Use of a gas-operated ventilator as a noninvasive bridging respiratory therapy in critically Ill COVID-19 patients in a middle-income country.

During the COVID-19 pandemic, there was a notable undersupply of respiratory support devices, especially in low- and middle-income countries. As a result, many hospitals turned to alternative respiratory therapies, including the use of gas-operated ventilators (GOV). The aim of this study was to describe the use of GOV as a noninvasive bridging respiratory therapy in critically ill COVID-19 patients and to compare clinical outcomes achieved with this device to conventional respiratory therapies. Retrospective cohort analysis of critically ill COVID-19 patients during the first local wave of the pandemic. The final analysis included 204 patients grouped according to the type of respiratory therapy received in the first 24 h, as follows: conventional oxygen therapy (COT), n = 28 (14%); GOV, n = 72 (35%); noninvasive ventilation (NIV), n = 49 (24%); invasive mechanical ventilation (IMV), n = 55 (27%). In 72, GOV served as noninvasive bridging respiratory therapy in 42 (58%) of these patients. In the other 30 patients (42%), 20 (28%) presented clinical improvement and were discharged; 10 (14%) died. In the COT and GOV groups, 68% and 39%, respectively, progressed to intubation (P ≤ 0.001). Clinical outcomes in the GOV and NIV groups were similar (no statistically significant differences). GOV was successfully used as a noninvasive bridging respiratory therapy in more than half of patients. Clinical outcomes in the GOV group were comparable to those of the NIV group. These findings support the use of GOV as an emergency, noninvasive bridging respiratory therapy in medical crises when alternative approaches to the standard of care may be justifiable.

Do Compression Garments Prevent Subcutaneous Edema After Abdominoplasty?

BACKGROUND: The main disadvantages of wearing a compression garment following abdominoplasty are the increase in intra-abdominal pressure and risk of venous stasis. On the one hand, the wearing of garments may increase the risk of venous thromboembolism. On the other hand, it may be beneficial in decreasing edema formation after surgery. OBJECTIVES: The authors sought to evaluate the effectiveness of compression garments in reducing subcutaneous edema after abdominoplasty. METHODS: Thirty-two women aged 19 to 50 years were selected and randomly allocated to either the garment (n = 16) or no-garment (n = 16) group. All patients underwent abdominoplasty and received 10 sessions of manual lymphatic drainage during the postoperative period. Postoperative edema formation was assessed by perimetry and bioimpedance, and seroma formation was assessed by ultrasound. Statistical tests included t test, mixed linear models, analysis of variance with repeated measures, and the Kolmogorov-Smirnov test, which were performed at a significance level α of .05 (P ≤ .05). RESULTS: The no-garment group showed a trend toward lower mean waist circumference at 29 days following abdominoplasty and significantly lower waist circumference after postoperative day 35 compared with the garment group (P < .001). The mean total body water was slightly lower in the no-garment group than in the garment group 7 days after surgery (P = .05). CONCLUSIONS: Patients who did not wear a compression garment after abdominoplasty showed less subcutaneous edema formation after 24 days of surgery than those who wore the garment.

Do Abdominal Binders Prevent Seroma Formation and Recurrent Diastasis Following Abdominoplasty?

BACKGROUND: For decades, the postoperative wearing of abdominal binders has been suggested to reduce dead space and prevent mobilization of the musculoaponeurotic layer in an attempt to decrease the risk of seroma formation and recurrent diastasis. OBJECTIVES: This study sought to evaluate whether the postoperative wearing of an abdominal binder provides any additional contribution to the reduction of either seroma formation or recurrent diastasis recti when abdominoplasty is performed with quilting sutures. METHODS: Thirty-four women undergoing abdominoplasty were randomized into 2 groups: the binder group (n = 16) wore abdominal binders during the postoperative period, whereas the control group (n = 18) did not. Ultrasound examination was performed on postoperative days 7 and 14 to assess seroma formation and at 6 months postoperatively to assess recurrence of diastasis recti. A t test for independent samples was applied to compare means between 2 numeric variables. Generalized estimation equation models were used to evaluate seroma volume at different time points for the 2 groups. RESULTS: No significant differences in seroma volume were found between groups on postoperative days 7 (P = 0.830) and 14 (P = 0.882). Seven cases of subclinical recurrent diastasis were observed by ultrasound examination in the supraumbilical (4 cases) and infraumbilical regions (3 cases), but without significant differences (P = 1.000) between the 2 groups. Recurrent diastasis was not detected during physical examinations. CONCLUSIONS: The postoperative wearing of abdominal binders was not effective in preventing either seroma formation or recurrent diastasis following abdominoplasty with quilting sutures.

Association of Tumor Mutational Burden with Efficacy of Pembrolizumab±Chemotherapy as First-Line Therapy for Gastric Cancer in the Phase III KEYNOTE-062 Study.

PURPOSE: This prespecified exploratory analysis evaluated the association between tumor mutational burden (TMB) status and outcomes of first-line pembrolizumab±chemotherapy versus chemotherapy in KEYNOTE-062. PATIENTS AND METHODS: In patients with advanced gastric cancer and evaluable TMB data, we evaluated the association between TMB (continuous variable; square root scale) assessed with FoundationOne CDx and clinical outcomes [objective response rate (ORR), progression-free survival (PFS), and overall survival (OS)] using logistic (ORR) and Cox proportional hazards (PFS, OS) regression models. Clinical utility of TMB was assessed using the prespecified cutoff of 10 mut/Mb. RESULTS: TMB data were available for 306 of 763 patients (40.1%; pembrolizumab, 107; pembrolizumab+chemotherapy, 100; chemotherapy, 99). TMB was significantly associated with clinical outcomes in patients treated with pembrolizumab and pembrolizumab+chemotherapy (ORR, PFS, and OS; all P < 0.05) but not with chemotherapy (all P > 0.05). The overall prevalence of TMB ≥10 mut/Mb was 16% across treatment groups; 44% of patients who had TMB ≥10 mut/Mb had high microsatellite instability (MSI-H) tumors. Improved clinical outcomes (ORR, PFS, and OS) were observed in pembrolizumab-treated patients (pembrolizumab monotherapy and pembrolizumab+chemotherapy) with TMB ≥10 mut/Mb. When the analysis was limited to the non-MSI-H subgroup, both the positive association between clinical outcomes with pembrolizumab or pembrolizumab+chemotherapy and TMB as a continuous variable and the clinical utility of pembrolizumab (with or without chemotherapy) versus chemotherapy by TMB cutoff were attenuated. CONCLUSIONS: This exploratory analysis of KEYNOTE-062 suggests an association between TMB and clinical efficacy with first-line pembrolizumab-based therapy in patients with advanced gastric/gastroesophageal junction adenocarcinoma. However, after the exclusion of patients with MSI-H tumors, the clinical utility of TMB was attenuated.

The Effect of Quilting Sutures on the Tension Required to Advance the Abdominal Flap in Abdominoplasty.

BACKGROUND: Quilting sutures attaching the abdominal flap to the aponeurosis contribute to the prevention of seroma formation following abdominoplasty. The sutures distribute the tension over the subcutaneous tissue along the flap length, theoretically decreasing tension at the distal (cutaneous) end of the flap. This is expected to reduce the risks of necrosis, dehiscence, and enlarged or hypertrophic scars. OBJECTIVES: This study sought to verify whether quilting sutures decrease the tension required to advance the dermal-fat flap in abdominoplasty. METHODS: Thirty-four women undergoing abdominoplasty with quilting sutures participated in the study. The tensile force required for flap advancement was measured with a digital force gauge before and after placement of quilting sutures and then compared. Differences in tensile force were tested for correlations with BMI, age, weight of flap tissue removed, number of previous pregnancies, and postoperative complications, including seroma formation, hematoma, necrosis, dehiscence, and enlarged or hypertrophic scars. RESULTS: A mean reduction in tension of 27.7% was observed at the skin suture after the placement of quilting sutures (P < 0.001). No significant correlation was found between reduced flap tension and BMI, age, weight of tissue removed, or number of births. One case of seroma formation and 2 cases of enlarged scars were observed, but no case of hematoma, necrosis, or wound dehiscence was detected. CONCLUSIONS: The use of quilting sutures to attach the abdominal flap to the aponeurosis of the anterior abdominal wall reduced tension at the advancing edge of the flap in abdominoplasty.

Social Distancing and Economic Crisis During COVID-19 Pandemic Reduced Cancer Control in Latin America and Will Result in Increased Late-Stage Diagnoses and Expense.

Since December 2019, the world has been mired in an infectious pandemic that has displaced other health priorities for 21st century populations. Concerned about this situation, Latin American experts on cancer decided to evaluate the impact of the pandemic on cancer control in the region. The analysis was based on information obtained from public sources and scientific publications and included the characteristics of the health care and cancer control prior to the pandemic, the COVID-19 pandemic and measures implemented by the governments of the region, and the regional impact of the pandemic on cancer control together with the costs of cancer care and possible impact of the pandemic on cancer expense. We compared 2019 and 2020 data corresponding to the period March 16-June 30 and found a significant reduction in the number of first-time visits to oncology services (variable depending on the country between -28% and -38%) and a corresponding reduction in pathology (between -6% and -50%), cancer surgery (between -28% and -70%), and chemotherapy (between -2% and -54%). Furthermore, a significant reduction in cancer screening tests was found (PAP smear test studies: between -46% and -100%, mammography: between -32% and -100%, and fecal occult blood test: -73%). If this situation becomes a trend, the health and economic impact will be compounded in the postpandemic period, with an overload of demand on health services to ensure diagnostic tests and consequent treatments. On the basis of this information, a set of prevention and mitigation measures to be immediately implemented and also actions to progressively strengthen health systems are proposed.

Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial.

Importance: Safe and effective therapies for untreated, advanced gastric/gastroesophageal junction (G/GEJ) cancer remain an unmet need. Objective: To evaluate the antitumor activity of pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy alone in patients with untreated, advanced G/GEJ cancer with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater. Design, Setting, and Participants: The phase 3 KEYNOTE-062 randomized, controlled, partially blinded interventional trial enrolled 763 patients with untreated, locally advanced/unresectable or metastatic G/GEJ cancer with PD-L1 CPS of 1 or greater from 200 centers in 29 countries between September 18, 2015, and May 26, 2017. Interventions: Patients were randomized 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1 to 5 or capecitabine 1000 mg/m2 twice daily), or chemotherapy plus placebo, every 3 weeks. Main Outcomes and Measures: Primary end points were overall survival (OS) and progression-free survival (PFS) in patients with PD-L1 CPS of 1 or greater or 10 or greater. Results: A total of 763 patients were randomized to pembrolizumab (n = 256), pembrolizumab plus chemotherapy (n = 257), or chemotherapy (n = 250). The median (range) age of all patients in the study cohort was 62 (20-87) years; 554 of 763 (72.6%) were men. At final analysis, after a median (range) follow-up of 29.4 (22.0-41.3) months, pembrolizumab was noninferior to chemotherapy for OS in patients with CPS of 1 or greater (median, 10.6 vs 11.1 months; hazard ratio [HR], 0.91; 99.2% CI, 0.69-1.18). Pembrolizumab monotherapy was not superior to chemotherapy in patients with CPS of 1 or greater. Pembrolizumab prolonged OS vs chemotherapy in patients with CPS of 10 or greater (median, 17.4 vs 10.8 months; HR, 0.69; 95% CI, 0.49-0.97), but this difference was not statistically tested. Pembrolizumab plus chemotherapy was not superior to chemotherapy for OS in patients with CPS of 1 or greater (12.5 vs 11.1 months; HR, 0.85; 95% CI, 0.70-1.03; P = .05) or CPS of 10 or greater (12.3 vs 10.8 months; HR, 0.85; 95% CI, 0.62-1.17; P = .16) or for PFS in patients with CPS of 1 or greater (6.9 vs 6.4 months; HR, 0.84; 95% CI, 0.70-1.02; P = .04). Grade 3 to 5 treatment-related adverse event rates for pembrolizumab, pembrolizumab plus chemotherapy, and chemotherapy were 17%, 73%, and 69%, respectively. Conclusions and Relevance: This phase 3 randomized clinical trial found that among patients with untreated, advanced G/GEJ cancer, pembrolizumab was noninferior to chemotherapy, with fewer adverse events observed. Pembrolizumab or pembrolizumab plus chemotherapy was not superior to chemotherapy for the OS and PFS end points tested. Trial Registration: ClinicalTrials.gov Identifier: NCT02494583.

Insuficiencia cardíaca aguda tras administración de propofol y fentanilo en pacientes sin enfermedad cardíaca estructural: reporte de dos casos / Acute heart failure following propofol and fentanyl adminis-tration in patients without structural heart disease: two cases report

La insuficiencia cardíaca aguda se presenta excepcionalmente en pacien-tes sin enfermedad cardíaca estructural. Se presenta dos casos clínicos con insuficiencia cardiaca luego de intervención quirúrgica en donde se administraron dosis de propofol y fentanilo, fármacos relacionados con efecto depresor cardiovascular; se observa un deterioro hemodinámico súbito, con disminución de la fracción de eyección que en el seguimiento regresaría a parámetros de normalidad. Al descartarse patología orgánica de corazón, el uso de estos fármacos se relaciona con el desarrollo de la insuficiencia cardiaca, por lo que se propone tenerlo en cuenta en el diag-nóstico diferencial de esta patología.

Acute heart failure occurs exceptionally in patients without structural heart disease. Two clinical cases with heart failure after surgical intervention were presented, in which doses of propofol and fentanyl were administered, drugs related to cardiovascular depressant effect; a sudden hemodynamic deterioration is observed, with a decrease in the ejection fraction, which in the monitoring would return to normal parameters. When discarding orga-nic pathology of heart, the use of these drugs is related to the development of heart failure, so it is proposed to take it into account in the differential diagnosis of this condition.

Avaliação da regulação exteroceptiva e interoceptiva do equilíbrio corporal de idosas ativas / Evaluation of exteroceptive and interoceptive regulation of body balance of active seniors

O processo do envelhecimento humano traz consigo um conjunto de alterações para o organismo, dentre elas há a diminuição da eficácia das estratégias motoras do equilíbrio corporal e o aumento do tempo de reação muscular, o que torna o indivíduo mais suscetível à queda. O objetivo deste estudo foi avaliar o desempenho do equilíbrio de um grupo de idosas fisicamente ativas, com ênfase na regulação do sistema visual, vestibular e somatossensorial do equilíbrio estático e dinâmico, bem como sua performance em testes de marcha e flexibilidade. Trata-se de um estudo transversal analítico, realizado com 32 mulheres (67,48±4,88 anos), praticantes regulares de Pilates e hidroginástica. Os instrumentos utilizados foram: Escala do Equilíbrio de Berg (EEB), Timed Up and Go Test (TUG), Teste de Alcance Funcional (TAF) e o Teste de Equilíbrio Corporal (TEC). As idosas foram estratificadas em grupos: G1 (60-64 anos), G2 (65-69 anos), G3 (70-74 anos) e G4 (75-79 anos). A EEB atestou para um equilíbrio conservado [F(3,29)=1,766, p≥0,50], o TUG para independência funcional preservada [F(3,29)=0,418; p≥0,50] e o TAF sem risco para quedas [F(3,20)=2,228; p≥0,50]. O TEC identificou déficit da regulação interoceptiva do equilíbrio para todas as idades e comprometimento regulação interoceptiva do equilíbrio dinâmico para septuagenárias [F(3,29)= 0,301; p≥0,50]. Observou-se correlação moderada entre EEB-TEC (r=0,416; p=0,018), TEC-TUG (r=-345; p=0,013) e negativa entre EEB-TUG (r=-0,427; p=0,013). Sendo que, o TAF não se mostrou equivalente aos demais instrumentos. Conclui-se que mulheres sexagenárias e septuagenárias, praticantes regulares de exercícios físicos, apesar de indicarem bom desempenho nos testes de equilíbrio, marcha e flexibilidade, apresentaram comprometimento dos sistemas de regulação sensorial do equilíbrio estático e dinâmico...(AU)

The process of human aging brings with it a number of alterations to the organism, among them there is a decrease in the effectiveness of the motor strategies of the body balance and the increase of the time of muscular reaction, which makes the individual more susceptible to fall. The aim of this study was to evaluate the balance performance of a group of physically active elderly women, with emphasis on the regulation of the visual, vestibular and somatosensory systems of the static and dynamic balance, as well as their performance in gait tests and flexibility. This is a cross-sectional, analytical study of 32 women (67.48 ± 4.88 years), regular Pilates practitioners, and water aerobics. The instruments used were: Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Functional Reach Test (TAF) and Body Balance Test (TEC). The elderly were stratified into groups: G1 (60-64 years), G2 (65-69 years), G3 (70- 74 years) and G4 (75-79 years). BBS attained a conserved equilibrium [F(3.29)=1.766, p≥0.50], the TUG for preserved functional independence [F(3.29)=0.418; p≥0.50] and TAF without risk of falls [F(3,20)=2,228; p≥0.50]. The TEC identified deficit of interoceptive regulation of balance for all ages and compromise interoceptive regulation of dynamic balance for septuagenarians [F(3,29)=0.301; p≥0.50]. It was observed a moderate correlation between BBS-TEC (r=0.416, p=0.018), TEC-TUG (r=-345, p=0.013) and negative between BBS-TUG (r=-0.427, p=0.013). The TAF did not prove to be equivalent to the other instruments. It was concluded that sexagenarian and septuagenarian women, regular physical exercise practitioners, despite indicating good performance in tests of balance, gait and flexibility, presented impairment of the systems of sensorial regulation of the static and dynamic balance...(AU)

Impact of PSA density of transition zone as a potential parameter in reducing the number of unnecessary prostate biopsies in patients with PSA levels between 2. 6 and 10. 0 ng/mL

ABSTRACT Purpose: To assess the accuracy of prostate-specific antigen (PSA) adjusted for the transition zone volume (PSATZ) in predicting prostate cancer by comparing the ability of several PSA parameters in predicting prostate cancer in men with intermediate PSA levels of 2.6 - 10.0 ng/mL and its ability to reduce unnecessary biopsies. Materials and Methods: This study included 656 patients referred for prostate biopsy who had a serum PSA of 2.6 - 10.0 ng/mL. Total prostate and transition zone volumes were measured by transrectal ultrasound using the prolate ellipsoid method. The clinical values of PSA, free-to-total (F/T) ratio, PSA density (PSAD) and PSATZ for the detection of prostate cancer were calculated and statistical comparisons between biopsy-positive (cancer) and biopsy-negative (benign) were conducted. Results: Cancer was detected in 172 patients (26.2%). Mean PSA, PSATZ, PSAD and F/T ratio were 7.5 ng/mL, 0.68 ng/mL/cc. 0.25 ng/mL/cc and 0.14 in patients with prostate cancer and 6.29 ng/mL, 0.30 ng/mL/cc, 0.16 ng/mL/cc and 0.22 in patients with benign biopsies, respectively. ROC curves analysis demonstrated that PSATZ had a higher area under curve (0,838) than F/T ratio (0.806) (P<0.001) and PSAD (0.806) (P<0.001). With a cut-off value of 0.22 ng/mL/cc, PSATZ had 100% of sensitivity and could have prevented 24% of unnecessary biopsies. Conclusions: PSATZ may be useful in enhancing the specificity of serum PSA. Compared to other PSA related parameters, it was better in differentiating between prostate cancer and benign prostatic enlargement. Also, PSATZ could reduce a significant number of unnecessary biopsies.

Impact of PSA density of transition zone as a potential parameter in reducing the number of unnecessary prostate biopsies in patients with psa levels between 2.6 and 10.0 ng/mL.

PURPOSE: To assess the accuracy of prostate-specific antigen (PSA) adjusted for the transition zone volume (PSATZ) in predicting prostate cancer by comparing the ability of several PSA parameters in predicting prostate cancer in men with intermediate PSA levels of 2.6 - 10.0 ng/mL and its ability to reduce unnecessary biopsies. MATERIALS AND METHODS: This study included 656 patients referred for prostate biopsy who had a serum PSA of 2.6 - 10.0 ng/mL. Total prostate and transition zone volumes were measured by transrectal ultrasound using the prolate ellipsoid method. The clinical values of PSA, free-to-total (F/T) ratio, PSA density (PSAD) and PSATZ for the detection of prostate cancer were calculated and statistical comparisons between biopsy-positive (cancer) and biopsy-negative (benign) were conducted. RESULTS: Cancer was detected in 172 patients (26.2%). Mean PSA, PSATZ, PSAD and F/T ratio were 7.5 ng/mL, 0.68 ng/mL/cc. 0.25 ng/mL/cc and 0.14 in patients with prostate cancer and 6.29 ng/mL, 0.30 ng/mL/cc, 0.16 ng/mL/cc and 0.22 in patients with benign biopsies, respectively. ROC curves analysis demonstrated that PSATZ had a higher area under curve (0,838) than F/T ratio (0,806) (P<0.001) and PSAD (0,806) (P<0.001). With a cut-off value of 0.22 ng/mL/cc, PSATZ had 100% of sensitivity and could have prevented 24% of unnecessary biopsies. CONCLUSIONS: PSATZ may be useful in enhancing the specificity of serum PSA. Compared to other PSA related parameters, it was better in differentiating between prostate cancer and benign prostatic enlargement. Also, PSATZ could reduce a significant number of unnecessary biopsies.

Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study.

BACKGROUND: Although trastuzumab plus chemotherapy is the standard of care for first-line treatment of HER2-positive advanced gastric cancer, there is no established therapy in the second-line setting. In GATSBY, we examined the efficacy and tolerability of trastuzumab emtansine in patients previously treated for HER2-positive advanced gastric cancer (unresectable, locally advanced, or metastatic gastric cancer, including adenocarcinoma of the gastro-oesophageal junction). METHODS: This is the final analysis from GATSBY, a randomised, open-label, adaptive, phase 2/3 study, done at 107 centres (28 countries worldwide). Eligible patients had HER2-positive advanced gastric cancer and progressed during or after first-line therapy. In stage one of the trial, patients were randomly assigned to treatment groups (2:2:1) to receive intravenous trastuzumab emtansine (3·6 mg/kg every 3 weeks or 2·4 mg/kg weekly) or physician's choice of a taxane (intravenous docetaxel 75 mg/m2 every 3 weeks or intravenous paclitaxel 80 mg/m2 weekly). In stage two, patients were randomly assigned to treatment groups (2:1) to receive the independent data monitoring committee (IDMC)-selected dose of trastuzumab emtansine (2·4 mg/kg weekly) or a taxane (same regimen as above). We used permuted block randomisation, stratified by world region, previous HER2-targeted therapy, and previous gastrectomy. The primary endpoint (overall survival) was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01641939. FINDINGS: Between Sept 3, 2012, and Oct 14, 2013, 70 patients were assigned to receive trastuzumab emtansine 3·6 mg/kg every 3 weeks, 75 to receive trastuzumab emtansine 2·4 mg/kg weekly, and 37 to receive a taxane in the stage 1 part of the trial. At the pre-planned interim analysis (Oct 14, 2013), the IDMC selected trastuzumab emtansine 2·4 mg/kg weekly as the dose to proceed to stage 2. By Feb 9, 2015, a further 153 patients had been randomly assigned to receive trastuzumab emtansine 2·4 mg/kg weekly and a further 80 to receive a taxane. At data cutoff, median follow-up was 17·5 months (IQR 12·1-23·0) for the trastuzumab emtansine 2·4 mg/kg weekly group and 15·4 months (9·2-18·1) in the taxane group. Median overall survival was 7·9 months (95% CI 6·7-9·5) with trastuzumab emtansine 2·4 mg/kg weekly and 8·6 months (7·1-11·2) with taxane treatment (hazard ratio 1·15, 95% CI 0·87-1·51, one-sided p=0·86). The trastuzumab emtansine 2·4 mg/kg group had lower incidences of grade 3 or more adverse events (134 [60%] of 224 patients treated with trastuzumab emtansine vs 78 [70%] of 111 patients treated with a taxane), and similar incidences of adverse events leading to death (eight [4%] vs four [4%]), serious adverse events (65 [29%] vs 31 [28%]), and adverse events leading to treatment discontinuation (31 [14%] vs 15 [14%]) than did taxane treatment. The most common grade 3 or more adverse events in the trastuzumab emtansine 2·4 mg/kg weekly group were anaemia (59 [26%]) and thrombocytopenia (25 [11%]) compared with neutropenia (43 [39%]), and anaemia (20 [18%]), in the taxane group. The most common serious adverse events were anaemia (eight [4%]), upper gastrointestinal haemorrhage (eight [4%]), pneumonia (seven [3%]), gastric haemorrhage (six [3%]), and gastrointestinal haemorrhage (five [2%]) in the trastuzumab emtansine 2·4 mg/kg weekly group compared with pneumonia (four [4%]), febrile neutropenia (four [4%]), anaemia (three [3%]), and neutropenia (three [3%]) in the taxane group. INTERPRETATION: Trastuzumab emtansine was not superior to taxane in patients with previously treated, HER2-positive advanced gastric cancer. There is still an unmet need in this patient group and therapeutic options remain limited. FUNDING: F Hoffmann-La Roche.

Síndrome cortico-basal como una presentación clínica de una enfermedad de Creutzfeldt-Jakob esporádica / Corticobasal syndrome as a clinical spectrum of a sporadic Creutzfeldt-Jakob disease

La enfermedad de Creutzfeldt-Jakob (ECJ) es una enfermedad neurodegenerativa caracterizada por demencia rápidamente progresiva, mioclonías, compromiso motor y alteraciones características en los exámenes auxiliares; sin embargo existen presentaciones clínicas atípicas del cuadro. Presentamos un caso de ECJ esporádica en asociación clínica con un síndrome cortico-basal caracterizado por apraxia de extremidades, déficit sensorial cortical, fenómeno del miembro ajeno, bradicinesia y rigidez asimétricos; que es la presentación clásica de la degeneración corticobasal. Además los hallazgos en el electroencefalograma, resonancia magnética cerebral y resultado de la proteína 14-3-3 en LCR fueron compatibles con ECJ esporádico probable. Este caso sugiere que el compromiso neurológico asimétrico puede asociarse a ECJ esporádico...

Creutzfeldt-Jakob disease (CJD) is a neurodegenerative disease characterized by rapidly progressive dementia, myoclonus, motor impairment and typical features on complementary tests; however, unusual clinical features might be associated. We report one case of sporadic CJD associated with corticobasal syndrome characterized by asymmetric limb apraxia, cortical sensory impairment, alien limb phenomenon, bradykinesia and rigidity; which is the classic clinical spectrum of the corticobasal degeneration. In addition, findings in electroencephalography (EEG), brain magnetic resonance imaging (MRI) and positive CSF protein 14-3-3 were compatible with probable sporadic CJD. This case suggest that asymmetric neurologic impairment may be associated with sporadic CJD...

Morbidade da biópsia da próstata transretal guiada por ultrassonografia / Morbidity of transrectal ultrasound guided prostate biopsy

OBJETIVO: Avaliar a incidência de complicações pós-procedimento nos pacientes submetidos a biópsia prostática transretal guiada por ultrassom no setor de intervenção do Departamento de Diagnóstico por Imagem da Escola Paulista de Medicina - Universidade Federal de São Paulo.MATERIAIS E MÉTODOS: Foram avaliados, via contato telefônico, 132 pacientes submetidos a biópsia de próstata transretal guiada por ultrassom no período de abril/2011 a junho/2011, seguindo o protocolo padrão do nosso setor.RESULTADOS: As complicações pós-biópsia foram categorizadas em maiores e menores de acordo com a necessidade de avaliação médica adicional. Cinquenta e nove pacientes (61,8%) apresentaram complicações, e desses, grande parte (86,4%) apresentou sintomas leves e autolimitados, considerados menores. Oito pacientes (8,2%) apresentaram complicações maiores, sendo que apenas um deles necessitou de tratamento sob regime de internação hospitalar. A retenção urinária foi a complicação maior mais incidente no nosso estudo.CONCLUSÃO: Corroborando outros estudos da literatura, nosso trabalho demonstrou baixa prevalência de complicações maiores após a biópsia prostática transretal.

OBJECTIVE: To evaluate the incidence of postprocedural complications in patients submitted to transrectal ultrasound-guided prostate biopsy at the Unit of Intervention, Department of Imaging Diagnosis of Escola Paulista de Medicina - Universidade Federal de São Paulo.MATERIALS AND METHODS: Telephone interviews were conducted with 132 patients who had undergone transrectal ultrasound-guided prostate biopsy in the period from April 2011 to June 2011, according to the institution's protocol.RESULTS: Post-biopsy complications were categorized into two groups - minor and major complications, according to their need for further clinical evaluation. Complications were reported by 59 patients (61.8%), most of them (86.4%) with mild and self-limited symptoms, classified as minor complications. Eight patients (8.2%) had major complications, one of which required in-hospital treatment. Urinary retention was the major and most common complication.CONCLUSION: The present study has demonstrated a low prevalence of major complications after transrectal prostate biopsy.

Contribuição da densidade do PSA para predizer o câncer da próstata em pacientes com valores de PSA entre 2, 6 e 10, 0 ng/ml / Contribution of PSA density in the prediction of prostate cancer in patients with PSA values between 2.6 and 10.0 ng/ml

OBJETIVO: Estudar o perfil dos pacientes submetidos a biópsia prostática, determinando possíveis padrões que, associados aos níveis de PSA entre 2,6 e 10,0 ng/ml, possam levar a uma diminuição de biópsias desnecessárias. MATERIAIS E MÉTODOS: De 2007 a 2009, foi realizado um estudo transversal com 1.282 indivíduos submetidos a biópsia prostática e que apresentavam níveis de PSA entre 2,6 e 10,0 ng/ml. RESULTADOS: A prevalência de câncer foi de 28,6 por cento. Pacientes com câncer eram, em média, mais idosos, com valores de PSA e densidade de PSA mais altos e menor volume da próstata. Na análise da densidade de PSA, os pacientes com câncer tiveram média de 0,31 ng/ml/cc, enquanto nos pacientes com resultado negativo a média foi de 0,10 ng/ml/cc. Utilizando como critério de positividade para câncer o ponto de corte de densidade de PSA de 0,15 ng/ml/cc, obtivemos especificidade de 74 por cento e sensibilidade de 70 por cento. Para aumentar a sensibilidade é preciso reduzir o ponto de corte. Com o valor 0,09 ng/ml/cc, obtivemos sensibilidade de 84 por cento (IC 95 por cento: 80-87 por cento) e especificidade de 75 por cento (IC 95 por cento: 72-78 por cento). CONCLUSÃO: O uso sistemático da densidade de PSA na indicação de prosseguimento da investigação do paciente com biópsia poderia reduzir a quantidade de procedimentos desnecessários.

OBJECTIVE: To study the profile of patients with PSA level between 2.6 and 10.0 ng/ml and submitted to prostate biopsy, determining possible patterns that might lead to a reduction of unnecessary biopsies. MATERIALS AND METHODS: In the period from 2007 to 2009, a cross-sectional study was developed with 1,282 patients with PSA levels between 2.6 and 10.0 ng/ml, and submitted to prostate biopsy. RESULTS: Cancer prevalence was 28.6 percent. On average, the patients with positive biopsies were older, with higher PSA levels and density, and smaller prostate volume as compared with the patients with negative biopsies. In the analysis of PSA density, the cancer patients averaged 0.31 ng/ml/cc, while patients with negative results averaged 0.10 ng/ml/cc. Utilizing a cutoff value of 0.15 ng/ml/cc for PSA density as a cancer positiveness criterion, the authors obtained sensitivity of 74 percent and specificity of 70 percent. The cutoff value should be reduced to increase the sensitivity. With a cutoff value of 0.09 ng/ml/cc, sensitivity reached 84 percent (CI 95 percent: 80-87 percent), and specificity, 75 percent (CI 95 percent: 72-78 percent). CONCLUSION: The systematic use of PSA density as an indicator to proceed with the investigation of a patient with biopsy could substantially reduce the amount of unnecessary procedures.

Brucelosis: una revisión práctica / Brucellosis: a practical revision

La brucelosis es una enfermedad zoonótica causada por bacterias pertenecientes al género Brucella que ocasiona problemas de salud importantes entre los individuos que ingieren alimentos contaminados o mantienen un estrecho contacto con el ganado. En el presente trabajo se describen, brevemente, algunas características de las bacterias de este género, la patología que producen, la respuesta inmune que desencadenan y se destaca la metodología empleada en el diagnóstico de la enfermedad, tanto en el hombre como en los animales. Se profundiza además en los aspectos presentes y futuros de las vacunas preventivas. Finalmente, se considera en particular a la brucelosis humana, describiendo su cuadro clínico, los métodos directos e indirectos de diagnóstico y la interpretación de sus resultados con el objeto de contribuir a esclarecer aspectos relevantes que deben tenerse en cuenta para un correcto seguimiento de la infección.

Cierre percutáneo del ductus arterioso: evaluación de cortocircuito residual marzo 1997 - diciembre de 2001 / Close percutaneous of the ductus arteriosus: evaluation of residual short circuit march 1997 - december 2001

El objetivo de este estudio fue determinar la eficacia y seguridad del método después de un año de seguimiento. También evaluamos la eficacia de los diferentes dispositivos. Se práctico el cierre percutáneo del conducto arterioso a sesenta y un niños de ambos sexos, entre uno y diez y seis años de edad, en el período comprendido entre marzo de 1997 y diciembre de 2001. Todos los pacientes fueron evaluados con RX de tórax, ecocardiograma y Doppler a color. El tipo de dispositivo usado se decidió de acuerdo al tamaño y tipo de conducto arterioso en la aortografía en posición lateral. Se clasificaron en pequeños, cuando el orificio pulmonar del cierre percutáneo del conducto arterioso fue igual o menor a 2,5 mm, medianos entre 3 a 5 mm y grandes en aberturas mayores de 5 mm. La presencia del cortocircuito residual fue evaluada inmediatamente después del procedimiento, un mes, tres meses, seis meses y un año en todos los pacientes. La mayoría de los pacientes con cierre percutáneo del conducto arterioso pequeño (36 por ciento) se cerraron con espirales de Gianturco de Cook. Los de mediano tamaño (49 por ciento) fueron cerrados con Nit Occluder (pfm), Duct occluder (pfm) y el dispositivo de Amplatzer (Aga). Los ductus grandes fueron cerrados todos (15 por ciento) con el dispositivo de Amplatzer la distribución de los dispositivos fue como sigue: espirales de Gianturco coils (Cook) in 22 pacientes, Nit Occluder (pfm) en 5 pacientes, Duct Occluder (pfm) en 4 pacientes y el dispositivo de Amplatzer en 30 pacientes (AGA). En el seguimiento, 12 pacientes tenían cortocircuito residual al mes, 6 pacientes a los 3 meses, 2 pacientes a los 6 meses y sólo 1 paciente al año. Después de los seis meses todos los pacientes tenían cierre completo excepto 1 paciente cerrado con cortocircuito trivial. El cierre percutáneo del conducto arterioso persistente es efectivo y seguro. Es una técnica con un alto porcentaje de éxito y con una morbilidad muy baja, 0 por ciento mortalidad y una proporción de cierre total mayor del 98 por ciento al año. En nuestra institución es el método de elección para corregir esta patología. El Amplatzer devices es mejor en ductus de tamaño mediano y grandes. Los Nit y Duct occluder son seguros y eficientes en ductus pequeños y medinos

Cáncer de mama en el varón, presentación de tres casos y revisión / Breast cancer in males. Presentation of three cases and review

El carcinoma de mama es muy poco frecuente en el varón (0,1 a 0,2 /100 de todos los cánceres masculinos)en el año 2002 la Sociedad Americana del Cáncer estimó que 1400 casos de cáncer de mama se diagnosticaron en hombres y aproximadamente 400 murieron.Se presentan tres casos de carcinomas de mama en tres varones con edad media de 69 años (59 a 80 años) y tiempo medio primer síntoma-intervención de 18 meses. Los estadios fueron I (1) y II(2). El estudio histopatológico evidenció tres carcinomas intraductales. Todos se trataron con mastectomía radical modificada. Dos pacientes recibieron tratamiento adyuvante con quimioterapia, radioterapia y hormonoterapia...

Los microbios y el hombre, ¿enemigos o amigos? / Microorganisms and man: enemies or friends?

Todos los microorganismos (bacterias, parásitos, hongos y virus) han constituido desde siempre un panel de agresores para el hombre, siendo responsables directos o indirectos de múltiples patologías de origen infeccioso que se desarrollan enfrentando a los mecanismos de la inmunidad. El presente artículo se divide en dos partes: la primera constituye una resumida actualización de los eventos inmunes y la segunda una discusión de la relación microbios-hombre en términos evolutivos replanteando desde esa óptica el clásico antagonismo. En ese sentido, un dinámico equilibrio entre ambos, puede ser alternativamente alterado por uno de los responsables con una consecuente compensación a cargo de la contraparte. Así, tomando como referencia el permanente cambio en las estrategias de evasión microbiana, puede especularse que los mecanismos inespecíficos junto a las barreras naturales pueden haber sido la defensa ancestral del hombre. Más adelante la inflamación inicial puede haber sido mejorada mediante la generación de moléculas activadoras del complemento. Posteriormente, las moléculas de histocompatibilidad y los receptores antigénicos de los linfocitos B y de los linfocitos T pueden haber sido generadas para montar los eventos específicos que hoy se conocen. La participación de células fundamentales y accesorias en forma conjunta ha hecho necesaria la expresión de moléculas de adhesión y la generación y ampliación del espectro de citoquinas y sus receptores. La producción de anticuerpos puede haber inducido el mejoramiento efector de sistemas moleculares como el complemento y así juntos, eficientizar la primitiva fagocitosis. La evolución del linaje T puede haber sido más compleja, habida cuenta que debieron generarse subpoblaciones o sets citotóxicos por un lado y orquestadores y reguladores por otro. Por otra parte la diversidad de reconocimiento que se hizo necesaria a nivel de los receptores específicos se desarrolló con un gasto mínimo de información genética, pero posibilitó la aparición de fenómenos no deseados con participación de efectores inmunes, lo que impuso la aparición de críticos mecanismos reguladores donde participan sinérgicamente todos los sistemas biológicos...