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Efficacy and Safety of a New 10% Intravenous Immunoglobulin Product in Patients with Primary Immune Thrombocytopenia (ITP)

  • 주제(키워드) Thrombocytopenia , Immune Thrombocytopenia , IV Immunoglobulins , Bleeding , Hemorrhage
  • 주제(기타) Medicine, General & Internal
  • 설명문(일반) [Hong, Junshik] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Internal Med, Seoul, South Korea; [Bang, Soo-Mee] Seoul Natl Univ, Bundang Hosp, Coll Med, Dept Internal Med, Seoul, South Korea; [Mun, Yeung-Chul] Ewha Womans Univ, Med Ctr, Sch Med, Dept Internal Med, Seoul, South Korea; [Yhim, Ho-Young] Chonbuk Natl Univ, Chonbuk Natl Univ Hosp, Med Sch, Dept Internal Med, Jeonju, South Korea; [Lee, Jaehoon] Green Cross Co, Yongin, South Korea; [Lim, Hyeong-Seok] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Clin Pharmacol & Therapeut, Seoul, South Korea; [Oh, Doyeun] CHA Univ, CHA Bundang Med Ctr, Sch Med, Dept Internal Med, 11 Yatap Ro 65 Beon Gil, Seongnam 13496, South Korea
  • 발행기관 KOREAN ACAD MEDICAL SCIENCES
  • 발행년도 2018
  • URI http://www.dcollection.net/handler/ewha/000000151588
  • 본문언어 영어
  • Published As http://dx.doi.org/10.3346/jkms.2018.33.e142

초록/요약

Background: In the current study, we aimed to investigate the efficacy and safety of intravenous immunoglobulin (IVIg)-SN 10%, a new 10% IVIg formulation, in adult patients with severe primary immune thrombocytopenia (ITP; platelet count < 20 x 10(9)/L). Methods: Patients diagnosed as primary ITP, aged 19 years old or more, and had a platelet count of < 20 x 10(9)/L by screening complete blood cell count performed within 2 weeks of study commencement were eligible. Patients received IVIg-SN 10% at a dose of 1 g/kg/day for two consecutive days. Response was defined as the achievement of a platelet count of >= 50 x 109/L at day 8. Results: Out of 81 eligible patients, 31 patients were newly diagnosed, 7 patients had persistent ITP, and 43 patients had chronic ITP. In intent-to-treat analysis, 61.3 patients (75.7%) achieved response and satisfied the pre-defined non-inferiority condition. Median time to response was 2 days and mean duration of maintaining response after the completion of IVIg therapy was 9.13 +/- 8.40 days. Response rates were not found to be dependent on the phase of ITP or previous treatment for ITP. The drug was well tolerated and the frequency of mucocutaneous bleeding decreased during the study period. Conclusion: In summary, IVIg-SN 10% formulation was found to be safe and effective in adult ITP patients.

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