Liu Yang, Liu Xianjun, Xia Binbin, Chen Jing, Sun Wenfang, Liu Fang, Cheng Hua
Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
Front Oncol. 2024 May 8;14:1230514. doi: 10.3389/fonc.2024.1230514. eCollection 2024.
This study aimed to establish an antineoplastic drugs trigger tool based on Global Trigger Tool (GTT), to examine the performance by detecting adverse drug events (ADEs) in patients with cancer in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of antineoplastic ADEs.
Based on the triggers recommended by the GTT and those used in domestic and foreign studies and taking into account the scope of biochemical indexes in our hospital, some of them were adjusted. A total of 37 triggers were finally developed. Five hundred medical records of oncology patients discharged in our hospital from 1 June 2020 to 31 May 2021 were randomly selected according to the inclusion and exclusion criteria. These records were reviewed retrospectively by antineoplastic drugs trigger tool. The sensitivity and specificity of the triggers were analyzed, as well as the characteristics and risk factors for the occurrence of ADEs.
Thirty-three of the 37 triggers had positive trigger, and the sensitivity rate was 91.8% (459/500). For the specificity, the positive predictive value of overall ADEs was 46.0% (715/1556), the detection rate of ADEs was 63.0% (315/500), the rate of ADEs per 100 admissions was 136.0 (95% CI, 124.1-147.9), and the rate of ADEs per 1,000 patient days was 208.33 (95% CI, 201.2-215.5). The top three antineoplastic drugs related to ADEs were antimetabolic drugs (29.1%), plant sources and derivatives (27.1%), and metal platinum drugs (26.3%). The hematologic system was most frequently involved (507 cases, 74.6%), followed by gastrointestinal system (89 cases, 13.1%). Multivariate logistic regression analysis showed that the number of combined drugs (OR = 1.14; 95% CI, 1.07-1.22; < 0.001) and the previous history of adverse drug reaction (ADR) (OR = 0.38; 95% CI, 0.23-0.60; < 0.001) were the risk factors for ADEs. The length of hospital stay (OR = 0.40; 95% CI, 0.14-1.12; < 0.05) and the previous history of ADR (OR = 2.18; 95% CI, 1.07-4.45; < 0.05) were the risk factors for serious adverse drug events (SAE).
The established trigger tool could be used to monitor antineoplastic drugs adverse events in patients with tumor effectively but still needs to be optimized. This study may provide some references for further research in order to improve the rationality and safety of antineoplastic medications.
本研究旨在基于全球触发工具（GTT）建立一种抗肿瘤药物触发工具，通过对一家中国医院癌症患者不良药物事件（ADEs）进行检测（回顾性研究）来检验其性能，并调查与抗肿瘤ADEs发生相关的因素。
基于GTT推荐的触发因素以及国内外研究中使用的触发因素，并考虑我院生化指标范围，对其中一些进行了调整。最终共制定了37个触发因素。根据纳入和排除标准，随机选取我院2020年6月1日至2021年5月31日出院的500份肿瘤患者病历。通过抗肿瘤药物触发工具对这些病历进行回顾性审查。分析触发因素的敏感性和特异性，以及ADEs发生的特征和危险因素。
37个触发因素中有33个触发为阳性，敏感率为91.8%（459/500）。就特异性而言，总体ADEs的阳性预测值为46.0%（715/1556），ADEs的检出率为63.0%（315/500），每100例入院患者的ADEs发生率为136.0（95%CI，124.1 - 147.9），每1000患者日的ADEs发生率为208.33（95%CI，201.2 - 215.5）。与ADEs相关的前三位抗肿瘤药物是抗代谢药物（29.1%）、植物来源及衍生物（27.1%）和金属铂类药物（26.3%）。血液系统受累最为常见（507例，74.6%），其次是胃肠道系统（89例, 13.1%）。多因素logistic回归分析显示，联合用药数量（OR = 1.14；95%CI，1.07 - 1.22；P < 0.001）和既往药物不良反应（ADR）史（OR = 0.38；95%CI，0.23 - 0.60；P < 0.001）是ADEs的危险因素。住院时间（OR = 0.40；95%CI，0.14 - 1.12；P < 0.05）和既往ADR史（OR = 2.18；95%CI，1.07 - 4.45；P < 0.05）是严重不良药物事件（SAE）的危险因素。
所建立的触发工具可有效用于监测肿瘤患者的抗肿瘤药物不良事件，但仍需优化。本研究可为进一步研究提供一些参考，以提高抗肿瘤药物用药的合理性和安全性。
