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关于肌苷丙胺酸盐对免疫抑制且伴有持续性全身淋巴结肿大患者影响的双盲临床试验。

A double-blind clinical trial of the effects of inosine pranobex in immunodepressed patients with prolonged generalized lymphadenopathy.

作者信息

Wallace J I, Bekesi J G

出版信息

Clin Immunol Immunopathol. 1986 Apr;39(1):179-86. doi: 10.1016/0090-1229(86)90218-7.

DOI:10.1016/0090-1229(86)90218-7
PMID:2419019
Abstract

In a double-blind clinical trial, 61 immunodepressed males with persistent generalized lymphadenopathy (PGL) received one of two doses (1 or 3 g/day) of the immunomodulating drug inosine pranobex (INPX) or placebo for a period of 28 days. In the high-dose group, clinical improvement was reported by 11 of 21 patients (52%), within 5 months of the cessation of treatment. In contrast, 3 of 19 patients (16%) in the placebo group reported clinical improvement by that time. Patients receiving 3 g/day INPX showed a significant increase in NK cell activity by Day 14 and this elevation was still evident at the last follow-up examination 1 year after treatment. Increases in total T lymphocytes (T-11) and the percentage of T helper cells (T-4) were also observed. These responses were delayed and reached their peaks 2 months after the termination of drug treatment. The kinetics of these effects suggest that INPX stimulates the production of precursor cells and initiates a cascade of lymphocyte differentiation capable of producing long-term restoration of cell-mediated immunity. These data indicate that INPX may be beneficial to patients with PGL.

摘要

在一项双盲临床试验中,61名患有持续性全身性淋巴结病(PGL)的免疫抑制男性患者接受了两种剂量(1或3克/天)的免疫调节药物异丙肌苷(INPX)或安慰剂治疗,为期28天。在高剂量组中,21名患者中有11名(52%)在治疗停止后的5个月内报告有临床改善。相比之下,安慰剂组的19名患者中有3名(16%)在那时报告有临床改善。接受3克/天INPX治疗的患者在第14天时自然杀伤细胞(NK)活性显著增加,并且在治疗后1年的最后一次随访检查时这种升高仍然明显。还观察到总T淋巴细胞(T-11)和辅助性T细胞(T-4)百分比增加。这些反应出现延迟,在药物治疗终止后2个月达到峰值。这些效应的动力学表明,INPX刺激前体细胞的产生,并引发一系列能够长期恢复细胞介导免疫的淋巴细胞分化。这些数据表明,INPX可能对PGL患者有益。

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