Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases.

OBJECTIVE: To contribute our results to increase the scientific evidence about the use of radioembolization in the management of patients with hepatocellular carcinoma. MATERIAL AND METHODS: This retrospective review included 53 patients with hepatocellular carcinoma treated with radioembolization at our center. Patients were classified according to the BCLC algorithm in detail according to their Child-Pugh functional status. We analyzed survival using the Kaplan-Meier method. We used Cox regression analysis to determine clinically significant parameters, including the doses administered in the parameters studied. RESULTS: Patients ranged in age from 28 to 86 years (mean, 60 years). A total of 61 procedures were done. The mean activity administered was 2.8GBq (0.7-6.4GBq), with a mean dose of 229.9Gy (74-425.9Gy) administered in the tumor. Progression-free survival was 6.7 months and overall survival was 12.8 months. Differences in disease-free survival according to BCLC and Child-Pugh classification were not significant (p=0.848 and p=0.252, respectively). The clinical parameters that were significantly different with respect to overall survival were bilirubin levels (p<0.001), pretreatment transaminase levels (AST) (p=0.022), Child-Pugh subclassification (p=0.003), and dose administered in the tumor (p=0.001). Only one patient had a severe adverse reaction, developing posttreatment liver failure resulting in death. CONCLUSIONS: Radioembolization is safe and efficacious in the treatment of patients with hepatocellular carcinoma. Liver function and the doses received by the tumor are key parameters for the efficacy of treatment. The increase in the scientific evidence supports the inclusion of this technique in treatment guidelines.

Complications associated with three brachial plexus blocking techniques: Systematic review and meta-analysis.

BACKGROUND: Brachial plexus block has become one of the most widely-used anaesthetic techniques in the world for upper limb anaesthesia. There are three different brachial blocks techniques: supraclavicular, infraclavicular and axillary block. However, its execution is not exempt from possible clinical complications, and it is not clear which of these is associated with a lower complication rate and greater anaesthetic success. MATERIALS AND METHODS: Systematic review and meta-analysis following the Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines to identify controlled clinical trials reporting the three techniques. The main outcome was the incidence of anaesthetic complications, and the secondary ones were an anaesthetic success, time of performance and anaesthetic latency. RESULTS: 25 controlled clinical trials, with 2012 patient, were included. The methodological quality of the included studies is moderate to high. For the main outcome, the main complication reported was a vascular puncture, followed by transient neurological injury, symptomatic diaphragmatic paralysis and pneumothorax. No differences were found in complications associated with the three anaesthetic techniques. Additionally, no differences were found regarding anaesthetic success. CONCLUSIONS: Anesthetic complications associated with the three brachial block techniques are low, with no medium and long-term sequelae; however, none of the three techniques seems to be superior among them to reduce these complications. All three techniques are highly successful when performed using ultrasound imaging.

Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases. / Radioembolización de hepatocarcinomas: a propósito de 53 casos.

OBJECTIVE: To contribute our results to increase the scientific evidence about the use of radioembolization in the management of patients with hepatocellular carcinoma. MATERIAL AND METHODS: This retrospective review included 53 patients with hepatocellular carcinoma treated with radioembolization at our center. Patients were classified according to the BCLC algorithm in detail according to their Child-Pugh functional status. We analyzed survival using the Kaplan-Meier method. We used Cox regression analysis to determine clinically significant parameters, including the doses administered in the parameters studied. RESULTS: Patients ranged in age from 28 to 86 years (mean, 60 years). A total of 61 procedures were done. The mean activity administered was 2.8 GBq (0.7-6.4 GBq), with a mean dose of 229.9Gy (74-425.9Gy) administered in the tumor. Progression-free survival was 6.7 months and overall survival was 12.8 months. Differences in disease-free survival according to BCLC and Child-Pugh classification were not significant (p=0.848 and p=0.252, respectively). The clinical parameters that were significantly different with respect to overall survival were bilirubin levels (p<0.001), pretreatment transaminase levels (AST) (p=0.022), Child-Pugh subclassification (p=0.003), and dose administered in the tumor (p=0.001). Only one patient had a severe adverse reaction, developing posttreatment liver failure resulting in death. CONCLUSIONS: Radioembolization is safe and efficacious in the treatment of patients with hepatocellular carcinoma. Liver function and the doses received by the tumor are key parameters for the efficacy of treatment. The increase in the scientific evidence supports the inclusion of this technique in treatment guidelines.

VIVA (VIsualization of VAriants): A VCF File Visualization Tool.

High-throughput sequencing produces an extraordinary amount of genomic data that is organized into a number of high-dimension datasets. Accordingly, visualization of genomic data has become essential for quality control, exploration, and data interpretation. The Variant Call Format (VCF) is a text file format generated during the variant calling process that contains genomic information and locations of variants in a group of sequenced samples. The current workflow for visualization of genomic variant data from VCF files requires use of a combination of existing tools. Here, we describe VIVA (VIsualization of VAriants), a command line utility and Jupyter Notebook based tool for evaluating and sharing genomic data for variant analysis and quality control of sequencing experiments from VCF files. VIVA combines the functionality of existing tools into a single command to interactively evaluate and share genomic data, as well as create publication quality graphics.

Reference ranges for Doppler indices of umbilical and fetal middle cerebral arteries and cerebroplacental ratio: systematic review.

OBJECTIVE: To assess studies reporting reference ranges for umbilical artery (UA) and fetal middle cerebral artery (MCA) Doppler indices and cerebroplacental ratio (CPR), using a set of predefined methodological quality criteria for study design, statistical analysis and reporting methods. METHODS: This was a systematic review of observational studies in which the primary aim was to create reference ranges for UA and MCA Doppler indices and CPR in fetuses of singleton gestations. A search for relevant articles was performed in MEDLINE, EMBASE, CINAHL, Web of Science (from inception to 31 December 2016) and references of the retrieved articles. Two authors independently selected studies, assessed the risk of bias and extracted the data. Studies were scored against a predefined set of independently agreed methodological criteria and an overall quality score was assigned to each study. Linear multiple regression analysis assessing the association between quality scores and study characteristics was performed. RESULTS: Thirty-eight studies met the inclusion criteria. The highest potential for bias was noted in the following fields: 'ultrasound quality control measures', in which only two studies demonstrated a comprehensive quality-control strategy; 'number of measurements taken for each Doppler variable', which was apparent in only three studies; 'sonographer experience', in which no study on CPR reported clearly the experience or training of the sonographers, while only three studies on UA Doppler and four on MCA Doppler did; and 'blinding of measurements', in which only one study, on UA Doppler, reported that sonographers were blinded to the measurement recorded during the examination. Sample size estimations were present in only seven studies. No predictors of quality were found on multiple regression analysis. Reference ranges varied significantly with important clinical implications for what is considered normal or abnormal, even when restricting the analysis to the highest scoring studies. CONCLUSIONS: There is considerable methodological heterogeneity in studies reporting reference ranges for UA and MCA Doppler indices and CPR, and the resulting references have important implications for clinical practice. There is a need for the standardization of methodologies for Doppler velocimetry and for the development of reference standards, which can be correctly interpreted and applied in clinical practice. We propose a set of recommendations for this purpose. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Intervalos de referencia para los índices Doppler de la arterias umbilical y cerebral media del feto y la relación cerebroplacentaria: una revisión sistemática OBJETIVO: Evaluar los estudios que informan sobre intervalos de referencia para los índices Doppler y la relación cerebroplacentaria (RCP) de la arteria umbilical (AU) y la arteria cerebral media (ACM) del feto, mediante un conjunto de criterios de calidad metodológica predefinidos para el diseño del estudio, el análisis estadístico y los métodos de notificación. MÉTODOS: Esta fue una revisión sistemática de estudios observacionales en los que el objetivo principal fue crear intervalos de referencia para los índices Doppler de la AU y la ACM y la RCP de fetos de gestaciones con feto único. Se realizó una búsqueda de artículos relevantes en MEDLINE, EMBASE, CINAHL, Web of Science (desde el inicio hasta el 31 de diciembre de 2016) y en las referencias de los artículos recuperados. Dos autores, de forma independiente, seleccionaron los estudios, evaluaron el riesgo de sesgo y extrajeron los datos. Los estudios se calificaron según un conjunto predefinido de criterios metodológicos acordados de forma independiente y se asignó una puntuación de calidad global a cada estudio. Se realizó un análisis de regresión múltiple lineal para evaluar la asociación entre las puntuaciones de calidad y las características del estudio. RESULTADOS: Un total de 38 estudios cumplieron los criterios de inclusión. El mayor potencial de sesgo se observó en los siguientes casos: 'medidas de control de calidad del ultrasonido', donde sólo dos estudios demostraron una estrategia integral de control de calidad; 'número de mediciones tomadas para cada variable Doppler', que solo fue aparente en tres estudios; 'experiencia del ecografista', puesto que ningún estudio sobre la RCP informó claramente sobre la experiencia o la formación de los ecografistas, y tan solo lo hicieron tres estudios sobre el Doppler de la AU y cuatro sobre el Doppler de la ACM; y 'mediciones a ciegas', donde tan sólo un estudio sobre el Doppler de la AU comunicó que los ecografistas no tuvieron acceso a la medición registrada durante el estudio. Las estimaciones del tamaño de la muestra sólo se comunicaron en siete estudios. No se encontraron predictores de calidad en el análisis de regresión múltiple. Los intervalos de referencia variaron significativamente con implicaciones clínicas importantes para lo que se considera normal o anómalo, incluso cuando se restringió el análisis a los estudios con mayor puntuación. CONCLUSIONES: Existe una heterogeneidad metodológica considerable en los estudios que informan sobre los intervalos de referencia para los índices Doppler de la AU y la ACM y la RCP, y las referencias resultantes tienen implicaciones importantes para la práctica clínica. Es necesario estandarizar las metodologías de la velocimetría Doppler y desarrollar estándares de referencia que puedan ser interpretados y aplicados correctamente en la práctica clínica. Se propone una serie de recomendaciones para este fin.

Predictive accuracy of cerebroplacental ratio for adverse perinatal and neurodevelopmental outcomes in suspected fetal growth restriction: systematic review and meta-analysis.

OBJECTIVE: The cerebroplacental ratio (CPR) has been proposed for the routine surveillance of pregnancies with suspected fetal growth restriction (FGR), but the predictive performance of this test is unclear. The aim of this study was to determine the accuracy of CPR for predicting adverse perinatal and neurodevelopmental outcomes in suspected FGR. METHODS: PubMed, EMBASE, CINAHL and Lilacs were searched from inception to 31 July 2017 for cohort or cross-sectional studies reporting on the accuracy of CPR for predicting adverse perinatal and/or neurodevelopmental outcomes in singleton pregnancies with FGR suspected antenatally based on sonographic parameters. Summary receiver-operating characteristics (ROC) curves, pooled sensitivities and specificities, and summary likelihood ratios (LRs) were generated. RESULTS: Twenty-two studies (including 4301 women) met the inclusion criteria. Summary ROC curves showed that the best predictive accuracy of CPR was for perinatal death and the worst was for neonatal acidosis, with areas under the summary ROC curves of 0.83 and 0.57, respectively. The predictive accuracy of CPR was moderate to high for perinatal death (pooled sensitivity and specificity of 93% and 76%, respectively, and summary positive and negative LRs of 3.9 and 0.09, respectively) and low for composite of adverse perinatal outcomes, Cesarean section for non-reassuring fetal status, 5-min Apgar score < 7, admission to the neonatal intensive care unit, neonatal acidosis and neonatal morbidity, with summary positive and negative LRs ranging from 1.1 to 2.5 and 0.3 to 0.9, respectively. An abnormal CPR result had moderate accuracy for predicting small-for-gestational age at birth (summary positive LR of 7.4). CPR had a higher predictive accuracy in pregnancies with suspected early-onset FGR. No study provided data for assessing the predictive accuracy of CPR for adverse neurodevelopmental outcome. CONCLUSION: CPR appears to be useful in predicting perinatal death in pregnancies with suspected FGR. Nevertheless, before incorporating CPR into the routine clinical management of suspected FGR, randomized controlled trials should assess whether the use of CPR reduces perinatal death or other adverse perinatal outcomes. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data.

OBJECTIVE: To assess the efficacy of vaginal progesterone for the prevention of preterm birth and neonatal morbidity and mortality in asymptomatic women with a twin gestation and a sonographic short cervix (cervical length ≤ 25 mm) in the mid-trimester. METHODS: This was an updated systematic review and meta-analysis of individual patient data (IPD) from randomized controlled trials comparing vaginal progesterone with placebo/no treatment in women with a twin gestation and a mid-trimester sonographic cervical length ≤ 25 mm. MEDLINE, EMBASE, POPLINE, CINAHL and LILACS (all from inception to 31 December 2016), the Cochrane Central Register of Controlled Trials, Research Registers of ongoing trials, Google Scholar, conference proceedings and reference lists of identified studies were searched. The primary outcome measure was preterm birth < 33 weeks' gestation. Two reviewers independently selected studies, assessed the risk of bias and extracted the data. Pooled relative risks (RRs) with 95% confidence intervals (CI) were calculated. RESULTS: IPD were available for 303 women (159 assigned to vaginal progesterone and 144 assigned to placebo/no treatment) and their 606 fetuses/infants from six randomized controlled trials. One study, which included women with a cervical length between 20 and 25 mm, provided 74% of the total sample size of the IPD meta-analysis. Vaginal progesterone, compared with placebo/no treatment, was associated with a statistically significant reduction in the risk of preterm birth < 33 weeks' gestation (31.4% vs 43.1%; RR, 0.69 (95% CI, 0.51-0.93); moderate-quality evidence). Moreover, vaginal progesterone administration was associated with a significant decrease in the risk of preterm birth < 35, < 34, < 32 and < 30 weeks' gestation (RRs ranging from 0.47 to 0.83), neonatal death (RR, 0.53 (95% CI, 0.35-0.81)), respiratory distress syndrome (RR, 0.70 (95% CI, 0.56-0.89)), composite neonatal morbidity and mortality (RR, 0.61 (95% CI, 0.34-0.98)), use of mechanical ventilation (RR, 0.54 (95% CI, 0.36-0.81)) and birth weight < 1500 g (RR, 0.53 (95% CI, 0.35-0.80)) (all moderate-quality evidence). There were no significant differences in neurodevelopmental outcomes at 4-5 years of age between the vaginal progesterone and placebo groups. CONCLUSION: Administration of vaginal progesterone to asymptomatic women with a twin gestation and a sonographic short cervix in the mid-trimester reduces the risk of preterm birth occurring at < 30 to < 35 gestational weeks, neonatal mortality and some measures of neonatal morbidity, without any demonstrable deleterious effects on childhood neurodevelopment. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Vaginal progesterone decreases preterm birth ≤ 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study.

OBJECTIVE: To evaluate the efficacy of vaginal progesterone administration for preventing preterm birth and perinatal morbidity and mortality in asymptomatic women with a singleton gestation and a mid-trimester sonographic cervical length (CL) ≤ 25 mm. METHODS: This was an updated systematic review and meta-analysis of randomized controlled trials comparing the use of vaginal progesterone to placebo/no treatment in women with a singleton gestation and a mid-trimester sonographic CL ≤ 25 mm. Electronic databases, from their inception to May 2016, bibliographies and conference proceedings were searched. The primary outcome measure was preterm birth ≤ 34 weeks of gestation or fetal death. Two reviewers independently selected studies, assessed the risk of bias and extracted the data. Pooled relative risks (RRs) with 95% confidence intervals (CI) were calculated. RESULTS: Five trials involving 974 women were included. A meta-analysis, including data from the OPPTIMUM study, showed that vaginal progesterone significantly decreased the risk of preterm birth ≤ 34 weeks of gestation or fetal death compared to placebo (18.1% vs 27.5%; RR, 0.66 (95% CI, 0.52-0.83); P = 0.0005; five studies; 974 women). Meta-analyses of data from four trials (723 women) showed that vaginal progesterone administration was associated with a statistically significant reduction in the risk of preterm birth occurring at < 28 to < 36 gestational weeks (RRs from 0.51 to 0.79), respiratory distress syndrome (RR, 0.47 (95% CI, 0.27-0.81)), composite neonatal morbidity and mortality (RR, 0.59 (95% CI, 0.38-0.91)), birth weight < 1500 g (RR, 0.52 (95% CI, 0.34-0.81)) and admission to the neonatal intensive care unit (RR, 0.67 (95% CI, 0.50-0.91)). There were no significant differences in neurodevelopmental outcomes at 2 years of age between the vaginal progesterone and placebo groups. CONCLUSION: This updated systematic review and meta-analysis reaffirms that vaginal progesterone reduces the risk of preterm birth and neonatal morbidity and mortality in women with a singleton gestation and a mid-trimester CL ≤ 25 mm, without any deleterious effects on neurodevelopmental outcome. Clinicians should continue to perform universal transvaginal CL screening at 18-24 weeks of gestation in women with a singleton gestation and to offer vaginal progesterone to those with a CL ≤ 25 mm. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

First- and second-trimester tests to predict stillbirth in unselected pregnant women: a systematic review and meta-analysis.

BACKGROUND: Several biophysical and biochemical tests have been proposed to predict stillbirth but their predictive ability remains unclear. OBJECTIVE: To assess the accuracy of tests performed during the first and/or second trimester of pregnancy to predict stillbirth in unselected women with singleton, structurally and chromosomally normal fetuses through use of formal methods for systematic reviews and meta-analytic techniques. SEARCH STRATEGY: Electronic databases, bibliographies and conference proceedings. SELECTION CRITERIA: Observational studies that evaluated the predictive accuracy for stillbirth of tests performed during the first two trimesters of pregnancy. DATA COLLECTION AND ANALYSIS: Two reviewers selected studies, assessed risk of bias and extracted data. Summary receiver operating characteristic curves, pooled sensitivities, specificities and likelihood ratios (LRs) were generated. Data were synthesised separately for stillbirth as a sole category and for specific stillbirth categories. MAIN RESULTS: Seventy-one studies, evaluating 16 single and five combined tests, met the inclusion criteria. A uterine artery pulsatility index >90th centile during the second trimester and low levels of pregnancy-associated plasma protein A (PAPP-A) during the first trimester had a moderate to high predictive accuracy for stillbirth related to placental abruption, small-for-gestational-age or pre-eclampsia (positive and negative LRs from 6.3 to 14.1, and from 0.1 to 0.4, respectively). All biophysical and biochemical tests assessed had a low predictive accuracy for stillbirth as a sole category. CONCLUSIONS: Currently, there is no clinically useful first-trimester or second-trimester test to predict stillbirth as a sole category. Uterine artery pulsatility index and maternal serum PAPP-A levels appeared to be good predictors of stillbirth related to placental dysfunction disorders.

Pregnancy dating by fetal crown-rump length: a systematic review of charts.

BACKGROUND: Fetal crown-rump length (CRL) measurement by ultrasound in the first trimester is the standard method for pregnancy dating; however, a multitude of CRL equations to estimate gestational age (GA) are reported in the literature. OBJECTIVE: To evaluate the methodological quality used in studies reporting CRL equations to estimate GA using a set of predefined criteria. SEARCH STRATEGY: Searches of MEDLINE, EMBASE, and CINAHL databases, from 1948 to 31 January 2011, and secondary reference sources, were performed. SELECTION CRITERIA: Observational ultrasound studies, where the primary aim was to create equations for GA estimation using a CRL measurement. DATA COLLECTION AND ANALYSIS: Included studies were scored against predefined independently agreed methodological criteria: an overall quality score was calculated for each study. MAIN RESULTS: The searches yielded 1142 citations. Two reviewers screened the papers and independently assessed the full-text versions of 29 eligible studies. The highest potential for bias was noted in inclusion and exclusion criteria, and in maternal demographic characteristics. No studies had systematic ultrasound quality-control measures. The four studies with the highest scores (lowest risk of bias) satisfied 18 or more of the 29 criteria; these showed lower variation in GA estimation than the remaining, lower-scoring studies. This was particularly evident at the extremes of GA. AUTHOR'S CONCLUSIONS: Considerable methodological heterogeneity and limitations exist in studies reporting CRL equations for estimating GA, and these result in a wide range of estimated GAs for any given CRL; however, when studies with the highest methodological quality are used, this range is reduced.

Infecciones del tracto urinario bajo en adultos y embarazadas: consenso para el manejo empírico / Lower Urinary Tract Infections in Adults and Pregnant Women: A Consensus for Empirical Treatment

Introducción: La infección no complicada del tracto urinario bajo y la bacteriuria asintomática son causas frecuentes de consulta médica ambulatoria y en el servicio de urgencias en Colombia y el mundo. La falta de pautas y consenso para el manejo, así como la emergencia de resistencia a las múltiples opciones terapéuticas disponibles en los uropatógenos provenientes de la comunidad, hacen necesario elaborar unas recomendaciones que orienten al clínico sobre el abordaje óptimo de estas entidades. Objetivo: Definir un consenso sobre el manejo empírico de la bacteriuria asintomática y la infección del tracto urinario (ITU) bajo en adultos y mujeres embarazadas en Colombia. Metodología: Se lleva a cabo una metodología de consenso con expertos en urología, infectología, medicina interna, ginecología y microbiología basada en la revisión de las referencias bibliográficas disponibles en los términos de búsqueda relacionados, haciendo énfasis en estudios locales. Resultados: Se elaboró un algoritmo de manejo para el tratamiento empírico de la ITU baja no complicada en adultos con antisépticos urinarios como nitrofurantoína y fosfomicina trometamol como primera línea, con recomendaciones terapéuticas específicas para el tratamiento de la bacteriuria asintomática en mujeres embarazadas. Adicionalmente, se formuló un algoritmo de decisión para el procesamiento de cultivos de orina. La recurrencia o recaída frecuente justifica remisión a urología e infectología. Conclusiones: Se generan recomendaciones prácticas de fácil implementación en el diagnóstico y manejo de la ITU bajo en adultos y embarazadas, y de los casos donde es necesario tratar la bacteriuria asintomática, con opciones terapéuticas efectivas y de espectro reducido.

Background: Uncomplicated infection of the lower urinary tract and asymptomatic bacteriuria are frequent causes of visits to outpatient clinics and emergency departments in Colombia and worldwide. The lack of guidelines and a consensus for their management, and the emergence of resistance of community-based uropathogens to the available therapeutic options, make it necessary to develop recommendations to guide clinicians on the optimal approach to these entities. Objective: Define a consensus for the empiric management of asymptomatic bacteriuria and Urinary Tract Infection (UTI) in adults and pregnant women in Colombia. Methods: We carried out a consensus methodology with experts in urology, infectious diseases, internal medicine, gynecology and clinical microbiology; based on reviewing the available literature on the related terms, and emphasizing local studies. Results: We developed a management algorithm for the empirical treatment of uncomplicated lower UTI in adults with urinary antiseptics such as nitrofurantoin and fosfomycin trometamol as first line, with specific therapeutic recommendations for the treatment of asymptomatic bacteriuria in pregnant women. Additionally, we created a decision algorithm for processing urine cultures. Frequent recurrence or relapse justifies referral to urology and infectious disease professionals. Conclusions: We generated straightforward and easy-to-implement recommendations for the diagnosis and management of UTI in adults and pregnant women, and in cases where it is necessary to treat asymptomatic bacteriuria, with effective therapeutic and narrow spectrum options.

Efectividad y seguridad del esquema genérico lamivudina/zidovudina/efavirenz en pacientes VIH (+). Estudio fase IV y comparación con el mismo esquema de medicamentos innovadores / Effectiveness and safety of generic lamivudine/zidovudine/efavirenz in HIV (+) patients. Phase IV study and comparison with generic and innovator drugs

Antecedentes: El fortalecimiento de la política de productos competidores (genéricos) se puede acompañar de interrogantes sobre la calidad y, por tanto, sobre la efectividad de algunos de estos medicamentos. Los estudios fase IV son una opción válida para valorar la efectividad y seguridad de estos medicamentos. Objetivos: Valorar la efectividad y seguridad del esquema genérico Lamivudina/Zidovudina/Efavirenz en pacientes con VIH/SIDA que no han recibido terapia antirretroviral, que son atendidos en un programa de atención integral ambulatoria especializada, y comparar estos resultados con los datos de eficacia y seguridad reportados en un estudio de referencia (que utiliza el mismo esquema de medicamentos innovadores y fue realizado con pacientes con condiciones similares). Métodos: Se realizó un estudio clínico abierto no controlado del tipo fase IV. Se valoró la efectividad (disminución de carga viral en plasma y aumento de linfocitos CD4+) y seguridad (reacciones adversas) del esquema genérico Lamivudina/Zidovudina/Efavirenz durante 12 meses en pacientes mayores de 18 años VIH (+), que no habían recibido terapia antirretroviral y con indicación para recibirla. Los seguimientos clínicos y el seguimiento farmacoterapéutico fueron utilizados como estrategias de valoración y recolección de datos. Los resultados fueron comparados con los resultados reportados en un estudio referencia, contrastando la hipótesis de no inferioridad de dichos resultados. Resultados: El estudio incluyó 47 pacientes, de los cuales 33 estuvieron presentes hasta el final del estudio. Al año de tratamiento, en 28 pacientes (el 85%) la carga viral (valorada por indetectabilidad de las copias de RNAm viral/mL) alcanzó una disminución estadísticamente significativa, mientras que en 30 pacientes (el 91%) el recuento de linfocitos T-CD4+ mayor a 200 células/mm3 alcanzó un aumento progresivo y estadísticamente significativo. Para la comparación se halló un artículo que cumplió con...

Novel biomarkers for predicting intrauterine growth restriction: a systematic review and meta-analysis.

BACKGROUND: Several biomarkers for predicting intrauterine growth restriction (IUGR) have been proposed in recent years. However, the predictive performance of these biomarkers has not been systematically evaluated. OBJECTIVE: To determine the predictive accuracy of novel biomarkers for IUGR in women with singleton gestations. SEARCH STRATEGY: Electronic databases, reference list checking and conference proceedings. SELECTION CRITERIA: Observational studies that evaluated the accuracy of novel biomarkers proposed for predicting IUGR. DATA COLLECTION AND ANALYSIS: Data were extracted on characteristics, quality and predictive accuracy from each study to construct 2×2 tables. Summary receiver operating characteristic curves, sensitivities, specificities and likelihood ratios (LRs) were generated. MAIN RESULTS: A total of 53 studies, including 39,974 women and evaluating 37 novel biomarkers, fulfilled the inclusion criteria. Overall, the predictive accuracy of angiogenic factors for IUGR was minimal (median pooled positive and negative LRs of 1.7, range 1.0-19.8; and 0.8, range 0.0-1.0, respectively). Two small case-control studies reported high predictive values for placental growth factor and angiopoietin-2 only when IUGR was defined as birthweight centile with clinical or pathological evidence of fetal growth restriction. Biomarkers related to endothelial function/oxidative stress, placental protein/hormone, and others such as serum levels of vitamin D, urinary albumin:creatinine ratio, thyroid function tests and metabolomic profile had low predictive accuracy. CONCLUSIONS: None of the novel biomarkers evaluated in this review are sufficiently accurate to recommend their use as predictors of IUGR in routine clinical practice. However, the use of biomarkers in combination with biophysical parameters and maternal characteristics could be more useful and merits further research.

Systematic review of methodology used in ultrasound studies aimed at creating charts of fetal size.

BACKGROUND: Reliable ultrasound charts are necessary for the prenatal assessment of fetal size, yet there is a wide variation of methodologies for the creation of such charts. OBJECTIVE: To evaluate the methodological quality of studies of fetal biometry using a set of predefined quality criteria of study design, statistical analysis and reporting methods. SEARCH STRATEGY: Electronic searches in MEDLINE, EMBASE and CINAHL, and references of retrieved articles. SELECTION CRITERIA: Observational studies whose primary aim was to create ultrasound size charts for bi-parietal diameter, head circumference, abdominal circumference and femur length in fetuses from singleton pregnancies. DATA COLLECTION AND ANALYSIS: Studies were scored against a predefined set of independently agreed methodological criteria and an overall quality score was given to each study. Multiple regression analysis between quality scores and study characteristics was performed. MAIN RESULTS: Eighty-three studies met the inclusion criteria. The highest potential for bias was noted in the following fields: 'Inclusion/exclusion criteria', as none of the studies defined a rigorous set of antenatal or fetal conditions which should be excluded from analysis; 'Ultrasound quality control measures', as no study demonstrated a comprehensive quality assurance strategy; and 'Sample size calculation', which was apparent in six studies only. On multiple regression analysis, there was a positive correlation between quality scores and year of publication: quality has improved with time, yet considerable heterogeneity in study methodology is still observed today. CONCLUSIONS: There is considerable methodological heterogeneity in studies of fetal biometry. Standardisation of methodologies is necessary in order to make correct interpretations and comparisons between different charts. A checklist of recommended methodologies is proposed.

Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the efficacy and safety of using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10-20 mm) at 19 + 0 to 23 + 6 weeks of gestation. Women were allocated randomly to receive vaginal progesterone gel or placebo daily starting from 20 to 23 + 6 weeks until 36 + 6 weeks, rupture of membranes or delivery, whichever occurred first. Randomization sequence was stratified by center and history of a previous preterm birth. The primary endpoint was preterm birth before 33 weeks of gestation. Analysis was by intention to treat. RESULTS: Of 465 women randomized, seven were lost to follow-up and 458 (vaginal progesterone gel, n=235; placebo, n=223) were included in the analysis. Women allocated to receive vaginal progesterone had a lower rate of preterm birth before 33 weeks than did those allocated to placebo (8.9% (n=21) vs 16.1% (n=36); relative risk (RR), 0.55; 95% CI, 0.33-0.92; P=0.02). The effect remained significant after adjustment for covariables (adjusted RR, 0.52; 95% CI, 0.31-0.91; P=0.02). Vaginal progesterone was also associated with a significant reduction in the rate of preterm birth before 28 weeks (5.1% vs 10.3%; RR, 0.50; 95% CI, 0.25-0.97; P=0.04) and 35 weeks (14.5% vs 23.3%; RR, 0.62; 95% CI, 0.42-0.92; P=0.02), respiratory distress syndrome (3.0% vs 7.6%; RR, 0.39; 95% CI, 0.17-0.92; P=0.03), any neonatal morbidity or mortality event (7.7% vs 13.5%; RR, 0.57; 95% CI, 0.33-0.99; P=0.04) and birth weight < 1500 g (6.4% (15/234) vs 13.6% (30/220); RR, 0.47; 95% CI, 0.26-0.85; P=0.01). There were no differences in the incidence of treatment-related adverse events between the groups. CONCLUSIONS: The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome.