Division of Medical Oncology, Department of Internal Medicine, Buddhasothorn Hospital, Chachoengsao, Thailand.
Vibharam Amatanakorn Specialized Cancer Hospital, Chonburi, Thailand.
Asian Pac J Cancer Prev. 2022 Apr 1;23(4):1331-1336. doi: 10.31557/APJCP.2022.23.4.1331.
To study the efficacy of the prevention of immediate hypersensitivity reactions (HSRs) from omitting ranitidine in the premedication protocol in patients who had chemotherapy with taxane regimen.
This was a Multicenter, Ambispective Non-Randomized Historical Controlled Cohort Study. The incidence of HSRs in the patients who had the modified premedication without ranitidine were collected to compare with the historical group who had the standard premedication protocol with ranitidine. The relationships of each HSRs in the experimental group were compared with the historical control group using a multilevel regression analysis with the random-effects model.
A total of 441 patients were enrolled and analyzed in this study. 221 patients received the modified premedication protocol compared with 220 patients who received the standard premedication protocol in the historical group. HSRs were observed in 6 of 768 cycles of chemotherapy (0.78%) in a group of patients with the modified premedication protocol. Moreover, it was found in 4 of 761 cycles of chemotherapy (0.52%) in a group of patients with the standard premedication protocol. When comparing the relationship of the HSRs incidence between the groups using multilevel regression analysis with the random-effects model, there were no differences with a statistical significance (regression coefficients = 0.008, p-value = 0.30).
The results of the study comprised evidence-based medicine supporting the safety of omitting ranitidine from the premedication protocol for the patients who had a taxane regimen and had a similar rate of HSRs to the use of ranitidine.
研究在紫杉醇方案化疗患者的预用药方案中省略雷尼替丁预防即刻过敏反应（HSR）的疗效。
这是一项多中心、前瞻性非随机历史对照队列研究。收集了未使用雷尼替丁的改良预用药组患者的 HSR 发生率，并与使用雷尼替丁的标准预用药方案的历史组进行比较。使用随机效应模型的多层次回归分析比较实验组中每种 HSR 与历史对照组的关系。
本研究共纳入并分析了 441 例患者。221 例患者接受改良预用药方案，220 例患者接受历史组的标准预用药方案。在接受改良预用药方案的患者中，有 6 例（0.78%）接受了 768 个周期的化疗，观察到 HSR。在接受标准预用药方案的患者中，有 4 例（0.52%）接受了 761 个周期的化疗。使用随机效应模型的多层次回归分析比较两组之间 HSR 发生率的关系时，差异无统计学意义（回归系数=0.008，p 值=0.30）。
该研究结果为在接受紫杉醇方案化疗的患者的预用药方案中省略雷尼替丁提供了循证医学证据，其 HSR 发生率与使用雷尼替丁相似，安全性相当。
