Repeated Filling of Elastomeric Pumps for Home-Based Subcutaneous Infusions: A Cost Analysis of 240 Devices.

BACKGROUND: The use of continuous subcutaneous infusion of drugs using the repeated filling of elastomeric infuser pumps (EIP) has gained clinical recognition for palliative care at home. However, to date, there has been a notable absence of research examining the cost implications associated with the repeated EIP filling procedure. We aimed to evaluate the cost associated to the repeated filling of EIP used in a home-based palliative care team. METHODS: We conducted an analysis of the cost associated to the repeated filling of 240 EIP (1-day, n = 136; 2-day, n = 102; 7-day, n = 2) (110 patients). RESULTS: The refilling procedure led to a reduction in the utilization of 409 devices, resulting in savings of €4.031. EIP refilling did not result in a decrease in the number of home visits, the duration of each visit, the expenses associated with transportation to patients' residences, or the nurse-to-hour cost. CONCLUSION: Refilling EIPs reduces costs by reducing the number of devices purchased. No additional cost savings were noted in nursing time, number of home visits and duration, and expenses with transportation. Further cost savings could be realized by training laycarers to refill EIP at home independently. Future research should assess the feasibility of laycarers training programs on performing EIP filling at home.

Ketamine subcutaneous continuous infusion for non-cancer neuropathic pain at home: a case report.

OBJECTIVE: Ketamine is a drug that can effectively treat neuropathic pain by blocking the N-methyl-D-aspartate receptor. It has been studied as a supplement to opioids for cancer pain, but its effectiveness for non-cancer pain is still limited. However, despite its usefulness in managing refractory pain, ketamine is not commonly used for home-based palliative care. METHODS: A case report of a patient with severe central neuropathic pain who was treated with a subcutaneous continuous infusion of morphine and ketamine at home. RESULTS: The introduction of ketamine in the patient's treatment plan effectively controlled pain. Only one possible ketamine side effect was observed and easily treated with pharmacological and non-pharmacological measures. CONCLUSIONS: We have found success in using subcutaneous continuous infusion of morphine and ketamine to alleviate severe neuropathic pain in a home setting. We also observed a positive impact on the patient's family members' personal, emotional and relational well-being after ketamine was introduced.

Revisiting the Frequency and Antimicrobial Resistance Patterns of Bacteria Implicated in Community Urinary Tract Infections.

Urinary tract infections (UTIs) are one of the most common infectious diseases at the community level. The continue misuse of antimicrobials is leading to an increase in bacterial resistance, which is a worldwide problem. The objective of this work was to study the incidence and pattern of antimicrobial resistance of the main bacteria responsible for UTI in the community of central and northern Portugal, and establish an appropriate empirical treatment. The urine samples were collected in Avelab­Laboratório Médico de Análises Clínicas over a period of 5 years (2015−2019). The urine cultures were classified as positive when bacterial growth was equal to or higher than 105 CFU/mL, and only for these cases, an antimicrobial susceptibility test was performed. Of the 106,019 samples analyzed, 15,439 had a urinary infection. Urinary infections were more frequent in females (79.6%) than in males (20.4%), affecting more elderly patients (56.9%). Escherichia coli (70.1%) was the most frequent uropathogen, followed by Klebsiella pneumoniae (8.9%). The bacteria responsible for UTI varied according to the patient's sex, with the greatest differences being observed for Enterococcus faecalis and Pseudomonas aeruginosa, these being more prevalent in men. In general, there was a growth in bacterial resistance as the age of the patients increased. The resistance of bacteria in male patients was, in most cases, statistically different (Chi-Square test, p < 0.05) from that observed for bacteria isolated from female patients, showing, in general, higher resistance in male patients. Although E. coli was the most responsible uropathogen for UTI, it was among the bacteria most susceptible to antibiotics. The isolates of K. pneumoniae, Proteus vulgaris and Enterobacter showed high resistance to the tested antimicrobials. The most common multidrug-resistant (MDR) bacteria implicated in UTI were K. pneumoniae (40.4%) and P. aeruginosa (34.7%), but E. coli, the most responsible bacteria for UTI, showed a MDR of 23.3%. When we compared our results with the results from 10 years ago for the same region, in general, an increase in bacterial resistance was observed. The results of this study confirmed that urinary tract infections are a very common illness, caused frequently by resistant uropathogens, for which the antibiotic resistance profile has varied over a short time, even within a specific region. This indicates that periodically monitoring the microbial resistance of each region is essential in order to select the best empirical antibiotic therapy against these infections, and prevent or decrease the resistance among uropathogenic strains.

Facial edema as an adverse drug reaction to olanzapine in a patient with cancer receiving palliative care.

OBJECTIVE: Atypical neuroleptics such as olanzapine are indicated for the treatment of various psychiatric disorders and have been used in the palliative care setting also for several clinical indications. Peripheral and facial edema are a rare side effect of the treatment with olanzapine. We report a case of an advanced cancer patient cared receiving palliative care who developed severe facial edema after initiating a low dose of olanzapine in monotherapy. METHOD: A patient with advanced cancer who presented with severe facial edema after initiating olanzapine for the treatment of her opioid use disorder. RESULTS: After excluding other differential diagnosis for facial edema, olanzapine was discontinued with complete resolution of the edema. SIGNIFICANCE OF RESULTS: To the best of our knowledge, this is the first case reporting facial edema due to olanzapine treatment in a patient with advanced cancer. Our report will help clinicians recognize the possible role of olanzapine in cases of rapid onset of facial edema, allowing its rapid resolution.

Treatment of Lower Extremity Edema by Controlled Subcutaneous Drainage at Home: A Case Report.

Lower severe edema is a common condition faced by advanced cancer patients with an impact on comfort, quality of life, and care planning. Diuresis and mechanical interventions are the mainstream options for the treatment of edema, but, although effective, may not be indicated for frail, bed-bound, and dependent patients cared for in the community setting.We present a case report of a young female with severe edema to her right lower limb, which accepted controlled subcutaneous fluid drainage at her home. Subcutaneous fluid drainage at home was effective, safe, and feasible and improved the patient's comfort and well-being.

Perception of Labial Size and Objective Measurements-Is There a Correlation? A Cross-Sectional Study in a Cohort Not Seeking Labiaplasty.

INTRODUCTION: Poor genital self-image is a common phenomenon leading to an increasing interest in female genital surgery over the last years. AIM: The aim was to correlate objective measurements of the labia minora with the individual subjective perception of the labial size. METHODS: In a cross-sectional study with 200 premenopausal women (median age 33.5 years) presenting for gynecological issues other than vulvar diseases, labial width and length were measured, and psychological and physical complaints were assessed. Multivariable logistic regression analyses were performed to identify factors that influenced self-reported complaints and subjective perception of labia size. MAIN OUTCOME MEASURE: The main outcome measure was labial appearance (width and length in mm, color), subjective perception of the labial size, and complaints. RESULTS: The median width of the labia minora was 19.0 mm (interquartile range = 12.6-27.5), and the median length was 35.5 mm (interquartile range = 27.8-48.9). The objective size of the labia was significantly associated with womens' subjective perception of the labial size, but not with self-reported complaints. Nearly one-third of the women (n = 53, 27%) reported complaints of their labia minora which were mainly physical (n = 41, 77%) or a combination of physical and psychological problems (n = 9, 17%), while only a small group reported experiencing only psychological complaints (n = 3, 6%). Predictors of complaints were previous cosmetic surgery and the subjective perception of the labia size. The latter was significantly associated with discomfort during intercourse and when visiting a sauna and by labia minora that protruded over the labia majora. CLINICAL IMPLICATIONS: Cutoff values to define labial hypertrophy and to justify labial reduction surgery should be avoided. STRENGTH & LIMITATIONS: This is a large sample of labial measurements in women not seeking labiaplasty. Standardized and validated questions regarding quality of life, sexuality, and body image could have provided more insight into psychological aspects. CONCLUSION: These data demonstrate the variability of labial anatomy and its perception. Widschwendter A, Riedl D, Freidhager K, et al. Perception of Labial Size and Objective Measurements-Is There a Correlation? A Cross-Sectional Study in a Cohort Not Seeking Labiaplasty. J Sex Med 2020;17:461-469.

Opioids and reproduction.

More than 40years ago, the endogenous opioids were first described. Their role as important neuromodulators of pain and their influence on a variety of neuroendocrine control systems within the central nervous system has been recognized. More recently, endogenous opioids and their receptor have been identified in a variety of reproductive and non-reproductive tissues outside the central nervous system. What role the opioid system plays in these peripheral tissues and organs is not completely understood and thus the subjects of current research. In the central nervous system, endogenous opioids inhibit pulsatile Gonadotropin Releasing Hormone (GnRH) release, affecting the release of gonadotropins from the pituitary, and thus mediating stress response within the central nervous-pituitary-gonadal axes in both women and men-Peripherally, endogenous opioids have been demonstrated to be present-among other organs-in the pancreas and in the ovary, where they are produced by granulosa cells and may influence oocyte maturation. In men, endogenous opioids play a role in sperm production within the testis. Opioid antagonists such as naltrexone have been used to restore cyclicity in women through improvement in insulin resistance, GnRH-pulsatility and hyperandrogenemia stemming from specific pathophysiological conditions such as hypothalamic amenorrhea, polycystic ovarian syndrome, hyperinsulinemia, ovarian hyperstimulation syndrome. Opioid antagonists have also been used to treat male sexual disorders and male infertility. In summary, endogenous opioids exert a variety of actions within the reproductive system which are reviewed in this chapter.

Connatal Urinary Ascites in a Female Preterm.

BACKGROUND: Connatal urinary ascites is rare in females without associated malformations and occurs following bladder rupture. CASE PRESENTATION: A female very preterm was delivered by caesarean section because of abnormal Doppler findings. The mother suffered from viral pneumonia requiring intensive care in the third trimester of pregnancy. Serial fetal ultrasound examinations showed a megacystis and ascites. Postnatally, pronounced isolated ascites was drained and its urinary nature was confirmed. The bladder leak was demonstrated when blue dye, instilled via a Foley catheter, appeared in the ascitic drain. After removal of the catheter spontaneous micturition was unremarkable. A micturating cystourethrogram showed spontaneous closure of the bladder leak. CONCLUSION: The female infant experienced fetal bladder rupture and connatal urinary ascites due to maternal pneumonia and intensive care. The use of blue dye is an effective alternative method to any contrast media radiography and should be considered, especially in very preterm infants.

Estudio comparado (Europa versus Estados Unidos) sobre el concepto de medicamento genérico / Comparative study (Europe vs the United States) on the concept of generic medicine

Objetivo: Determinar las similitudes y las diferencias del concepto científico de medicamento genérico en Europa y en Estados Unidos a partir de un estudio comparado de la legislación vigente en ambas regiones. Material y Método: Análisis de la legislación vigente en Europa y en Estados Unidos relativa al concepto de medicamento genérico, analizando detalladamente cada aspecto de la definición del mismo, composición (principio activo y excipientes), forma farmacéutica, características de calidad, bioequivalencia y concepto de medicamento de referencia. Estudio comparado de los resultados para concluir similitudes y diferencias en el ámbito conceptual. Resultados: Se observan similitudes y diferencias en cuanto al concepto científico de medicamento genérico en Europa y en Estados Unidos. En concreto, se observan diferencias al concepto de "mismo principio activo", "misma forma farmacéutica", al uso de excipientes con respecto al medicamento de referencia y a la elección del propio medicamento de referencia. También se observan diferencias en cuanto a cómo demostrar bioequivalencia con respecto al medicamento de referencia. Se observan similitudes en cuanto al concepto de "misma dosis", características de calidad, etiquetado e indicaciones con respecto al medicamento de referencia. Conclusiones: Estas diferencias van a tener un impacto en el desarrollo, registro y comercialización del medicamento genérico que desee comercializar una compañía farmacéutica de forma global en estas regiones

Aim: The objective is to determine the similarities and differences between Europe and the United States on the scientific concept of generic medicine. The study is based on a comparative study of the current legislation in both regions. Materials and Methods: Analysis of the current legislation in Europe and the United States in reference to the concept of generic medicine, analyzing each aspect of the definition in detail: composition (active substance and excipients), pharmaceutical form, quality characteristics, bioequivalence and the concept of reference medicinal product. Comparative study of the results obtained to conclude similarities and differences on the conceptual scope. Results: Similarities and differences are observed on the scientific concept of generic medicine between Europe and the United States. In particular, differences on the concept "same active substance" and "same pharmaceutical form", the use of excipients versus the reference medicinal product and the election of the reference medicinal product are observed. Moreover, differences on how to demonstrate bioequivalence with the reference medicinal product are also observed. Similarities on the concept of "same strength", quality characteristics, labelling and indications versus the reference medicinal product are observed. Conclusions: These differences will have an impact on the development, registration and marketing of a generic medicine by a company which decides to market a generic medicine globally in these regions

Prenatal sonographic diagnosis of intrahepatic portosystemic shunts.

The incidence of fetal portosystemic anastomoses is unknown, and it is presumed that many cases remain undetected, as visualization of the hepatic vasculature is not part of the routine 20-week sonographic scan in pregnancy. However, portosystemic anastomoses are associated with fetal growth restriction due to a diminished oxygen supply to hepatocytes and, hence, downregulation of liver function. In these cases, uteroplacental perfusion might be normal.

Medical management of early pregnancy failure (EPF): a retrospective analysis of a combined protocol of mifepristone and misoprostol used in clinical practice.

PURPOSE: To evaluate the efficacy of a combined protocol of mifepristone and misoprostol in the management of early pregnancy failure (EPF) and the average time to expulsion of tissue and rate of side effects. METHODS: Retrospective chart review of all consecutive women treated with primary medical management for EPF at our institution from 2006 to 2012. RESULTS: 168 patients were included in the present study. The overall success rate, defined as the absence of the need for surgical intervention, was 61 % and did not differ by calendar year. There was no difference in success rate grouped by diagnosis [intrauterine embryonic/fetal demise (IUED/IUFD) vs. anembryonic gestation; p = 0.30] or gestational age (<9 or ≥9 weeks; p = 0.48). The success rate varied significantly according to the required dose of misoprostol, ≤800 or >800 µg (68 vs. 50 %, p = 0.029). Of the possible predictive factors of success, only the dose of misoprostol required was a significant independent negative predictor. Mean and median time to tissue expulsion after the first dose of misoprostol were 8.4 and 5.5 h, respectively. The incidence of side effects was low with no blood transfusions required. CONCLUSIONS: The success rate in this study is markedly below published data. This can possibly be attributed to retrospective study design, allowing for physician subjectivity and patients' wishes in the absence of strict study requirements. The protocol was well tolerated with a paucity of side effects. We make suggestions for enhancing success rates in the clinical setting by optimizing medication protocols, establishing precise treatment guidelines and training physicians in the accurate interpretation of treatment outcomes.

Looking for suitable biomarkers in benthic macroinvertebrates inhabiting coastal areas with low metal contamination: comparison between the bivalve Cerastoderma edule and the Polychaete Diopatra neapolitana.

Metals accumulated in marine sediments are often a threat to benthic communities. With the recognized importance and wide use of stress biochemical responses as indicators of metal contamination it becomes essential to compare these markers between different species and verify their ubiquity and accuracy. Using wild Diopatra neapolitana and Cerastoderma edule, collected at several areas differing in metal contamination, this study aimed to assess the use of these two macrobenthic species as sentinel organisms and to determine the applicability of currently used biomarkers in benthic species exposed to a range of low metal and As concentrations. Total metal accumulation and intracellular partitioning was analyzed and metal-induced alterations were assessed through the analysis of several biochemical parameters in both organisms, including stress-induced reactive oxygen species (ROS), lipid peroxidation and protein content, the activity of antioxidant enzymes catalase (CAT), superoxide dismutase (SOD) and of glutathione S-transferase (GST). Metal chelation by Metallothioneins (MTs) was also determined. Results revealed that D. neapolitana accumulated higher levels of metals when compared to C. edule, independently of the sediment concentration. Results also showed strong species-specific responses to metals and differences in the ability to sequester metals. Overall, C. edule showed to be more efficient metal chelator and precipitatior than D. neapolitana, which was less tolerant and presented oxidative stress. MTs proved to be a good predictor of metal accumulation in both species, even under low metal exposures. On the other hand, lipid peroxidation was a good indicator of oxidative damage, only observed in D. neapolitana, which was a result of higher metal retention in the soluble fraction.

Complicaciones nutricionales después del tratamiento quirúrgico de la obesidad: ¿qué ocurre en el bypass gástrico? / Nutritional deficiencies following bariatric surgery: what happens with gastric bypass?

Fundamento y objetivos: Las deficiencias en macronutrientes y micronutrientes son complicaciones frecuentes de la cirugía de la obesidad. El objetivo de este trabajo es estudiar la repercusión del bypass gástrico en la evolución ponderal y las concentraciones de proteínas, vitaminas y minerales, así como documentar el porcentaje de pacientes que precisan suplementación nutricional. Material y método: Se estudió a 109 pacientes a los que se practicó bypass gástrico antes del 1 de marzo de 2004 y se siguió durante al menos 2 años. Se valoró la evolución del peso, el índice de masa corporal (IMC), la albúmina, la ferritina, el ácido fólico, la vitamina B12, la 25-OH-vitamina D3, vitamina A y vitamina E, a los 0, 6, 12, 18 y 24 meses tras la cirugía. Resultados: El peso y el IMC se estabilizan entre 12 y 18 meses tras la intervención. El porcentaje de sobrepeso perdido a los 6, 12, 18 y 24 meses fue del 53, el 66, el 70 y el 69%, respectivamente. Las concentraciones de ferritina y 25-OH-vitamina D3 fueron significativamente menores que las basales a partir de los 6 meses tras cirugía. El 54,7% de los pacientes requirió ferroterapia oral y el 9,5% recibió hierro vía intravenosa. Al 31,1% se le prescribió vitamina B12 intramuscular y al 31,7%, hidroferol oral a dosis altas. El 10,4% de los pacientes requirió suplementación proteínica y el 7,6%, suplementos de vitamina A. Conclusiones: El bypass gástrico consigue unos buenos resultados ponderales durante los primeros 24 meses después de la intervención. Este período coincide con el de mayores carencias nutricionales, y la ferropenia, la depleción de vitamina B12 y 25-OH-vitamina D3 son las complicaciones nutricionales más frecuentes (AU)

Background and objectives: Deficiencies of vitamins and other nutrients are common complications following bariatric surgery. The aim of this study was to analyze the impact of gastric bypass on weight reduction and analyze protein, vitamin and mineral depletion. Material and method: We studied 109 obese patients in whom gastric bypass was performed before March 2004 and were followed for more than 2 years. We determined weight, body mass index (BMI), serum albumin, ferritin, vitamin B12, folate, 25-OH-vitamin D3, vitamin A and vitamin E at 0, 6, 12, 18 and 24 months following surgery. Results: Weight and BMI nadir occurred at 12 to18 months after gastric bypass. The percentage excess weight loss at 6, 12 18 and 24 months was of 53%, 66%, 70% and 69% respectively. Mean levels of ferritin and 25-OH-vitamin D3 were significantly lower than baseline levels after 6 months following surgery. Oral and parenteral iron supplements were needed in 54.7% and 9.5% of patients respectively. 31.1% of patients received parenteral vitamin B12 and 31.7% high doses of vitamin D supplements. Oral protein supplements and vitamin A supplements were prescribed to 10.4% and 7.6% patients respectively. Conclusions: Gastric bypass showed good weight loss results in the 24 months following surgery. Iron, vitamin B12 and vitamin D3 deficiencies, are the more frequent nutritional complications (AU)

Costal cartilage autografts to simulated degenerative intervertebral discs in the rat.

STUDY DESIGN: An autograft of costal cartilage was transplanted into the rat intervertebral space in the proximal tail following 2 weeks of simulated degeneration by chondroitinase ABC (CABC). OBJECTIVES: The purpose of this study was to evaluate costal cartilage transplantation into a degenerated disc as a possible therapy. SUMMARY OF BACKGROUND DATA: Reversal of degenerative disc dehydration is an attractive goal. Costal cartilage is plentiful, hydrophilic, and avascular, leading us to speculate that it would survive transplantation into the degenerated disc, increase proteoglycan content, and restore disc height. MATERIALS AND METHODS: Costal cartilage fragments were transplanted into a single proximal intervertebral disc in each of the rats' tails following a 2-week period of simulated degeneration. The intervertebral space was measured on radiographs under 2.5x magnification taken pretreatment and 21 days posttreatment. Each specimen was sagittally sectioned, mounted, and stained. The slides were graded for proteoglycan content. RESULTS: A 64% increase in intervertebral disc height was observed in the implant group compared with a 4% increase in sham operated group and a 39% increase in the CABC only group. Histology demonstrated a viable implant in 7 of 9 rats. The transplant group had significantly more proteoglycan staining than either the CABC group or sham group (P < 0.05). CONCLUSIONS: Costal cartilage transplantation may rehydrate degenerated intervertebral discs and might serve as a promising model for understanding and perhaps modifying this complex degenerative disease.