The Effects of the Uncontrolled Use of Biomodulina T on the Severity of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection in Older Cuban Adults: An Open Label Evaluation.

BACKGROUND: The ongoing coronavirus disease 2019 (COVID-19) pandemic is a worldwide public health threat. Millions of people are at risk and older adults are more susceptible to developing the most serious manifestations of the disease, in part because of the effects of ageing on the immune system. Biomodulina T is an injectable immune modulator that has been licensed for use in Cuba for many years. OBJECTIVE: An open-label, uncontrolled trial was conducted to investigate whether or not it might be useful to prevent or modulate the serious effects of severe acute respiratory syndrome coronavirus 2 infections in older Cuban adults before the availability of vaccinations. METHODS: From April 12 to August 31, 2021, 1239 adults aged 60 years and older, unvaccinated against COVID-19 were recruited from the José Luis Dubrocq polyclinics, to receive Biomodulina T, 1 intramuscular 3 mL dose weekly for 6 weeks. Each person was visited at home weekly to be administered Biomodulina T. Once daily patients were seen by a medical student to collect information on any possible adverse events related to the medication as well as any symptoms of COVID-19. The possible usefulness of the intervention and its potential adverse events were assessed based on the number of older adults who became infected with COVID-19, and the severity of any symptoms reported or noted both during the 6-week treatment period and during an additional 6-week posttreatment observation period. RESULTS: Sixteen patients were diagnosed with symptomatic COVID-19 during the intervention using a specific reverse transcription polymerase chain reaction test. One patient died because of COVID-19. The most common preexisting diagnoses in treated patients included high blood pressure in 64.8%, diabetes mellitus in 19.85%, and ischemic cardiopathy in 13.88%. Biomodulina T was well tolerated. Only infrequent, mild, transient, and self-limited adverse events were identified. Both the incidence of COVID-19 infections and the overall mortality rate were lower in the treated patients than what was observed in the untreated general population of this Cuban province during the same time period. CONCLUSIONS: Although further, confirmatory, double-blind, controlled clinical trials are needed, Biomodulina T injections were well tolerated, and the results of this open, uncontrolled study suggest that it may have been useful to decrease the incidence and severity of symptomatic COVID-19 infection in these older Cuban adults. (Curr Ther Res Clin Exp. 2022; 82:XXX-XXX) © 2022 Elsevier HS Journals, Inc.

Effectiveness and Tolerability of 3-Day Mebendazole Treatment of Giardia duodenalis Infection in Adults and Children: Two Prospective, Open-Label Phase IV Trials.

BACKGROUND: Giardia duodenalis is the most common intestinal pathogenic protozoan infection reported in humans. Both in vitro studies and 4 separate, sequential, comparative clinical trials conducted by our group in Cuba demonstrated mebendazole activity against G. duodenalis infection in both children and adults. OBJECTIVE: The 2 additional, prospective, open-label, Phase IV follow-up studies reported here were performed to further assess the effectiveness and safety profile of mebendazole in the outpatient treatment of G. duodenalis infection. METHODS: Assenting children (n = 522) whose guardians gave permission and consenting adults (n = 423) diagnosed with G. duodenalis infection were given mebendazole (200 mg 3 times daily for 3 days). Medical histories and stool samples were obtained and physical/laboratory examinations were performed pretreatment then repeated on days 3, 5, and 7 after treatment completion. The evaluation of efficacy (ie, cure) was based on parasitologic response to therapy. Participants were considered cured, if no Giardia trophozoites or cysts were found in any of the 3 posttreatment fecal specimens evaluated by direct wet mounts and/or after Ritchie concentration techniques. RESULTS: No participant refused to be enrolled and all returned for follow-up examinations. At the end of the treatment, stool samples were negative in 450 out of 522 children (86.2%) and 392 of 423 adults (92.7%). Treatment was well tolerated. In adults, the only adverse effect reported was abdominal pain (6.2%). Side effects reported in children included abdominal pain (5.6%), nausea (2.9%), and vomiting (2.3%). Reported side effects were all mild, transient, and self-limited and did not require discontinuation of treatment or additional medication. CONCLUSIONS: Mebendazole may be an effective alternative treatment of G. duodenalis infections in both children and adults.

Prevalence of intestinal parasites and associated risk factors among schoolchildren from Unión de Reyes municipality, Matanzas Province, Cuba.

Intestinal parasites are widely distributed around the world and children are the most common affected group. The prevalence of intestinal parasites and associated risk factors by a cross-sectional study among children at a primary school in the Union de Reyes municipality, Matanzas province, Cuba, was carried out during April-May, 2022. Blastocystis spp. and Giardia intestinalis were the most common parasites found.

Pharmacodynamic of Recombinant Human Interferon Alpha-2b Nasal Drops and Effective Prophylaxis Against SARS-COV-2 Infection.

The recombinant human interferon alpha-2b (IFN-α2b) nasal drop formulation (Nasalferon) was studied as prophylaxis for SARS-CoV-2. Healthy volunteers between 19 and 80 years of age received 0.5 million international units of IFN in one drop (0.05 mL ) in each nostril, twice a day, for 10 consecutive days. The nondetection of SARS-CoV-2 by real-time polymerase chain reaction was the primary outcome variable. Several IFN-α biomarkers, including intranasal gene expression and innate immune effector activity, were increased in participants who received intranasal IFN-α2b. The study included 2,930 international travelers and 5,728 persons who were their close contacts. The subjects were treated with Nasalferon in January 2021, and 9,162 untreated travelers were included as controls. COVID-19 rate in treated subjects was significantly lower than in untreated subjects (0.05% vs. 4.84%). The proportion of travelers with COVID-19 decreased from 60.9% to 2.2% between December 2020 and February 2021. Furthermore, 1,719 tourism workers also received Nasalferon, and no cases of SARS-CoV-2 infection were detected, whereas 39 COVID-19 cases (10.6%) were reported in 367 untreated subjects. The main adverse events associated with the use of intranasal IFN-α2b were nasal congestion, headache, and rhinorrhea. Our prophylactic health interventions study demonstrates that the daily administration of Nasalferon for 10 days decreases the risk of developing COVID-19 in healthy volunteers. [Figure: see text].

[Acute fasciolosis: a Cuban case report]. / Fasciolosis aguda: presentación de un caso de Cuba.

Fasciolosis is a worldwide parasitic disease in human and domestic animals. The causative agents of fasciolosis are Fasciola hepatica and Fasciola gigantica but, in Cuba, only F. hepatica has been notified. As others neglected diseases, F. hepatica is more common in people living in rural areas where infected animals, intermediate hosts and susceptible hosts coexist. We describe the clinical features of a case that could contribute to the process of continuing medical education of health professionals in our geographic area.

Intestinal protozoan and helminth infections in the Municipality San Juan y Martínez, Pinar del Río, Cuba.

A cross-sectional study was carried out to determine the prevalence of intestinal parasitic infections and the intensity of soil-transmitted helminths (STHs) among children who attend the educational centres of San Juan y Martinez, Cuba. Ascaris lumbricoides, Blastocystis hominis and Giardia lamblia were the most common parasites found, with prevalence rates of 40.5%, 38.5% and 25%, respectively. In total, 91% of children harboured at least one type of intestinal parasite. The rates and intensity of intestinal parasitic infections found permit us to speculate that the conditions that predispose to acquire intestinal protozoan and STH infections persist in this municipality.

Randomized clinical study of five days apostrophe therapy with mebendazole compared to quinacrine in the treatment of symptomatic giardiasis in children.

AIM: To compare the efficacy and safety of five days apostrophe therapy of mebendazole (MBZ) versus quinacrine (QC) on human giardiasis in children. METHODS: A clinical trial was carried out in paediatric patients (aged 5-15 years) with confirmed symptomatic G. duodenalis mono-infection. Patients were randomly assigned to receive either MBZ [200 mg taken three times per day (TID) (n = 61)] or QC [2 mg/kg bodyweight tid (n = 61)], both for five days. Follow-up faecal samples were obtained at 3, 5 and 7 d after the end of the treatment. RESULTS: Although the frequency of cure was higher for QC (83.6%) than for MBZ (78.7%), the difference was not statistically significant (P > 0.05). Adverse events were reported more in the QC group (P < 0.05), all of them transient and self-limiting. CONCLUSION: Despite final cure rates ocurring lower than expected, the overall results of this study reconfirmed the efficacy of MBZ in giardiasis and also indicate that, although comparable to QC, at least in this setting the 5 d course of MBZ did not appear to improve the cure rates in this intestinal parasitic infection.

Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: a randomized, placebo-controlled, double-blind clinical trial.

BACKGROUND: Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. AIM: To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. MATERIALS AND METHODS: A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day) or placebo. Patients were evaluated during treatment period. RESULTS: Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%), nausea and vomiting (80%). CONCLUSION: Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy.

Intestinal parasites in children from a day care centre in Matanzas City, Cuba.

BACKGROUND: Intestinal parasitic infections are widely distributed throughout the world and children are the most affected population. Day care centres are environments where children have proven to be more susceptible to acquiring IP. METHODS AND PRINCIPAL FINDINGS: A cross-sectional study was carried to determine the prevalence of intestinal parasites in stool samples among children who attend to a day care centre in an urban area of Matanzas city, Cuba, from March to June 2012. 104 children under five years old were included on the study after informed consent form was signed by parents or legal guardians. Three fresh faecal samples were collected from each child in different days and were examined by direct wet mount, formalin-ether, and Kato- Katz techniques. Data relating to demography, socioeconomic status, source of drinking water, and personal hygiene habits were also collected using a standardized questionnaire. In total, 71.1% of children harbored at least one type of intestinal parasite and 47 (45.2%) were infected by more than one species. Giardia duodenalis and Blastocystis sp. were the most common parasites found, with prevalence rates of 54.8% and 38.5% respectively. CONCLUSIONS: Despite public health campaigns, improvement in the level of education, and the availability of and access to medical services in Cuba infections by intestinal protozoan is high in this centre. Almost nothing is published regarding intestinal parasites in Matanzas province during the last 40 years so this work could also be the initial point to carry out other studies to clarify the IP status in this region.

Albendazole versus metronidazole in the treatment of adult giardiasis: a randomized, double-blind, clinical trial.

BACKGROUND: Albendazole (ABZ) is a benzimidazole carbamate compound currently in use for human medical practice against enterobiasis and soil-transmitted helminthiasis (STH); However, its spectrum of activity is broad and goes beyond these infections. OBJECTIVE: This study compares the efficacy and safety of ABZ versus metronidazole (MTZ) in human giardiasis. RESEARCH DESIGN AND METHODS: A randomized, double-blind, clinical trial was carried out at the Centre of Hygiene, Epidemiology and Microbiology in Matanzas City, Cuba. Adult patients with confirmed symptomatic G. duodenalis mono-infection were randomly assigned to receive either ABZ [400 mg daily (n = 75)] or MTZ [250 mg t.i.d. (n = 75)], both for 5 days. Follow-up fecal samples were obtained at 3, 5, 7 days after treatment end. RESULTS: The efficacy was similar for both treatment groups: ABZ (82.6%) and MTZ (85.3%); p > 0.05. Side-effects including bitter taste, headache, vomiting and dizziness were significantly higher in the MTZ group. Abdominal pain was significantly higher in ABZ group. CONCLUSION: ABZ was found as effective as MTZ in the treatment of G. duodenalis infections in adult patients from Cuba and could be a useful drug in areas where co-infection with STH infections is common.

Mebendazole compared with secnidazole in the treatment of adult giardiasis: a randomised, no-inferiority, open clinical trial.

To compare the efficacy and safety of mebendazole and secnidazole in the treatment of giardiasis in adult patients, a single-centre, parallel group, open-label, randomized non-inferiority trial was carried out. One-hundred and 26 participants who had symptomatic Giardia mono-infection took part in the study. Direct wet mount and/or Ritchie concentration techniques and physical examinations were conducted at the time of enrolment and at the follow-up visit. The primary outcome measure was parasitological cure, performed at 3, 5, 10 days post-treatment. Negative faecal specimens for Giardia were ensured by the same parasitological techniques. At follow up (day 10) the parasitological cure rate for the per protocol populations was 88.7% (55/62) for MBZ and 91.8% (56/61) for SNZ. For the intention to treat populations the cure rate at the end of treatment was 85.9% (55/64) for MBZ and 90.3% (56/62) for SNZ. Both analyzes showed there was not significant statistical difference between MBZ and SNZ treatment efficacy. Both drugs were well tolerated, only mild, transient and self-limited side effects were reported and did not require discontinuation of treatment. A 3-day course of mebendazole seems to be as efficacious and safe for treatment of giardiasis as a single dose of secnidazole in adults.

Reacciones adversas en ensayos clínicos con nuevos fármacos conducidos en Brasil: años 2000 y 2012 / Adverse reactions in clinical trials carried out in Brazil with new drugs, years 2000-2012

Introducción: los ensayos clínicos constituyen un diseño de tipo experimental utilizado para evaluar cualquier actuación diagnóstica y terapéutica aplicada a humanos.Objetivo: evaluar los relatos de reacciones adversas a medicamentos, en cuanto a causalidad, gravedad, edad y grupos vulnerables en protocolos de ensayos clínicos con nuevos fármacos analizados en el Comité de Ética de la Investigación de la Secretaria de Salud de Brasilia. Distrito Federal, Brasil.Método: estudio observacional, descriptivo y transversal, en la modalidad de estudio de caso, se consideró como universo de trabajo los proyectos evaluados por el Comité de Ética en Investigación-CEI/SES/DF en el período comprendido entre los años 2000 y 2012. Resultados: el 59 por ciento de las investigaciones se correspondieron con estudios nacionales y el 41 por ciento con estudios internacionales. La industria farmacéutica fue la fuente financiadora en el 65 por ciento de los casos y en el 41 por ciento de ellos existió participación extranjera. De los medicamentos estudiados el 19 por ciento no poseían registro en la Agencia Nacional de Vigilancia Sanitaria-ANVISA y solo en el 9,5 por ciento de los ensayos se utilizó grupo control. Las reacciones adversas fueron consideradas como relacionadas a los medicamentos, posibles o improbables en el 15,7 por ciento, 19,8 por ciento y 63,6 por ciento, respectivamente.Conclusiones: la mayor parte de las investigaciones en las que se evaluaron nuevos medicamentos fueron conducidas por instituciones brasileñas y en la mayoría se recibió financiación internacional. La falta de registro de algunos de los nuevos productos en la agencia nacional reguladora y la no existencia de grupo control, en diferentes ensayos clínicos, fueron limitaciones identificadas en el proceso de evaluación. Se identificó la no existencia de modelos únicos legalmente validados para la evaluación de los eventos adversos a los medicamentos(AU)

Background: clinical trials are an experimental kind design used to assess any diagnostic and therapeutic performance applied to human beings.Aim: to assess the reports of adverse reactions to drugs, according to causality, seriousness, age and vulnerable groups in protocols of new drugs clinical trials analyzed in the Research Ethic Committee of Brasilia Health Secretariat, Federal District, Brazil. Method: cross-sectional, descriptive, observational study of case study kind. As universe of work, we took into account the projects assessed by the Research Ethic Committee of Brasilia Health Secretariat, Federal District (CEI/SES/DF in Portuguese) in the period from 2000 to 2012.Outcomes: 59 percent of the research corresponded to national studies and 41 percent to international ones. The pharmaceutical industry was the financeable source in 65 percent of the cases and there it was foreign participation in 41 percent of them. 19 percent of the studied drugs were not registered in the National Agency of Sanitary Surveillance (ANVISA in Portuguese) and control group was used in only 9,5 percent of the trials. The adverse reactions were considered as related to drugs, possible or improbable in 15,7 percent, 19,8 percent and 63,6 percent, respectively.Conclusions: most of the research where new drugs were assessed was carried out by Brazilian institutions and most of them received international financial support. The lack of registration of several new products in the national regulatory agency and not using control groups were limitations identified during the assessing process in several clinical trials. We identified the inexistence of unique models legally validated for the evaluation of adverse events to drugs(AU)

Microsporidiosis gastrointestinal: una actualización / Gastrointestinal microsporidiosis: an update

La microsporidiosis es una infección emergente y oportunista producida por microorganismos intracelulares obligados formadores de esporas que han sido taxonómicamente reclasificados como hongos. La eficacia y seguridad de diferentes productos farmacéuticos ha sido evaluada a lo largo de los años, sin embargo, es limitado el arsenal terapéutico del que se dispone a la hora de tratar individuos infectados por esos microorganismos. La actualización necesaria en relación con esta temática, así como la necesidad de un documento de consulta para los estudiantes de pre y post graduación determinó la realización de este trabajo, con el que se pretende ofrecer información actual, pertinente y de calidad que permita una mejor atención a los usuarios del sector salud y mantener el proceso de educación continuada de los profesionales en todos los niveles de atención(AU)

The microsporidiosis is an emergent and opportunist infection produced by spore-forming intracellular microorganisms, recently reclassified by taxonomists as fungi. The efficacy and safety of different pharmaceutical products has been evaluated along the years, however, the therapeutic arsenal is limited when treating infected people. The necessary update on this theme, and the necessity of a consultation document for pre and post graduate students determined the accomplishing of this review, pretending to offer the updated, pertinent and qualitative information that may allows a better medical care to the users of the health sector and maintaining the continued educational process of the professionals at all the public health care levels(AU)

Microsporidiosis gastrointestinal: una actualización / Gastrointestinal microsporidiosis: an update

La microsporidiosis es una infección emergente y oportunista producida por microorganismos intracelulares obligados formadores de esporas que han sido taxonómicamente reclasificados como hongos. La eficacia y seguridad de diferentes productos farmacéuticos ha sido evaluada a lo largo de los años, sin embargo, es limitado el arsenal terapéutico del que se dispone a la hora de tratar individuos infectados por esos microorganismos. La actualización necesaria en relación con esta temática, así como la necesidad de un documento de consulta para los estudiantes de pre y post graduación determinó la realización de este trabajo, con el que se pretende ofrecer información actual, pertinente y de calidad que permita una mejor atención a los usuarios del sector salud y mantener el proceso de educación continuada de los profesionales en todos los niveles de atención.

The microsporidiosis is an emergent and opportunist infection produced by spore-forming intracellular microorganisms, recently reclassified by taxonomists as fungi. The efficacy and safety of different pharmaceutical products has been evaluated along the years, however, the therapeutic arsenal is limited when treating infected people. The necessary update on this theme, and the necessity of a consultation document for pre and post graduate students determined the accomplishing of this review, pretending to offer the updated, pertinent and qualitative information that may allows a better medical care to the users of the health sector and maintaining the continued educational process of the professionals at all the public health care levels.

Development of an institutional curriculum in ethics and public health

La enseñanza de la bioética se ha enfocado tradicionalmente en actividades de aula, pero hay una necesidad ampliamente reconocida de oportunidades de desarrollo profesional para las personas con funciones científicas, clínicas o administrativas activas. Por otra parte, hay una escasez de evaluaciones de los programas de ética y programas de estudio. En este estudio transversal, encuestamos a profesionales de la higiene, epidemiología y microbiología, que asistieron a siete cursos de ética en la provincia de Matanzas, Cuba. El plan de estudios consistió en dos temas principales: ética de la investigación y ética de la salud pública. Esta medición comprendió una pre y post evaluación y entrevistas en profundidad con todos los participantes tres meses después del final de cada curso. La mayoría de los participantes (i) parecía demostrar un aumento de los conocimientos sobre investigación y ética de la salud pública, incluidas las directrices internacionales, (ii) dio una evaluación positiva de los cursos, y (iii) ratificó la importancia y pertinencia de este tipo de actividades de capacitación. Este pequeño estudio sugiere tipos de oportunidades de desarrollo profesional disponibles en entornos de recursos limitados(AU)

Bioethics teaching has traditionally focused on classroom activities, but there is a widely recognized need for professional development opportunities for people with active scientific, clinical or administrative duties. Moreover, there is a shortage of evaluations of ethics programs and curricula. In this cross-sectional study, we surveyed hygiene, epidemiology and microbiology professionals who attended 7 ethics courses in Matanzas province, Cuba. The curriculum consisted of 2 main themes: research ethics and public health ethics. The survey comprised pre- and post-test assessments and in-depth interviews of all participants 3 months after the end of each course. Most attendees (i) appeared to demonstrate increased of knowledge in research and public health ethics, including international guidelines, (ii) gave positive assessments of the courses and (iii) affirmed the importance and pertinence of such training activities. This small study is suggestive of the kinds of professional development opportunities available in limited resource settings(AU)