Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing
- VernacularTitle:2018－2023年北京市注射用曲妥珠单抗不良反应统计分析
- Author:
Hong LIU
1
;
Yu BAI
1
;
Xiaoyang WANG
1
;
Wensi ZHANG
1
;
Benjing ZHANG
2
;
Yanhua ZHANG
1
Author Information
1. Dept. of Pharmacy，Beijing Cancer Hospital & Beijing Institute for Cancer Research/Key Laboratory of Carcinogenesis and Translational Research，Ministry of Education，Beijing 100142，China
2. Beijing Drug Adverse Event Monitoring Center，Beijing 101117，China
- Publication Type:Journal Article
- Keywords:
trastuzumab for injection;
adverse drug reaction;
chill;
fever;
prognosis
- From:
China Pharmacy
2024;35(21):2663-2667
- CountryChina
- Language:Chinese
-
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 occurred within 1 day of medication （OR＝5.63， 95%CI was 2.26-14.02， P＜ 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， P＝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.
