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曲妥珠单抗联合雷莫芦单抗方案在实体瘤患者中无需 H1 抗组胺药预处理的安全性。

Safety of Ramucirumab Regimen Without H1-antihistamine Premedication in Patients With Solid Cancers.

机构信息

Department of Pharmacy, Osaka Medical College Hospital, Takatsuki, Japan.

Laboratory of Medical Pharmaceutics, Kobe Pharmaceutical University, Kobe, Japan.

出版信息

In Vivo. 2020 Nov-Dec;34(6):3489-3493. doi: 10.21873/invivo.12189.

Abstract

BACKGROUND/AIM: To prevent infusion-related reactions (IRRs), H1-antihistamines (HAT) are recommended as a premedication for monoclonal antibodies, such as Ramucirumab (RAM), even though there are HAT-related side effects, such as drowsiness and dizziness. Here, we investigated the safety of HAT-free RAM regimens in patients with solid cancer.

PATIENTS AND METHODS

We retrospectively reviewed the patients with solid cancer receiving RAM without HAT at Osaka Medical College Hospital between 2015 and 2019.

RESULTS

Among the 123 registered patients, 58 were identified as eligible. The total number of RAM infusions was 291, and the median number of RAM administration was 4 cycles (range=1-23 cycles). IRRs were not observed in any patient.

CONCLUSION

Although our data are preliminary and limited, HAT-free RAM regimens may be a treatment option for cancer patients having a significant risk of developing HAT-related side effects. Further studies are needed to confirm the safety of HAT-free RAM regimens.

摘要

背景/目的:为了预防输注相关反应(IRR),推荐使用 H1 抗组胺药(HAT)作为单克隆抗体(如 Ramucirumab,RAM)的预处理药物,尽管 HAT 会引起一些副作用,如嗜睡和头晕。在此,我们研究了 HAT 免费 RAM 方案在实体瘤患者中的安全性。

患者和方法

我们回顾性分析了 2015 年至 2019 年在大阪医科大学医院接受 RAM 治疗且未使用 HAT 的实体瘤患者。

结果

在 123 名登记患者中,有 58 名符合条件。共进行了 291 次 RAM 输注,中位数 RAM 给药次数为 4 个周期(范围=1-23 个周期)。未观察到任何患者出现 IRR。

结论

尽管我们的数据初步且有限,但 HAT 免费 RAM 方案可能是具有 HAT 相关副作用高风险的癌症患者的一种治疗选择。需要进一步的研究来确认 HAT 免费 RAM 方案的安全性。

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