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确定影响硼替佐米治疗新诊断多发性骨髓瘤时不良事件的因素。

Determining the factors affecting bortezomib's adverse events in the treatment of newly diagnosed multiple myeloma.

作者信息

Dong Mengmeng, Han Xiaoyan, He Jingsong, Yang Li, Zheng Gaofeng, Cai Zhen

机构信息

Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.

Institute of Hematology, Zhejiang University, Hangzhou, People's Republic of China.

出版信息

Hematology. 2025 Dec;30(1):2548069. doi: 10.1080/16078454.2025.2548069. Epub 2025 Sep 1.

DOI:10.1080/16078454.2025.2548069
PMID:40891147
Abstract

BACKGROUND

Multiple myeloma (MM) is a plasma cell malignant tumor known for its high incidence rate. Bortezomib was the first proteasome inhibitor approved for MM. Many factors can result in bortezomib's adverse events, influencing its continuous treatment. It remains a controversial topic requiring more evidence to support its appropriate use.

METHODS

The -values of single-factor analysis between basic clinical characters and bortezomib's adverse events were used to make a heat map, and the variables with high correlation were selected as the objects of the study. Peripheral neuropathy (PN), infection, dyspepsia and constipation were considered which were common adverse events of bortezomib.

RESULTS

The multivariate-adjusted linear regression and smooth curve fitting results showed that compared with 85 patients in intravenous (IV) arm, 70 patients in the subcutaneous (SC) arm had less adverse reaction, with no significant influence on therapy efficacy. The dosage of bortezomib in 69 MM patients was 1.0 , and 1.3 mg/m in 86 MM patients. As to DS stage, we found that patients with DS stage III had more severe peripheral neuropathy than patients with DS stage I. As per our findings, MM patients in the reduced dose group had higher infection rate, but the efficacy was not significantly different between the two groups.

CONCLUSIONS

This observational study shows that bortezomib applied via SC injection had a lower incidence of peripheral neuropathy, infection, and dyspepsia when compared to IV injection. Patients with DS stage III had higher peripheral neuropathy adverse reactions than patients with stage I. The patients with reduced dose of bortezomib were associated with increased infection in MM patients.

摘要

背景

多发性骨髓瘤(MM)是一种以高发病率著称的浆细胞恶性肿瘤。硼替佐米是首个被批准用于治疗MM的蛋白酶体抑制剂。许多因素可导致硼替佐米的不良事件,影响其持续治疗。这仍是一个有争议的话题,需要更多证据支持其合理使用。

方法

利用单因素分析中基本临床特征与硼替佐米不良事件之间的P值制作热图,并选择高相关性变量作为研究对象。考虑了周围神经病变(PN)、感染、消化不良和便秘等硼替佐米常见的不良事件。

结果

多变量调整线性回归和平滑曲线拟合结果显示,与静脉注射(IV)组的85例患者相比,皮下注射(SC)组的70例患者不良反应较少,对治疗效果无显著影响。69例MM患者的硼替佐米剂量为1.0mg/m²,86例MM患者为1.3mg/m²。关于DS分期,我们发现DS III期患者的周围神经病变比DS I期患者更严重。根据我们的研究结果,减量组的MM患者感染率较高,但两组疗效无显著差异。

结论

这项观察性研究表明,与静脉注射相比,皮下注射硼替佐米的周围神经病变、感染和消化不良发生率较低。DS III期患者的周围神经病变不良反应高于I期患者。硼替佐米剂量减少的MM患者感染增加。

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