Objective: To determine the principal adverse effects of the tuberculosis treatment regimen recommended by the Brazilian Ministry of Health. Methods: A prospective descriptive study involving 79 tuberculosis patients treated at the Clinical Research Center of the Cassiano Antonio Moraes University Hospital, in the city of Vitória, Brazil, between 2003 and 2006. The treatment regimen consisted of isoniazid, rifampicin, pyrazinamide and ethambutol for four months, followed by rifampicin and isoniazid for two months. During the treatment period, the patients were clinically evaluated every week and had a monthly medical visit. Results: The overall incidence of adverse effects was 83.54%. Articular/bone/muscle involvement was the most common, followed by skin involvement (24.94% and 22.09%, respectively). Adverse effects were more common in the second month of treatment (41.59%). Modification of the treatment regimen was unnecessary. One patient required concomitant medication to counter the adverse effects. The cure rate was 100%. Conclusions: The overall incidence of adverse effects related to the new treatment regimen recommended by the Brazilian Ministry of Health was high. However, none of those effects demanded a change in the regimen, which was effective in the patients evaluated.

Keywords: Treatment outcome;Tuberculosis; Antitubercular agents; Adverse drug reaction reporting systems.

Objective: To compare clinical, radiological, and laboratory characteristics of individuals with pulmonary tuberculosis co-infected or not with HIV. Methods: A cross-sectional study, in which signs and symptoms were assessed by anamnesis and physical examination in patients hospitalized with pulmonary tuberculosis. The results of sputum smear microscopy and culture for Mycobacterium tuberculosis, as well as hemoglobin levels and CD4+ T-cell counts, were obtained from medical records, and chest X-ray reports were consulted. Results: We included 50 pulmonary tuberculosis patients, who were divided into two groups (HIV-positive and HIV-negative; n = 25 per group). The mean age of the participants was 38.4 ± 10.5 years; 46 (92%) were males; and 27 (54%) were White. Expectoration was presented by 21 (84%) and 13 (52%) of the patients in the HIV-negative and HIV-positive groups, respectively (p = 0.016). Radiological findings of cavitation were present in 10 (43%) and 2 (10%) of the patients in the HIV-negative and HIV-positive groups, respectively (p = 0.016), whereas an interstitial pattern was observed in 18 (78%) and 8 (40%), respectively (p = 0.012). The mean hemoglobin level was 11.1 ± 2.9 g/dL and 9.3 ± 2.2 g/dL in the HIV-negative and HIV-positive groups, respectively (p = 0.015). Conclusions: In our sample of tuberculosis patients, expectoration was less prevalent, hemoglobin levels were lower, and cavitation was less common, as was an interstitial pattern, among those co-infected with HIV than among those without HIV co-infection.

Keywords: HIV; Tuberculosis; Acquired immunodeficiency syndrome.

Objetivo: Descrever as taxas de cura, falência e abandono do tratamento da tuberculose com o esquema básico preconizado pelo Ministério da Saúde (tratamento com rifampicina, isoniazida, pirazinamida e etambutol por dois meses seguido de isoniazida e rifampicina por quatro meses) utilizando comprimidos em dose fixa combinada em regime autoadministrado e descrever os eventos adversos e seus possíveis impactos nos desfechos do tratamento. Métodos: Estudo descritivo utilizando dados coletados prospectivamente dos prontuários médicos de pacientes com tuberculose (idade ≥ 18 anos) tratados com o esquema básico em duas unidades básicas de saúde da região metropolitana de Goiânia, GO. Resultados: A amostra foi composta por 40 pacientes com tuberculose. A taxa de cura foi de 67,5%, a taxa de abandono foi de 17,5%, e não ocorreram casos de falência. Nessa amostra, 19 pacientes (47%) relataram reações adversas aos medicamentos. Essas foram leves e moderadas, respectivamente, em 87% e 13% dos casos. Em nenhum caso houve necessidade de mudança do esquema ou suspensão do tratamento. Conclusões: A taxa de cura do esquema básico com o uso de comprimidos em dose fixa combinada sob regime autoadministrado foi semelhante às taxas históricas do esquema anterior. A taxa de abandono, na amostra estudada, foi muito acima da taxa preconizada como adequada (até 5%).

Keywords: Tuberculose; Resultado de tratamento; Combinação de medicamentos.

Objective: To determine the efficacy of the scoring system, recommended by the Brazilian National Ministry of Health (NMH), for the diagnosis of pulmonary tuberculosis (TB) in children and adolescents, regardless of their HIV status. Methods: This was a cross-sectional analytical study carried out between January of 2002 and December of 2006, involving 239 individuals less than 15 years of age. The patients were divided into four groups: latent TB (LTB group; n = 81); no-TB (NTB group; n = 41); TB group (n = 104); and TB/HIV group (n = 13). We studied the clinical, radiological and laboratory findings according to the scoring system. Results: Reports of fever, cough, asthenia and weight loss for at least two weeks were significantly higher in the TB group (p < 0.0001). The proportion of cases with a history of any contact and household contact with a TB patient was, respectively, 95.0% and 86.1% in the TB group, versus 75.0% and 58.3% in the TB/HIV group. In the TB and TB/HIV groups, respectively, chest X-rays revealed parenchymal alterations in 75.0% and 53.9%, revealing combined parenchymal/lymph node alterations in 18.2% and 30.8%. There were no significant differences among the groups regarding the tuberculin skin test results. In the TB group, 16.3% of the patients were malnourished (p < 0.005 vs. the LTB group). The mean NMH system scores in the LTB, NTB, TB and TB/HIV groups were, respectively, 24.2, 18.5, 45.3 and 41.5. Conclusions: The NMH system scores were significantly higher in the TB and TB/HIV groups than in the other two groups. Therefore, this scoring system was valid for the diagnosis of pulmonary TB in this population, regardless of HIV status.

Keywords: Tuberculosis/diagnosis; HIV seropositivity; Diagnostic techniques and procedures.

Objective: To estimate the rates of recurrence, cure, and treatment abandonment in patients with pulmonary tuberculosis treated with a four-drug fixed-dose combination (FDC) regimen, as well as to evaluate possible associated factors. Methods: This was a retrospective observational study involving 208 patients with a confirmed diagnosis of pulmonary tuberculosis enrolled in the Hospital Tuberculosis Control Program at the Institute for Thoracic Diseases, located in the city of Rio de Janeiro, Brazil. Between January of 2007 and October of 2010, the patients were treated with the rifampin-isoniazid-pyrazinamide (RHZ) regimen, whereas, between November of 2010 and June of 2013, the patients were treated with the rifampin-isoniazid-pyrazinamide-ethambutol FDC (RHZE/FDC) regimen. Data regarding tuberculosis recurrence and mortality in the patients studied were retrieved from the Brazilian Case Registry Database and the Brazilian Mortality Database, respectively. The follow-up period comprised two years after treatment completion. Results: The rates of cure, treatment abandonment, and death were 90.4%, 4.8%, and 4.8%, respectively. There were 7 cases of recurrence during the follow-up period. No significant differences in the recurrence rate were found between the RHZ and RHZE/FDC regimen groups (p = 0.13). We identified no factors associated with the occurrence of recurrence; nor were there any statistically significant differences between the treatment groups regarding adverse effects or rates of cure, treatment abandonment, or death. Conclusions: The adoption of the RHZE/FDC regimen produced no statistically significant differences in the rates of recurrence, cure, or treatment abandonment; nor did it have any effect on the occurrence of adverse effects, in comparison with the use of the RHZ regimen.

Keywords: Tuberculosis, pulmonary, Drug combinations; Recurrence.

Objective: To determine, based on international guidelines for asthma management, the appropriateness of the treatment that the Unified Health Care System provides to patients with asthma. Methods: This was a cross-sectional study involving patients suspected of having asthma and referred to the Pulmonology Clinic of the Federal University of Minas Gerais Hospital das Clínicas, Brazil, between November of 2006 and October of 2007. Results: A total of 102 patients were included, and 70 were diagnosed with asthma. The previous treatment was consistent with the guidelines in 18.6% of the patients; 50.0% of the patients had previously been submitted to spirometry, and 34.3% had previously been submitted to PEF. The most frequently prescribed medication was short-acting β2 agonists (90.3%). Conclusions: The results show that the majority of non-specialized physicians working within the public health care system do not manage the treatment of patients with asthma in accordance with the guidelines. This situation calls for continuing medical education programs that prioritize primary care.

Keywords: Asthma; Guideline adherence; Therapeutics; Public health.

Abstract Objectives: To determine the frequency of adverse effects related to the use of the tuberculosis treatment regimen designated Regimen I and the need for regimen alterations due to these effects. Methods: A retrospective analysis of 329 medical charts of patients who were treated with Regimen I and discharged after cure between March 2000 and April 2006 was carried out at the Tuberculosis Outpatient Clinic, Department of Pulmonology of the Santa Casa de Misericórdia de São Paulo Hospital in the city of São Paulo, Brazil. Adverse effects and the timing of their appearance, as well as subsequent modifications in the treatment regimen, were investigated. Results: We included 297 patients, 146 (49.1%) of whom presented one or more adverse effects related to antituberculosis medications. The frequency of minor side effects was 41.1%, and that of major side effects was 12.8%. The most common reactions were those involving the gastrointestinal tract (40.3%) and the skin (22.1%). Adverse effects were more common in the first and second months of treatment (58.4%). Modification of the treatment regimen was necessary in 11 cases (3.7% of the total sample). Drug-induced hepatitis was the adverse effect that demanded the most regimen changes. Conclusions: In this group of patients, the frequency of adverse effects related to treatment with Regimen I was 49.1%. However, in most of the cases, it was not necessary to modify the treatment regimen due to side effects.

Keywords: Tuberculosis/therapy; Antitubercular agents/adverse effects; Hepatitis, toxic.

This article reviews Act 3,523 of the Brazilian Ministry of Health which regulates the indoor air quality of air-conditioned environments, focusing mainly on biological standards for contaminant particles. Additionally, a concise analysis on nosocomial air-borne infections is performed, as well as on nosocomial units where air-borne infectious diseases may be important and a special ventilation system is required. Detailed analysis of the most common biological contaminant particles, differences between countries of both Northern and Southern hemispheres, and the aspects of the methodology used to perform their analysis are considered. The authors conclude that there are no established standards for safe levels of air-borne organisms, and that there is no available data in Brazil to set up standards for biological contaminant particles

Keywords: Air pollutants. Air conditioning. Air quality standards. Indoor air pollution. Brazil.

Objective: Preventive treatment of active tuberculosis is one of the main strategies for reducing the incidence of tuberculosis. We sought to evaluate the rates of latent tuberculosis infection (LTBI) treatment completion with three months of once-weekly isoniazid plus rifapentine (3HP) and compare them with those for six to nine months of daily isoniazid (6H/9H). Methods: This was a retrospective cross-sectional study. Consecutive patients undergoing LTBI treatment with 3HP or 6H/9H were included in the study. Treatment completion rates and adverse effects were analyzed. Results: A total of 226 patients were included in the study: 113 in the 3HP group and 113 in the 6H/9H group. The frequency of adverse effects was not significantly different between the 3HP and 6H/9H groups. The 3HP group had a higher treatment completion rate (93.8%) than did the 6H/9H group (84.1%), the difference being significant. Conclusions: The rates of LTBI treatment completion appear to be higher with 3HP than with 6H/9H. Health care professionals should be vigilant in managing adverse effects to further maximize LTBI treatment completion.

Keywords: Tuberculosis, pulmonary; Latent tuberculosis/prevention & control; Mycobacterium tuberculosis.

Objective: To compare the incidence and intensity of acute adverse effects and the variation in the temperature of facial skin by thermography after the use of noninvasive ventilation (NIV). Methods: We included 20 healthy volunteers receiving NIV via oronasal mask for 1 h. The volunteers were randomly divided into two groups according to the ventilatory mode: bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP). Facial thermography was performed in order to determine the temperature of the face where it was in contact with the mask and of the nasal dorsum at various time points. After removal of the mask, the volunteers completed a questionnaire about adverse effects of NIV. Results: The incidence and intensity of acute adverse effects were higher in the individuals receiving BiPAP than in those receiving CPAP (16.1% vs. 5.6%). Thermographic analysis showed a significant cooling of the facial skin in the two regions of interest immediately after removal of the mask. The more intense acute adverse effects occurred predominantly among the participants in whom the decrease in the mean temperature of the nasal dorsum was lower (14.4% vs. 7.2%). The thermographic visual analysis of the zones of cooling and heating on the face identified areas of hypoperfusion or reactive hyperemia. Conclusions: The use of BiPAP mode was associated with a higher incidence and intensity of NIV-related acute adverse effects. There was an association between acute adverse effects and less cooling of the nasal dorsum immediately after removal of the mask. Cutaneous thermography can be an additional tool to detect adverse effects that the use of NIV has on facial skin.

Keywords: Masks; Noninvasive ventilation; Thermography.

Objective: Evaluate the impact of the instrument of the "Stratification by Degree of Clinical Severity and Abandonment Risk of Tuberculosis Treatment" (SRTB) on the tuberculosis outcome. Methods: This study was a pragmatic clinical trial involving patients with a confirmed diagnosis of tuberculosis treated at one of the 152 primary health care units in the city of Belo Horizonte, Brazil, between May of 2016 and April of 2017. Cluster areas for tuberculosis were identified, and the units and their respective patients were divided into intervention (use of SRTB) and nonintervention groups. Results: The total sample comprised 432 participants, 223 and 209 of whom being allocated to the nonintervention and intervention groups, respectively. The risk of treatment abandonment in the nonintervention group was significantly higher than was that in the intervention group (OR = 15.010; p < 0.001), regardless of the number of risk factors identified. Kaplan-Meier curves showed a hazard ratio of 0.0753 (p < 0.001). Conclusions: The SRTB instrument was effective in reducing abandonment of tuberculosis treatment, regardless of the number of risk factors for that. This instrument is rapid and easy to use, and can be adapted to different realities. Its application showed characteristics predisposing to a non-adherence to the treatment and established bases to mitigate its impact.

Keywords: Tuberculosis; Patient compliance; Risk factors; Treatment adherence.

The epidemiological relevance of tuberculosis is directly related to the socioeconomic profile of a given country. Vulnerability to tuberculosis is influenced by biological factors (e.g., malnutrition, HIV infection, and age) and social factors (e.g., unhealthy housing, high population density, inappropriate working conditions, and lack of access to health services). In many cases, multiple vulnerabilities occur in conjunction. We propose here a reflection on tuberculosis from the point of view of the social determinants of health, as well as the costs associated with its diagnosis and treatment in Brazil, based not only on data in the international literature but also on evidence related to the national context. Given the magnitude of tuberculosis as a socially mediated disease, there is an evident need for greater involvement of health professionals and of the scientific community to implement relevant operational and research measures to understand the social conditions influencing the health-illness continuum for tuberculosis patients. Although the recent economic crisis in Brazil has contributed to increased mortality from all causes, including tuberculosis, health and social protection expenditures have mitigated detrimental health effects. The evidence presented here underscores the importance of public social protection policies for minimizing the effects of tuberculosis indicators, with the aim of eliminating tuberculosis in Brazil.

Keywords: Tuberculosis; Social determinants of health; Cost of illness; Costs and cost analysis.

We estimated the costs of a molecular test for Mycobacterium tuberculosis and resistance to rifampin (Xpert MTB/RIF) and of smear microscopy, within the Brazilian Sistema Único de Saúde (SUS, Unified Health Care System). In SUS laboratories in the cities of Rio de Janeiro and Manaus, we performed activity-based costing and micro-costing. The mean unit costs for Xpert MTB/RIF and smear microscopy were R$35.57 and R$14.16, respectively. The major cost drivers for Xpert MTB/RIF and smear microscopy were consumables/reagents and staff, respectively. These results might facilitate future cost-effectiveness studies and inform the decision-making process regarding the expansion of Xpert MTB/RIF use in Brazil

Keywords: Costs and cost analysis; Tuberculosis; Nucleic acid amplification techniques.

Summary: b-agonists are considered the agents of first choice for the treatment of asthmatic symptoms and are usually available for aerosol administration. Its propellants damage the ozone layer and are often not used properly by the patients. Turbuhaler seems a better alternative since it does not present these inconveniences. In Brazil, it has been recently introduced. Purpose: Compare salbutamol aerosol (SA) to terbutaline turbuhaler (TT) in relation to technical use, bronchodilation and adverse effects in outpatients with mild-obstruction asthma (PFR ³ 60 and < 80% predicted). Material and methods: Open, parallel randomized study performed in each arm of 20 patients (SA: 200 mg and TT: 500 mg). After 30 minutes, a second dose was given if PFR was not 15% or 30 L/min greater than the initial one; a second dose was also delivered if PFR was not greater than 80%. All patients were instructed on how to use both devices. Results: Clinical improvement and increase in PFR were similar in both groups (SA 69.5 vs. TT 58.1 L/min, p > 0.05). A second dose was given to 13 patients (SA 6 and TT 7) with similar results. Errors in the usage were observed in all 20 patients of group SA vs. 11 patients in group TT (p < 0.05). Adverse effects were more frequent with TT - 9 patients - due to its unpleasant taste. Fifteen patients of group TT and with previous experience with SA considered turbuhaler easier. Conclusions: 1) administration by the patient is easier with turbuhaler than with SA; 2) bronchodilation is not different with SA 200 mg and TT 500 mg; 3) unpleasant taste was noted only in group TT (50% of the patients).

Keywords: Asthma. Salbutamol aerosol. Terbutaline Turbuhaler.

To describe and characterize local adverse effects (in the oral cavity, pharynx, and larynx) associated with the use of inhaled corticosteroids (ICSs) in patients with moderate or severe asthma. Methods: This was a cross-sectional study involving a convenience sample of 200 asthma patients followed in the Department of Pharmaceutical Care of the Bahia State Asthma and Allergic Rhinitis Control Program Referral Center, located in the city of Salvador, Brazil. The patients were ≥ 18 years of age and had been using ICSs regularly for at least 6 months. Local adverse effects (irritation, pain, dry throat, throat clearing, hoarseness, reduced vocal intensity, loss of voice, sensation of thirst, cough during ICS use, altered sense of taste, and presence of oral candidiasis) were assessed using a 30-day recall questionnaire. Results: Of the 200 patients studied, 159 (79.5%) were women. The mean age was 50.7 ± 14.4 years. In this sample, 55 patients (27.5%) were using high doses of ICS, with a median treatment duration of 38 months. Regarding the symptoms, 163 patients (81.5%) reported at least one adverse effect, and 131 (65.5%) had a daily perception of at least one symptom. Vocal and pharyngeal symptoms were identified in 57 (28.5%) and 154 (77.0%) of the patients, respectively. The most commonly reported adverse effects were dry throat, throat clearing, sensation of thirst, and hoarseness. Conclusions: Self-reported adverse effects related to ICS use were common among the asthma patients evaluated here.

Keywords: Asthma; Glucocorticoids; Administration, inhalation; Pharmaceutical services.