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Biomedical subjects

S Spinaci

Publications and source records attributed to S Spinaci.

At least 19 recordsLinked to original sources
PubMed2003

The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis.

There is considerable exigency to take all necessary steps to cure tuberculosis cases and prevent further emergence of drug-resistant tuberculosis. The most important of these steps is to ensure that the treatment, particularly of sputum smear-positive cases, is adequate and that patients adhere to their treatment by supervised, direct observation of drug-taking according to the standardized regimens. Use of fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO and the International Union Against Tuberculosis and Lung Disease (IUATLD) as an additional step to ensuring proper treatment. FDCs simplify the prescription of drugs and the management of drug supply, and may also limit the risk of drug-resistant tuberculosis arising as a result of inappropriate drug selection and monotherapy. Only FDCs of proven quality and proven rifampicin bioavailability should be purchased and used. In most situations, blood levels of the drugs are inadequate because of poor drug quality rather than poor absorption. This is true irrespective of the human immunodeficiency virus (HIV) infection status of the tuberculosis patients (other than those with overt acquired immunodeficiency syndrome, with CD4 counts < 200 cells/mm3). Currently, WHO, IUATLD and their partners are developing strategies for ensuring that only quality FDCs are used in tuberculosis programmes. A simplified and effective protocol for assessment of rifampicin bioavailability has been developed, and laboratories are being recruited to form a supranational network for quality assurance of FDCs. Standardization of FDC drug formulations has been proposed, which limits rifampicin-containing preparations to nine (including a four-drug FDC and three paediatric FDCs).

Antitubercular Agents↗
PubMed2000

Response from WHO.

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Communicable Disease Control↗
PubMed1999

DOTS (Directly Observed Treatment Strategy) project in Mongolia, 1995.

OBJECTIVE: To establish a tuberculosis (TB) control programme consistent with recommendations made by the WHO and the International Union Against Tuberculosis and Lung Disease (IUATLD) in a country where, as in control programmes of the former USSR, TB management previously relied on active case-finding with radiology and long-term monitoring and treatment of patients. DESIGN AND METHODS: A pilot DOTS strategy (directly observed treatment, short course) project was implemented in Dornod Aimak, Eastern Mongolia During a 6-week period, individuals with chronic cough of > or =3 weeks were screened with sputum smear microscopy. Smear-positive patients received a supervised 6-month regimen (2SRHZ/4RH). Outcome was assessed with smear examination 2, 5, and 6 months after the initiation of treatment. RESULTS: Screening of 1241 symptomatic individuals identified 169 smear-positive TB cases (14%). Most of them (92%) were cured as demonstrated by documented sputum conversion. Five patients completed treatment, but were not available for follow-up smear examination, four patients died and four defaulted. CONCLUSION: The DOTS strategy was successfully introduced in a former socialist model country, paving the way to national DOTS implementation in Mongolia. It may serve as an example for countries with a health care tradition similar to that of the Commonwealth of Independent States.

Antitubercular Agents↗
PubMed1999

Estimate of the global market for rifampicin-containing fixed-dose combination tablets.

SETTING: Despite WHO and IUATLD recommendations to use fixed-dose combination (FDC) tablets for treatment of tuberculosis, more than 75% of all rifampicin used in the public sector globally is administered as single drug tablets. OBJECTIVE: To estimate the potential global market for rifampicin-containing FDCs in the public and private sectors. DESIGN: The public sector market for FDCs was calculated from the number of tuberculosis cases notified to WHO for 1996 and from information on treatment regimens currently used in each country. The private sector market was calculated from the estimated number of treated tuberculosis cases and the treatment regimens presumed to be used in the private sector. RESULTS: The potential global market for the four-drug FDC tablet (rifampicin 150 mg, isoniazid 75 mg, pyrazinamide 400 mg and ethambutol 275 mg) is 305 (90%CI 145-505) million tablets per year, 105 (90%CI 50-160) and 200 (90%CI 95-345) million of which would be distributed in the public and private sectors, respectively. The uncertainty of the estimate remains considerable, as shown by the 90% confidence intervals. CONCLUSION: The study demonstrated a large potential global market for FDCs that should encourage pharmaceutical manufacturers to produce WHO-recommended dosages of FDCs at affordable prices.

Antibiotics, Antitubercular↗
PubMed1999

Structures required, roles and responsibilities in maintaining laboratories for quality assurance of anti-tuberculosis fixed-dose combinations in accordance with the IUATLD/WHO statement.

Combining rifampicin in the same tablet with isoniazid, with or without pyrazinamide, is known to affect the bioavailability of the drug. It is also known that many fixed-dose combination (FDC) preparations exist in the market which are of inferior quality, but are unknowingly used extensively in tuberculosis treatment programmes in low-income countries with high tuberculosis caseloads. This has led to joint statements by the International Union Against Tuberculosis and Lung Disease and the World Health Organization (WHO) pointing out that anti-tuberculosis FDCs should only be used in National Tuberculosis Programmes if the bioavailability of at least the rifampicin component has been demonstrated. Through the FDC Quality Assurance Project launched by the WHO in 1997, a strategy was proposed which aimed to provide specific guidance to ensure the improved quality of such preparations, and in particular the bioavailability of the rifampicin component. A crucial component of drug quality assurance is to ensure that the infrastructure and logistics required to carry out the operational aspects of quality assurance are adequate and sustainable. This paper describes the structures and management responsibilities required to meet this objective, based on general WHO guidelines for the quality assurance of pharmaceuticals.

Antibiotics, Antitubercular↗
PubMed1999

Availability of quality fixed-dose combinations for the treatment of tuberculosis: what can we learn from studying the World Health Organization's vaccine model?

SETTING: In efforts to promote the use of fixed-dose combinations (FDCs) for the treatment of tuberculosis (TB), the World Health Organization (WHO) and partners address the issue of quality assurance. OBJECTIVE: To provide guidance for the development of strategies for quality assurance of FDCs. DESIGN: This review examines the WHO strategies for and experience with quality assurance and supply of vaccines. RESULTS: Several elements in the strategies for quality assurance and supply of vaccines may be applicable for FDCs. At national level, the important strategies are to strengthen National Regulatory Authorities (NRA) and procurement systems and develop planning activities. Stressing quality assurance of FDCs in training activities for regulatory personnel and recommending that aid agencies require adherence to quality assurance policies as conditions for support would promote the implementation of quality assurance of FDCs at country level. At the global level, pre-qualification of manufacturers of FDCs should be explored as a mechanism to assure quality. The pre-qualification process should include evaluation of product files, initial testing for compliance and consistency of specifications, and site visits to producers and NRAs. The vaccine model defines criteria for reassessment that can be used for FDCs.

Antitubercular Agents↗
PubMed1997

National tuberculosis programme review: experience over the period 1990-95.

Since 1990 the WHO Global Tuberculosis Programme (GTB) has promoted the revision of national tuberculosis programmes to strengthen the focus on directly observed treatment, short-course (DOTS) and close monitoring of treatment outcomes. GTB has encouraged in-depth evaluation of activities through a comprehensive programme review. Over the period 1990-95, WHO supported 12 such programme reviews. The criteria for selection were as follows: large population (Bangladesh, Brazil, China, Ethiopia, India, Indonesia, Mexico, and Thailand); good prospects of developing a model programme for a region (Nepal, Zimbabwe); or at advanced stage of implementation of a model programme for a region (Guinea, Peru). The estimated combined incidence of smear-positive pulmonary tuberculosis was 82 per 100,000 population, about 43% of the global incidence. The prevalence of infection with human immunodeficiency virus (HIV) was variable, being very high in Ethiopia and Zimbabwe, but negligible in Bangladesh, China, Nepal and Peru. The programme reviews were conducted by teams of 15-35 experts representing a wide range of national and external institutions. After a 2-3-month preparatory period, the conduct of the review usually lasted 2-3 weeks, including a first phase of meetings with authorities and review of documents, a second phase for field visits, and a third phase of discussion of findings and recommendations. The main lessons learned from the programme reviews were as follows: programme review is a useful tool to secure government commitment, reorient the tuberculosis control policies and replan the activities on solid grounds; the involvement of public health and academic institutions, cooperating agencies, and nongovernmental organizations secured a broad support to the new policies; programme success is linked to a centralized direction which supports a decentralized implementation through the primary health care services; monitoring and evaluation of case management functions well if it is based on the right classification of cases and quarterly reports on cohorts of patients; a comprehensive programme review should include teaching about tuberculosis in medical, nursing, and laboratory workers' schools; good quality diagnosis and treatment are the essential requirements for expanding a programme beyond the pilot testing; and control targets cannot be achieved if private and social security patients are left outside the programme scope. The methodology of comprehensive programme review should be recommended to all countries which require programme reorientation; it is also appropriate for carrying out evaluations at 4-5-year intervals in countries that are implementing the correct tuberculosis control policies.

Cost-Benefit Analysis↗
PubMed1996

Why a TB corner?

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AIDS-Related Opportunistic Infections↗
PubMed1993

Secular trends of tuberculosis in western Europe.

Deaths due to tuberculosis have decreased uniformly in all countries in Western Europe, and most have occurred among those aged > or = 65 years. In recent years, tuberculosis case notifications have continued to decline in Belgium, Finland, France, Germany, and Spain, and have levelled off in Sweden and the United Kingdom; increases have, however, been recorded in Austria, Denmark, Ireland, Italy, Netherlands, Norway, and Switzerland. In Denmark, Netherlands, Norway, Sweden, and Switzerland an increasing number of cases of tuberculosis among foreign-born residents has resulted in a change from the expected downward trend. Human immunodeficiency virus (HIV) infection appears to contribute only marginally to the overall tuberculosis morbidity; however, it appears to be important in Paris and its surrounding areas, and tuberculosis is very common among HIV-infected persons in Italy and Spain. Despite these recent changes in the incidence of tuberculosis, there is currently no evidence of its increased transmission among the youngest age groups of the indigenous populations. Properly designed disease surveillance systems are critical for monitoring the tuberculosis trends so that each country can identify its own high-risk groups and target interventions to prevent, diagnose, and treat the disease. Tuberculosis remains a global disease and because of increasing human migrations, its elimination in Western Europe cannot be envisaged without concomitant improvements in its control in high-incidence, resource-poor countries.

AIDS-Related Opportunistic Infections↗
PubMed1991

Tuberculosis elimination in the countries of Europe and other industrialized countries.

The working group summarized the conclusions of the workshop with the intention of providing a guide for the preparation of national plans for tuberculosis elimination. The basic strategies that appear consistently effective are: 1. Direct government responsibility for diagnosis, treatment and prevention of tuberculosis (the government is responsible by law for assuring that tuberculosis is identified early, and that cure of the patients is achieved). 2. Maintenance (or development) of properly designed disease surveillance and a programme monitoring system. 3. Availability of specialized tuberculosis personnel at regional and provincial level, responsible for close monitoring of the diagnostic skills and patient prioritization in general health institutions. Regarding research it was felt that no immediate practical applications of new techniques in the diagnosis of mycobacterial diseases, in treatment, or in vaccination can be recommended, but that further basic research in the field of mycobacteria should be pursued and supported.

Communicable Disease Control↗
PubMed1989

Tuberculin survey among Afghan refugee children. Tuberculosis control programme among Afghan refugees in North West Frontier Province (NWFP) Pakistan.

Since 1982 over 2 million Afghan refugees have settled in the North West Frontier Province (NWFP) of Pakistan. Socio-economical factors, sudden urbanisation and psychological stress may influence the pattern of tuberculosis morbidity and infection among refugees as compared with the original population. In order to study the prevalence of tuberculous infection among Afghan children a tuberculin survey was carried out in April and May 1985 on a cluster sample of male children attending the first two grades of primary schools in refugee camps in the NWFP. The sample size was 4108 male children with an average age of 8 years. 1358 of them, average age of 7.8 years, had not been vaccinated with BCG. An infection prevalence of 13.8% was found when using a transverse diameter of 10 mm induration or more for the tuberculin test as the criterion for infection. The findings were compared with the results of a national sample survey carried out in Afghanistan in 1978: a downward trend of the annual risk of infection (ARI) of 7.8% per year was found in children of the same age group. Thus, Afghan children living in refugee camps in NWFP showed a lower ARI than was observed in their homeland 7 years earlier.

Afghanistan↗
PubMed1987

Reduction of histamine-induced bronchoconstriction by magnesium in asthmatic subjects.

The effects of inhaled MgSO4 on histamine bronchoprovocation test (BPT) were studied in nine asthmatics in clinical remission (FEV1 greater than 80% of predicted). Patients performed histamine BPT on 2 separate days, one day after saline and the other after MgSO4 inhalation, in a randomized double-blind design. Spirometry and flow/volume curve were recorded on each test day before and 5 min after NaCl or MgSO4. No significant difference was observed in lung function measurements 2 days before and after either NaCl or MgSO4. The dose of histamine which produced a 20% decrease in control FEV1 (PD20FEV1) was significantly increased by aerosolized MgSO4 (from 0.177 +/- 0.036 mg after NaCl to 0.350 +/- 0.085 after MgSO4, P less than 0.05. After MgSO4 the dose-steps of histamine concentration increased two-fold in two subjects and one-fold in five.

Administration, Inhalation↗
PubMed1985

A multivariate analysis of the risk in chronic obstructive lung disease (COLD).

This study was undertaken to assess the validity of cluster analysis for stratifying patients with severe COLD into homogenous subgroups in view of further prospective studies. To this aim, physiological measurements and questionnaire data were obtained from 532 outpatients with severe COLD (e.g. a 1 sec forced expiratory volume (FEV1) below 1.5-1/sec). The model variables selected for the partition in cluster were FEV1, PaO2, response to bronchodilators and heart rate. Two subgroups of patients were identified by the analysis: cluster I with significantly greater physiological impairment than cluster II. The comparison of the prevalences of the variables outside the model between the 2 clusters showed, in fact, that cluster I had a significantly higher prevalence of subjects with heavy smoking (p less than 0.01), prolonged occupational exposure (p less than 0.05), low body weight (p less than 0.05), recent hospitalizations for respiratory troubles (p less than 0.02) and emphysema (p less than 0.01). In conclusion, cluster analysis based on few physiological variables was able to identify, among patients with severe COLD, those with poorer general conditions and higher exposure to specific risk factors, for whom a worse prognosis of life can be expected. The advantages of cluster analysis in comparison to other techniques of classification in this kind of patient is discussed.

Analysis of Variance↗
PubMed1985

Salbutamol plus beclomethasone dipropionate versus theophylline for the prevention of methacholine-induced bronchospasm in patients with chronic bronchitis.

Forty patients suffering from chronic bronchitis with basal forced expiratory volume in one second (FEV1) values at least 20% below ECSC (European Community Steel and Coal) predicted values were treated with a combination of salbutamol plus beclomethasone dipropionate or with theophylline for a period of 4 weeks. Methacholine bronchial inhalation challenges were performed before and after treatment. Both treatments produced significant increases in FEV1, forced vital capacity (FVC) and FEV1 100/FVC, while only the salbutamol plus beclomethasone dipropionate combination significantly reduced the decrease in FEV1 values after bronchial inhalation challenge.

Adult↗
PubMed1984

Pulmonary involvement in chronic pancreatitis.

Although the association between acute pancreatitis and pleuropulmonary damage is well documented, so far no information on lung function in patients with chronic pancreatitis is available. In this study functional, radiological, and clinical investigations have been carried out in 42 patients affected by chronic calcific pancreatitis (CCP) and in 50 controls in a case-control study. An impairment of pulmonary diffusing capacity has been detected in CCP patients, while all the parameters of ventilatory function were not different from controls. This finding suggests the presence of early lung parenchymal damage in chronic pancreatitis secondary to either emphysema or pulmonary fibrosis.

Adult↗
PubMed1984

Different performance of two commercial nebulizers.

Two different nebulizers, the DeVilbiss 646 and the Mefar were tested for differences in output characteristics (air flow rate, amount of nebulized liquid and particle size) and it was found that there is a high variability between nebulizers of both brands. In the light of these findings, neither of these devices can be chosen as a standard nebulizer for bronchial provocation.

Aerosols↗
PubMed1983

Site of airway obstruction after rapid saline infusion in healthy subjects.

Static and dynamic lung volumes, flow-volume curve in air and after He-O2 were carried out in 5 normal subjects baseline, immediately after rapid infusion of 2 litres of normal saline, and then 15, 30 and 60 min after. At the end of the infusion, a marked reduction of delta MEF50, FVC, FEV1, MEF50, MEF25 and an increase of Viso V and CV/VC were observed in all the subjects. The poor response to He-O2 suggests a predominant increase of small airway resistance after rapid infusion. In the recovery phase, He-O2 tests promptly returned to control values, while an increased CV/VC was detectable until 30 min after the infusion.

Adult↗