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中国多发性骨髓瘤患者免疫调节药物相关静脉血栓形成新风险评估模型的开发与验证

Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma.

作者信息

Li Xiaozhe, Sun Xiuli, Fang Baijun, Leng Yun, Sun Fangfang, Wang Yaomei, Wang Qing, Jin Jie, Yang Min, Xu Bing, Fang Zhihong, Chen Lijuan, Chen Zhi, Yang Qimei, Zhang Kejie, Ye Yinhai, Geng Hui, Sun Zhiqiang, Hao Dan, Huang Hongming, Wang Xiaotao, Jing Hongmei, Ma Lan, Pan Xueyi, Chen Wenming, Li Juan

机构信息

Department of Haematology, First Affiliated Hospital of Sun Yat-sen University, No. 58 Zhongshan Er Road, Guangzhou, 510000, Guangdong, China.

Department of Haematology, First Affiliated Hospital of Dalian Medical University, Dalian, China.

出版信息

Thromb J. 2023 Oct 4;21(1):105. doi: 10.1186/s12959-023-00534-y.

DOI:10.1186/s12959-023-00534-y
PMID:37794471
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC10552366/
Abstract

BACKGROUND

Individuals with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs) are at risk of developing venous thromboembolism (VTE), a serious complication. There is no established clinical model for predicting VTE in the Chinese population. We develop a new risk assessment model (RAM) for IMiD-associated VTE in Chinese MM patients.

METHODS

We retrospectively selected 1334 consecutive MM patients receiving IMiDs from 16 medical centers in China and classified them randomly into the derivation and validation cohorts. A multivariate Cox regression model was used for analysis.

RESULTS

The overall incidence of IMiD-related VTE in Chinese MM patients was 6.1%. Independent predictive factors of VTE (diabetes, ECOG performance status, erythropoietin-stimulating agent use, dexamethasone use, and VTE history or family history of thrombosis) were identified and merged to develop the RAM. The model identified approximately 30% of the patients in each cohort at high risk for VTE. The hazard ratios (HRs) were 6.08 (P < 0.001) and 6.23 (P < 0.001) for the high-risk subcohort and the low-risk subcohort, respectively, within both the derivation and validation cohorts. The RAM achieved satisfactory discrimination with a C statistic of 0.64. The stratification approach of the IMWG guidelines yielded respective HRs of 1.77 (P = 0.053) and 1.81 (P = 0.063). The stratification approach of the SAVED score resulted in HRs of 3.23 (P = 0.248) and 1.65 (P = 0.622), respectively. The IMWG guideline and the SAVED score-based method yielded C statistics of 0.58 and 0.51, respectively.

CONCLUSIONS

The new RAM outperformed the IMWG guidelines and the SAVED score and could potentially guide the VTE prophylaxis strategy for Chinese MM patients.

摘要

背景

接受免疫调节药物(IMiDs)治疗的多发性骨髓瘤(MM)患者有发生静脉血栓栓塞(VTE)这一严重并发症的风险。在中国人群中,尚无用于预测VTE的成熟临床模型。我们针对中国MM患者开发了一种新的IMiD相关VTE风险评估模型(RAM)。

方法

我们回顾性选取了来自中国16家医疗中心的1334例连续接受IMiDs治疗的MM患者,并将他们随机分为推导队列和验证队列。采用多变量Cox回归模型进行分析。

结果

中国MM患者中IMiD相关VTE的总体发生率为6.1%。确定了VTE的独立预测因素(糖尿病、东部肿瘤协作组(ECOG)体能状态、促红细胞生成素使用情况、地塞米松使用情况以及VTE病史或血栓形成家族史)并将其合并以开发RAM。该模型在每个队列中识别出约30%的VTE高危患者。在推导队列和验证队列中,高危亚组和低危亚组的风险比(HR)分别为6.08(P<0.001)和6.23(P<0.001)。RAM的C统计量为0.64,具有令人满意的区分度。国际骨髓瘤工作组(IMWG)指南的分层方法得出的HR分别为1.77(P=0.053)和1.81(P=0.063)。SAVED评分的分层方法得出的HR分别为3.23(P=0.248)和1.65(P=0.622)。基于IMWG指南和基于SAVED评分的方法得出的C统计量分别为0.58和0.51。

结论

新的RAM优于IMWG指南和SAVED评分,可能为中国MM患者的VTE预防策略提供指导。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/0e4598b6f024/12959_2023_534_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/ae3e5db2717a/12959_2023_534_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/918d56ef560d/12959_2023_534_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/0e4598b6f024/12959_2023_534_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/ae3e5db2717a/12959_2023_534_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/918d56ef560d/12959_2023_534_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef8f/10552366/0e4598b6f024/12959_2023_534_Fig1_HTML.jpg

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