Pharmacodynamic Interactions Between Ketamine and Psychiatric Medications Used in the Treatment of Depression: A Systematic Review.

BACKGROUND: The use of ketamine for depression has increased rapidly in the past decades. Ketamine is often prescribed as an add-on to other drugs used in psychiatric patients, but clear information on drug-drug interactions is lacking. With this review, we aim to provide an overview of the pharmacodynamic interactions between ketamine and mood stabilizers, benzodiazepines, monoamine oxidase-inhibitors, antipsychotics, and psychostimulants. METHODS: MEDLINE and Web of Science were searched. RESULTS: Twenty-four studies were included. For lithium, no significant interactions with ketamine were reported. Two out of 5 studies on lamotrigine indicated that the effects of ketamine were attenuated. Benzodiazepines were repeatedly shown to reduce the duration of ketamine's antidepressant effect. For the monoamine oxidase-inhibitor tranylcypromine, case reports showed no relevant changes in vital signs during concurrent S-ketamine use. One paper indicated an interaction between ketamine and haloperidol, 2 other studies did not. Four papers investigated risperidone, including 3 neuroimaging studies showing an attenuating effect of risperidone on ketamine-induced brain perfusion changes. Clozapine significantly blunted ketamine-induced positive symptoms in patients with schizophrenia but not in healthy participants. One paper reported no effect of olanzapine on ketamine's acute psychotomimetic effects. CONCLUSION: Current literature shows that benzodiazepines and probably lamotrigine reduce ketamine's treatment outcome, which should be taken into account when considering ketamine treatment. There is evidence for an interaction between ketamine and clozapine, haloperidol, and risperidone. Due to small sample sizes, different subject groups and various outcome parameters, the evidence is of low quality. More studies are needed to provide insight into pharmacodynamic interactions with ketamine.

Isolation and identification of mycobacteria responsible for tuberculosis of dromedaries in Algeria. / Isolement et identification de mycobactéries responsables de la tuberculose du dromadaire en Algérie.

Tuberculosis in dromedaries in Algeria has been little studied to date. The purpose of this study is to determine the prevalence of tuberculosis in dromedaries in three Algerian slaughterhouses using samples from suspected tuberculosis lesions, which were detected on carcasses during a post-mortem visual inspection. The study also uses laboratory diagnosis to isolate and identify the agents responsible for the infection. Between 2016 and 2018, 102 carcasses (3.05%; with a confidence interval [CI] of 95% from 2.05 to 3.69) were suspected of tuberculosis out of a total of 3,342 dromedary carcasses inspected. The lesions were located as follows in the carcasses: 64 of 102 were in the lungs, 37 in the liver and 1 in a bronchial ganglion. Five and six samples respectively of suspected tuberculosis lesions were found to be positive by bacilloscopy (4.9%; with a CI of 95% from 1.61 to 11.1) and in culture (5.88%; with a CI of 95% from 2.19 to 12.36). The concordance between bacilloscopy and culture was good (kappa coefficient of 0.71) and the probability of finding a positive culture was 184 times greater when the bacilloscopy was positive (value of p = 0.01). Molecular characterisation by polymerase chain reaction of extracts of DNA gave a positive signal, indicating that the isolated strains belonged to a mycobacterium genus. An enzymatic restriction on DNA extracts indicated the presence of mycobacterium DNA belonging to the Mycobacterium tuberculosis complex. Spoligotyping on the same DNA extracts confirmed the presence of four strains of Mycobacterium bovis with the same spoligotype SB0941 and another strain with spoligotype SB2562, a newly described profile in this study, which is phylogenetically close to the previous profile. Using suspected tuberculosis lesions in dromedaries, a non-tuberculosis mycobacterium was identified as Mycobacterium virginiense MO-233 (sequence ID: Nr149186) using the sequencing technique on the region 16SrDNA. Having demonstrated the presence of tuberculosis with M. bovis in the Algerian dromedary population, it is now necessary to implement measures to control it in order to reduce transmission between animals and humans.

À ce jour, la tuberculose a été peu étudiée chez les camélidés en Algérie. L'objectif de cette étude est de déterminer la prévalence de la tuberculose cameline dans trois abattoirs algériens à partir de prélèvements de lésions suspectes de cette maladie qui ont été détectées sur des carcasses lors de l'examen à l'inspection visuelle post-mortem. L'étude vise aussi à isoler et à identifier les agents responsables de cette infection par un diagnostic de laboratoire. Durant la période de 2016 à 2018, 102 carcasses (3,05 % ; avec un intervalle de confiance [IC] à 95 % de 2,05 à 3,69) ont été déclarées suspectes de tuberculose sur un total de 3 342 carcasses de dromadaires inspectées. Concernant la localisation des lésions sur ces 102 carcasses, 64 présentaient des lésions aux poumons, 37 au niveau du foie et 1 dans un ganglion bronchique. Respectivement cinq et six échantillons de lésions suspectes de tuberculose cameline ont été trouvés positifs à la bacilloscopie (4,90 % ; avec un IC à 95 % de 1,61 à 11,10) et en culture (5,88 % ; avec un IC à 95 % de 2,19 à 12,36). La concordance entre la bacilloscopie et la culture était bonne (coefficient kappa de 0,71) et la probabilité de trouver une culture positive était 184 fois plus élevée lorsque la bacilloscopie était positive (valeur de p = 0,01). La caractérisation moléculaire par réaction de polymérisation en chaîne (PCR) des extraits d'ADN a montré un signal positif, signifiant que les souches isolées appartenaient au genre mycobactérien. Une restriction enzymatique réalisée sur des extraits d'ADN a indiqué la présence d'ADN d'une mycobactérie appartenant au complexe Mycobacterium tuberculosis. Une technique de spoligotypage réalisée sur les mêmes extraits d'ADN a permis de confirmer la présence de quatre souches de Mycobacterium bovis avec un même spoligotype SB0941 et d'une autre souche avec un spoligotype SB2562, un profil nouvellement décrit dans cette étude et qui est phylogénétiquement proche du profil précédent. Au départ de lésions suspectes de tuberculose chez le dromadaire, une souche de mycobactérie non tuberculeuse a été identifiée comme étant un Mycobacterium virginiense MO-233 (séquence ID : Nr149186) par la technique de séquençage de la région 16SrDNA. La présence de la tuberculose à M. bovis ayant été démontrée dans la population cameline algérienne, il est dès lors nécessaire de mettre en oeuvre des mesures visant à la contrôler en vue de réduire la transmission entre l'animal et l'homme.

A día de hoy, la tuberculosis está poco estudiada en los camélidos de Argelia. Los autores presentan un estudio encaminado a determinar la prevalencia de la tuberculosis de los camélidos en tres mataderos argelinos a partir de muestras de lesiones sospechosas, detectadas en las canales durante la inspección visual post-mortem. El estudio consistía pues en aislar e identificar, mediante técnicas de diagnóstico de laboratorio, a los agentes responsables de la infección. Entre 2016 y 2018, de un total de 3 342 canales de dromedarios inspeccionadas, 102 fueron declaradas sospechosas de tuberculosis (un 3,05%; intervalo de confianza [IC] del 95%: 2,05-3,69). En cuanto a la localización de las lesiones, en 64 de los 102 animales, estas se encontraban en los pulmones, en 37 de los 102 en la región del hígado y 1 de los animales presentaba una lesión en un ganglio bronquial. De las muestras de lesiones sospechosas de tuberculosis de los camélidos, cinco resultaron positivas por baciloscopia (un 4,90%; IC del 95%: 1,61-11,10) y seis en cultivo (un 5,88%; IC del 95%: 2,19-12,36). Entre la baciloscopia y el cultivo hubo una estrecha concordancia (coeficiente kappa: 0,71) y la probabilidad de encontrar un cultivo positivo fue 184 veces mayor cuando la baciloscopia era positiva (p = 0,01). La caracterización molecular de extractos de ácido desoxirribonucleico (ADN) por reacción en cadena de la polimerasa (PCR) deparó una señal positiva, lo que significa que las cepas aisladas pertenecían al género Mycobacterium. La aplicación de una técnica de restricción enzimática a extractos de ADN puso de relieve la presencia de ADN de una micobacteria perteneciente al complejo Mycobacterium tuberculosis. Aplicando una técnica de espoligotipificación a los mismos extractos de ADN se pudo confirmar la presencia de cuatro cepas de Mycobacterium bovis con un mismo espoligotipo, SB0941, y de otra cepa con el espoligotipo SB2562, patrón nuevo y filogenéticamente cercano al anterior que se describe aquí por primera vez. A partir de lesiones sospechosas de tuberculosis detectadas en dromedarios se pudo caracterizar una cepa de micobacteria no tuberculosa, identificada como Mycobacterium virginiense MO-233 (secuencia ID: Nr149186), con la técnica de secuenciación de la región 16S rDNA. Habiendo quedado demostrada la presencia de tuberculosis por M. bovis en la población de camélidos argelina, se impone la necesidad de implantar medidas para controlarla, a fin de reducir la transmisión entre los animales y el ser humano.

Evaluation of the bacteriological quality of raw cow's milk at various stages of the milk production chain on farms in Algeria. © OIE (World Organisation for Animal Health), 2016. / Évaluation de la qualité bactériologique du lait cru bovin à divers stades de la chaîne de production laitière dans des fermes en Algérie.

This study evaluates hygiene practices on 53 dairy farms in the Jijel and Blida regions of Algeria. A survey questionnaire was drawn up covering milking conditions and cleaning of the equipment. In parallel, bacteriological analyses were carried out to estimate the rate, source and development of bacterial contamination in raw milk produced on the farm. In addition, screening was performed to detect the presence of inhibitor residues. The results of the survey revealed poor livestock conditions and milking practices that could explain the presence of bacteria in cow's milk. The bacteriological results showed that 76.1% of milk samples taken from cow udders complied with legal standards, compared with only 35.8% of milk samples taken from storage tanks. Moreover, bacterial inhibitors were detected in 28.8% of milk samples. These results showed that the hands of milkers, udders, teat cups, utensils, the water used during milking and the milking environment were all potential sources of milk contamination by the bacteria under investigation. These results suggest that, to improve the bacteriological quality of milk, there is a need to introduce a quality policy which places a premium on milk of high bacteriological quality and aims to generalise good hygiene practices throughout the dairy production chain.

La présente étude consiste à évaluer les pratiques d'hygiène instaurées dans 53 exploitations bovines laitières réparties dans les régions de Jijel et de Blida en Algérie. Pour cela, un questionnaire d'enquête a été élaboré, portant sur les conditions de la traite et sur le nettoyage du matériel utilisé. En parallèle, des analyses bactériologiques ont été effectuées afin d'estimer le taux, l'origine et l'évolution de la contamination bactérienne du lait cru produit à la ferme. En outre, des recherches ont été effectuées pour déceler la présence de résidus d'inhibiteurs. Les résultats de l'enquête ont mis en évidence les mauvaises conditions d'élevage et des pratiques de la traite qui peuvent expliquer la présence de bactéries dans le lait de vache. Les résultats bactériologiques ont montré que 76,1 % des échantillons de lait prélevé au pis des vaches étaient conformes aux critères légaux, contre 35,8 % seulement des échantillons de lait provenant des cuves de stockage. De plus, la présence d'inhibiteurs bactériens a été décelée dans 28,8 % des échantillons de lait. Ces résultats ont permis de déterminer que les mains des trayeurs, les mamelles, les gobelets trayeurs, les ustensiles, l'eau et l'environnement de la traite étaient les sources potentielles de contamination du lait par les bactéries recherchées. À la lumière de ces résultats, l'amélioration de la qualité bactériologique du lait repose sur l'instauration d'une politique de qualité, visant à vulgariser les bonnes pratiques d'hygiène tout au long de la chaîne de production laitière et à mettre en place une prime à la qualité bactériologique du lait.

Los autores exponen un estudio destinado a evaluar las prácticas de higiene empleadas en 53 explotaciones bovinas lecheras de las regiones de Jijel y Blida (Argelia). Para ello se elaboró un cuestionario relativo a las condiciones de ordeño y a la limpieza del material utilizado. Paralelamente se realizaron análisis bacteriológicos con el fin de estimar la tasa, el origen y la evolución de la contaminación bacteriana de la leche cruda producida en cada explotación. Además, se efectuaron investigaciones para detectar la presencia de residuos de inhibidores. Los resultados de la investigación pusieron de manifiesto que las condiciones de cría y las prácticas de ordeño eran inadecuadas, lo que puede explicar la presencia de bacterias en la leche de vaca. Los resultados bacteriológicos evidenciaron que un 76,1 % de las muestras de leche tomadas en la ubre de las vacas cumplían los criterios legales, por solo un 35,8 % de las muestras procedentes de las cubas de almacenamiento. Por otro lado, se detectó la presencia de inhibidores bacterianos en un 28,8 % de las muestras de leche. Estos resultados sirvieron para determinar que las posibles fuentes de contaminación de la leche por las bacterias investigadas se encontraban en las manos de los ordeñadores, las ubres, los cubos de ordeño, los utensilios empleados, el agua y el espacio en que discurría el ordeño. A tenor de los resultados, la mejora de la calidad bacteriológica de la leche pasa por la aplicación de una política de calidad, que sirva para divulgar las prácticas idóneas de higiene en toda la cadena de producción lechera y para instituir una prima a la calidad bacteriológica de la leche.

Contribution to the study of staphylococcus contamination of cows' milk on a number of farms in Algiers: its impact on human health.

The authors describe a survey and screening programme for staphylococcus. The study covers 14 dairy farms in the Algiers region, from which 203 samples of cows' milk were taken for bacteriological testing. The survey results show that poor husbandry conditions are the main cause of staphylococcus in cows' milk. Staphylococcus was found in the milk of 30% of the cows sampled. These results were influenced by a variety of factors, in that: the contamination rate rose with the number of pregnancies, age, and volume of milk output of the cow, as well as the bedding thickness; the milk contamination rate was greater when milking occurred outside a milking parlour and when it was performed by machine; higher rates of staphylococcus infection were found in the milk of cows at the end of lactation, in red and white breeds, and in those with cylindricalteats. Identification of the bacteria found (staphylococcus) showed that coagulase- negative staphylococci were present in 67.21% of samples, whereas coagulase- positive staphylococci were present in only 32.79%. The average count for the latter was equal to 0.54 x 10(4) colony-forming units per ml of Staphylococcus aureus. Seventy percent of the milk analysed was free from staphylococci and most of the bacteria identified were not pathogenic to consumers (coagulase- negative staphylococci); nevertheless, consuming fresh milk still presents a degree of risk.

[Analysis of the variability of the control region and cytochrome b gene of mtDNA of Capreolus pygargus Pall].

Analysis the of cytochrome b gene (1140 b.p.) polymorphism and polymorphism of 79 specimens of the control region (934 b.p.) of mtDNA of the Siberian roe deer Capreolus pygargus from 23 regions of Russia and Kazakhstan has been carried out. The combined alignment of two fragments ofmitochondrial DNA revealed 36 haplotypes, which are distributed in three haplogroups. The net distance was 0.8, 1.3, and 1.3%. The specific pattern of haplogroups was described for roe deer of each region (Ural, trans-Ural, Eastern Siberia, Far East, Northeastern China). Unrelated haplogroups were found in populations of the Urals and Siberia. The variation pattern and spatial distribution of mitochondrial lines allowed us to suggest that a haplogroup that initially belongs to C. p. tianschanicus occurs secondarily in C. p. pygargus.

Study of the relationship between acetaminophen and asthma in Mexican children aged 6 to 7 years in 3 Mexican cities using ISAAC methodology.

OBJECTIVE: To establish the relationship between the use of acetaminophen and the frequency of asthma in Mexican children in 3 Mexican cities. METHODS: Ours was a multicenter, observational, descriptive, cross-sectional study. Patients from 6 to 7 years of age participating in Phase Three B of the ISAAC (International Study of Asthma and Allergies in Children) living in the north of Mexico City, Victoria City, and Merida were included. After adjusting for confounders, we calculated the odds ratios (OR) for the presence of wheezing ever, wheezing in the last 12 months, asthma ever, and the use of acetaminophen in the first year of life and during the last 12 months. RESULTS: The ORs for wheezing ever, wheezing in the last year, and asthma ever with respect to use of acetaminophen in the first year of life were not statistically significant (P > .05) in Mexico City, but they were significant in Victoria City (P < .05) and Merida (P < .05). The ORs (95% confidence intervals) for wheezing ever, wheezing in the last year, and asthma ever with respect to use of acetaminophen in the last year were 3.44 (2.96-4.0), 7.97 (5.89-10.78), and 6.10 (3.30-8.81) (P < .05) in Mexico City. Values forVictoria City were 1.36 (1.13-1.63), 3.80 (2.88-5.05), and 2.18(1.57-3.01) (P < .05). Those for Merida were 1.61 (1.40-1.85), 2.07 (1.73-2.48), and 1.53 (1.29-1.82) (P < .05). CONCLUSION: The use of acetaminophen is associated with the presence of wheezing and asthma in 3 different cities in Mexico.

Clinical Follow-up of a Fissure Sealant Placed Using Different Adhesive Protocols: A 24-month Split-mouth Study.

The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months. Twenty-four subjects with no restorations or caries received fissure sealants (Clinpro Sealant, 3M ESPE) placed using different adhesive protocols. A total of 292 sealants were placed as follows by two previously calibrated dentists using a table of random numbers (n=73): group I, acid-etch/without adhesive; group II, with a self-etch adhesive (Adper Easy Bond, 3M ESPE); group III, with an etch-and-rinse adhesive (Adper Single Bond 2, 3M ESPE); group IV, with acid + self-etch adhesive (Adper Easy Bond). Two other calibrated examiners independently evaluated the sealants at baseline and at six-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1 = total retention, 2 = partial loss, and 3 = total loss. Pearson's χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period. At the end of 24 months, total retention rates were 57.5%, 27.4%, 84.9%, and 76.7% in the acid-etch, self-etch adhesive, etch-and-rinse adhesive, and acid + self-etch adhesive groups, respectively. Although there were no statistically significant differences between the retention rates among the adhesive protocols at 6 months ( p=0.684), significant differences were observed at the 12-, 18-, and 24-month evaluations. At 24 months, the lowest retention rates were observed in the self-etch group ( p<0.05). No caries development was observed in any of the groups. The retention rate of sealants placed using self-etch adhesive was poor compared with the other groups.

Mexican anthropometric percentiles for ages 10-18.

OBJECTIVE: To elaborate Mexican growth charts based on international methodology. DESIGN: Data were obtained from the Mexican National Health Survey. The survey was stratified and probabilistic representative of all the country. SETTING: Nationwide open population living in urban and rural areas. SUBJECTS: Boys (8545) and girls (9983) from 10 to 18 years participating in the survey. METHODS: Age, weight and height were recorded. Empirical percentiles were calculated and smoothed. Smoothed curves were approximated using least-mean square estimation. RESULTS: Tables and figures for percentile values of weight, height and body mass index (BMI) for age, as well as percentile values of weight and BMI for height for both genders are presented. Regarding 50th BMI for age percentiles, Mexicans had higher levels than the Americans in the Centers for Disease Control and Prevention growth charts; Mexicans were lower but had similar weights than the Americans. Owing to the high BMI, the percentile corresponding to an overweight level (25 kg/m(2)) at 18 years was 74.5 in boys and 72.5 in girls, whereas obesity level (30 kg/m(2)) at 18 years was 97.3 and 97.4 in boys and girls, respectively. CONCLUSIONS: The present growth charts are snapshots of a Mexican population. Because of the high median BMI compared to US and World Health Organization standards, we must be cautious in establishing an upper normal cutoff for clinical normality, not merely selecting the 85th and 95th percentiles as equivalents of overweight and obesity, respectively. Therefore, we proposed percentiles 74.5 in boys and 72.5 in girls as the action points of overweight as they are the percentiles corresponding to BMI 25 kg/m(2) at 18 years. SPONSORSHIP: The survey was supported by the Mexican Minister of Health. Statistical analyses were sponsored by Dr Del-Rio-Navarro.

Factors associated with allergic rhinitis in children from northern Mexico City.

BACKGROUND: The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire allows users to find factors associated with allergic diseases, but thus far most of the studies on risk factors for allergic diseases have been devoted to asthma and not to rhinitis. OBJECTIVE: To determine the main factors associated with symptoms of allergic rhinitis and rhinoconjunctivitis in school children and adolescents in northern Mexico City. PATIENTS AND METHODS: A cross sectional, multicenter survey was conducted in northern Mexico City, in children aged 6-7 and 13-14 years. The survey instrument was the Phase Three B ISAAC questionnaire, which was validated and standardized in Spanish. RESULTS: There were 4106 6-7-year-olds and 6576 13-14-year-olds. The total prevalence of diagnosis of allergic rhinitis was 4.6%. The prevalence of cumulative and current symptoms of rhinitis was considered high (>29%), but the prevalence of the diagnosis of allergic rhinitis was considered low (ranging from 3.4% to 5.6%). The prevalence of symptoms of rhinitis with conjunctivitis had intermediate values (ranging from 20.3% to 30.2%). Cumulative symptoms of allergic rhinitis, current symptoms of allergic rhinitis, and rhinoconjunctivitis were related to symptoms of current or cumulative asthma, symptoms of current or cumulative atopic eczema, and current use of paracetamol (odds ratio > 1, P < .05). CONCLUSION: The present results support the concept of rhinitis and asthma as common chronic respiratory diseases, and this study also found a relation between paracetamol use and rhinitis in children.

Clinical Evaluation of a Silorane- and a Methacrylate-Based Resin Composite in Class II Restorations: 24-Month Results.

OBJECTIVE: To compare the 24-month clinical performance of two different resin composites in class II slot restorations. METHODS AND MATERIALS: Thirty-seven patients having at least two approximal carious lesions were enrolled in the study. A total of 116 teeth (58 pairs) were restored with either a silorane-based composite (Filtek Silorane) and its self-etch adhesive (Silorane Adhesive System, 3M ESPE) or a methacrylate-based packable resin composite (X-tra Fil) and its self-etch adhesive (Futurabond NR, VOCO GmbH) according to the toss of a coin. The restorations were evaluated at baseline and at six-, 12-, and 24-month recalls by two calibrated examiners according to the modified US Public Health Service criteria. The comparison of the two restorative materials for each category was performed with the Pearson chi-square test. Within group differences of the materials at different recall times were compared using the Cochran Q and Friedman tests. Bonferroni-adjusted McNemar test was used when significant difference was found (p<0.05). RESULTS: After 24 months, no statistically significant differences were found between the two restorative materials for the criteria evaluated. CONCLUSIONS: Both silorane- and methacrylate-based resin composites showed clinically acceptable performance in class II slot restorations after 24 months.

The management of sportsman's groin hernia in professional and amateur soccer players: a revised concept.

BACKGROUND: Chronic groin pain appears in athletes with a diverse etiology. In a select few, it can be defined as a sportsman's hernia, that may be related, among other pathologies, to weakness of the posterior inguinal wall and may successfully respond to surgery. HYPOTHESIS: Surgical repair of the sportsman's hernia is associated with good functional outcomes, if the diagnosis is based on meticulous examination and follows a simple selection flowchart. STUDY DESIGN: Prospective case cohort study. METHODS: The study assessed patients recruited from 2006 until the present assessed by a dedicated team with clinical and radiographic features of a sportsman's hernia who had failed a specified period of conservative therapies. Surgery was performed using a tension-free mesh open inguinal hernia repair. RESULTS: Of 246 male patients with chronic groin pain, 51 underwent surgery (mean age 20.7 years, range 14-36 years) with 58 inguinal procedures performed. Of the operated group, seven underwent bilateral surgery with a direct hernia found in 9/58 operated sides (15.5%), an indirect hernial sac in 8/58 (14%) and a direct and indirect hernia being found in 3/58 (5%) of operated sides. There was no post-operative morbidity (median follow-up 36.1 months; range 1-74 months), with two failures (3.45 % of operated sides). All other patients were asymptomatic, returned to full sports activity within 4.3 weeks (range 3-8 weeks) after surgery, and required no analgesics or further treatment. CONCLUSION: Selective surgical hernia repair, based on meticulous anamnesis and physical examination is effective in the management of chronic groin pain in athletes.

Safety and efficacy of two courses of OM-85 BV in the prevention of respiratory tract infections in children during 12 months.

BACKGROUND: Acute respiratory tract infections (ARTIs) are among the main causes of morbidity and mortality in children. The bacterial extract OM-85 BV (bronchovaxom) has shown protective effect for ARTIs on children. We report a double-blind, placebo-controlled, parallel, prospective clinical trial to assess the safety and efficacy of two courses of OM-85 BV in the prevention of ARTIs in susceptible children during 12 months. METHODS: Fifty-four susceptible children from 1 to 12 years of age living in the metropolitan area of Chihuahua City were selected. They were randomized to receive either OM-85 BV or placebo (one capsule a day for 10 days a month for 3 consecutive months) at the beginning of the trial and 6 months later with the same schedule. Patients were followed up for 12 months, including the administration period. The trial began in July 1997 and ended in April 1999. RESULTS: The number (mean +/- SD) of ARTIs was 5.04 +/- 1.99 (median, 5.0) in the OM-85 BV group vs 8.0 +/- 2.55 (median, 8.0) in the placebo group, with a mean difference of - 2.96 (95% confidence interval [CI], - 4.22 to - 1.7). The number of antibiotic courses was 2.46 +/- 2.08 (median, 1.5) in the treatment group vs 4.46 +/- 2.08 (median, 4.0) in the control group, a difference of - 2.0 (95% CI, - 3.14 to - 0.86). The total duration of ARTIs was 35.23 +/- 17.64 days (median, 30.5 days) in the OM-85 BV group vs 60.75 +/- 25.44 days (median, 55.0 days) in the placebo group, ie, a difference of - 25.52 days (95% CI, - 37.56 to - 13.47 days), p < 0.001 by Student's t test and Mann-Whitney U test for all the items. Four patients in the OM-85 BV group had five adverse events. Only one episode of skin rash was related to the medication intake. Six patients in the control group had six adverse events. CONCLUSIONS: OM-85 BV had a preventive effect on ARTI in the susceptible children for 12 months with an important reduction on the antibiotic requirements and the number of days of suffering ARTIs.

Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial.

BACKGROUND: Acute respiratory tract infections (ARTIs) are among the main causes of morbidity and mortality in children. The bacterial extract OM-85 BV has shown some protective effect for ARTIs in preschool children and a reduction in exacerbations of chronic bronchitis in adults. OBJECTIVES: This trial reports results of a double-masked, placebo-controlled, parallel-group clinical study that assessed the efficacy and tolerability of OM-85 BV in the prevention of ARTIs in school girls living in an orphanage. METHODS: Two hundred girls (age range, 6 to 13 years) living in an orphanage entered the trial. Participants were randomly allocated to receive either OM-85 BV or placebo for 10 consecutive days a month for 3 consecutive months. Patients were followed up for 6 months, including the administration period. The trial began in September 1996 and finished in March 1997. Primary end points were the type and number of infections. Secondary end points included when an infection occurred, time to clinical cure, severity of infection, absenteeism from school due to an ARTI, number of antibiotics or other drugs prescribed, and duration of concomitant drug treatment. RESULTS: During the trial, patients in the OM-85 BV group experienced 143 ARTIs (135 upper ARTIs and 8 otitis episodes) and patients in the placebo group experienced 299 ARTIs (273 upper ARTIs, 1 lower ARTI, and 25 otitis episodes). The median number of ARTIs was 1.0 (0.0, 3.0; 5th percentile, 95th percentile) in the OM-85 BV group compared with 3.0 (2.0, 4.0; 5th percentile, 95th percentile) in the placebo group. This difference was statistically significant (P < 0.001). Participants who received OM-85 BV also showed significantly better results (P < 0.001) than participants who received placebo in terms of median duration of illness, median number of missed school days due to an ARTI, median number of antibiotic and drug courses, and median duration of concomitant treatment. There were significant differences (P < 0.05) in severity of ARTIs during month 4 of the trial, with patients receiving OM-85 BV showing less severe ARTIs than patients receiving placebo and shorter mean time to clinical cure from the second month to the fourth month. No adverse events related to the trial medications were reported. CONCLUSIONS: OM-85 BV had a preventive effect on ARTIs in the school girls, with a reduction in the antibiotic requirements and the duration of ARTIs. Future studies are needed to further explore the role of OM-85 BV in the prevention of ARTIs.

Use of Broncho-Vaxom in private practice: phase IV trial in 587 children.

We conducted a Phase IV, open-label clinical trial to test the efficacy and safety of the immunomodulating agent Broncho-Vaxom in private practice. The trial comprised 587 children younger than 12 years of age who had an acute respiratory tract infection at entry and a history of recurrent respiratory tract infections. The patients were given one capsule daily, 10 days per month, for 3 consecutive months. During the acute phase of the disease the patients also received antibiotic therapy. Comparing the infection present at entry with previous infections, the time to improvement (mean +/- SD) decreased from 6.77 +/- 4.42 days to 3.76 +/- 2.18 days, while the time to cure decreased from 11.86 +/- 8.41 days to 7.36 +/- 4.93 days. During the 3 months of therapy, the number of infections decreased from 1.79 +/- 0.96 1 month before treatment to 0.24 +/- 0.46 in the third month of treatment; absenteeism decreased from 3.17 +/- 3.07 days to 0.16 +/- 0.63 days; and the number of antibiotic treatments decreased from 1.71 +/- 1.06 to 0.16 +/- 0.51. In the patients who experienced a recurrent respiratory tract infection during the study, the time to improvement decreased from 5.46 +/- 3.28 days before treatment to 2.79 +/- 1.36 days after treatment, and the time to cure decreased from 8.71 +/- 3.96 days to 4.54 +/- 2.26 days. Adverse events included asthenia and adynamia in 3 patients, diarrhea in 3, rash in 2, fever in 2, exacerbation of symptoms in 2, adenitis in 1, and flulike syndrome in 1. We conclude that Broncho-Vaxom is effective and safe for the treatment of acute episodes of respiratory tract infections and for preventing recurrences.

Efficacy and safety of mepyramine-theophylline-acetate in the treatment of asthmatic crisis in children.

Mepyramine-theophylline-acetate (MTA), a theophylline derivative combined with an antihistamine, is used to treat patients with asthma. A double-blind, randomized, prospective, parallel-group study was conducted to evaluate the efficacy and safety of MTA in the treatment of asthmatic crisis in children 2 to 6 years of age. Forty patients with mild-to-moderate asthma were admitted to the study. The MTA group received 8 mg/kg per day of MTA by mouth in three divided doses for 7 days. The other group received 50 microL/kg per day of placebo in three divided doses for 7 days. Salbutamol (albuterol) syrup was used as the rescue drug if manifestations of asthma persisted. Both the MTA group and the placebo group had similar demographic characteristics at baseline. Both groups showed improvement of the asthma symptoms (cough, dyspnea, hypoventilation, and wheezing), as evaluated by the investigators at days 3 and 7. Patient diary scores showed earlier improvements in the MTA group than in the placebo group. Both groups showed improvement in peak flow at days 3 and 7 (P = 0.005). The control group used more doses of salbutamol than the MTA group on days 2 through 6 and globally (mean +/- SD, 6.79 +/- 9.11 doses vs 1.29 +/- 2.23 doses). The improvements in the placebo group were thought to be due to salbutamol. Three MTA patients dropped out of the trial, one because the parents felt that the treatment was not effective and two because of gastrointestinal manifestations (epigastric discomfort and vomiting). In the placebo group, two patients dropped out. One patient had epigastric discomfort and the other had to be treated in the emergency department for an exacerbation of the asthma. We conclude that MTA may be a good therapeutic option for the treatment of asthmatic crisis in children 2 to 6 years of age.

Compilation and meta-analysis of randomized placebo-controlled clinical trials on the prevention of respiratory tract infections in children using immunostimulants.

BACKGROUND: Several immunostimulants presume to prevent respiratory tract infections (RTIs) in children, but their efficacy is controversial. OBJECTIVES: To compile the findings of the randomized, placebo-controlled trials (RCTs) on the prevention of acute respiratory tract infections (ARTIs) in children using immunostimulants, and to perform a meta-analysis. DATA SOURCES: Medline, EMBASE databases, and register of Cochrane Acute Respiratory Infection Group. REVIEW METHODS: We searched all the references of immunostimulants and selected papers referring to RCTs on the prevention of ARTIs in children. Papers were rated according to Jadad's instrument. We abstracted the number of ARTIs, and a one-tailed probability value (p) was abstracted for each trial. Effect of medication was determined as weighted mean +/- SE of percent reduction of ARTIs regarding ARTIs of placebo groups as 100%. RESULTS: Four of five RCTs with Jadad's score > 3 showed significant reduction of ARTIs in immunostimulant groups. When only the trials reporting mean +/- SD and/or dispersion were considered (n = 16), the global weighted percent effect of immunostimulants showed a change of -42.64%, with 95% confidence intervals from -45.19% to -40.08%; i. e., the treated group presented about 60% of the mean number of ARTIs in the placebo group. CONCLUSIONS: According to this meta-analysis and RCTs with Jadad's score > 3, immunostimulants are an effective treatment for the prevention of ARTI. Further high-quality RCTs are required to demonstrate the effect and the size of the effect of each individual immunostimulant.

The relationship between asthma symptoms and anthropometric markers of overweight in a Hispanic population.

BACKGROUND: Previous studies have revealed the relationship between asthma and obesity, but the relationship with other markers of overweight and obesity has not yet been investigated. OBJECTIVE: To establish the relationship between asthma symptoms and simple anthropometric indexes (BMI, waist circumference (WC), and waist-to-hip ratio (WHR)) as markers of overweight in an adult Hispanic population. METHODS: The data were obtained from the PRIT (Prevalence of Cardiovascular Risks in General Hospital Workers) 2001 survey. The participants were workers at the Hospital General de México in Mexico City and included 135 men and 398 women aged 43.8 +/- 11.9 and 43.0 +/- 10.5, respectively. Odds ratios for asthma symptoms at different BMI, WC, and WHR cutoff points associated with excessive weight were calculated. The likelihood ratios for having asthma symptoms in participants with various cutoff values of BMI, WC, and WHR also were calculated. RESULTS: Asthma symptoms were not related to anthropometric markers of overweight or obesity in men, while they were associated in women with WC cutoff levels of 80 and 85 cm, and BMI of 25 and 27 kg/m2. No level of WHR was related to asthma symptoms in women. In women, the likelihood ratio for asthma symptoms increased proportionally from WC levels of 73.5 cm up to 86 cm, while this risk increased significantly from BMI levels of 22 up to 29 kg/m2. CONCLUSION: Overweight as assessed by BMI and WC (but not WHR) was related to asthma symptoms in women in the studied population.

Use of OM-85 BV for the prevention of acute respiratory tract infections in occupational medicine.

This study evaluated the safety and efficacy of the immunostimulatory agent OM-85 BV in 112 male car-factory workers who were highly susceptible to acute respiratory tract infections (ARTIs), each having experienced > or = 4 ARTIs during 1999. From January to March 2000, each worker received one capsule of OM-85 BV (7 mg) per day for 10 consecutive days each month. The patients were followed for a further 9 months. Mean number of ARTIs decreased from 8.2 +/- 2.1 per worker in 1999 to 5.3 +/- 2.9 in 2000; i.e. a difference of -2.9 (95% confidence intervals, -3.5 to -2.4). Similar effects were observed in men who had different job roles, and no adverse events were reported during drug administration. We concluded that OM-85 BV appears to be safe and effective in reducing the incidence of ARTIs in susceptible workers, although further double-blind, placebo-controlled clinical trials are required.

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An open, prospective trial was conducted to compare the efficacy of a bacterial extract (OM-85 BV) [;Broncho-Vaxom'] vs conventional management in the prevention of chronic, recurrent respiratory diseases in children. 61 children aged between 1 and 11 years who had presented three or more respiratory tract infections in the last 6 months were enrolled. 30 children (mean age 4.1 +/- 2.7 years) received one capsule a day of Broncho-Vaxom, 10 days a month, for 3 consecutive months, and 31 (mean age 3.8 +/- 2.0 years) received no Broncho-Vaxom and served as a control group. During the 6-month follow-up period, patients treated with Broncho-Vaxom showed a significant reduction in the average number of infections (2.25 +/- 0.58 vs 4.68 +/- 0.94, p < 0.05); they were ill a lesser number of days (11.8 +/- 3.67 vs 28.06 +/- 6.72, p < 0.05), were exposed to fewer antibacterial treatments (1.1 +/- 0.76 vs 2.52 +/- 0.85, p < 0.05), required less additional treatment with conventional drugs (2.17 +/- 0.59 vs 4.39 +/- 0.88, p < 0.05), and spent fewer days under treatment (14.27 +/- 7.27 vs 30 +/- 6.49, p < 0.05). In conclusion, Broncho-Vaxom appears to be a practical, safe option for lowering the incidence of respiratory tract infections in susceptible children.