Iglesias-Santamaría Araceli
Oncology Pharmacy Department, Hospital Universitario Lucus Augusti, Lugo, Spain.
J Oncol Pharm Pract. 2024 Oct 3:10781552241288143. doi: 10.1177/10781552241288143.
To minimize the risk of hypersensitivity reactions (HSRs) caused by paclitaxel infusion, premedication with corticosteroid, H1-antagonist and H2 antagonist (ranitidine) was standard of care. Discontinuation of ranitidine in 2020 led to adjustments in premedication regimens and a new regimen without ranitidine was implemented in our center. This study aimed to compare the incidence of HSRs during paclitaxel treatment of a standard premedication regimen including ranitidine with a new premedication regimen without ranitidine and with a titrated infusion rate during the first two administrations.
Retrospective data analysis was performed on two cohorts of adult patients with solid tumors who started treatment with paclitaxel and received a premedication regimen with and without ranitidine over the years 2021 and 2023 respectively (before and after ranitidine withdrawal). Univariable and multivariable logistic regression models were used to investigate any associations with H2 antagonist treatment adjusting for confounding variables.
A total of 319 patients were included. 158 patients received the standard premedication regimen with ranitidine compared to 161 patients who did not received ranitidine. HSRs were observed in 10 of 1101 administrations of paclitaxel (0,90%) in ranitidine group compared to 2 of 899 (0,22%) in the ranitidine-free cohort (p = 0.048). Analysis incidence per patient also found results with statistically significant differences: 5.7% (9 of 158 patients) in the ranitidine cohort compared to 1.2% (2 of 161 patients) in the ranitidine-free cohort (p = 0.029).
The results of the study show the effectiveness of a premedication regimen including only dexchlorpherinamine and dexamethasone, along with a titrated infusion rate during the first two administrations, in reducing the incidence of paclitaxed-induced HSRs.
为将紫杉醇输注引起的超敏反应（HSR）风险降至最低，使用皮质类固醇、H1拮抗剂和H2拮抗剂（雷尼替丁）进行预处理是标准治疗方案。2020年停用雷尼替丁导致预处理方案调整，我们中心实施了一种不含雷尼替丁的新方案。本研究旨在比较在紫杉醇治疗期间，含雷尼替丁的标准预处理方案与不含雷尼替丁且在前两次给药期间采用滴定输注速率的新预处理方案中HSR的发生率。
对两组成年实体瘤患者进行回顾性数据分析，这两组患者分别于2021年和2023年（雷尼替丁停用前后）开始使用紫杉醇治疗，并接受了含和不含雷尼替丁的预处理方案。使用单变量和多变量逻辑回归模型来研究与H2拮抗剂治疗的任何关联，并对混杂变量进行调整。
共纳入319例患者。158例患者接受了含雷尼替丁的标准预处理方案，161例患者未接受雷尼替丁。雷尼替丁组在1101次紫杉醇给药中有10次观察到HSR（0.90%），而无雷尼替丁组在899次给药中有2次（0.22%）（p = 0.048）。按患者分析的发生率也发现了具有统计学显著差异的结果：雷尼替丁组为5.7%（158例患者中的9例），无雷尼替丁组为1.2%（161例患者中的2例）（p = 0.029）。
研究结果表明，仅包含右氯苯那敏和地塞米松的预处理方案，以及在前两次给药期间采用滴定输注速率，在降低紫杉醇诱导的HSR发生率方面是有效的。
