中国首个10% IVIg （RonsenGlob）治疗成人ITP的疗效和安全性分析

IF 3 3区医学 Q2 HEMATOLOGY

Annals of Hematology Pub Date : 2025-05-01 Epub Date: 2025-05-10 DOI:10.1007/s00277-025-06391-1

Lijun Fang, Ting Sun, Hu Zhou, Guitao Jie, Jiaping Fu, Enqin Yang, Zeping Zhou, Ligen Liu, Jingyu Zhang, Shenxian Qian, Yun Chen, Ling Liu, Jian Gu, Fanliang Kong, Ruibin Huang, Yunfei Chen, Lei Zhang

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引用次数: 0

摘要

2020年4月27日至2021年6月15日，在中国多个中心进行了一项前瞻性、单组、开放标签的III期临床试验，以评估10%静脉注射免疫球蛋白（IVIg）治疗成人免疫性血小板减少性紫癜（ITP）的有效性和安全性。在治疗开始的7天内，10% IVIg组的总缓解率为87.0%，32例患者（46.4%）达到完全缓解，28例患者（40.6%）达到部分缓解，与5% IVIg组相当。值得注意的是，10% IVIg组达到血小板计数（PLT） 50 × 109/L的中位时间在2天（IQR: 2-3）明显短于5% IVIg组的3天（IQR: 3-5）。此外，10% IVIg组PLT在3天内达到100 × 109/L (IQR: 3-4)，而5% IVIg组为5天（IQR: 4-6）。治疗后出血评分明显降低，无明显不良反应报告。这项首次研究强调了10% IVIg在成人ITP紧急治疗中的有效性和安全性，将其定位为一种快速治疗选择。

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Efficacy and safety analysis of China's first 10% IVIg (RonsenGlob) therapy in treating adult ITP.

A prospective, single-arm, open-label Phase III clinical trial was conducted across multiple centers in China from April 27, 2020, to June 15, 2021, to assess the efficacy and safety of 10% intravenous immunoglobulin (IVIg) in treating adult immune thrombocytopenic purpura (ITP). Within 7 days of treatment initiation, the 10% IVIg group exhibited an overall response rate of 87.0%, with 32 patients (46.4%) achieving complete response and 28 patients (40.6%) demonstrating partial response, comparable to the 5% IVIg group. Notably, the median time to achieve a platelet count (PLT) of 50 × 10⁹/L was significantly shorter for the 10% IVIg group at 2 days (IQR: 2-3) versus 3 days (IQR: 3-5) for the 5% IVIg group. Additionally, the 10% IVIg group reached a PLT of 100 × 10⁹/L in 3 days (IQR: 3-4), compared to 5 days (IQR: 4-6) for the 5% IVIg group. Post-treatment bleeding scores significantly decreased, and no significant adverse reactions were reported. This inaugural study highlights the efficacy and safety of 10% IVIg in the urgent management of adult ITP, positioning it as a rapid therapeutic option.

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来源期刊

Annals of Hematology 医学-血液学

CiteScore

5.60

自引率

2.90%

发文量

304

审稿时长

2 months

期刊介绍： Annals of Hematology covers the whole spectrum of clinical and experimental hematology, hemostaseology, blood transfusion, and related aspects of medical oncology, including diagnosis and treatment of leukemias, lymphatic neoplasias and solid tumors, and transplantation of hematopoietic stem cells. Coverage includes general aspects of oncology, molecular biology and immunology as pertinent to problems of human blood disease. The journal is associated with the German Society for Hematology and Medical Oncology, and the Austrian Society for Hematology and Oncology.