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[健康志愿者中重组干扰素的反应原性、毒性和耐受性]

[Reactogenicity, toxicity and tolerance of reaferon in healthy volunteers].

作者信息

Pokrovskiĭ V I, Zmyzgova A V, Murzabaeva R T, Fomina T N, Shalygina N B

出版信息

Zh Mikrobiol Epidemiol Immunobiol. 1988 Jan(1):69-73.

PMID:3364074
Abstract

In the clinical trial of reaferon, introduced intramuscularly and intravenously in different doses (2 X 10(6), 6 X 10(6) and 9 X 10(6) I. U. daily) for 3 days, various side effects were observed. Their intensity depended on the dose of the preparation and the route of administration. The most regular reaction was a rise in temperature, accompanied by slight weakness, headache, loss of appetite, slight dizziness, euphoria. All side effects were transient. No toxic or allergic reactions involving the organs and systems of the body were observed. Low doses of the preparation (2 X 10(6) I. U. daily) promoted an increase in the amount of lymphocytes in the peripheral blood, stimulated cellular immunity factors and contributed to the optimal functioning of the interferon systems. High doses (6 X 10(6) to 9 X 10(6) I. U. daily) had a pronounced immunosuppressing effect. On the whole, reaferon proved to be fairly tolerable.

摘要

在对瑞芬干扰素进行的临床试验中,以不同剂量(每日2×10⁶、6×10⁶和9×10⁶国际单位)进行肌肉注射和静脉注射,持续3天,观察到了各种副作用。其强度取决于制剂的剂量和给药途径。最常见的反应是体温升高,伴有轻微乏力、头痛、食欲不振、轻度头晕、欣快感。所有副作用都是短暂的。未观察到涉及身体器官和系统的毒性或过敏反应。低剂量制剂(每日2×10⁶国际单位)促使外周血淋巴细胞数量增加,刺激细胞免疫因子,并有助于干扰素系统的最佳功能。高剂量(每日6×10⁶至9×10⁶国际单位)具有明显的免疫抑制作用。总体而言,瑞芬干扰素被证明相当耐受。

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