中国药物警戒 ›› 2025, Vol. 22 ›› Issue (6): 654-658.
DOI: 10.19803/j.1672-8629.20240766

• 安全与合理用药 • 上一篇    下一篇

133例女性患者药品不良反应报告分析

郑斯莉1,2, 张晓庆1,2*   

  1. 1上海交通大学医学院附属国际和平妇幼保健院药剂科,上海 200030;
    2上海市胚胎源性疾病重点实验室,上海 200030
  • 收稿日期:2024-09-29 发布日期:2025-06-18
  • 通讯作者: *张晓庆,女,博士,主任药师,妇产科用药。E-mail: zxqkitten@163.com
  • 作者简介:郑斯莉,女,博士,临床药师,妇产科用药。
  • 基金资助:
    中国福利会国际和平妇幼保健院医学科技人才托举工程—鸿鹄计划（HHJH2402、HHJH2415）; 上海申康中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目（SHDC2022CRS051）; 院内临床研究能力提升三年行动计划（IPMCH2022CR1-05）

133 Cases of Adverse Drug Reactions in Female Patients

ZHENG Sili1,2, ZHANG Xiaoqing1,2*   

  1. 1Department of Pharmacy, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China;
    2Shanghai Key Laboratory of Embryo Original Diseases, Shanghai 200030, China
  • Received:2024-09-29 Published:2025-06-18

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摘要： 目的 分析上海某三甲妇幼保健院药品不良反应（Adverse Drug Reaction,ADR）的特征,为女性安全用药提供参考。方法 收集2022年1月1日至2024年6月30日医院上报至国家药品不良反应监测系统的ADR报告133例,回顾性分析患者年龄、用药原因、怀疑药品种类、给药途径、ADR发生时间、累及系统-器官及临床表现、ADR转归情况。结果 133例ADR患者主要为18岁以上的女性,用药原因以抗肿瘤药和抗感染药居多,抗肿瘤用药患者年龄主要为45岁以上（66.67%）,抗感染用药患者主要为18~44岁（74.57%）;共涉及73种药品183例次用药,以抗肿瘤药及免疫调节剂最多（39.89%）,其次为抗感染药（28.42%）;涉及怀疑用药例次最多的药品为多西他赛注射液（9.84%）和紫杉醇注射液（8.20%）;给药途径主要为静脉给药（81.97%）;ADR主要发生在用药后1 d以内（70.68%）;累及系统-器官排名第1位的为皮肤及其附件（32.35%）;严重的ADR为16例（12.03%）,其中有13例为肿瘤化疗药;经停药或治疗后绝大多数症状好转。结论 患妇科肿瘤疾病的女性在使用化疗药时容易发生ADR,应加强ADR监护和预测;孕产妇用药时对ADR发生率较高的药物应尤其关注,促进临床合理用药安全。

关键词: 女性患者, 妇科肿瘤疾病, 孕产妇, 多西他赛注射液, 紫杉醇注射液, 抗感染, 药品不良反应, 合理用药

Abstract: Objective To analyze the characteristics of adverse drug reactions (ADR) from a Grade III Level A maternal and child health hospital in Shanghai, so as to provide reference for the safe and rational drug use in female patients. Methods A total of 133 cases of ADR reported to the National Adverse Drug Reaction Monitoring System from January 1, 2022 to June 30, 2024 by the hospital were collected. Retrospective analysis was conducted on patients’ gender, age,reasons for medication, classifications of suspected drugs, routes of administration, time of ADR, involved system-organs and clinical manifestations, and ADR prognosis. Results Among the 133 cases of ADR, most patients were woman over 18 years old. The most used drugs were for anti-gynecological tumors therapy and anti-infection therapy, with the ages of major patients being over 45 years old (66.67%) and 18 to 44 years old (74.57%), respectively. A total of 73 drugs and 183 times of administration were involved. The most used suspected drugs were anti-tumor drugs docetaxel injection and paclitaxel injection. The main administration route was intravenous infusion (81.97%). 70.68% of the ADR occurred within one day after medication.The skin and its appendages were most affected (32.35%). There were 16 serious ADR cases (12.03%), 13 of which involved tumor chemotherapy drugs. Most of the symptoms were relieved after drug withdrawal or treatment. Conclusion Women suffering from gynecological tumor diseases are prone to ADR when using chemotherapy drugs, therefore, ADR monitoring and prediction should be strengthened. As to medication for pregnant and parturient women, much attention should be paid to drugs with high incidence of ADR to promote safe and rational drug use in clinic.

Key words: Female Patients, Gynecological Tumor Diseases, Pregnant and Parturient Women, Paclitaxel Injection, Docetaxel Injection, Anti-Infection, Adverse Drug Reaction, Rational Drug Use

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