内蒙古地区吉西他滨的药物不良反应及危险因素分析 点击下载
| 论文标题： | 内蒙古地区吉西他滨的药物不良反应及危险因素分析 |
| 英文标题： | |
| 中文摘要： | 目的 对国家药品集中带量采购（以下简称“集采”）注射用吉西他滨的药物不良反应（ADR）发生特点及危险因素进行分析，为临床安全用药提供参考。方法采用回顾性研究方法，收集2022年1月－2023年12月内蒙古自治区上报国家ADR监测系统的注射用吉西他滨的相关病例报告，收集患者基本信息、用药情况及患者转归、合理用药等信息，分析白细胞减少、骨髓抑制、中性粒细胞减少、血小板减少和肝功能异常患者ADR的发生特点。采用单因素和多因素Logistic回归分析患者的性别、年龄、联用抗肿瘤药物、原患恶性肿瘤及药物剂量等与ADR的相关性。结果本研究共纳入315份（315例患者）集采吉西他滨致ADR病例报告，患者男女占比为1.42∶1；年龄为（61.17±9.13）岁；原患恶性肿瘤以胰腺癌患者最多（73例，占23.17%）。ADR以白细胞减少、骨髓抑制和恶心较为常见，其次为中性粒细胞减少、血小板减少、肝功能异常等。ADR的严重程度分级以1～2级为主，大部分ADR转归情况良好。多因素Logistic回归分析结果显示，联用抗肿瘤药物是骨髓抑制及中性粒细胞减少的危险因素（RR＝2.154，95%CI为1.218～3.807，P＝0.008；RR＝3.099，95%CI为1.240～7.744，P＝0.016）；患者的性别（女性）是白细胞减少及肝功能异常的危险因素（RR＝0.508，95%CI为0.302～0.853，P＝0.010；RR＝0.301，95%CI为0.102～0.887，P＝0.029）。用药合理性方面，符合说明书适应证用药的有143例（45.40%），超说明书用药的有172例（54.60%），其中原患恶性肿瘤为膀胱癌、胆管癌和卵巢癌用药位居超说明书用药前3位。结论内蒙古地区吉西他滨致ADR发生以血液系统、消化系统为主，ADR严重程度分级主要为1～2级，且大部分ADR转归情况良好。性别（女性）和联合用药是吉西他滨致ADR发生的危险因素。应根据患者的病情和身体状况，选择合适的化疗方案，并在吉西他滨用药期间重点监护血液系统和消化系统ADR。 |
| 英文摘要： | OBJECTIVE To analyze the occurrence characteristics and risk factors of adverse drug reactions （ADR） of gemcitabine for injection in national centralized volume-based procurement （hereinafter referred to as “centralized procurement”）， and provide reference for clinical safe drug use. METHODS A retrospective study was conducted to collect the relevant case reports of gemcitabine for injection reported to the National Adverse Drug Reaction Monitoring System by Inner Mongolia Autonomous Region from January 2022 to December 2023； basic information of patients， drug use status， patient outcomes， rational drug use and other information were collected， and the occurrence characteristics of ADRs with leukopenia， myelosuppression， neutropenia， thrombocytopenia and liver dysfunction were analyzed. Univariate analysis and multivariate Logistic regression were used to analyze the correlation of gender， age， combination of antitumor drugs， original malignant tumor and drug dose with ADR. RESULTS A total of 315 cases reports （315 patients） of gemcitabine-induced ADR were included in this study， with a male-to-female ratio of 1.42∶1 and age of （61.17±9.13） years. The primary malignant tumor was pancreatic cancer （73 cases， 23.17%）. Leukopenia， myelosuppression and nausea were the most common ADR， followed by neutropenia， thrombocytopenia， liver dysfunction and so on. The severity grade of ADR was mainly 1-2， and the outcome of most ADR was good. Multivariate Logistic regression analysis showed that combination of antitumor drugs was a risk factor for myelosuppression and neutropenia （RR＝2.154， 95%CI： 1.218- 3.807， P＝0.008； RR＝3.099， 95%CI： 1.240-7.744， P＝0.016）； gender （female） was a risk factor for leukopenia and liver dysfunction （RR＝0.508， 95%CI： 0.302-0.853， P＝0.010； RR＝0.301， 95%CI： 0.102-0.887， P＝0.029）. In terms of drug use rationality， there were 143 cases （45.40%） of drug 126.com use in accordance with the indications of the label， and 172 cases （54.60%） of off-label drug use. Among them， the primary malignant tumors were bladder cancer， bile duct cancer and ovarian cancer， which ranked the top three off-label drug use. CONCLUSIONS The ADR caused by gemcitabine in Inner Mongolia is mainly in the blood and digestive systems. The severity of ADRs is mainly classified as 1-2 levels， and most ADRs have good outcomes. Gender （female） and combination medication are risk factors for gemcitabine-induced ADR. Appropriate chemotherapy regimen should be selected according to the patient’s condition and physical condition， and ADR monitoring in blood and digestive systems should be strengthened during medication of gemcitabine. |
| 期刊： | 2025年第36卷第04期 |
| 作者： | 杨胜男；世伟；赵玉芳；刘治恩；雷雯朴；张亚男；赵科；郭浩 |
| 英文作者： | YANG Shengnan，SHI Wei，ZHAO Yufang，LIU Zhien，LEI Wenpu，ZHANG Yanan，ZHAO Ke，GUO Hao |
| 关键字： | 吉西他滨；药物不良反应；危险因素；合理用药 |
| KEYWORDS： | gemcitabine； adverse drug reactions； risk factors； rational drug use |
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