Socio-academic Factors Influencing Knowledge About Organ Donation among Medical Students in Paraguay, 2018.

Organ donation currently is an extremely important issue in public health. Proper information about the details of this topic is extremely important, but is not yet widespread among the public. This study was carried out with the aim to determine the level of knowledge about organ donation among medical students in Paraguay and associated socio-academic factors influencing their level of knowledge. This was an analytical cross-sectional study, based on a multicenter survey among university medical students. About 68.7% (235) of the respondents were preclinical students doing basic sciences. Two aspects were evaluated, the knowledge regarding the donation of the organs and the socio-academic factors, then both the aspects were evaluated through bivariate and multivariate analyses. There were 342 respondents with a median age of 22 years (interquartile range: 20-23 years) of which 263 (77%) were women. One hundred and eighty-eight (55%) reported not knowing the law that protects and regulates the activities of organ and tissue donation in Paraguay. In the multivariate analysis, the highest frequency of a good level of knowledge of organ donation occurred in those who were older [RPA: 1.07, 95% confidence interval (CI): 1.02-1.12, P = 0.007] and in two of the universities evaluated (both with values P <0.012). On the contrary, those who were preclinical students, in general, had a lower level of knowledge of organ donation (RPa: 0.61, 95% CI: 0.46-0.79; value P <0.001). Our findings denote relatively a poor knowledge of organ donation in some socio-academic subsets. Therefore, it is important to develop strategies to increase the knowledge about the subject, by creating opportunities by way of discussions and debates among the students at all academic levels and also by conducting academic conferences on the subject.

BOMET-QoL-10 questionnaire for breast cancer patients with bone metastasis: the prospective MABOMET GEICAM study.

BACKGROUND: Bone metastasis (BM) is the most common site of disease in metastatic breast cancer (MBC) patients. BM impacts health-related quality of life (HRQoL). We tested prospectively the psychometric properties of the Bone Metastasis Quality of Life (BOMET-QoL-10) measure on MBC patients with BM. METHODS: Patients completed the BOMET-QoL-10 questionnaire, the Visual Analogue Scale (VAS) for pain, and a self-perceived health status item at baseline and at follow-up visits. We performed psychometric tests and calculated the effect size of specific BM treatment on patients´ HRQoL. RESULTS: Almost 70% of the 172 patients reported symptoms, 23.3% experienced irruptive pain, and over half were receiving chemotherapy. BOMET-QoL-10 proved to be a quick assessment tool performing well in readability and completion time (about 10 min) with 0-1.2% of missing/invalid data. Although BOMET-QoL-10 scores remained fairly stable during study visits, differences were observed for patient subgroups (e.g., with or without skeletal-related events or adverse effects). Scores were significantly correlated with physician-reported patient status, patient-reported pain, symptoms, and perceived health status. BOMET-QoL-10 scores also varied prospectively according to changes in pain intensity. CONCLUSIONS: BOMET-QoL-10 performed well as a brief, easy-to-administer, useful, and sensitive HRQoL measure for potential use for clinical practice with MBC patients. TRIAL REGISTRATION: NCT03847220. Retrospectively registered on clinicaltrials.gov (February the 20th 2019).

Understanding the different relationships between mood and sleep disorders in several groups of non-oncological patients with chronic pain.

OBJECTIVE: To compare sleep dimensions in patients suffering from chronic pain of different origins, and with a group of pain-free subjects. To analyze the relationship between depression and/or anxiety and sleep disorders in musculoskeletal, neuropathic, and fibromyalgia patients. METHODS: This cross-sectional study included patients diagnosed with neuropathic pain (NP) (n = 104), musculoskeletal pain (MSK) (n = 99), or fibromyalgia (FM) (n = 51), and pain free subjects (n = 72). Information about sleep dimensions (MOS-sleep), duration and intensity of pain (Visual Analog Scale), and anxiety and depression (Hospital Anxiety and Depression scale) was collected. RESULTS: Of the 254 patients with chronic pain (PCP) studied, the mean pain intensity was 6.6 (SD = 1.9), with an average duration of 9 years. The scores in all sleep dimensions of the MOS-sleep were higher in CPP (more disturbances) compared to pain free patients, and differences were observed among the three groups of PCP, with FM most severely affected. Anxiety (ß = 1.3), depression (ß = 1.1), intensity (ß = 1.7), and duration of pain (ß = 0.04) were associated with more sleep problems in MSK patients. In contrast, anxiety (ß = 2.5) and duration of pain (ß = 0.05) were negatively related to sleep in the NP patients, and only depression (ß = 1.3) affected FM patients. CONCLUSIONS: The sleep pattern differs among groups of PCP in the presence or absence of mood disorders. Understanding these disorders in each specific group of PCP is fundamental, and it can contribute to improve the clinical situation of the patients and better orientating therapeutic strategies.

Assessing the Construct Validity and Internal Reliability of the Screening Tool Test Your Memory in Patients with Chronic Pain.

Patients with chronic pain often complain about cognitive difficulties, and since these symptoms represent an additional source of suffering and distress, evaluating the cognitive status of these patients with valid and reliable tests should be an important part of their overall assessment. Although cognitive impairment is a critical characteristic of pain, there is no specific measure designed to detect these effects in this population. The objective was to analyze the psychometric properties of the "Test Your Memory" (TYM) test in patients with chronic pain of three different origins. A cross-sectional study was carried out on 72 subjects free of pain and 254 patients suffering from different types of chronic pain: neuropathic pain (104), musculoskeletal pain (99) and fibromyalgia (51). The construct validity of the TYM was assessed using the Mini-Mental State Examination (MMSE), Hospital Anxiety and Depression Scale (HADs), Index-9 from MOS-sleep, SF-12, and through the intensity (Visual Analogical Scale) and duration of pain. An exploratory factor analysis was also performed and internal reliability was assessed using Cronbach's alpha. After adjusting for potential confounders the TYM could distinguish between pain and pain-free patients, and it was correlated with the: MMSE (0.89, p<0.001); HAD-anxiety (-0.50, p<0.001) and HAD-depression scales (-0.52, p<0.001); MOS-sleep Index-9 (-0.49, p<0.001); and the physical (0.49, p < .001) and mental components (0.55, p < .001) of SF-12. The exploratory structure of the TYM showed an 8-factor solution that explained 53% of the variance, and Cronbach's alpha was 0.66. The TYM is a valid and reliable screening instrument to assess cognitive function in chronic pain patients that will be of particular value in clinical situations.

Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study.

Anthracycline and taxane-based primary chemotherapy (PCT) is the standard treatment for high-risk breast cancer (HRBC). However, conventional anthracyclines are not commonly used in elderly patients or those prone to cardiotoxicity. Pegylated liposomal doxorubicin, (PLD) has comparable efficacy, but less cardiotoxicity than conventional anthracyclines. We conducted a phase II single-arm trial to assess the efficacy and safety of PCT based on PLD followed by paclitaxel (PTX) in a HRBC population usually undertreated. Fifty patients with stage II-IIIB breast cancer and at least one risk factor for developing cardiotoxicity initiated PLD 35 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 4 weeks for four cycles, followed by 80 mg/m(2) weekly PTX for 12. Close cardiac monitoring was performed. Primary endpoint was the pathological complete response rate (pCR) in the breast. Treatment delivery and toxicities were assessed. Eighty-four per cent of patients were older than 65 years, 64 % suffered from hypertension, and 10 % had prior cardiac disease. In an intention-to-treat analysis, breast pCR was 32 % (95 % CI 19.5-46.7 %) and pCR in breast and axilla was 24 % (95 % CI 12.1-35.8 %). At diagnosis only, 26 % of patients were candidates for breast conservative surgery, which increased to 58.7 % after PCT. No significant decrease in left ventricular ejection fraction was seen. PLD followed by PTX was feasible in a fragile population of patients who were not candidates for conventional doxorubicin. Moreover, it achieved a pCR similar to standard therapy and could therefore be an option for elderly patients or cardiotoxicity-prone who present HRBC.

Prescription refill, patient self-report and physician report in assessing adherence to oral endocrine therapy in early breast cancer patients: a retrospective cohort study in Catalonia, Spain.

AIMS: To compare different methods in order to assess adherence and persistence with oral endocrine therapy in women diagnosed with breast cancer (BC) in Catalonia. MATERIALS AND METHODS: This study covered all women newly diagnosed with stage I, II or IIIa BC and positive hormone receptors at six hospitals in Catalonia (Spain) in 2004. Adherence was assessed on the basis of physician report and patient self-report using a telephone questionnaire. Persistence was measured by refill prescriptions. We used the Kappa index to compare adherence measures and logistic regression to evaluate adherence-related risk factors. RESULTS: The study covered a total of 692 women. Adherence ranged from 92% (self-report) to 94.7% (physician report), depending on the measure used; persistence was 74.7% at 5 years of follow-up. Low concordance between measures was observed (Kappa range: 0.018-0.267). Patients aged 50-74 years showed higher adherence than those aged <50 years. Adherence was also associated with: adjuvant chemotherapy and sequential hormonal therapy. CONCLUSIONS: Concordance between the different measures was remarkably low, indicating the need for further research. Adherence is an issue in the management of BC patients taking oral drugs, and should be assessed in clinical practice.

Increased signalling of EGFR and IGF1R, and deregulation of PTEN/PI3K/Akt pathway are related with trastuzumab resistance in HER2 breast carcinomas.

BACKGROUND: Trastuzumab resistance hampers its well-known efficacy to control HER2-positive breast cancer. The involvement of PI3K/Akt pathway in this mechanism is still not definitively confirmed. METHODS: We selected 155 patients treated with trastuzumab after development of metastasis or as adjuvant/neoadjuvant therapy. We performed immunohistochemistry for HER2, ER/PR, epidermal growth factor 1-receptor (EGFR), α-insulin-like growth factor 1-receptor (IGF1R), phosphatase and tensin homologue (PTEN), p110α, pAkt, pBad, pmTOR, pMAPK, MUC1, Ki67, p53 and p27; mutational analysis of PIK3CA and PTEN, and PTEN promoter hypermethylation. RESULTS: We found 46% ER/PR-positive tumours, overexpression of EGFR (15%), α-IGF1R (25%), p110α (19%), pAkt (28%), pBad (22%), pmTOR (23%), pMAPK (24%), MUC1 (80%), PTEN loss (20%), and PTEN promoter hypermethylation (20%). PIK3CA and PTEN mutations were detected in 17% and 26% tumours, respectively. Patients receiving adjuvant trastuzumab with α-IGF1R or pBad overexpressing tumours presented shorter progression-free survival (PFS) (all P≤0.043). Also, p110α and mTOR overexpression, liver and brain relapses implied poor overall survival (OS) (all P≤0.041). In patients with metastatic disease, decreased PFS correlated with p110α expression (P=0.024), whereas for OS were the presence of vascular invasion and EGFR expression (P≤0.019; Cox analysis). CONCLUSION: Our results support that trastuzumab resistance mechanisms are related with deregulation of PTEN/PI3K/Akt/mTOR pathway, and/or EGFR and IGF1R overexpression in a subset of HER2-positive breast carcinomas.

Advanced ovarian cancer: phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel vs carboplatin-paclitaxel.

BACKGROUND: Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy. METHODS: Women aged 75 years or younger with newly diagnosed stage IIB or greater ovarian cancer, Eastern Cooperative Oncology Group Performance Status of 1 or less, were stratified by type of primary surgery and residual disease, treatment center, and age; then randomly assigned to one of the two 21-day intravenous regimens. Patients in arm 1 (n = 409) were administered four cycles of cisplatin 50 mg/m(2) on day 1 and topotecan 0.75 mg/m(2) on days 1-5, then four cycles of paclitaxel 175 mg/m(2) over 3 hours on day 1 followed by carboplatin (area under the curve = 5) on day 1. Patients in arm 2 (n = 410) were given paclitaxel plus carboplatin as in arm 1 for eight cycles. We compared progression-free survival (PFS), overall survival, and cancer antigen-125 normalization rates in the two treatment arms. A stratified log-rank test was used to assess the primary endpoint, PFS. All statistical tests were two-sided. RESULTS: A total of 819 patients were randomly assigned. At baseline, the median age of the patients was 57 years (range = 28-78); 81% had received debulking surgery, and of these, 55% had less than 1 cm residual disease; 66% of patients were stage III and 388 (47.4%) patients had measurable disease. After a median follow-up of 43 months, 650 patients had disease progression or died without documented progression and 406 had died. Patients in arm 1 had more hematological toxicity and hospitalizations than patients in arm 2; PFS was 14.6 months in arm 1 vs 16.2 months in arm 2 (hazard ratio = 1.10, 95% confidence interval = 0.94 to 1.28, P = .25). Among patients with elevated baseline cancer antigen-125, fewer in arm 1 than in arm 2 had levels return to normal by 3 months after random assignment (51.6% vs 63.3%, P = .007) CONCLUSIONS: Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and paclitaxel alone, but without improved efficacy. Carboplatin plus paclitaxel remains the standard of care for advanced epithelial ovarian cancer.

Incorporación de un componente espiritual religioso en el tratamiento de pacientes terminales de una unidad del dolor en un hospital general / Inclusion of a religious spiritual component in the treatment of terminally ill patients in a general hospital pain unit

La presente investigación describe y compara creencias religiosas en 200 pacientes con enfermedad oncológica avanzada, un grupo de 200 pacientes sin patología oncológica evidente y un equipo de 100 profesionales de la salud pública de un hospital general en Santiago de Chile. Se utiliza el cuestionario de religiosidad de la encuesta CNAP de Barber y OQ-45.2 de Lambert, validado en Chile por De la Parra y Von Bergen. Los pacientes con enfermedad oncológica avanzada presentan un 95,5 por ciento de adherencia a una religión, en comparación a un 86,7 por ciento de los profesionales que los atienden. Los pacientes sin enfermedad oncológica avanzada presentan un 79 por ciento de adherencia religiosa, en comparación con los profesionales que los atienden 92,5 por ciento. No se observan diferencias significativas entre pacientes adherentes y no adherentes, con respecto a OQ-45.2 para los dos grupos de pacientes. Se describe observancia religiosa tanto en pacientes con enfermedad oncológica avanzada, como en pacientes sin patología oncológica evidente, y en profesionales de la salud pública de un hospital general y diferencias de religiosidad en cuanto a datos sociodemográficos.

This research describes and compares religious believes in 200 final stage cancer patients, a group of 200 patients who show no evident signs of cancer, and team of 100 professionals working in public health in a general hospital in Santiago de Chile. We applied the PUC-Adimark GFK religion questionnaire used in the CNAP Barber survey and the CNAP of Lambert OQ-45.2 that De la Parra and Von Bergen validated in Chile. 95,5 percent of final stage of cancer patients adhere to a religion compared to 86,7 percent of the professionals that take care of them. With respect to OQ-45.2, we observed no significant differences between both groups of patients, religious and no religious. Final stage cancer patients and those with no evident signs of cancer and public health professionals working in a general hospital have religious believes, however, there are differences in terms of socio-demographic data.

Gemcitabine and capecitabine in previously anthracycline-treated metastatic breast cancer: a multicenter phase II study (SOLTI 0301 trial).

BACKGROUND: On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. PATIENTS AND METHODS: Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. RESULTS: Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. CONCLUSION: Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.

Update in the management of ovarian and cervical carcinoma.

Ovarian and cervical cancers are significant health problems. This article provides an update in selected management topics. Paclitaxel and platinum derivatives are the first-line treatment for patients with advanced disease. In selected patients, intraperitoneal chemotherapy has been associated with improved survival but the broad applicability of this strategy is limited by issues of toxicity and feasibility. Management of patients with recurrent disease is based on a number of factors and includes surgery in selected cases, platinum-based chemotherapy for patients with platinum-sensitive disease and other agents such as topotecan and pegylated liposomal formulation of doxorubicin for patients with platinum-resistant disease. In cervical cancer, the most significant issue/event is the demonstration of superior survival with topotecan and cisplatin compared to cisplatin alone. Finally, new agents such as epidermal growth factor receptor inhibitors and antiangiogenic agents are being currently tested in these settings.

Diagnóstico citogenético prenatal: experiencia de 10 años en el Hospital Regional Rancagua / Prenatal diagnosis and cytogenetics: 10 year experience in a regional hospital

Objective: To present a 10-year experience with prenatal karyiotyping in cases of fetal malformations in a Regional NHS hospital. Methods: Pregnancies complicated with congenital abnormalities detected prenatally by ultrasonography and undergoing an invasive procedure for fetal Karyotyping were reviewed. Information on maternal demographics, number and type of procedure, indications, complications, and cytogenetic results was obtained by reviewing the ultrasound reports and medical records. Results: In the 10- year period from January 1997 to December 2006, 1.139 pregnancies complicated by a fetal structural anomaly were evaluated in our unit. In 270 cases, an invasive procedure for fetal karyotyping was carried out, including 212 (78 percent) fetal blood sampling procedures, 43 (16 percent) amniocenteses, 8 ( 3 percent) chronic villus sampling procedures. In 178 (66 percent) the karyotype result was reported as normal, in 68 (25 percent) as abnormal, in 22 (8 percent) there was a culture failure, and in 2 (1 percent) a failed procedure. Among the 68 chromosomal abnormalities, 32 percent were trisomy 21 (n=22), 32 percent trisomy 18 (n=22), and 25 percent a monosomy X(n=17). In the remaining cases there was a trisomy 13, trisomy 14, triploidy, or a chromosomal structural defect. In the first 4 years, the detection rate of a chromosomal defect was approximately 15 percent, which increased to 35 percent in the last 6 years, without a significant increase in the number of procedures. Conclusions: Our unit deals with more than 100 cases of fetal malformations per year. The implementation of a cytogenetic laboratory allows the provision of critical information for the subsequent management of the pregnancy and future genetic counseling. Overall, 25 percent of the procedures yielded an abnormal result. With increasing experience, the efficiency is improving considerable without a concomitant increase in the number of procedures.

Objetivo: Presentar la experiencia acumulada de 10 años con el diagnóstico citogenético prenatal en fetos con malformaciones congénitas detectados por ultrasonografía en un hospital base del sector público. Métodos : Se revisó nuestra base de datos seleccionando aquellas pacientes evaluadas exclusivamente por malformaciones fetales únicas o múltiples que fueron sometidas a estudio citogenético prenatal. Se recolectó la información demográfica y clínica, evaluando el número total de procedimientos por año, la relación normales/anormales, el rendimiento por tipo de muestra, el porcentaje de procedimientos frustros en la toma de muestra y la fallas del cultivo. Resultados: En el período entre enero de 1997 y diciembre del 2006, se evaluaron 1.139 embarazos complicados con malformaciones congénitas, en los cuales se realizaron 270 procedimientos invasivos prenatales. De ellos 212 (78 por ciento) fueron cordocentesis, 43 (16 por ciento) amniocentesis, 8 (3 por ciento) biopsias placentarias y 7 (3 por ciento) biopsia de vellosidades coriales. En 178 (66 por ciento) casos el cariograma fue informado como normal en 68 (25 por ciento) como anormal, en 22 (8 por ciento) no hubo crecimiento de cultivo celular y en 2 (1 por ciento) hubo una punción frustra. De los 68 resultados anormales, un 32 por ciento corresponden a trisomías 21 (n=22), un 32 por ciento a trisomías 18 (n= 22) y un 25 por ciento a monosomía del cromosoma X (n=17). El 10 por ciento restante corresponde a anomalías del cromosoma 13 ó 14, triploidías o defectos estructurales rearreglos cromosómicos. De un promedio de resultados anormales de un 15 por ciento en los primeros 4 años del estudio, se mejoró la detección a un 35 por ciento en los últimos 6 años, sin un aumento significativo en el número de procedimientos. Conclusiones: Nuestra Unidad de Ultrasonografía maneja un volumen superior a los 100 casos de anomalías fetales anuales...

Biweekly gemcitabine plus vinorelbine in first-line metastatic breast cancer: efficacy and correlation with HER2 extracellular domain.

Purpose. To assess the toxicity and efficacy of biweekly gemcitabine plus vinorelbine in first-line advanced breast cancer, and to establish whether circulating HER2 ECD levels correlate with the efficacy of the combination. Patients and methods. 52 patients were treated with gemcitabine 2500 mg/m(2) plus vinorelbine 30 mg/m(2), both on day 1 of 14-day cycles, for a maximum of 10 cycles. Baseline serum levels of HER2 ECD were assessed with an ELISA. Results. All patients were evaluable for toxicity, and 50 for efficacy. Overall toxicity was moderate. Grade 3 neutropenia occurred in 35% of patients and grade 4 in 19%. Other grade 3 toxicities were observed in less than 6%. There was one episode of febrile neutropenia, and one death after cycle three. Overall response rate was 52% (95% CI: 38% to 66%), with 2 patients achieving a CR (4%). Response rate did not correlate with HER2 ECD, with 50% of HER2 ECD positive patients responding, vs 48.5% of the HER2 ECD negative. Median overall survival was 24.6 months. Conclusion. Gemcitabine plus vinorelbine, given as an every-two-week schedule, is an active regimen in advanced breast carcinoma. This combination can be an option when anthracyclines and taxanes are not preferred. HER2 ECD has no predictive value in this non-taxane combination.

[Effect of flour folic acid fortification on the incidence of cranio encephalic congenital defects]. / Defectos congénitos cráneo-encefálicos: variedades y respuesta a la fortificación de la harina con ácido fólico.

BACKGROUND: In Chile, flour is fortified with folic acid since 2000, and the incidence of neural tube defects has decreased. Cranio-encephalic congenital defects (CECD) have a wider clinical scope, includind classical neural tube defects (NTD) such as anencephalia and acrania, but also incorporating other defects. Therefore, the effects of folic acid fortification on the incidence of CECD could be different. AIM: To study the effect of folic acid fortification on the incidence of CECD. MATERIAL AND METHODS: All prenatal diagnoses of CECD and cases registered locally in the Latin American Collaborative Study of Congenital Malformations (ECLAMC) were reviewed. The obtained data were crossed with all death certificates of newborns or stillborns of more than 500 g in the Sixth Region, in Central Chile. All cases were classified again in four subtypes, according to their phenotype. The incidences of all subtypes prior (1996-2000) and after folic acid supplementation (2001-2004), were compared. RESULTS: Between 1996 and 2004, there were 64 cases of CEDC among 109,176 infants born alive. The global rate was 8.86 per 10,000 born alive in the period prior to fortification and 3.03 per 10,000 born alive after fortification. Comparing both periods, there was a 66% reduction in all CECD and a 77 and 100% reduction in subtypes A and B of CECD, respectively (p <0.05). No significant reductions in type C and D CECD, were observed. CONCLUSIONS: After the start of flour folic acid fortification, there was a global reduction in the incidence of CECD. However, only types A and B CECD, supposedly more responsive to folic acid, were reduced.

Defectos congénitos cráneo-encefálicos: variedades y respuesta a la fortificación de la harina con ácido fólico / Effect of flour folic acid fortification on the incidence of cranio encephalic congenital defects

Background: In Chile, flour is fortified with folic acid since 2000, and the incidence of neural tube defects has decreased. Cranio-encephalic congenital defects (CECD) have a wider clinical scope, includind classical neural tube defects (NTD) such as anencephalia and acrania, but also incorporating other defects. Therefore, the effects of folic acid fortification on the incidence of CECD could be different. Aim: To study the effect of folic acid fortification on the incidence of CECD. Material and methods: All prenatal diagnoses of CECD and cases registered locally in the Latin American Collaborative Study of Congenital Malformations (ECLAMC) were reviewed. The obtained data were crossed with all death certificates of newborns or stillborns of more than 500 g in the Sixth Region, in Central Chile. All cases were classified again in four subtypes, according to their phenotype. The incidences of all subtypes prior (1996-2000) and after folic acid supplementation (2001-2004), were compared. Results: Between 1996 and 2004, there were 64 cases of CEDC among 109,176 infants born alive. The global rate was 8.86 per 10,000 born alive in the period prior to fortification and 3.03 per 10,000 born alive after fortification. Comparing both periods, there was a 66 percent reduction in all CECD and a 77 and 100 percent reduction in subtypes A and B of CECD, respectively (p <0.05). No significant reductions in type C and D CECD, were observed. Conclusions: After the start of flour folic acid fortification, there was a global reduction in the incidence of CECD. However, only types A and B CECD, supposedly more responsive to folic acid, were reduced.

[Renal function and cardiovascular risk in patients with essential hypertension. The "FRESHA" study]. / Función renal y riesgo cardiovascular en pacientes con hipertensión arterial esencial. Estudio FRESHA.

BACKGROUND: In the past few years there has been a growing amount of information about renal dysfunction and cardiovascular risk. The objectives of this study were to assess the prevalence of renal dysfunction and evaluate the relation between renal function and cardiovascular risk in patients with essential hypertension. METHODS: A multicenter, cross-sectional survey of unselected patients with essential hypertension attending primary care settings in Spain was performed between june and november 2004. Renal function was evaluated with the abbreviated equation of the Modification of Diet in Renal Disease study. Renal insufficiency was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m2. RESULTS: Eighty-eight investigators from 50 centers recruited 2130 patients being mean age 65.6 +/- 11 years and female 53%. Prevalence of diabetes, lipid abnormalities, and previous cardiovascular disease were 30.3%, 45.9%, and 42.1% respectively. Prevalence of renal insufficiency was 32.4% (95% CI 30.4-34.4). Patients suffering from renal insufficiency showed a higher prevalence of cardiovascular disease when comparing with those with an estimated glomerular filtration rate = or >60 ml/min/1.73 m2 (56.2% vs. 35.3%, OR 2.35, 95% CI 1.95-2.82, p < 0.001). A logistic regression analysis showed that the relation of renal dysfunction with cardiovascular disease was independent of other variables or classical cardiovascular risk factors as age, female sex, diabetes, smoking, hypercholesterolemia, and systolic blood pressure. CONCLUSIONS: Renal insufficiency was present in 32.4% of patients with essential hypertension attending primary care settings. Cases with renal dysfunction showed a higher cardiovascular risk. Hypertensive patients with renal insufficiency should be considered as candidates for an aggressive approach of cardiovascular risk management.

Alta prevalencia de síndrome de Down en el Hospital Regional Rancagua, Chile: Período 1997-2003 / High prevalence of Down syndrome in the Rancagua Hospital in central Chile

Background: The Latin American Collaborative Study for Congenital Malformations (ECLAMC) has detected a higher incidence of Down syndrome in a zone of central Chile than in the rest of the country. Aim: To analyze the incidence rates of Down syndrome between 1997 and 2003 at the Regional Hospital of Rancagua, located 90 km south of Santiago, Chile. Material and methods: The information obtained by ECLAMC was used. This program, using a case control methodology, registers all newborns with congenital malformations and assigns, as a control, the next normal newborn of the same sex. Results: During the study period, 106 newborns with Down syndrome were registered, with a mean rate of 29.61 per 10,000 live births, twice higher than expected. The rate variations along the years of study suggest a cyclic change, with a hemicycle of six years. Conclusions: In this hospital, mothers under 35 years of age, have twice the risk of having a child with Down syndrome, than in the rest of the country.

Randomized phase II trial of carboplatin versus paclitaxel and carboplatin in platinum-sensitive recurrent advanced ovarian carcinoma: a GEICO (Grupo Espanol de Investigacion en Cancer de Ovario) study.

BACKGROUND: The aim of this study was to determine whether the response rate for the paclitaxel-carboplatin combination is superior to carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma. PATIENTS AND METHODS: Patients with recurrent ovarian carcinoma, 6 months after treatment with a platinum-based regimen and with no more than two previous chemotherapy lines, were randomized to receive carboplatin area under the curve (AUC) 5 (arm A) or paclitaxel 175 mg/m(2) + carboplatin AUC 5 (arm B). The primary end point was objective response, following a 'pick up the winner' design. Secondary end points included time to progression (TTP), overall survival, tolerability and quality of life (QoL). RESULTS: Eighty-one patients were randomized and included in the intention-to-treat analysis. The response rate in arm B was 75.6% [26.8% complete response (CR) + 48.8% partial response (PR)] [95% confidence interval (CI) 59.7% to 87.6%] and 50% in arm A (20% CR + 30% PR) (95% CI 33.8% to 66.2%). No significant differences were observed in grade 3-4 hematological toxicity. Conversely, mucositis, myalgia/arthralgia and peripheral neurophaty were more frequent in arm B. Median TTP was 49.1 weeks in arm B (95% CI 36.9-61.3) and 33.7 weeks in arm A (95% CI 25.8-41.5). No significant differences were found in the QoL analysis. CONCLUSIONS: Paclitaxel-carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.