Viallat J R, Costantini D, Boutin C, Farisse P
Poumon Coeur. 1983 Jan-Feb;39(1):53-7.
A double-blind trial was conducted to evaluate the capacity of an immunomodulator of bacterial origin (Biostim) to diminish the frequency of infectious episodes in chronic bronchitis. The study duration was 9 months, Biostim being administered orally initially, with follow-up examinations after 2 and 4 months. Of the 73 subjects selected, 38 received Biostim and 35 a placebo (no significant differences between the two groups). By the 9th month, the duration in days of infectious episodes and of antibiotic therapy was 13 +/- 1.3 and 11.5 +/- 1.4 days respectively for the group receiving Biostim, and 33 +/- 5.8 and 41 +/- 9.5 respectively for the placebo group (p less than 0.05). No signs of intolerance and particularly no immunotoxicity were observed: absence of elevation of IgE or anti-Biostim antibody titres. Pre-winter administration of Biostim to subjects at high risk would appear to significantly diminish the frequency of infectious episodes and thus the consumption of antibiotics.
进行了一项双盲试验，以评估一种细菌来源的免疫调节剂（Biostim）减少慢性支气管炎感染发作频率的能力。研究持续时间为9个月，最初口服Biostim，并在2个月和4个月后进行随访检查。在所选的73名受试者中，38人接受Biostim，35人接受安慰剂（两组之间无显著差异）。到第9个月时，接受Biostim组的感染发作天数和抗生素治疗天数分别为13±1.3天和11.5±1.4天，而安慰剂组分别为33±5.8天和41±9.5天（p<0.05）。未观察到不耐受迹象，尤其未观察到免疫毒性：IgE或抗Biostim抗体滴度未升高。在冬季来临前对高危受试者施用Biostim似乎可显著减少感染发作频率，从而减少抗生素的使用。
