[Delayed-release drugs or with enteric cover: are they correctly used?]. / Fármacos de liberación retardada o con cubierta entérica: se utilizan correctamente?

OBJECTIVES: To estimate the prevalence of the correct use of a group of oral drugs, which must keep the integrity of their pharmaceutical pattern at the moment of taking them, by the population who uses them. DESIGN: A transversal and descriptive study based on observation, by means of a questionnaire, which evaluated how the interviewees used the drugs. SETTING: Twenty-eight communal chemists. PARTICIPANTS: Patients who came up to the chemist to get drugs included in the study. MEASURES AND RESULTS: 612 questionnaires were evaluated. It was detected that the 7% (95% CI, 5.1-9.2) of the interviewees chewed or grinded the delayed release drugs or with enteric cover, and the 72% (95% CI, 68.7-75.8) made at least one mistake when using these drugs. The most frequent errors were related to the conservation and the intake of the drug related to the food. No relation between the reading of the patient information leaflet and the correct use of these drugs has been observed. CONCLUSIONS: Due to the high percentage of interviewees who use drugs incorrectly, we believe that every health professional should provide the drug users with oral and written information on how to handle such drugs, specifically emphasizing how to use them and where to keep them.

Fármacos de liberación retardada o con cubierta entérica: ¿se utilizan correctamente? / Delayed-Release Drugs or With Enteric Cover: Are They Correctly Used?

Objetivo. Estimar la prevalencia de la correcta utilización de un grupo de medicamentos de administración oral que deben conservar la integridad de su forma farmacéutica en el momento de su utilización. Diseño. Estudio observacional transversal descriptivo realizado mediante cuestionario. Emplazamiento. Un total de 28 farmacias comunitarias de la provincia de Tarragona. Participantes. Personas que acudían a la farmacia a adquirir algún medicamento de los seleccionados en el estudio. Mediciones y resultados. Se evaluaron 612 cuestionarios. Los resultados indican que el 7% (intervalo de confianza [IC] del 95%, 5,1-9,2) de los entrevistados mastica o tritura los medicamentos de liberación retardada o con cobertura entérica, y el 72% (IC del 95%, 68,7-75,8) comete al menos un error al utilizar estos medicamentos. Los errores cometidos con más frecuencia han sido los referentes a la conservación del fármaco y la toma de los medicamentos respecto a los alimentos. No se ha observado ninguna relación entre la lectura del prospecto y la correcta utilización de estos medicamentos. Conclusiones. Debido al elevado porcentaje de entrevistados que utiliza la medicación de manera incorrecta, creemos que los profesionales de la salud deberían facilitar a los usuarios del medicamento información verbal y escrita sobre cómo manejarlos, y remarcar específicamente los aspectos relacionados con su utilización y conservación (AU)

Objectives. To estimate the prevalence of the correct use of a group of oral drugs, which must keep the integrity of their pharmaceutical pattern at the moment of taking them, by the population who uses them. Design. A transversal and descriptive study based on observation, by means of a questionnaire, which evaluated how the interviewees used the drugs. Setting. Twenty-eight communal chemists. Participants. Patients who came up to the chemist to get drugs included in the study. Measures and results. 612 questionnaires were evaluated. It was detected that the 7% (95% CI, 5.1-9.2) of the interviewees chewed or grinded the delayed release drugs or with enteric cover, and the 72% (95% CI, 68.7-75.8) made at least one mistake when using these drugs. The most frequent errors were related to the conservation and the intake of the drug related to the food. No relation between the reading of the patient information leaflet and the correct use of these drugs has been observed. Conclusions. Due to the high percentage of interviewees who use drugs incorrectly, we believe that every health professional should provide the drug users with oral and written information on how to handle such drugs, specifically emphasizing how to use them and where to keep them (AU)

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Diagnostic accuracy and case management of clinical malaria in the primary health services of a rural area in south-eastern Tanzania.

Malaria control continues to rely on the diagnosis and prompt treatment of both suspected and confirmed cases through the health care structures. In south-eastern Tanzania malaria is one of the leading causes of morbidity and mortality. The absence of microscopic examination in most of the health facilities implies that health workers must rely on clinical suspicion to identify the need of treatment for malaria. Of 1558 randomly selected paediatric consultations at peripheral health facilities throughout Kilombero District, 41.1% were diagnosed by the attending health worker as clinical malaria cases and 42.5% prescribed an antimalarial. According to our malaria case definition of fever or history of fever with asexual falciparum parasitaemia of any density, 25.5% of all children attending the health services had malaria. This yielded a sensitivity of 70.4% (IC95% = 65.9-74.8%) and a specificity of 68.9% (IC95% = 66.2-71.5%). Accordingly, 30.4% of confirmed cases left with no antimalarial treatment. Among malaria-diagnosed patients, 10% were underdosed and 10.5% were overdosed. In this area, as in many African rural areas, the low diagnostic accuracy may imply that the burden of malaria cases may be overestimated. Greater emphasis on the functioning and quality of basic health services in rural endemic areas is required if improved case management of malaria is to help roll back this scourge.

[Assessment of the comprehension of new rephrasing drug package inserts]. / Evaluación de la comprensión de un nuevo modelo de prospecto del medicamento.

BACKGROUND: The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed. SUBJECTS AND METHOD: A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms. RESULTS: 1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employment status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet. CONCLUSIONS: The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.

The impact of placental malaria on gestational age and birth weight.

Maternal malaria is associated with reduced birth weight, which is thought to be effected through placental insufficiency, which leads to intrauterine growth retardation (IUGR). The impact of malaria on preterm delivery is unclear. The effects of placental malaria-related changes on birth weight and gestational age were studied in 1177 mothers (and their newborns) from Tanzania. Evidence of malaria infection was found in 75.5% of placental samples. Only massive mononuclear intervillous inflammatory infiltration (MMI) was associated with increased risk of low birth weight (odds ratio ¿OR, 4.0). Maternal parasitized red blood cells and perivillous fibrin deposition both were associated independently with increased risk of premature delivery (OR, 3.2; OR, 2.1, respectively). MMI is an important mechanism in the pathogenesis of IUGR in malaria-infected placentas. This study also shows that placental malaria causes prematurity even in high-transmission areas. The impact of maternal malaria on infant mortality may be greater than was thought previously.

Maternal mortality in a rural district of southeastern Tanzania: an application of the sisterhood method.

BACKGROUND: Deaths from maternal causes represent the leading cause of death among women of reproductive age in most developing countries. It is estimated that the highest risk occurs in Africa, with 20% of world births but 40% of the world maternal deaths. The level of maternal mortality is difficult to assess especially in countries without an adequate vital registration system. Indirect techniques are an attractive cost-effective tool to provide estimates of orders of magnitude for maternal mortality. METHOD: The level of maternal mortality estimated by the sisterhood method is presented for a rural district in the Morogoro Region of Southeastern Tanzania and the main causes of maternal death are studied. Information from region-specific data using the sisterhood method is compared to data from other sources. RESULTS: The maternal mortality ratio (MMR) was 448 maternal deaths per 100,000 live births (95%CI : 363-534 deaths per 100,000 live births). Maternal causes accounted for 19% of total mortality in this age group. One in 39 women who survive until reproductive age will die before age 50 due to maternal causes. The main cause of death provided by hospital data was puerperal sepsis (35%) and postpartum haemorrhage (17%); this is compatible with the main causes reported for maternal death in settings with high levels of maternal mortality, and similar to data for other regions in Tanzania. The sisterhood method provides data comparable with others, together with a cost-effective and reliable estimate for the determination of the magnitude of maternal mortality in the rural Kilombero District.

Cost-effectiveness of iron supplementation and malaria chemoprophylaxis in the prevention of anaemia and malaria among Tanzanian infants.

Prerequisites for effective interventions against severe anaemia and malaria among infants are economic evaluations to aid the setting of priorities and the making of health policy. In the present study we analysed the cost and effectiveness of three control strategies hypothetically delivered through the Expanded Programme on Immunization (EPI). For the prevention of severe anaemia and from the perspective of the health provider, the cost-effectiveness ratios were, respectively, US$ 8, US$ 9, and US$ 21 per disability-adjusted life year (DALY) for malaria chemoprophylaxis with Deltaprim (a combination of 3.125 mg pyrimethamine and 25 mg dapsone) + iron, Deltaprim alone, or iron supplementation alone. For malaria prevention, Deltaprim + iron cost US$ 9.7 per DALY and Deltaprim alone cost US$ 10.2 per DALY. From a sociocultural perspective the cost-effectiveness ratios ranged from US$ 9 to US$ 26 for severe anaemia prevention and from US$ 11 to US$ 12 for the prevention of clinical malaria. These ratios were highly cost-effective, as defined by the World Bank's proposed threshold of less than US$ 25 per DALY for comparative assessments. Furthermore, all the preventive interventions were less costly than the current malaria and anaemia control strategies that rely on clinical case management. This economic analysis supports the inclusion of both malaria chemoprophylaxis and iron supplementation delivered through EPI as part of the control strategies for these major killers of infants in parts of sub-Saharan Africa.

African children with malaria in an area of intense Plasmodium falciparum transmission: features on admission to the hospital and risk factors for death.

Malaria remains the most important parasitic cause of mortality in humans. Its presentation is thought to vary according to the intensity of Plasmodium falciparum transmission. However, detailed descriptions of presenting features and risk factors for death are only available from moderate transmission settings. Such descriptions help to improve case management and identify priority research areas. Standardized systematic procedures were used to collect clinical and laboratory data on 6,624 children admitted to hospital over a 1-year period in an intensely malarious part of Tanzania. Frequencies of signs and symptoms were calculated and their association with a fatal outcome was assessed using multivariate logistic regression. There were 72 deaths among 2,432 malaria cases (case fatality rate [CFR] = 3.0%); 44% of the cases and 54% of the deaths were in individuals less than 1 year of age. There was no association between level of parasitemia and CFR. Increased risk of dying was independently found in all children with hypoglycemia (odds ratio [OR] = 6.7, 95% confidence interval [CI] = 3.9-11.7), in children 1-7 months of age with tachypnea (OR = 8.8, 95% CI = 2.6-30.5) and dehydration (OR = 5.0, 95% CI = 1.9-14.2), and in children 8 months to 4 years of age with chest indrawing (OR = 4.7, 95% CI = 2.0-11.2) and inability to localize a painful stimulus (OR = 6.9, 95% CI = 2.9-16.5). Children in the bottom quartile of weight-for-age were more likely to die (OR = 2.1, 95% CI = 1.3-3.5). Eight percent of the malaria cases had severe anemia (packed cell volume < 15%) but 24% received a blood transfusion. The epidemiology of malaria disease may be more complex than previously thought. Improved case management in a wide variety of health facilities may result from adequate identification and treatment of dehydration and hypoglycemia. Transfusion-requiring anemia is a major problem and sustainable, effective preventive measures are urgently needed.

Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants.

BACKGROUND: Malaria and anaemia, especially that due to iron deficiency, are two leading causes of morbidity worldwide. Little is known about the relative contribution of Plasmodium falciparum infection and iron deficiency to the aetiology of anaemia in malaria-endemic areas. We undertook a randomised comparison of different strategies for control of anaemia and malaria in infants, including an assessment of the effect of iron supplementation on malaria susceptibility. METHODS: 832 infants born at one hospital in a malaria-hyperendemic area of Tanzania between January and October, 1995, were randomly assigned to group DI, receiving daily oral iron (2 mg/kg daily) plus weekly Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone); group IP, receiving iron plus weekly placebo; group DP, receiving daily placebo plus weekly Deltaprim; or group PP. supplementation was given from 8 to 24 weeks of age, and the weekly chemoprophylaxis from 8 to 48 weeks. The frequency of severe anaemia (packed-cell volume < 25%) and malaria episodes was assessed through a combination of passive case detection and cross-sectional surveys. FINDINGS: The groups that received iron supplementation had a lower frequency of severe anaemia than those that did not receive iron (0.62 vs 0.87 cases per person-year; protective efficacy 28.8% [95% CI 6.3-45.8). Iron supplementation had no effect on the frequency of malaria (0.87 vs 1.00 cases per person-year; protective efficacy 12.8% [-12.8 to 32.5]). The groups that received malaria prophylaxis had lower frequencies of both severe anaemia (0.45 vs 1.04 episodes per person-year; protective efficacy 57.3% [43.0-67.9]) and malaria (0.53 vs 1.34 episodes per person-year; protective efficacy 60.5% [48.2-69.9]) than the groups that did not receive prophylaxis. After the end of the intervention period, children who had received malaria chemoprophylaxis had higher rates of severe anaemia and malaria than non-chemoprophylaxis groups (relative risks 2.2 [1.3-3.7] and 1.8 [1.3-2.6]). INTERPRETATION: Malaria chemoprophylaxis during the first year of life was effective in prevention of malaria and anaemia but apparently impaired the development of natural immunity. Iron supplementation was effective in preventing severe anaemia without increasing susceptibility to malaria. Our findings support iron supplementation of infants to prevent iron-deficiency anaemia, even in malaria-endemic areas.

PIP: The impact of iron supplementation and malaria chemoprophylaxis was investigated in a double-blind, placebo-controlled study involving 832 infants born in a malaria-hyperendemic area of Tanzania in 1995. Infants were randomly assigned to receive daily oral iron (2 mg/kg) and weekly Deltaprim (3-125 mg pyrimethamine plus 25 mg dapsone), daily iron plus weekly placebo, or daily and weekly placebo. Daily supplementation was provided from 8 to 24 weeks of age, while weekly chemoprophylaxis was given from 8 to 48 weeks. The 2 groups that received iron supplementation had a lower frequency of severe anemia (packed cell volume under 25%) than those who received placebo (0.62 versus 0.87 cases per person-year; protective efficacy, 28.8%), but iron supplementation did not have a significant effect on malaria incidence (0.87 versus 1.00 cases per person-year; protective efficacy, 12.8%). Infants who received malaria prophylaxis had lower frequencies of both severe anemia (0.45 versus 1.04 episodes per person-year; protective efficacy, 57.3%) and malaria (0.53 versus 1.43 episodes per person-year; protective efficacy, 60.5%) than those who received placebo. However, after the end of the intervention period, children who had received malaria prophylaxis had higher rates of severe anemia and malaria than those in the non-chemoprophylaxis groups (relative risks, 2.2 and 1.8, respectively). These findings indicate that malaria chemoprophylaxis during the first year of life can impair the development of natural immunity, while iron supplementation effectively prevents severe anemia without increasing susceptibility to malaria.

A comparative study of the efficacies of chloroquine and a pyrimethamine-dapsone combination in clearing Plasmodium falciparum parasitaemia in school children in Tanzania.

A randomized study on the in vivo efficacies of chloroquine and a pyrimethamine-dapsone combination (Maloprim) in clearing P. falciparum parasitaemia was carried out in 77 asymptomatic semi-immune schoolchildren in the Kilombero District of Tanzania. Children were randomized to receive either chloroquine at a dose of 25 mg/kg over three days, or Maloprim (6.25 mg pyrimethamine + 50 mg dapsone for children under 10 years, and 12.5 mg pyrimethamine + 100 mg dapsone for children 10 or more years old) as a single dose. Children were followed-up for malaria parasitaemia at days 2, 7 and 14 after screening, randomization and treatment. The slide positivity rate was lower in the Maloprim group at all cross-sectional surveys (23 vs 37% at day 2; 9 vs 20% at day 7; 21 vs 32% at day 14) but none of these differences reached statistical significance. No cases in the Maloprim group showed RII resistance, whereas in the chloroquine group, 2 cases showed RII resistance and a further 2 cases RIII resistance (6%). No major side-effects were reported. The combination of pyrimethamine-dapsone appears to be a better choice than chloroquine as a chemoprophylactic regimen for malaria in this area. Although they need to be confirmed in a larger study, these results may be of interest to the policy-makers as well as researchers.

Duration of protection and age-dependence of the effects of the SPf66 malaria vaccine in African children exposed to intense transmission of Plasmodium falciparum.

The SPf66 synthetic vaccine is safe and partly efficacious against Plasmodium falciparum malaria among children 1-5 years old. The estimated vaccine efficacy [VE] for all clinical episodes over a period of 18 months after the third dose is 25% (95% confidence interval [CI], 1%-44%; P = .044). The observed temporal variations in efficacy could have been due to chance (likelihood ratio chi 2 = 13.8, 8 df; P = .086). Efficacy against clinical malaria did not vary significantly with age (chi 2 = 1.07, 4 df; P = .90). Overall parasite density was 21% lower in vaccine recipients than in the placebo group (95% CI, 0%-38%; P = .044). Further development of SPf66 may require trials to evaluate safety, immunogenicity, and efficacy when administered in the first year of life, together with other vaccines contained in the Expanded Programme of Immunization schedule.

Efecto antitumoral del factor de crecimiento epidérmico (EGF) en carcinomas de piel humanos: reporte preliminar / Anti-tumoral effect of epidermal growth factor (EGF) in human skin carcinomas: preliminary report

El factor de crecimiento epidérmico (EGF), es un polipéptido mitogénico para células de origen epitelial y mesenquimatoso; sin embargo, tiene un efecto inhibitor de la proliferación in vitro de las células que tienen un número muy elevado de receptores de EGF en su superficie. Resultados precedentes de nuestro laboratorio demostraron que este efecto inhibidor también puede obtenerse in vivo, en tumores humanos creciendo como xenotransplantes en ratones atímicos. En este artículo presentamos las primeras evidencias clínicas del efecto del EGF en carcinomas humanos. Se trataron 10 carcinomas de piel (9 pacientes) mediante la aplicación diaria tópica de una crema que contenía 10*g/g de EGF humano recombinante. Durante las tres semanas de tratamiento no se obtuvo ninguna evidencia de progresión tumoral, al contrario, la mitad de las lesiones mostraron una respuesta objetiva favorable. Cuatro pacientes refirieron mejoría subjetiva intensa, dada por alivio del dolor y recuperación funcional de las estructuras afectadas por el tumor. En cuatro pacientes se registraron notables cambios histológicos, dados por una disminución en la proporción de células tumorales en el tejido, un aumento en la reacción estromal y la aparición de infiltrado inflamatorio. La ampliación del concepto de hormono-dependencia, para incluir la regulación de tumores por factores de crecimiento, implica como corolario la aplicación del campo de la terapia hormonal, para incluir el tratamiento con factores de crecimiento o sus análogos. Estos resultados preliminares son la primera evidencia de que estos conceptos pueden ser aplicables en la clínica.

Efecto antitumoral del factor de crecimiento epidérmico (EGF) en carcinomas de piel humanos: reporte preliminar / Anti-tumoral effect of epidermal growth factor (EGF) in human skin carcinomas: preliminary report

El factor de crecimiento epidérmico (EGF), es un polipéptido mitogénico para células de origen epitelial y mesenquimatoso; sin embargo, tiene un efecto inhibitor de la proliferación in vitro de las células que tienen un número muy elevado de receptores de EGF en su superficie. Resultados precedentes de nuestro laboratorio demostraron que este efecto inhibidor también puede obtenerse in vivo, en tumores humanos creciendo como xenotransplantes en ratones atímicos. En este artículo presentamos las primeras evidencias clínicas del efecto del EGF en carcinomas humanos. Se trataron 10 carcinomas de piel (9 pacientes) mediante la aplicación diaria tópica de una crema que contenía 10*g/g de EGF humano recombinante. Durante las tres semanas de tratamiento no se obtuvo ninguna evidencia de progresión tumoral, al contrario, la mitad de las lesiones mostraron una respuesta objetiva favorable. Cuatro pacientes refirieron mejoría subjetiva intensa, dada por alivio del dolor y recuperación funcional de las estructuras afectadas por el tumor. En cuatro pacientes se registraron notables cambios histológicos, dados por una disminución en la proporción de células tumorales en el tejido, un aumento en la reacción estromal y la aparición de infiltrado inflamatorio. La ampliación del concepto de hormono-dependencia, para incluir la regulación de tumores por factores de crecimiento, implica como corolario la aplicación del campo de la terapia hormonal, para incluir el tratamiento con factores de crecimiento o sus análogos. Estos resultados preliminares son la primera evidencia de que estos conceptos pueden ser aplicables en la clínica.