| 90 | 0 | 173 |
| 下载次数 | 被引频次 | 阅读次数 |
目的 分析盐酸吉西他滨药品不良反应的发生特征，为临床安全用药提供参考。方法 纳入2020年11月至2024年10月使用盐酸吉西他滨发生药品不良反应的病例261例，收集病例年龄、肿瘤类型、用药情况、药品不良反应发生时间、临床症状、严重程度及临床转归等信息，采用Apriori算法进行关联规则分析。结果 261例病例年龄为（63.2±8.9）岁，其中61～70岁占比最高（占38.70%）。在药品不良反应累及器官/系统中，占比最高的是血液系统（占60.00%）。与药品不良反应发生时间在用药后2～10 d关联性较强的规则有一般药品不良反应和药品不良反应累及器官为血液系统。关联规则分析结果显示，在性别为男性、发生时间为用药后10 d的药品不良反应中，药品不良反应累及器官/系统为血液系统的置信度为87.50%，严重药品不良反应的置信度为75.00%；在发生时间为用药后24 h的药品不良反应中，药品不良反应累及器官/系统为胃肠系统的置信度为59.09%。结论 使用注射用盐酸吉西他滨时，应监测血液系统和胃肠系统的药品不良反应发生情况。男性或用药超过10 d的患者易发生血液系统药品不良反应，应重点关注。医务人员应重视对药品不良反应的监测工作，总结药品不良反应发生特点，提升患者用药安全性。
Abstract：AIM To analyze the characteristics and patterns of adverse drug reactions(ADR) occurring with gemcitabine hydrochloride, providing a reference for the safe use of medication in clinical practice. METHODS Information on patients who had ADR to gemcitabine hydrochloride was collected from November 2020 to October 2024. The information including age, tumor type, medication use, time of occurrence of ADR, clinical symptoms, severity and regression, was statistically analyzed. Apriori algorithm was used to analyze the association information of the occurrence of ADR. RESULTS The age of the 261 patients was(63.2 ± 8.9) years. The largest proportion of patients with ADR was aged 61-70 years(accounting for 38.70%). The organ or system involved in ADR was hematologic damage(accounting for 60.00%). The rules most strongly associated with ADR occurrence within 2 to 10 days post-medication administration were general adverse drug reactions and those affecting the haematological system. The correlation rule indicated that in male patients with ADR occurring after 10 days, damage to the hematologic system accounted for 87.50% of the cases. Furthermore, among these male patients, serious ADR made up 75.00% of the cases. For ADR occurring within 24 hours post-administration, the confidence level for reactions involving the gastrointestinal system was 59.09%. CONCLUSION When administering gemcitabine hydrochloride for injection, monitoring for ADR affecting the haematological and gastrointestinal systems is essential. Male patients receiving treatment for over 10 days are at heightened risk of hematological toxicity, which warrants particular attention. Healthcare professionals should heighten vigilance in monitoring of ADR, summarize the characteristics of ADR, and thereby enhance patient medication safety.
[1]刘梦琪,邓建斌,雷东杰,等.吉西他滨联合用药治疗胰腺癌增敏作用机制研究进展[J].现代药物与临床,2024,39(9):2424.
[2]张艳,陈力,赵培西.吉西他滨对肺腺癌A549细胞生物学行为的影响及机制[J].广东医学,2023,44(4):397.
[3]HILMI M,EDERHY S,WAINTRAUB X,et al.Cardiotoxicity associated with gemcitabine:literature review and a pharmacovigilance study[J].Pharmaceuticals,2020,13(10):325.
[4]RAIMONDI L,RAIMONDI F M,ROSSI L,et al.Gemcitabineinduced dilated-cardiomyopathy in patient with platinum-refractory ovarian-cancer:a case report and literature review[J].J Oncol Pharm Pract,2021,27(6):1542.
[5]王霄女.数据挖掘技术在人血白蛋白临床合理使用专项点评中的研究与应用[D].大理:大理大学,2022.
[6]江霞,薛朝华.基于医疗大数据挖掘的护理决策支持系统模型设计研究[J].卫生软科学,2024,38(11):27.
[7]张庆,李梦,于晓涵.基于Apriori算法的糖尿病患者用药规律关联规则挖掘分析[J].中国卫生统计,2023,40(5):687.
[8]GUO H,LIU H,CHEN J Y,et al.Data mining and risk prediction based on apriori improved algorithm for lung cancer[J].J Signal Process Syst,2021,93(7):795.
[9]李梦霞,郭芷汛,刘欢,等.2012—2018年某肿瘤医院铂类药物不良反应分析[J].医药导报,2020,39(12):1750.
[10]许璇,叶璇,高菲菲,等.我院抗肿瘤药物临床试验可疑且非预期严重不良反应报告分析[J].中国临床药学杂志,2023,32(9):641.
[11]罗乐,葛启东,周永学,等.基于Apriori算法的装备数据关联规则挖掘[J].指挥控制与仿真,2021,43(6):29.
[12]刘慧悦,杨洋,李国垒,等.基于Python的Aprio ri算法在超长住院患者信息挖掘中的应用[J].中国病案,2022,23(6):68.
[13]李娟娟,王凤云,唐旭东,等.基于数据挖掘从脾论治功能性消化不良的组方用药规律研究[J].世界中医药,2019,14(12):3210.
[14]马雪娇,王学谦,吴晋芳,等.基于Apriori算法和因子分析挖掘肺癌分子靶向治疗中医用药配伍规律[J].西部中医药,2022,35(7):53.
[15]高强,秦柯,王月峰.热毒宁注射液不良反应影响因素的关联规则分析[J].现代药物与临床,2023,38(4):962.
[16]马洁,马瑞改,白秋江.基于Apriori算法的阿托伐他汀联合降压药相互作用不良反应高危因素的关联性分析[J].中国医院药学杂志,2020,40(18):1962.
[17]吴桂芝,田春华,王丹,等.WHOART和MedDRA在药品不良反应监测中的应用[J].中国药物警戒,2010,7(2):81.
[18]林鑫,郭进京,任慧玲.基于WHOART的我国心血管系统药物致不良反应病例报告分析[J].中国药物警戒,2019,16(3):157.
[19]邱爽,崔向丽,王颖.112例吉西他滨不良反应分析[J].中国新药杂志,2014,23(17):2085.
[20]徐伟佳,高勇,叶美玲,等.某三甲综合医院346例抗肿瘤药物致不良反应报告分析[J].中国药物应用与监测,2020,17(2):104.
[21]姚囡囡,林莉莉,黄珊,等.312例吉西他滨的不良反应分析[J].药学实践杂志,2020,38(2):174.
[22]ZHANG W,WANG Y H,JIANG X,et al.Newly identified adverse events for gemcitabine using the Food and Drug Administration Adverse Event Reporting System[J].Expert Opin Drug Saf,2024,23(7):917.
[23]WANG B,BAO E H,JIANG B L,et al.Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database[J].Expert Opin Drug Saf,2025,24(10):1241.
[24]VELTKAMP S A,BEIJNEN J H,SCHELLENS J H M.Prolonged versus standard gemcitabine infusion:translation of molecular pharmacology to new treatment strategy[J].Oncologist,2008,13(3):261.
[25]ZHANG C,LI K,XU S N,et al.A real-world pharmacovigilance study of FDA Adverse Event Reporting System(FAERS)for gemcitabine[J].Expert Opin Drug Saf,2025,24(3):365.
[26]FERNANDES C,MIRANDA M C C,ROQUE C R,et al.Is there an interplay between environmental factors,microbiota imbalance,and cancer chemotherapy-associated intestinal mucositis[J].Pharmaceuticals,2024,17(8):1020.
基本信息:
DOI：10.19577/j.1007-4406.2026.01.005
中图分类号:R979.1
引用信息:
[1]胡晔,张琳琳,吴慧,等.某院注射用盐酸吉西他滨的不良反应特征与关联规则分析[J].中国临床药学杂志,2026,35(01):28-33.DOI:10.19577/j.1007-4406.2026.01.005.
基金信息:
江苏省老年医学学会2023年度临床药学专项基金科研项目（编号JGS2023MSYX001）
2026-01-25
2026-01-25