Empirical model to assess leaching of pesticides in soil under a steady-state flow and tropical conditions.

Abstract: An empirical model of leaching of pesticides was developed to simulate the concentration of fungicides throughout unsaturated soil. The model was based on chemical reactions and the travel time of a conservative tracer to represent the travel time required for water to flow between soil layers. The model's performance was then tested using experimental data from dimethomorph and pyrimethanil applied to the soil under field and laboratory conditions. The empirical model simulated fungicide concentration on soil solids and in soil solution at different depths over time (mean square error between 2.9 mg2 kg-2 and 61mg2 kg-2) using sorption percentages and degradation rates under laboratory conditions. The sorption process was affected by the organic carbon, clay, and the effective cation exchange capacity of the soil. The degradation rate values of dimethomorph (0.039 d-1-0.009 d-1) and pyrimethanil (0.053 d-1-0.004 d-1) decreased from 0 to 40 cm and then remained constant in deeper soil layers (60-80 cm). Fungicide degradation was a critical input in the model at subsurface layers. The model was determined to be a reliable mathematical tool to estimate the leachability of pesticides in tropical soil under a steady-state flow. It may be extended to other substances and soils for environmental risk assessment projects. Supplementary Information: The online version contains supplementary material available at 10.1007/s13762-023-05038-w.

Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication.

BACKGROUND: The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. PATIENTS AND METHODS: Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. RESULTS: Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). CONCLUSIONS: Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Women and COVID-19: severity and mortality in hospitalized middle-aged and older patients.

OBJECTIVE: The aim of the study was to evaluate the clinical features, severity, and mortality of coronavirus disease-2019 (COVID-19) in hospitalized middle-aged and older women, and the risk factors associated with severity and mortality in women. METHODS: A retrospective study was conducted in hospitalized patients with COVID-19. The clinical features, severity, and mortality of COVID-19 in middle-aged and older women (age 45 years and older) were compared to those of younger women (age <45 years). RESULTS: A higher frequency of hypertension, invasive mechanical ventilation (IMV) requirement, and mortality was evidenced in middle-aged and older women. Age ≥45 years (odds ratio 2.7; 95% confidence interval 1.21-6.27; p = 0.01) and IMV requirement (odds ratio 3.0; 95% confidence interval 1.34-6.76; p = 0.004) predicted mortality. CONCLUSIONS: Severity and mortality are higher in middle-aged and older women with COVID-19 compared to younger women.

3D-printed anatomical models of the cystic duct and its variants, a low-cost solution for an in-house built simulator for laparoscopic surgery training.

OBJECTIVES: To explore a method to create affordable anatomical models of the biliary tree that are adequate for training laparoscopic cholecystectomy with an in-house built simulator. METHODS: We used a fused deposition modeling 3D printer to create molds of Acrylonitrile Butadiene Styrene (ABS) from Digital Imaging and Communication on Medicine (DICOM) images, and the molds were filled with silicone rubber. Thirteen surgeons with 4-5-year experience in the procedure evaluated the molds using a low-cost in-house built simulator utilizing a 5-point Likert-type scale. RESULTS: Molds produced through this method had a consistent anatomical appearance and overall realism that evaluators agreed or definitely agreed (4.5/5). Evaluators agreed on recommending the mold for resident surgical training. CONCLUSIONS: 3D-printed molds created through this method can be applied to create affordable high-quality educational anatomical models of the biliary tree for training laparoscopic cholecystectomy.

Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆.

BACKGROUND: Patients with brain metastases (BM) from human epidermal growth factor receptor 2 (HER2)-positive breast cancer represent a difficult-to-treat population. Trastuzumab emtansine (T-DM1) has shown potential activity in this subset of patients in small clinical series. PATIENTS AND METHODS: KAMILLA is an ongoing, phase IIIb study of T-DM1 in patients with HER2-positive locally advanced/metastatic breast cancer with prior HER2-targeted therapy and chemotherapy. Patients received T-DM1 3.6 mg/kg every 3 weeks (intravenously) until unacceptable toxicity, withdrawal of consent, or disease progression. Tumor response and clinical outcomes in patients with baseline BM were evaluated in this post hoc, exploratory analysis. The main outcome measures were best overall response rate (complete response + partial response) and clinical benefit rate (complete response + partial response + stable disease lasting ≥6 months) by RECIST v1.1 criteria, progression-free survival, overall survival, and safety. RESULTS: Of 2002 treated patients, 398 had baseline BM. In 126 patients with measurable BM, the best overall response rate and clinical benefit rate were 21.4% [95% confidence interval (CI) 14.6-29.6] and 42.9% (95% CI 34.1-52.0), respectively. A reduction in the sum of the major diameters of BM ≥30% occurred in 42.9% (95% CI 34.1-52.0), including 49.3% (95% CI 36.9-61.8) of 67 patients without prior radiotherapy to BM. In the 398 patients with baseline BM, median progression-free survival and overall survival were 5.5 (95% CI 5.3-5.6) months and 18.9 (95% CI 17.1-21.3) months, respectively. The adverse event profile was broadly similar in patients with and without baseline BM, although nervous system adverse events were more common in patients with [208 (52.3%)] versus without [701 (43.7%)] baseline BM. CONCLUSION: This exploratory analysis of patients with HER2-positive metastatic breast cancer and BM enrolled in a prospective clinical trial shows that T-DM1 is active and well-tolerated in this population. T-DM1 should be explored further in this setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01702571.

Glyco-engineered anti-EGFR mAb elicits ADCC by NK cells from colorectal cancer patients irrespective of chemotherapy.

BACKGROUND: The epidermal growth factor receptor (EGFR) is overexpressed in colorectal cancer (CRC), and is correlated with poor prognosis, making it an attractive target for monoclonal antibody (mAb) therapy. A component of the therapeutic efficacy of IgG1 mAbs is their stimulation of antibody-dependent cellular cytotoxicity (ADCC) by natural killer (NK) cells bearing the CD16 receptor. As NK cells are functionally impaired in cancer patients and may be further compromised upon chemotherapy, it is crucial to assess whether immunotherapeutic strategies aimed at further enhancing ADCC are viable. METHODS: CRC patients before, during and after chemotherapy were immunophenotyped by flow cytometry for major white blood cell populations. ADCC-independent NK cell functionality was assessed in cytotoxicity assays against K562 cells. ADCC-dependent killing of EGFR(+) A431 cancer cells by NK cells was measured with a degranulation assay where ADCC was induced by GA201, an anti-EGFR mAb glyco-engineered to enhance ADCC. RESULTS: Here, we confirm the observation that NK cells in cancer patients are dysfunctional. However, GA201 was able to induce robust NK cell-dependent cytotoxicity in CRC patient NK cells, effectively overcoming their impairment. CONCLUSIONS: These findings support the evaluation of the therapeutic potential of GA201 in combination with chemotherapy in CRC patients.

[Factors associated with jejunostomy complications]. / Factores asociados a complicaciones de yeyunostomía.

BACKGROUND: There are few studies in the literature that analyze jejunostomy complications and their associated factors. AIMS: To describe the rate of complications and analyze the factors associated with their development in a tertiary reference center in Mexico. METHODS: A retrospective study was carried out on patients that underwent Witzel jejunostomy within the time frame of January 2002 to December 2011. Patient demographic, clinical, and laboratory data were collected at the time of hospital admission and during follow-up. The factors associated with the development of complications were analyzed using the chi square test for categorical variables and the Student's t test for the continuous variables. Statistical significance was considered with a p<.05. RESULTS: One hundred and twelve patients (57 men) with a mean age of 54.2 years were included in the study. Forty-eight patients (42.9%) presented with postoperative complications. The most frequent surgical complications were severe sepsis (11.6%) and septic shock (7.14%) and the most frequent medical complications were pleural effusion (7.14%) and aspiration pneumonia (6.25%). The factors that were significantly associated with the development of complications were obesity, lymphocytopenia, and hypoalbuminemia. CONCLUSIONS: Jejunostomy is associated with an elevated medical, as well as surgical, complication frequency. Even though it has been established as a better alternative to parenteral nutrition, its associated morbidity should be taken into consideration before establishing its routine use as a means of nutritional support, especially in patients with factors associated with the development of complications.

Preeclampsia and risk of maternal pulmonary hypertension at high altitude in Bolivia.

Women with a history of preeclampsia (PE) have a greater risk of pulmonary arterial hypertension (PAH). In turn, pregnancy at high altitude is a risk factor for PE. However, whether women who develop PE during highland pregnancy are at risk of PAH before and after birth has not been investigated. We tested the hypothesis that during highland pregnancy, women who develop PE are at greater risk of PAH compared to women undergoing healthy highland pregnancies. The study was on 140 women in La Paz, Bolivia (3640m). Women undergoing healthy highland pregnancy were controls (C, n = 70; 29 ± 3.3 years old, mean±SD). Women diagnosed with PE were the experimental group (PE, n = 70, 31 ± 2 years old). Conventional (B- and M-mode, PW Doppler) and modern (pulsed wave tissue Doppler imaging) ultrasound were applied for cardiovascular íííassessment. Spirometry determined maternal lung function. Assessments occurred at 35 ± 4 weeks of pregnancy and 6 ± 0.3 weeks after birth. Relative to highland controls, highland PE women had enlarged right ventricular (RV) and right atrial chamber sizes, greater pulmonary artery dimensions and increased estimated RV contractility, pulmonary artery pressure and pulmonary vascular resistance. Highland PE women had lower values for peripheral oxygen saturation, forced expiratory flow and the bronchial permeability index. Differences remained 6 weeks after birth. Therefore, women who develop PE at high altitude are at greater risk of PAH before and long after birth. Hence, women with a history of PE at high altitude have an increased cardiovascular risk that transcends the systemic circulation to include the pulmonary vascular bed.

The utility of molecular diagnostics to predict recurrence of head and neck carcinoma.

BACKGROUND: Locoregional recurrence is the major cause of treatment failure after surgery for oral squamous cell carcinoma. Molecular diagnostics have the potential to improve on clinicopathological parameters to predict this recurrence and plan adjuvant treatment. The test most frequently applied is based on detecting TP53 mutations, but alternative methodology is required for cases that harbour the wild-type gene. METHODS: One hundred and two cases with tumour-adjacent margins, considered to be clear margins by microscopy, were examined using carefully optimised molecular diagnostics based on detection of the TP53 and Ly-6D markers. The markers were also combined to provide a dual approach. RESULTS: The dual molecular diagnostic identified cases with a significant increase in the probablility of developing locoregional recurrence when tumour-adjacent positive and clear margins were compared (P=0.0001). These tests were most useful when the clearance at the resection margins was 5 mm or less. The TP53-based diagnostic was a better predictor of locoregional recurrence than established clinicopathological parameters. CONCLUSION: The optimised TP53-based diagnostic rapidly identifies an important subgroup of cases with close margins that will benefit from new treatment modalities to reduce the risk of recurrence.

Specific versus non-specific exercises for the neck extensor muscles in women with chronic idiopathic neck pain: A randomized controlled trial.

BACKGROUND: Structural and functional impairments of the cervical extensor muscles have been demonstrated in people with neck pain. A global exercise approach targeting all neck extensor muscles has shown positive effects in this population. However, to date, the efficacy of exercises specifically targeting the deep neck extensors has neither been tested nor compared to global exercises for the neck extensors. OBJECTIVES: To compare the effects on pain and disability of a specific lower deep neck extensors (SLDNE) versus a general neck extensor (GNE) exercise program in women with chronic idiopathic neck pain. METHODS: Fourty-three women with chronic idiopathic neck pain were randomly allocated to either a six-week SLDNE or a GNE exercise program. As primary outcome, neck disability was measured with the Neck Disability Index (NDI). Secondarily, pain intensity (VAS), cervical ROM, pressure pain thresholds (PPTs), cervical and thoracic posture and self-perceived benefit of treatment (GROC) were also measured. Every outcome was measured at baseline and immediately after treatment, except NDI, which was also measured at 6-months follow-up. The GROC was only assessed post-intervention. RESULTS: Both exercise programs lead to reduced neck disability immediately post-intervention (within-group mean difference [MD] = -6.09; 95% Confidence Interval [CI]: 7.75, -4.42 and -4.73; 95%CI: 6.57, -2.91 respectively) and at the 6-months follow-up (-4.47; 95%CI: 6.41, -2.53 and -4.74; 95%CI: 6.50, -2.97), but with no between group differences. Similar results were found for pain intensity post-intervention, with no between group interaction (within-group MD = -20.87 mm; 95% CI: 28.55, -13.19 and -18.00 mm; 95%CI: (-26.24, -9.76) for SLDNE and GNE groups, respectively). GROC improved after both interventions without any between-group difference. CONCLUSIONS: A six-week exercise program specifically targeting the lower deep neck extensors lead to comparable outcomes as a general neck extensor exercise program in women with chronic idiopathic neck pain.

Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer.

BACKGROUND: KAMILLA is a single-arm safety study of trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (BC; NCT01702571). We report the final analysis of cohort 2 (Asia) within the context of published cohort 1 (Global) findings. METHODS: Patients had HER2-positive, locally advanced, or metastatic BC progressing after chemotherapy and anti-HER2 therapy or ≤6 months after adjuvant therapy. The primary objective was to further evaluate T-DM1 (3.6 mg/kg, administered intravenously every 3 weeks) safety/tolerability, including the following adverse events of primary interest (AEPIs): grade ≥3 AEPIs (hepatic events, allergic reactions, thrombocytopenia, hemorrhage events), all grade ≥3 treatment-related AEs, and all-grade pneumonitis. RESULTS: KAMILLA enrolled 2185 patients (cohort 1, n = 2003; cohort 2, n = 182) as of 31 July 2019. Of these, 2002 and 181 per cohort were treated and included in the safety population. Approximately 70% of patients had two or more previous treatment lines in the metastatic setting. Median T-DM1 exposure was 5.6 and 5.0 months per cohort; median follow-up was 20.6 and 15.1 months. The overall AEPI rate was higher in cohort 2 (93/181; 51.4%) versus cohort 1 (462/2002; 23.1%), mostly driven by a higher grade ≥3 thrombocytopenia rate in cohort 2. In cohort 2, grade ≥3 thrombocytopenia was not associated with grade ≥3 hemorrhagic events and most (128/138) fully resolved. Grade ≥3 treatment-related AEPI rates were 18.4% (cohort 1) and 48.6% (cohort 2), the latter mainly due to thrombocytopenia. Any-grade pneumonitis rates were 1.0% and 2.2%. No new safety signals were identified. Median (95% confidence interval) progression-free survival was 6.8 months (5.8-7.6 months) and 5.7 months (5.5-7.0 months) in cohorts 1 and 2, respectively; median overall survival was 27.2 months (25.5-28.7 months) and 29.5 months (21.1 months to non-estimable). In both cohorts, median progression-free survival and overall survival decreased with increasing prior therapy lines. CONCLUSIONS: Cohort 2 results aligned with previous findings in Asian patients, supporting the manageable safety profile and use of T-DM1 in advanced BC.

Flexible care in breast cancer.

Treatment of patients with cancer in hospitals or clinics is resource-intensive and imposes a burden on patients. 'Flexible care' is a term that can be used to describe treatment administered outside the oncology ward, oncological outpatient clinic or office-based oncologist setting. Programmes that reduce travel burden by bringing cancer treatment to the patient's home, workplace or closer to the patient's home, in the form of satellite clinics or mobile cancer units, expand treatment capacity and are well received. Clinical trial data show that, compared with intravenous administration, subcutaneous (s.c.) administration of trastuzumab is preferred by patients with breast cancer (BC), saves healthcare professionals' (HCPs) time, reduces drug preparation and administration time and reduces direct and indirect costs. As such, s.c. trastuzumab is well suited to flexible care. The results of a Belgian study (BELIS) show that home administration of s.c. trastuzumab is feasible and preferred by patients with BC. Numerous programmes and pilot studies in Europe show that s.c. trastuzumab can be administered effectively in the patient's home, in primary care settings or local hospitals. Such programmes require planning, training, careful patient selection and technology to link patients, caregivers and specialists in oncology clinics. Once these elements are in place, flexible care offers patients with BC a choice of how treatment may be delivered and lead to improved quality of life, while reducing pressure on HCPs and hospitals. The concept of flexible care is particularly relevant amid the COVID-19 pandemic where guidelines have been developed encouraging remote care.

Effect of silage source, physically effective neutral detergent fiber, and undigested neutral detergent fiber concentrations on performance and carcass characteristics of finishing steers.

This study was designed to evaluate the effect of silage source (barley vs. wheat silage) when harvested at two chop lengths (low vs. high physically effective neutral detergent fiber [peNDF]) and when barley silage was partially replaced with straw to increase the undigested neutral detergent fiber (uNDF) concentration on performance and carcass characteristics of finishing steers. Four hundred and fifty yearling commercial crossbred steers with an initial body weight (BW) of 432 ± 30.5 kg were allocated to 30 pens and fed diets containing 90% concentrate:10% forage for 123 d in a completely randomized block design with a 2 × 2 + 1 factorial arrangement. Treatments included 1) barley silage (BarS) with low peNDF (LpeNDF); 2) BarS with high peNDF (HpeNDF); 3) BarS with straw to yield a diet with LpeNDF + uNDF; 4) wheat silage (WhS) LpeNDF; and 5) WhS HpeNDF. There were no silage × peNDF interactions for dry matter intake (DMI), average daily gain (ADG), or gain to feed ratio (G:F), but cattle fed WhS LpeNDF had a lower (P < 0.01) proportion of yield grade 3 and a greater proportion in yield grade 2 carcasses than cattle fed BarS LpeNDF or HpeNDF and WhS HpeNDF. Cattle fed WhS LpeNDF had greater (P = 0.02) incidence of severe liver abscesses when compared with cattle fed BarS LpeNDF or HpeNDF and WhS HpeNDF. Cattle fed BarS consumed less (P < 0.01) uNDF as a percentage of BW, had increased (P = 0.02) ADG, heavier (P = 0.02) hot carcass weight, with greater (P = 0.01) back fat thickness, and (P < 0.01) incidence of minor liver abscesses when compared with cattle fed WhS. Feeding HpeNDF did not affect DMI, ADG, or G:F, but increased (P = 0.02) marbling score and reduced (P < 0.01) the proportion AA quality grade and increased (P < 0.01) those classified as AAA when compared with cattle fed LpeNDF. Cattle fed low uNDF had lesser (P < 0.01) uNDF intake as a percentage of BW, greater dressing percentage (P = 0.01), had a lower (P < 0.01) proportion of carcasses in yield grade 2, and a greater (P < 0.01) proportion of carcasses in yield grade 3 when compared with cattle fed high uNDF. Thus, silage source, peNDF, and uNDF content do not impact DMI or G:F when diets contain 10% forage, but BarS relative to WhS as well strategies increasing the peNDF concentration may increase ADG, HCW, back fat thickness, dressing percentage, marbling score, and carcasses classified as quality grade AAA. Future research is needed to evaluate the usefulness of peNDF and uNDF in rations for finishing cattle.

Shielding behavior of artisanal bricks against ionizing photons.

In the work reported in this article, were determined the shielding capabilities of three artisanal bricks used massively in the construction industry in Mexico. The linear attenuation coefficients for photons between 1 keV and 100 GeV are reported; and the half-value layers for energies used in the medical field, show that the three typical artisanal bricks have good shielding capabilities for photons below 50 keV. We compared the effective atomic numbers of one of our bricks against two widely used materials in the construction industry, and our results suggest that the greater the effective atomic number, the less material attenuation capacity. A comparison of the half-value layer of one of our bricks against the half-value layers of two clay bricks with different percentages of fly ash particles published in the literature, suggests that in the region between 0.001 and 2.8 MeV, all the three bricks have practically the same attenuation capacity and that from 2.8 MeV to 100 GeV the clay bricks with different percentages of fly ash particles, need less material to show the same attenuation capacity than our artisanal bricks. Energy Dispersed X-Ray Fluorescence suggests that regardless of the number of constituent elements in a sample, a critical mass per atom is required to have a positive impact on density; and as a consequence, in the capacity of attenuation of the materials. Normalized half-value layers suggest on the other hand, that the uncooked bricks have better shielding capabilities than cooked.

[Why do patients come to emergency departments? Analysis of the use of the extra-hospital Emergency Service of Pamplona]. / ¿Por qué vienen los pacientes a urgencias? Análisis de la utilización del Servicio de Urgencias extrahospitalario de Pamplona.

OBJECTIVES: The demand in the extra-hospital emergency department of Pamplona has increased considerably in 2015 and 2016. The objective of the study is to determine the profile of the patients, the reasons why they come, Primary Care centres of origin, and if they have requested an appointment in them. MATERIAL AND METHODS: A multicentre, descriptive study using a self-completed questionnaire by patients was conducted during one week per month, between August 2016 and January 2017. The variables collected were: gender, age, time of evolution of the disease, Primary Care Centre of origin, appointment request in Primary Care Centre, time of delay until the appointment, and reason for going to the extra-hospital emergency department. The association between the call made to the Primary Care Centre and the rest of the variables was analysed using the Pearson χy test. RESULTS: A total of 3489 questionnaires were collected, with 61.10% of the respondents being women, and 76.1% were between 15 and 55 years old. Almost two-thirds (65.7%) had not requested an appointment in their Primary Care Centre. Those who had not called the Primary Care Centre (65.7%), referred to it being "sudden" (27.82%) and "due to work schedule problems" (19.21%). While the reasons for those who had called (33.21%) were "suggestion of the Primary Care Centre" (33.21%) and "have to wait for many days" (31.30%). CONCLUSIONS: Most patients, who come to the extra-hospital emergency department, do so without having previously requested an appointment in their Primary Care Centre, although this is the gateway to the health system. It is essential to educate the population about self-care and the way they should use health services.

Quantum dot dipole orientation and excitation efficiency of micropillar modes.

The relative intensity of photonic modes in microcavity pillars with embedded self-assembled quantum dots is shown to be a sensitive function of quantum dot dipole orientation and position. This is deduced from a comparison of experiment and calculated intensities of light emission for many nominally identical pillars. We are able to obtain the overall degree of in-plane polarization of the quantum dot ensemble and also to obtain information on the degree of polarization along the growth axis.

A multi-centre, open-label, prospective, observational study to assess the safety of a nifedipine oral solution in the treatment of preterm labor / Estudio multicéntrico, de diseño abierto, prospectivo y observacional para evaluar la seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro

Objective: To analyze the safety profile of a nifedipine oral solution in the treatment of preterm labor (PTL). Methods: A multi-center, open-label, prospective, single-arm, observational study was conducted in 500 women with PTL to whom a nifedipine oral solution was prescribed according to its Summary of Product Characteristics. Safety profile and tolerability of oral administration of nifedipine solution during routine clinical practice was assessed as the primary objective of the study and treatment efficacy as secondary objective. Results: No severe adverse events were reported among these women, including severe hypotension. Eight patients (2.3%) reported adverse reactions of moderate intensity, and in 0.9% of the patients (3 cases), these adverse reactions caused the discontinuation of the treatment. Conclusions: The results of this study show that nifedipine oral solution exhibits an excellent safety profile used as a tocolytic treatment in women with PTL.(AU)

Objetivo: Analizar el perfil de seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro (PP). Métodos: Se llevó a cabo un estudio observacional, prospectivo, de diseño abierto, de rama única y multicéntrico en 500 mujeres que presentaban un PP, a las que se les administró una solución oral de nifedipino según la ficha técnica del producto. El perfil de seguridad y la tolerancia de la solución oral de nifedipino, en el contexto de la práctica clínica rutinaria, fueron evaluados como objetivo primario del estudio, y la eficacia del tratamiento, como objetivo secundario. Resultados: No se notificaron efectos adversos graves, incluyendo hipotensión severa. Ocho pacientes (2,3%) presentaron reacciones adversas de intensidad moderada, y en el 0,9% de las pacientes (3 casos) estos efectos adversos provocaron la discontinuación del tratamiento. Conclusiones: Los resultados de este estudio muestran que la solución oral de nifedipino dispone de un excelente perfil de seguridad para su uso como tocolítico en el tratamiento de mujeres con PP.(AU)

Insomnia in patients admitted to psychiatric hospital departments / Insomnio en pacientes que ingresan en unidades de hospitalización psiquiátricas.

Background. The aim of this study is to estimate the prevalence of insomnia in patients requiring admittance to short-stay hospital psychiatric units. Methodology. A descriptive observational study was designed with the participation of 16 units for brief adult psychiatric hospitalization in Spain. The Athens Insomnia Scale was the instrument used. Results. Four hundred and twenty-five patients were included, with an average value on the global score of the Athens Insomnia Scale of 8.56 (SD: 5.78). The item that obtained the highest average score concerned the presence of waking up during the night, followed by that concerning the time needed to fall asleep. The estimated prevalence of insomnia is 53% (CI 95%). Conclusions. Insomnia is a problem with a high prevalence in psychiatric hospitalization units. The greatest difficulties are found in inducing sleep and staying asleep.

[Intraoperative transesophageal echocardiography to guide removal of a hypernephroma with vena cava and right atrial extension]. / Ecocardiografía transesofágica intraoperatoria en el manejo de resección de hipernefroma con compromiso de vena cava y aurícula derecha.

We describe the case of a 70-year-old man who underwent resection of a right hypernephroma with vena caval and right atrial extension with continuous monitoring by transesophageal echocardiography. The monitoring technique brought important advantages, providing images that facilitated anatomical and functional evaluation of cardiac structures without obstructing the surgical field. Images of the heart and great vessels obtained in real time allowed the surgeon to make operative decisions based on accurate assessment of the cephalad extension of the tumor to the right chambers. Transesophageal echocardiography also allowed the anesthesiologist to monitor hemodynamic status throughout surgery and watch for tumoral emboli. The imaging technique proved to be highly useful for both anesthetic and surgical management of the patient.