400例抗肿瘤药品不良反应报告分析

doi:10.19803/j.1672-8629.2022.05.14

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 541-544.
DOI: 10.19803/j.1672-8629.2022.05.14

400例抗肿瘤药品不良反应报告分析

邰新娟¹, 马洪凤¹, 李君¹, 马维兴², 闫亚卫²

¹西安医学院附属宝鸡医院,陕西宝鸡 721006;
²宝鸡市药品安全监测与评价中心,陕西宝鸡721000

收稿日期:2020-06-19 出版日期:2022-05-15 发布日期:2022-05-18
通讯作者: ^*马洪凤,女,本科,主管药师,临床药学。E-mail：345810026@qq.com
作者简介:邰新娟,女,本科,主管药师,临床药学。

400 reports on adverse drug reactions associated with antineoplastic drugs

TAI Xinjuan¹, MA Hongfeng¹, LI Jun¹, MA Weixing², YAN Yawei²

¹Affiliated Baoji Hospital of Xi'an Medical University, Baoji Shaanxi 721006, China;
²Baoji Drug Safety Monitoring and Evaluation Center, Baoji Shaanxi 721000, China

Received:2020-06-19 Online:2022-05-15 Published:2022-05-18

摘要/Abstract

摘要： 目的分析某市抗肿瘤药品不良反应(ADR)的发生规律和特点,为临床安全用药提供参考。方法对某市2017年1月1日~2019年8月31日400例抗肿瘤药物致ADR报告按照患者年龄、性别、原患疾病、给药途径、严重级别、用药情况、ADR所累及系统-器官等方面进行回顾性统计分析。结果 400例ADR报告中,男159例（39.75%）,女241例（60.25%）,其中61~70岁患者构成比最高（30.25%）;原患疾病主要为乳腺癌151例（37.75%）;给药途径以静脉给药的构成比最高84.00%;新的、严重的ADR 28例（7.00%）,严重的ADR 88例（22.00%）;涉及药品构成比最多的为顺铂123例（23.16%）;ADR累及系统-器官以消化系统为主,共313例（43.78%）;痊愈及好转的ADR共377例（94.25%）。结论临床使用抗肿瘤药物要做好ADR监测工作,应从关注特殊人群、重点药物、典型症状入手,并及时正确预防和处理ADR,保障公众用药安全。

关键词: 抗肿瘤药物, 药品不良反应, 用药安全

Abstract: Objective To analyze the characteristics and regularities of adverse drug reactions (ADR) induced by antineoplastic drugs and provide reference for clinical rational use of antineoplastic drugs. Methods Totally 400 reports about ADR caused by antineoplastic drugs between January 1, 2017 and August 31, 2019 were collected and retrospectively analyzed based on patients' gender, age, routes of administration, reaction grading, drug types and organs/systems involved in the ADR caused by antineoplastic drugs. Results Amon the 400 reports of ADR, 159 involved males (39.75%) and 241 involved females (60.25%). The percentage of patients aged 61 to 70 was the highest (30.25%). Breast cancer was the primary disease in 151 of these cases (37.75%). Most of the ADR occurred during intravenous dripping (336, 84.00%). New and severe ADR occurred in 28 cases (7.00%) and severe ADR in 88 cases (22.00%). The highest composition ratio was with cisplatin in 123 cases (23.16%), and the digestive system was most likely to be involved in ADR, with a total of 313 cases (43.78%). A total of 377 cases (94.25%) of ADR were cured and improved. Conclusion To monitor ADR in clinical use of antitumor drugs, clinicians should focus on special populations, key drugs and typical symptoms while treating ADR promptly and properly to ensure the safety of drug use.

Key words: antineoplastic agents, adverse drug reaction, safe medication

中图分类号:

R994.11

邰新娟, 马洪凤, 李君, 马维兴, 闫亚卫. 400例抗肿瘤药品不良反应报告分析[J]. 中国药物警戒, 2022, 19(5): 541-544.

TAI Xinjuan, MA Hongfeng, LI Jun, MA Weixing, YAN Yawei. 400 reports on adverse drug reactions associated with antineoplastic drugs[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 541-544.

参考文献

[1] CHEN XQ, JIN YY, TANG G, et al.New Edited Materia Medica(新编药物学)[M]. 17 th Ed. Beijing: People's Medical Publishing House, 2011.
[2] WHO term set for adverse drug reactions. The system involved - organ code retrieval[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2009, 6(1): 63-64.
[3] XU WJ, GAO Y, YE ML, et al.Analysis of 346 adverse drug reactions reports associated with antineoplastic drugs in a tertiary class A hospital.[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2020, 17(2): 104-107.
[4] ZHENG RS, SUN KY, ZHANG SW, et al. Malignant tumor epidemiology in china, 2015[J]. Chinese Journal of Oncology(中华肿瘤杂志), 2019(1): 19-28.
[5] WANG YP, HU ZP, SA RN, et al.Incidence and mortality of cancer in Shaanxi cancer registries, 2015[J]. China Cancer(中国肿瘤), 2020, 29(5): 344-354.
[6] WU HW, BAI Y, LIU H, et al.Clinical analysis of 273 adverse drug reaction reports of antineoplastics in our hospital[J]. China Medical Herald(中国医药导报), 2017, 14(14): 126-130.
[7] MARKUS GALANSKI.Recent developments in the field of anticancer platinum complexes[J]. Recent Patents on Anti-Cancer Drug Discovery, 2006, 1(2): 285-295.
[8] YU P, YUE EL, XIAO CR, et al.A phase I clinical trial of dose escalation of lobaplatin in combination with fixeddose docetaxel for the treatment of human solid tumors that had progressed following chemotherapy[J]. Oncology Letters, 2015, 9(1): 67-74.
[9] WEI LY, QIU XC, ZHOU YL, et al.Analysis of 907 cases of adverse drug reactions induced by antineoplastic drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(4): 242-245.
[10] ZHANG N, WANG JG, LI JB, et al.Analysis of 304 cases of adverse reactions of antitumor drugs from spontaneous reporting[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2015, 24(2): 107-110.
[11] DOU F, CHEN Y, ZHANG W, et al.Analysis on adverse reactions induced by antineoplastic drugs in Xijing Hospital from 2015 to 2018[J]. Drugs & Clinic(现代药物与临床), 2019, 34(12): 3778-3781.
[12] NCCN clinical practice guidelines in oncology: antiemesis. Version1 2019 [EB/OL]. (2019-02-28)[2020-05-14]. http://www.nccn. org/ patients.
[13] WANG DZ, LIU BL. ZHANG SY, et al.Ridge regression study of restrainment of bone marrow in cancer patients with chemotherapy regiments and antitumor drugs[J]. Chinese Journal of Pharmaco-epidemiology(药物流行病学杂志), 2009, 18(3): 155-157.
[14] WANG D, REN JT, DONG D, et al.Trend analysis of ten-year annual reports on adverse drug reaction monitoring[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(5): 276-283.
[15] HANG JH, WANG SY, GUAN YP, et al.Application progress of population pharmacokenitics/pharmacodymanics modeling in clinical development of anti-cancer drugs[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2019, 35(22): 2930-2933, 2947.

400例抗肿瘤药品不良反应报告分析

400 reports on adverse drug reactions associated with antineoplastic drugs

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[2]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[3]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[4]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[5]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[6]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[7]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[8]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[9]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[10]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.
[11]	陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明. 326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析[J]. 中国药物警戒, 2024, 21(1): 107-110.
[12]	刘赛月, 吕小琴, 周耘. 疑似药品不良反应死亡病例调查及报告实施要点[J]. 中国药物警戒, 2023, 20(9): 971-974.
[13]	里筱竹, 王蔷, 逄瑜, 张轶菁. 个例药品不良反应报告管理浅析与思考[J]. 中国药物警戒, 2023, 20(9): 975-977.
[14]	逄瑜, 刘博, 吕少俐, 王涛, 邢颖, 秦星宇, 田月洁, 吴文宇. 基于国际药物警戒经验探讨收集患者报告的意义[J]. 中国药物警戒, 2023, 20(9): 978-981.
[15]	刘文东, 崔欢欢, 王晓晗, 苏娴, 王海学. 我国儿童用药临床试验期间药物警戒监管体系现状及思考[J]. 中国药物警戒, 2023, 20(9): 1002-1006.