[Double-blind study of Biostim in the prevention of superinfection in patients with chronic bronchopathy].
In a multicenter trial conducted with patients suffering from chronic bronchopathy, Biostim, an immunomodulating compound of biological origin has been studied using the double-blind placebo-controlled method for prevention of respiratory tract infections. One hundred and ten patients from 10 french pneumology health centers entered the study. The treatment was administered at random in three sequences of 8 days a month for 3 months (2 mg/day the first month, 1 mg/day the second and third months). Patients were separated into 2 groups regarding severity of the disease: group I (non complicated chronic bronchitis); group II (obstructive chronic bronchitis with or without respiratory failure). Patients were examined during 6 months with a monthly appraisal of number, duration and treatment clinically defined infectious episodes. The study of propensity to infections with respect to severity of the disease in patients given placebo showed a significantly lower number of infectious episodes in group I when compared to group II. In the group I (patients suffering from simple chronic bronchitis), no significant difference could be noted between placebo and Biostim but, at all events, the low frequency of episodes makes it difficult to evidence a protective effect in such a group. In contrast, with patients presenting a high infectious risk (group II), one can observe in Biostim treated patients compared with placebo group a significant decrease of infectious episodes and a larger number of patients standing free of episodes throughout the whole period of trial. Tolerance to Biostim has revealed itself satisfactory.
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D001424:Bacterial Infections / Q000517:prevention & control*; D001426:Bacterial Proteins; D001991:Bronchitis / Q000150:complications / Q000188:drug therapy*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006023:Glycoproteins / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male
D000276:Adjuvants, Immunologic; D001426:Bacterial Proteins; D006023:Glycoproteins; C037567:glycoprotein, Klebsiella pneumoniae
Etude en double aveugle du Biostim dans la prévention des surinfections des patiènts atteints de bronchopathie chronique.