白蛋白结合型紫杉醇不良反应/事件相关因素分析

doi:10.19803/j.1672-8629.20210148

摘要/Abstract

摘要： 目的通过了解我院妇科肿瘤患者白蛋白结合型紫杉醇（albumin bound paclitaxel,ABP）的药品不良反应/事件（ADR/ADE）现状,分析其与各种影响因素相关性,及我院临床安全用药监测管理存在的问题,为加强临床用药安全监测管理,保障患者用药安全提供参考。方法查阅国家药品不良反应监测系统和中国医院药物警戒系统（China hospital pharmacovigilance system, CHPS）中我院上报的ADR/ADE报告,以妇科肿瘤病区2020年1月1日至9月30日使用ABP发生ADR/ADE的住院患者作为研究对象,统计并分析ADR/ADE发生情况。结果检索到ADR/ADE报告85份,涉及43例患者。疾病类型以卵巢恶性肿瘤患者为主（73例次,85.88%）。相关因素分析结果提示,ADR/ADE的发生与年龄、生产厂家差异无统计学意义。身体质量指数（body mass index,BMI）对转氨酶升高的发生率有统计学意义（χ²=1.29,P=0.02）,剂量对贫血发生率有统计学意义（χ²=0.74,P=0.02）,合并不同化疗药物与骨髓抑制（χ²=1.09,P=0.03)和转氨酶升高（χ²=0.00,P=0.01)发生率有一定相关性。存在超适应证用药85例次（100%）,剂量不适宜3例次（3.53%）。结论医疗机构应加强超说明书用药管理、规范病历记录、加大医嘱审核力度,以期加强临床用药安全监测管理,规避严重ADR/ADE发生,提高患者生存质量。

关键词: 白蛋白结合型紫杉醇, 药品不良反应/事件, 妇科恶性肿瘤, 用药安全监测与管理

Abstract: Objective To find out about adverse drug reactions/events(ADR/ADE) caused by albumin-bound paclitaxel(ABP) in patients with gynecological tumors in our hospital and analyze the correlations between various influencing factors so as to provide reference for ensuring medication safety of patients. Methods The reports of ADR/ADE among patients who used ABP submitted by our hospital to the national adverse drug reactions monitoring system and the Chinese hospital pharmacovigilance system between January 1 and September 30, 2020 were retrieved and analyzed. Inpatients with gynecological cancer who had taken ABP and developed ADR in this period were selected as the subjects. The incidence of ADR/ADE was statistically analyzed. Results Eighty-five reports of ADR/ADE involving 43 patients were retrieved. The dominating disease was ovarian malignant tumor (73 cases, 85.88%). The results of correlation factor analysis showed that the incidence of ADR/ADE was not significantly correlated with the age of patients or with manufacturers. Body mass index (BMI) was of statistical significance for elevated transaminase (χ²=1.29, P=0.02), while dosage for the incidence of anemia (χ²=0.74, P=0.02). The combination of different chemotherapy drugs was correlated with the elevation of bone marrow inhibitors (χ²=1.09, P=0.03) and transaminase (χ²=0.00, P=0.01). There were 85 cases (100%) of off-label drug use, and 3 cases (3.53%) of improper doses. Conclusion Medical institutions should minimize off-label drug use, standardize medical records and review clinicians' instructions in earnest so as to prevent serious ADR/ADE and improve the life quality of patients.

Key words: albumin binds paclitaxel, adverse drug reaction/event, gynecologic malignant tumor, drug safety monitoring and management

中图分类号:

吴颖其, 朱婷, 童彤, 李民, 沈爱宗. 白蛋白结合型紫杉醇不良反应/事件相关因素分析[J]. 中国药物警戒, 2022, 19(10): 1123-1127.

WU Yingqi, ZHU Ting, TONG Tong, LI Min, SHEN Aizong. Factors related to ADR/ADE of albumin bound paclitaxel[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1123-1127.

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