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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.

DOI:10.1159/000195515
PMID:3073462
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。

相似文献

1
Double-blind trial RU 41740 vs. placebo: immunological and clinical effects in a group of patients with chronic bronchitis.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
Respiration. 1988;54(3):145-52. doi: 10.1159/000195515.
2
Immunological and clinical effect of long-term oral treatment with RU 41740 in patients with chronic bronchitis: double-blind trial long-term versus standard dose regimen.RU 41740长期口服治疗慢性支气管炎患者的免疫和临床效果:长期与标准剂量方案的双盲试验
Respiration. 1992;59(5):253-8. doi: 10.1159/000196069.
3
The effect of RU 41.740, an immune modulating compound, in the prevention of acute exacerbations in patients with chronic bronchitis.免疫调节化合物RU 41.740对预防慢性支气管炎患者急性加重的作用。
Eur J Respir Dis. 1986 Oct;69(4):235-41.
4
Immunostimulation of blood monocyte function by RU 41.740 (Biostim) in patients with chronic bronchitis.RU 41.740(生物刺激素)对慢性支气管炎患者血液单核细胞功能的免疫刺激作用。
Int J Immunopharmacol. 1986;8(6):589-92. doi: 10.1016/0192-0561(86)90030-5.
5
[Administration of RU 41740, a preventive anti-infective immunomodulator in an acute respiratory episode. Synthesis of 3 clinical trials].[在急性呼吸道发作中使用预防性抗感染免疫调节剂RU 41740。三项临床试验的综合报告]
Presse Med. 1988 Jul 27;17(28):1453-7.
6
[Chronic bronchitis. Value of RU 41740].[慢性支气管炎。RU 41740的价值]
Presse Med. 1988 Jul 27;17(28):1441-4.
7
[Effect of a purified glycoprotein substance extracted from Klebsiella pneumoniae in the clinical course of acute infections of the airways in patients with chronic bronchitis. Italian Group for the Study of Biological Immunomodulators].[从肺炎克雷伯菌中提取的一种纯化糖蛋白物质对慢性支气管炎患者气道急性感染临床病程的影响。意大利生物免疫调节剂研究小组]
Recenti Prog Med. 1988 Feb;79(2):73-8.
8
[Double-blind study of Biostim in the prevention of superinfection in patients with chronic bronchopathy].[生物刺激素预防慢性支气管病患者重复感染的双盲研究]
Rev Pneumol Clin. 1985;41(3):213-7.
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Oral immunotherapy of chronic bronchitis: a double-blind placebo-controlled multicentre study.慢性支气管炎的口服免疫疗法:一项双盲安慰剂对照多中心研究。
Respiration. 1989;55(3):129-35. doi: 10.1159/000195723.
10
Pidotimod activity against chronic bronchitis exacerbations.匹多莫德对慢性支气管炎急性加重期的作用
Arzneimittelforschung. 1994 Dec;44(12A):1516-20.

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