Fang Lijun, Sun Ting, Zhou Hu, Jie Guitao, Fu Jiaping, Yang Enqin, Zhou Zeping, Liu Ligen, Zhang Jingyu, Qian Shenxian, Chen Yun, Liu Ling, Gu Jian, Kong Fanliang, Huang Ruibin, Chen Yunfei, Zhang Lei
State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin & CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, 300020, China.
Tianjin Institutes of Health Science, Tianjin, 301600, China.
Ann Hematol. 2025 May;104(5):2643-2651. doi: 10.1007/s00277-025-06391-1. Epub 2025 May 10.
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 × 10/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 × 10/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.
2020年4月27日至2021年6月15日，在中国多个中心开展了一项前瞻性、单臂、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症（ITP）的疗效和安全性。在开始治疗的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%）表现为部分缓解，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的中位时间显著短于5%IVIg组，分别为2天（IQR：2-3）和3天（IQR：3-5）。此外，10%IVIg组在3天（IQR：3-4）内达到PLT 100×10⁹/L，而5%IVIg组为5天（IQR：4-6）。治疗后出血评分显著降低，且未报告明显不良反应。这项开创性研究突出了10%IVIg在成人ITP紧急治疗中的疗效和安全性，使其成为一种快速治疗选择。
