 10.6039/j.issn.1001-0408.2024.21.15.

LIU Hong,BAI Yu,WANG Xiaoyang,et al.Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing[J].ZHONGGUO YAOFANG,2024,35(21):2663-2667. DOI： 10.6039/j.issn.1001-0408.2024.21.15.

摘要

目的

为注射用曲妥珠单抗的临床安全应用提供依据。

方法

收集北京市2018年6月至2023年5月上报的注射用曲妥珠单抗相关的药品不良反应（ADR）报告，运用SPSS 25.0软件进行统计，分析出现ADR的患者性别、年龄、转归情况、所患癌症种类和ADR发生时间、严重程度、累及器官/系统等，并对患者发热及ADR预后情况进行单因素Logistic回归分析。

结果

共有195例患者累计318例次ADR纳入研究。女性（87.69%）和60～69岁年龄段（33.85%）患者出现ADR的情况较多；在癌症种类分布上，乳腺癌占据主导位置（86.67%）；从转归情况来看，大多数患者（67.69%）表现出好转，部分患者（27.69%）实现痊愈。68.72%的ADR主要在用药当天出现，95.38%的ADR严重程度为“一般”。出现ADR最多的器官/系统是全身性疾病及给药部位各种反应（40.57%），以寒战（18.87%）和发热（18.24%）最为常见。单因素Logistic回归分析结果显示，发热多出现在用药后1 d内（OR＝5.63，95%CI为2.26～14.02，

＜0.001）；ADR发生时间≥1 d是ADR预后差的危险因素（OR＝20.08，95%CI为2.45～164.43，

＝0.005），多表现为骨髓抑制和肝功能异常。粒细胞增多症、心脏呼吸骤停和混合性肝损伤为该药说明书未记录的新的ADR。

结论

女性和≥60岁患者为注射用曲妥珠单抗ADR的高发人群；寒战和发热是该药最常见的ADR，且多在用药后1 d内出现，但预后较好。在输注该药当天应密切关注患者的体温变化，适时干预；用药后应定期监测患者的血液学指标，关注其是否存在骨髓抑制和肝功能异常。

Abstract

OBJECTIVE

To provide evidence for the safe clinical application of Trastuzumab for injection.

METHODS

Reports of adverse drug reaction （ADR） related to Trastuzumab for injection submitted in Beijing from June 2018 to May 2023 were collected. Statistical analyses were performed using SPSS 25.0 software. The gender and age of patients with ADRs， outcome， types of cancer， and the time of onset， severity， affected organs/systems of ADRs were included for analyses. The univariate Logistic regression analysis was conducted on patient fever and ADR prognosis.

RESULTS

A total of 195 patients with 318 instances of ADRs were included in the study. Women （87.69%） and patients aged 60-69 （33.85%） were more likely to experience ADRs. Breast cancer dominated （86.67%） in terms of cancer types； in terms of outcomes， most patients （67.69%） showed improvement， and some patients （27.69%） achieved full recovery. Overall， 68.72% of ADRs mainly occurred on the day of medication， and 95.38% of ADRs were of “moderate” severity. The most affected organs/systems were general diseases and various reactions at the administration site （40.57%）， with chills （18.87%） and fever （18.24%） being the most common. Univariate Logistic regression analysis showed that fever mostly occurr

ed within 1 day of medication （OR＝5.63， 95%CI

was 2.26-14.02，

＜0.001）. The time of onset of ADR greater than 1 day was a risk factor for poor ADR prognosis （OR＝20.08， 95%CI was 2.45-164.43，

＝0.005）， mainly manifesting as bone marrow suppression and liver function abnormalities. Neutrophilia， cardiorespiratory arrest， and mixed liver damage were new ADRs not recorded in the drug’s instructions.

CONCLUSION

Women and patients aged ≥60 are high-risk groups for ADRs of Trastuzumab for injection. Chills and fever remain the most common ADRs of this drug， and these symptoms mostly occur within 1 day of medication， which have better prognoses. Close attention should be paid to the patient’s temperature changes on the day of drug infusion， with timely intervention. Regular monitoring of the patient’s hematological indicators is necessary to detect any bone marrow suppression and liver function abnormalities after medication.

关键词

注射用曲妥珠单抗药品不良反应寒战发热预后

Keywords

adverse drug reactionchillfeverprognosis

references

ZHONG L，LI Y S，XIONG L，et al. Small molecules in targeted cancer therapy：advances，challenges，and future perspectives[J]. Signal Transduct Target Ther，2021，6（1）：201.

MIN H Y，LEE H Y. Molecular targeted therapy for anticancer treatment[J]. Exp Mol Med，2022，54（10）：1670-1694.

国家药品不良反应监测中心.国家药品不良反应监测年度报告：2023年[EB/OL].（2024-03-27）[2024-08-12]. https：//www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202403/t20240326_50614.htmlhttps://www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202403/t20240326_50614.html.

National Adverse Drug Reaction Monitoring Center. Annual report of national adverse drug reaction monitoring：2023[EB/OL].（2024-03-27）[2024-08-12]. https：//www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202403/t202-40326_50614.htmlhttps://www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202403/t202-40326_50614.html.

Anna C Zhao-Wong，朱丽琳. 监管活动医学词典术语集简介与应用[J]. 中国药物警戒，2022，19（1）：74-78.

ZHAO-WONG A C，ZHU L L. An introduction to the Medical Dictionary For Regulatory Activities and its use[J]. Chin J Pharmacovigil，2022，19（1）：74-78.

中华人民共和国卫生部.药品不良反应报告和监测管理办法[EB/OL].（2011-05-04）[2024-08-12]. https：//www.gov.cn/gongbao/content/2011/content_2004739.htmhttps://www.gov.cn/gongbao/content/2011/content_2004739.htm.

National Health Commission of the PRC. Management measures for adverse drug reaction reporting and monito- ring[EB/OL]. （2011-05-04）[2024-08-12]. https：//www.gov.cn/gongbao/content/2011/content_2004739.htmhttps://www.gov.cn/gongbao/content/2011/content_2004739.htm.

国家药品监督管理局药品审评中心.药物临床试验不良事件相关性评价技术指导原则：试行[EB/OL].（2024-06-07）[2024-08-12]. https：//www.cde.org.cn/main/news/viewInfoCommon/0a5ae4924881321c07cce100e99f2a5chttps://www.cde.org.cn/main/news/viewInfoCommon/0a5ae4924881321c07cce100e99f2a5c.

National Medical Products Administration Drug Evaluation Center. Technical guidelines for adverse event correlation evaluation in drug clinical trials：trial[EB/OL].（2024-06-07）[2024-08-12]. https：//www.cde.org.cn/main/news/viewInfoCommon/0a5ae4924881321c07cce100e99f2a5chttps://www.cde.org.cn/main/news/viewInfoCommon/0a5ae4924881321c07cce100e99f2a5c.

谢伟，印慨. 人表皮生长因子受体2阳性胃癌靶向治疗的研究进展[J]. 中国肿瘤生物治疗杂志，2023，30（4）：344-351.

XIE W，YIN K. Research progress of targeted therapy for human epidermal growth factor receptor 2 positive gastric cancer[J]. Chin J Cancer Biother，2023，30（4）：344-351.

陈智翔. 曲妥珠单抗对HER2阳性晚期食管癌患者的疗效观察[J]. 智慧健康，2022，8（4）：123-126.

CHEN Z X. Efficacy of trastuzumab in patients with HER2 positive advanced esophageal cancer[J]. Smart Healthc，2022，8（4）：123-126.

周洁，车啸天. 曲妥珠单抗不良反应的特点及规律[J]. 山西医药杂志，2021，50（2）：196-198.

ZHOU J，CHE X T. Characteristics and regularities of adverse reactions of anti-tumor targeted drug trastuzumab[J]. Shanxi Med J，2021，50（2）：196-198.

吴海伟，白羽，刘红，等. 我院273例抗肿瘤药物不良反应报告分析[J]. 中国医药导报，2017，14（14）：126-130.

WU H W，BAI Y，LIU H，et al. Clinical analysis of 273 adverse drug reaction reports of antineoplastics in our hospital[J]. China Med Her，2017，14（14）：126-130.

VOGEL C L. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpres- sing metastatic breast cancer[J]. J Clin Oncol，2002，20（3）：719-726.

WING M. Monoclonal antibody first dose cytokine release syndromes-mechanisms and prediction[J]. J Immunotoxicol，2008，5（1）：11-15.

TABUCHI Y，TSUJIMOTO M，YAMAMOTO K，et al. Risk factors for infusion reactions in patients with breast cancer administered trastuzumab therapy[J]. Biol Pharm Bull，2023，46（7）：964-968.

金小于. 乳腺癌患者应用曲妥珠单抗治疗的临床疗效与护理[J]. 当代临床医刊，2018，31（3）：3899-3900.

JIN X Y. Clinical efficacy and nursing care of breast cancer patients treated with trastuzumab[J]. Med J Present Clin，2018，31（3）：3899-3900.

罗世书，屈杰，周楠，等. 289例单克隆抗体抗肿瘤药品不良反应报告分析[J]. 中国药物警戒，2023，20（4）：444-448.

LUO S S，QU J，ZHOU N，et al. 289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs[J]. Chin J Pharmacovigil，2023，20（4）：444-448.

刘小林，符一岚，朱秋燕，等. 曲妥珠单抗致不良反应分析[J]. 药学与临床研究，2017，25（1）：63-66.

LIU X L，FU Y L，ZHU Q Y，et al. Clinical analysis of adverse effects induced by trastuzumab[J]. Pharm Clin Res，2017，25（1）：63-66.

胡康，孙素红，程晓明，等. 曲妥珠单抗致罕见过敏性反应一例并文献复习[J]. 中国肿瘤生物治疗杂志，2018，25（5）：543-544.

HU K，SUN S H，CHENG X M，et al. A case of trastuzumab for rare allergic reaction and literature review[J]. Chin J Cancer Biother，2018，25（5）：543-544.

王聪，杨美凤，赵倩馨，等. 曲妥珠单抗致严重性过敏性反应一例[J]. 临床外科杂志，2023，31（6）：600.

WANG C，YANG M F，ZHAO Q X，et al. A case of severe allergic reaction caused by trastuzumab[J]. J Clin Surg，2023，31（6）：600.

毕亮亮，韩若凌，焦子义. 曲妥珠单抗相关不良反应的监测及防治研究进展[J]. 医学研究与教育，2020，37（3）：32-38.

BI L L，HAN R L，JIAO Z Y. Advances on monitoring prophylaxis and treatment trastuzumab related adverse reactions[J]. Med Res Educ，2020，37（3）：32-38.

解染，赵楠，崔一民. 1例曲妥珠单抗致肝毒性的病例报告及药物不良反应分析[J]. 中国临床药理学杂志，2017，33（10）：936-938.

XIE R，ZHAO N，CUI Y M. Trastuzumab-induced hepatotoxicity and analysis of adverse drug reaction：a case report[J]. Chin J Clin Pharmacol，2017，33（10）：936-938.

李亚佳，刘玲艳，杨平雄，等. 曲妥珠单抗对乳腺癌患者肝毒性和胃肠道不良反应的Meta分析[J]. 云南医药，2023，44（4）：58-65.

LI Y J，LIU L Y，YANG P X，et al. Meta-analysis of hepatic toxicity and gastrointestinal adverse reactions in breast cancer patients treated with trastuzumab[J]. Med Pharm Yunnan，2023，44（4）：58-65.

曾慧，唐雪苗. 曲妥珠单抗在乳腺癌患者治疗中的心脏毒性[J]. 实用医学杂志，2017，33（12）：2056-2058.

ZENG H，TANG X M. Cardiac toxicity of trastuzumab in the treatment of breast cancer patients[J]. J Pract Med，2017，33（12）：2056-2058.

徐翠玉. 曲妥珠单抗在乳腺癌患者治疗中的心脏毒性分析[J]. 世界复合医学，2020，6（7）：164-166.

XU C Y. Cardiotoxicity analysis of trastuzumab in breast cancer patients[J]. World J Complex Med，2020，6（7）：164-166.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Associations of MTRR gene polymorphism and methotrexate plasma concentration and adverse drug reaction in children with intracranial tumors

Practice and analysis of clinical pharmacist participating in the treatment of a case of acanthoma caused by navulizumab

曲妥珠单抗联合术前辅助化疗用于Her-2阳性乳腺癌的临床观察

XPC基因单核苷酸多态性与肺癌相关性的研究进展

Effects of Sacubitril Valsartan Sodium on Short-term Prognosis of Patients with Acute Anterior Myocardial Infarction Complicated with Acute Cardiac Insufficiency

Related Author

WANG Shumei

XU Xiqiao

SHI Zhengyuan

LI Miao

ZHAO Danqi

SONG Xia

YU Lili

ZHAO Hui

Related Institution

Dept. of Pharmacy， Beijing Shijitan Hospital， Capital Medical University

Dept. of Clinical Pharmacy， School of Pharmaceutical Sciences， Capital Medical University

Dept. of Pediatrics， Beijing Shijitan Hospital， Capital Medical University

Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use

Dept. of Pharmacy， Lanzhou University Second Hospital

Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰