Resistance to second-line injectables and treatment outcomes in multidrug-resistant and extensively drug-resistant tuberculosis cases.

No information is currently available on the influence of injectable second-line drugs on treatment outcomes of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) patients. To investigate this issue, a large series of MDR- and XDR-TB cases diagnosed in Estonia, Germany, Italy and the Russian Federation (Archangels Oblast) between 1999 and 2006 were analysed. All study sites performed drug susceptibility testing for first- and second-line anti-TB drugs, laboratory quality assurance and treatment delivery according to World Health Organization recommendations. Out of 4,583 culture-confirmed cases, 240 MDR- and 48 XDR-TB cases had a definitive outcome recorded (treatment success, death, failure). Among MDR- and XDR-TB cases, capreomycin resistance yielded a higher proportion of failure and death than capreomycin-susceptible cases. Resistance to capreomycin was independently associated with unfavourable outcome (logistic regression analysis: odds ratio 3.51). In the treatment of patients with multidrug-resistant and extensively drug-resistant tuberculosis, resistance to the injectable drug capreomycin was an independent predictor for therapy failure in this cohort. As Mycobacterium tuberculosis drug resistance is increasing worldwide, there is an urgent need for novel interventions in the fight against tuberculosis.

Double-blind study of OM-85 in patients with chronic bronchitis or mild chronic obstructive pulmonary disease.

BACKGROUND: Interventions against acute exacerbations (AEs) of chronic obstructive pulmonary disease (COPD) are increasingly called for to reduce morbidity, mortality and costs. OM-85, a detoxified immunoactive bacterial extract, has been shown to prevent recurrent exacerbations of bronchitis and COPD. OBJECTIVES: It was the aim of this study to demonstrate the protective effect of OM-85 against recurrent bronchitic exacerbations in patients with chronic bronchitis or mild COPD. The primary end point was the mean rate of AEs occurring within the study period. METHODS: This double-blind multi-centre study enrolled adult outpatients>40 years old of both sexes with a history of chronic bronchitis or mild COPD at the time of an AE. The treatment consisted of one capsule of OM-85 or placebo per day for 30 days, followed by three 10-day courses for months 3, 4 and 5, with a 6-month study duration and monthly control visits. RESULTS: One hundred and forty-two patients were treated with OM-85 and 131 received placebo. By the end of the treatment period, the mean number of AEs in the OM-85 group was 0.61 per patient versus 0.86 per patient in the placebo group (-29%; p=0.03). The difference between treatments was most notable in patients with a history of current or past smoking (-40%; p<0.01). No serious adverse events were attributed to the medication and no significant laboratory changes were reported. CONCLUSIONS: OM-85 significantly reduced the frequency of AEs in patients with a history of chronic bronchitis and mild COPD and was well tolerated. This study confirms the findings of previous trials conducted in elderly patients with chronic bronchitis or COPD.

[A new inhalation system for bronchodilatation. Study of the acceptance of the Ingelheim M inhaler in chronic obstructive respiratory tract diseases]. / Ein neues Inhalationssystem zur Bronchodilatation. Studie zur Akzeptanz des Inhalators Ingelheim M bei chronisch obstruktiven Atemwegserkrankungen.

The aim of this study was to investigate the acceptance and convenience of a new inhalation system for the treatment of chronic obstructive pulmonary disease. The Ingelheim M inhalator, an inhalation system with a supply magazine for six powder-filled capsules represents a further development of the Ingelheim inhalator in which only a single capsule can be utilized. The study was designed as an open, randomized, crossover trial involving 60 ambulatory adult patients. Each treatment period lasted two weeks. The medication tested was Berodual Inhaletten. The success of treatment was checked on the basis of peak flow metering each morning prior to and after initial inhalation. The results of the study show a highly significant preference on the part of the patients for the new inhalation system. The advantage most emphasized by the patients was the fact that they were able to carry with them their entire daily dose. Differences in the symptomatology of chronic obstructive pulmonary disease were not observed with these inhalation systems.

[New technics for producing inhalation aerosols--initial experiences and results with the piezoelectric inhalation device]. / Neue Techniken zur Erzeugung inhalierbarer Aerosole--Erste Erfahrungen und Ergebnisse mit dem piezoelektrischen Inhalationsgerät.

In the treatment of chronic obstructive airway diseases, the inhalative application of medicaments with a bronchodilatory effect is given preference throughout the world. In addition to inhalation solutions and powder capsules, so-called metered-dose aerosols have formed an established part of the treatment plan for approximately 30 years now. With the piezoelectric inhalation device, a fully portable ultrasonic atomiser that is small enough to fit within the pocket, has been developed for the first time. In this device, the piezoelectric effect is utilised to produced, pressure-free, microfine aerosols. Within it, an accurately metered volume containing the therapeutic dose is applied to an atomising element oscillating in the ultrasonic range. The particle spectrum generated with the piezo-system corresponds, in terms of size, to that of metered aerosol devices, and the mean particle diameter is approximately 2.1 microns. The atomisation process takes approximately one second.