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持续低剂量干扰素-α治疗HIV相关免疫性血小板减少性紫癜。

Continuous low-dose interferon-alpha therapy for HIV-related immune thrombocytopenic purpura.

作者信息

Northfelt D W, Charlebois E D, Mirda M I, Child C, Kaplan L D, Abrams D I

机构信息

Department of Medicine, University of California, San Francisco 94143-1270, USA.

出版信息

J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jan 1;8(1):45-50.

PMID:8548345
Abstract

Our objective was to examine the efficacy and toxicity of continuous, low-dose interferon-alpha therapy for human immunodeficiency virus-related immune thrombocytopenic purpura (HIV-ITP) in a Phase II clinical trial overseen by a community-based consortium of physicians conducting clinical trials in HIV-related diseases. Sixteen patients with HIV-ITP defined by prospective clinical criteria were enrolled; the majority had failed other therapies for HIV-ITP. Baseline and serial measurements were made of platelet counts, complete blood counts, serum chemistries, platelet-associated immunoglobulin, and CD4+ T-lymphocyte counts; subjective symptoms and bleeding were recorded. Three million units of interferon-alpha 2b were self-administered by subcutaneous injection every Monday, Wednesday, and Friday for 16 weeks. Thirteen participants were evaluable for response. One obtained a complete response, eight had partial responses, and four had no response to interferon-alpha therapy. The mean absolute platelet count of the group rose from 15.5 x 10(9)/L at baseline to 47.3 x 10(9)/L at 2 weeks and remained in this range for the duration of the study. CD4+ T-lymphocyte counts and serum chemistries did not change significantly during therapy. Ability to detect platelet-associated immunoglobulin did not change in a predictable manner in relation to platelet count response. Hematologic toxicity was limited to one episode of granulocytopenia, which resolved after a lowering of zidovudine dosage. Subjective toxicities were mild and tolerable, and minor bleeding problems improved in all participants so affected. Low-dose, continuous therapy with interferon-alpha resulted in meaningful increases in the platelet counts of the majority of study participants with HIV-ITP. Interferon-alpha was safe and tolerable for most participants with HIV-ITP at the dosage and schedule employed in this study. Interferon-alpha for clinically significant thrombocytopenia and who have failed to respond to zidovudine.

摘要

我们的目标是在一个由从事HIV相关疾病临床试验的社区医生联盟监督的II期临床试验中,研究持续低剂量α干扰素治疗人类免疫缺陷病毒相关免疫性血小板减少性紫癜(HIV-ITP)的疗效和毒性。根据前瞻性临床标准确定的16例HIV-ITP患者入组;大多数患者此前针对HIV-ITP的其他治疗均失败。对血小板计数、全血细胞计数、血清化学指标、血小板相关免疫球蛋白和CD4+T淋巴细胞计数进行基线和系列测量;记录主观症状和出血情况。每周一、三、五皮下自我注射300万单位α干扰素2b,共16周。13名参与者可评估反应。1例获得完全缓解,8例部分缓解,4例对α干扰素治疗无反应。该组的平均绝对血小板计数从基线时的15.5×10⁹/L升至2周时的47.3×10⁹/L,并在研究期间保持在该范围内。治疗期间CD4+T淋巴细胞计数和血清化学指标无显著变化。检测血小板相关免疫球蛋白的能力与血小板计数反应无可预测的变化关系。血液学毒性仅限于1次粒细胞减少发作,在降低齐多夫定剂量后缓解。主观毒性轻微且可耐受,所有有轻微出血问题的参与者情况均有改善。低剂量持续使用α干扰素治疗使大多数HIV-ITP研究参与者的血小板计数有显著增加。在本研究采用的剂量和疗程下,α干扰素对大多数HIV-ITP参与者安全且可耐受。α干扰素适用于有临床显著血小板减少且对齐多夫定无反应的患者。

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