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 x 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 x 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.
基金：
This work was supported by grants from the National Key
Research and Development Program of China (2023YFC2507802),
National Natural Science Foundation of China (Nos.82104618,
82170127, 82070125), CAMS Innovation Fund for Medical Sciences
(CIFMS) (2021-I2M-1-073).
第一作者机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Haihe Lab Cell Ecosyst, State Key Lab Expt Hematol,Natl Clin Res Ctr Blood, Tianjin 300020, Peoples R China[2]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, CAMS Key Lab Gene Therapy Blood Dis, Tianjin 300020, Peoples R China[3]Chinese Acad Med Sci & Peking Union Med Coll, Blood Dis Hosp, Tianjin 300020, Peoples R China[4]Tianjin Inst Hlth Sci, Tianjin 301600, Peoples R China
共同第一作者：
通讯作者：
通讯机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Haihe Lab Cell Ecosyst, State Key Lab Expt Hematol,Natl Clin Res Ctr Blood, Tianjin 300020, Peoples R China[2]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, CAMS Key Lab Gene Therapy Blood Dis, Tianjin 300020, Peoples R China[3]Chinese Acad Med Sci & Peking Union Med Coll, Blood Dis Hosp, Tianjin 300020, Peoples R China[4]Tianjin Inst Hlth Sci, Tianjin 301600, Peoples R China[5]Chinese Acad Med Sci & Peking Union Med Coll, Sch Populat Med & Publ Hlth, Beijing 100730, Peoples R China
推荐引用方式(GB/T 7714)：
Fang Lijun,Sun Ting,Zhou Hu,et al.Efficacy and safety analysis of China's first 10% IVIg (RonsenGlob) therapy in treating adult ITP[J].ANNALS OF HEMATOLOGY.2025,doi:10.1007/s00277-025-06391-1.
APA：
Fang, Lijun,Sun, Ting,Zhou, Hu,Jie, Guitao,Fu, Jiaping...&Zhang, Lei.(2025).Efficacy and safety analysis of China's first 10% IVIg (RonsenGlob) therapy in treating adult ITP.ANNALS OF HEMATOLOGY,,
MLA：
Fang, Lijun,et al."Efficacy and safety analysis of China's first 10% IVIg (RonsenGlob) therapy in treating adult ITP".ANNALS OF HEMATOLOGY .(2025)
