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RU 41740与安慰剂的双盲试验:一组慢性支气管炎患者的免疫学和临床效果

Double-blind trial RU 41740 vs. placebo: immunological and clinical effects in a group of patients with chronic bronchitis.

作者信息

Fietta A, Bersani C, De Rose V, Mangiarotti P, Merlini C, Uccelli M, Guidi G, Grassi G G

机构信息

Department of Chemotherapy, University of Pavia, Italy.

出版信息

Respiration. 1988;54(3):145-52. doi: 10.1159/000195515.

Abstract

A double-blind trail was performed to investigate the effects of RU 41740, a glycoprotein extract from Klebsiella pneumoniae, on host defenses and its efficacy in reducing the number of exacerbation in 29 evaluable patients with chronic bronchitis, out of 36 patients who entered the study. The drug enhanced the phagocytosis indexes of both polymorphonuclear and mononuclear phagocytes. Increased candidacidal activity of monocytes was also observed. These effects, already detectable after one course of therapy and during the entire period of treatment, were no longer detectable when tested 6 months after the end of treatment. A significantly (p less than 0.05) larger number of patients in the treated group than in the placebo group had no exacerbations during drug administration (0-3 months). Moreover, patients treated with RU 41740 had significantly fewer and shorter episodes of acute exacerbation. The positive decreases in these two parameters persisted throughout the follow-up.

摘要

在36名进入研究的患者中,对29名可评估的慢性支气管炎患者进行了一项双盲试验,以研究肺炎克雷伯菌糖蛋白提取物RU 41740对宿主防御的影响及其减少病情加重次数的疗效。该药物增强了多形核细胞和单核吞噬细胞的吞噬指数。还观察到单核细胞杀念珠菌活性增加。这些效应在一个疗程后以及整个治疗期间均可检测到,但在治疗结束6个月后检测时则不再可检测到。在给药期间(0 - 3个月),治疗组中无病情加重的患者数量显著多于安慰剂组(p < 0.05)。此外,接受RU 41740治疗的患者急性加重发作的次数显著减少且发作时间缩短。这两个参数的积极下降在整个随访期间持续存在。

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