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1.
Perit Dial Int ; : 8968608241240566, 2024 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-38596899

RESUMO

BACKGROUND: Hypertension is a leading cause of kidney failure, affects most dialysis patients and associates with adverse outcomes. Hypertension can be difficult to control with dialysis modalities having differential effects on sodium and water removal. There are two main types of peritoneal dialysis (PD), automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD). It is unknown whether one is superior to the other in controlling blood pressure (BP). Therefore, the aim of our study was to analyse the impact of switching between these two PD modalities on BP levels in a nationally representative cohort. METHODS: This was a cohort study of patients on PD from 122 dialysis centres in Brazil (BRAZPD II study). Clinical and laboratory data were collected monthly throughout the study duration. We selected all patients who remained on PD at least 6 months and 3 months on each modality at minimum. We compared the changes in mean systolic/diastolic blood pressures (SBP/DBP) before and after modality transition using a multilevel mixed-model where patients were at first level and their clinics at the second level. RESULTS: We analysed data of 848 patients (814 starting on CAPD and 34 starting on APD). The SBP decreased by 4 (SD 22) mmHg when transitioning from CAPD to APD (p < 0.001) and increased by 4 (SD 21) mmHg when transitioning from APD to CAPD (p = 0.38); consistent findings were seen for DBP. There was no significant change in the number of antihypertensive drugs prescribed before and after transition. CONCLUSIONS: Transition between PD modalities seems to directly impact on BP levels. Further studies are needed to confirm if switching to APD could be an effective treatment for uncontrolled hypertension among CAPD patients.

2.
Front Public Health ; 12: 1264292, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38362211

RESUMO

Background: Since the implementation of the stroke care line in Brazil, the relationship (adequacy) of costs spent during hospitalization with the Brazilian Ministry of Health indicators for a stroke unit have not yet been analyzed. Aims: This study aimed to assess the adequacy of a comprehensive stroke center for key performance indicators and analyze the costs involved in hospitalization. We verified the association between stroke severity at admission and care costs during hospitalization. Methods: A retrospective medical chart review of 451 patients was performed using semiautomatic electronic data from a single comprehensive stroke center in Brazil between July 2018 and January 2020. Clinical and resource utilization data were collected, and the mean acute treatment cost per person was calculated. The Kruskal-Wallis test with Dunn's post-test was used to compare the total costs between stroke types and reperfusion therapies. A robust linear regression test was used to verify the association between stroke severity at hospital admission and the total hospitalization costs. Good adequacy rates were observed for several indicators. Results: Data from 451 patients were analyzed. The stroke unit had good adaptation to key performance indicators, but some critical points needed revision and improvement to adapt to the requirements of the Ministry of Health. The average total cost of the patient's stay was the USD 2,637.3, with the daily hospitalization, procedure, operating room, and materials/medication costs equating to USD 2,011.1, USD 220.7, USD 234.1, and USD 98.8, respectively. There was a positive association between the total cost and length of hospital stay (p < 0.001). Conclusion: The stroke unit complied with most of the main performance indicators proposed by the Brazilian Ministry of Health. Underfunding of the costs involved in the hospitalization of patients was verified, and high costs were associated with the length of stay, stroke severity, and mechanical thrombectomy.


Assuntos
Benchmarking , Acidente Vascular Cerebral , Humanos , Brasil , Estudos Retrospectivos , Hospitalização , Acidente Vascular Cerebral/terapia
3.
Chronobiol Int ; 40(12): 1523-1528, 2023 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-37985469

RESUMO

The objective of this study was to assess the value of the abnormal circadian blood pressure pattern by ambulatory blood pressure monitoring (ABPM) to predict the onset of abnormal albuminuria in normotensive and normoalbuminuric DM1 patients. The participators were submitted to ABPM and followed prospectively until the onset of albuminuria or the end of follow-up. The patients with normal circadian blood pressure pattern were compared with the non-dippers in regard of the time interval free of albuminuria. The survival curves were evaluated by the Kaplan-Meier method. Of 34 patients screened, 10 patients matched the exclusion criteria. Therefore, 24 patients were submitted to ABPM, aged 24 ± 8.3 y, 18 men, and all Caucasian. Elevated levels of albuminuria did not occurin any individual with normal systolic blood pressure dip (>10%) at 54 months of follow-up. Only 22% of patients among non-dippers were free of albuminuria (<30 mg/g maintained for 3 months) at the same time (p = 0.049). Patients that reached the outcome were homogeneous in regard to other clinical and ABPM data evaluated. Abnormal systolic blood pressure circadian pattern predicts the evolution to incipient nephropathy in normotensive normoalbuminuric DM1 patients.


Assuntos
Diabetes Mellitus Tipo 1 , Hipertensão , Nefropatias , Masculino , Humanos , Pressão Sanguínea/fisiologia , Albuminúria , Monitorização Ambulatorial da Pressão Arterial , Ritmo Circadiano/fisiologia
4.
Sci Rep ; 13(1): 14603, 2023 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-37670032

RESUMO

Carbapenem-resistant Klebsiella pneumoniae (CRKP) are highly disseminated worldwide, and isolates co-resistant to other antimicrobial agents pose a threat to effective antimicrobial therapy. Therefore, evaluation of novel antimicrobial drugs is needed to identify potential treatments with better outcomes. We evaluated the in vitro activity of novel antimicrobial drugs/combinations against 97 KPC-producing Klebsiella pneumoniae isolates recovered from different hospitals in Brazil during 2021-2022. Clonality, resistance and virulence genes were detected by whole-genome sequencing. The majority of the isolates (54.6%) were classified as extensively drug resistant or multidrug resistant (44.3%); one isolate showed a pandrug resistance phenotype. The most active antimicrobial agents were meropenem-vaborbactam, cefiderocol, and ceftazidime-avibactam, with sensitivities higher than 90%; resistance to ceftazidime-avibactam was associated with KPC-33 or KPC-44 variants. Colistin and polymyxin B were active against 58.6% of the isolates. The 97 isolates were distributed into 17 different sequence types, with a predominance of ST11 (37.4%). Although high in vitro susceptibility rates were detected for meropenem-vaborbactam and cefiderocol, only ceftazidime-avibactam is currently available in Brazil. Our findings showed limited susceptibility to antimicrobial drugs employed for infection treatment of carbapenem-resistant K. pneumoniae, underscoring the urgent need for stringent policies for antimicrobial stewardship to preserve the activity of such drugs.


Assuntos
Lactamas , Inibidores de beta-Lactamases , Brasil , Klebsiella pneumoniae , Meropeném , Genômica , Carbapenêmicos
5.
Pathogens ; 12(7)2023 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-37513765

RESUMO

Pseudomonas aeruginosa, an opportunistic pathogen causing infections in immunocompromised patients, usually shows pronounced antimicrobial resistance. In recent years, the frequency of carbapenemases in P. aeruginosa has decreased, which allows use of new beta-lactams/combinations in antimicrobial therapy. Therefore, the in vitro evaluation of these drugs in contemporary isolates is warranted. We evaluated the antimicrobial susceptibility and genomic aspects of 119 clinical P. aeruginosa isolates from 24 different hospitals in Brazil in 2021-2022. Identification was performed via MALDI-TOF-MS, and antimicrobial susceptibility was identified through broth microdilution, gradient tests, or disk diffusion. Whole-genome sequencing was carried out using NextSeq equipment. The most active drug was cefiderocol (100%), followed by ceftazidime-avibactam (94.1%), ceftolozane-tazobactam (92.4%), and imipenem-relebactam (81.5%). Imipenem susceptibility was detected in 59 isolates (49.6%), and the most active aminoglycoside was tobramycin, to which 99 (83.2%) isolates were susceptible. Seventy-one different sequence types (STs) were detected, including twelve new STs described herein. The acquired resistance genes blaCTX-M-2 and blaKPC-2 were identified in ten (8.4%) and two (1.7%) isolates, respectively. Several virulence genes (exoSTUY, toxA, aprA, lasA/B, plcH) were also identified. We found that new antimicrobials are effective against the diverse P. aeruginosa population that has been circulating in Brazilian hospitals in recent years.

7.
Front Med (Lausanne) ; 9: 717385, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36507496

RESUMO

Background: Patients with end-stage kidney disease (ESKD) who start unplanned dialysis therapy are more likely to be treated with hemodialysis (HD) using a central venous catheter, which has been associated with a greater risk of infections and other complications, as well as with a higher long-term risk of death. Urgent-start PD is an alternative that has been suggested as an option for starting dialysis in these cases, with potentially better patient outcomes. However, the definition of urgent-start PD is not homogeneous, and no study, to our knowledge, has compared clinical outcomes among urgent start, early start, and conventional start of PD. In this study, we aimed to compare these types of initiation of dialysis therapy in terms of a composite outcome of patient survival and technique failure. Methods: This is a retrospective, multicenter, cohort study, involving data from 122 PD clinics in Brazil. We used the following: Urgent-start groups refer to patients who initiated PD within 72 h after the PD catheter insertion; early-start groups are those starting PD from 72 h to 2 weeks after the catheter insertion; and conventional-start groups are those who used the PD catheter after 2 weeks from its insertion. We analyzed the composite endpoint of all causes of patient's mortality and technique failure (within the initial 90 days of PD therapy) using the following three different statistical models: multivariate Cox, Fine and Gay competing risk, and a multilevel model. Results: We included 509 patients with valid data across 68 PD clinics. There were 38 primary outcomes, comprising 25 deaths and 13 technique failures, with a total follow-up time of 1,393.3 months. Urgent-start PD had no association with the composite endpoint in all three models. Conclusion: Unplanned PD seems to be a safe and feasible option for treatment for patients with non-dialysis ESKD in urgent need of dialysis.

8.
Front Med (Lausanne) ; 9: 911047, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36160161

RESUMO

Background: Overhydration (OH) is common in peritoneal dialysis (PD) and increases the cardiovascular risk. Multifrequency bioimpedance spectroscopy (BIS) has been proposed to estimate the hydration in dialysis. Our objective was to evaluate if BIS is superior than control based on clinical assessment plus single-frequency bioimpedance (SF-BIA) on the fluid control and intermediate cardiovascular outcomes. Methods: Randomized controlled study in adult PD patients, with a 9-month follow-up, allocated into two groups: control and BIS. Data were collected from medical records. SF-BIA and BIS, laboratory exams, ambulatory blood pressure monitoring, echocardiography (ECHO), and pulse wave velocity (PWV) were evaluated. The BIS data were available to the medical team only in BIS group. Results: 34 patients completed the study, 17 in each group. At the endpoint the BIS group had a significant (p < 0.05) greater proportion of patients with OH/extracellular water (OH/ECW%) ≤ 15% than the control (94.1% vs. 52.9%), and a lower OH mean (2.1 ± 1.6 vs. 0.9 ± 1.1 L). The control group has a significant increase in the tumor necrosis factor alpha median concentration from baseline to six [11.9 (6.0-24.1) vs. 44.7 (9.4-70.6) pg/ml] and 9 months [11.9 (6.0-24.1) vs. 39.4 (27.9-62.6) pg/ml], and in the N-terminal fragment of pro-B-type natriuretic peptide median [239 (171.5-360.5) vs. 356 (219-1,555) pg/ml]. For cardiovascular parameters, BIS group presented a significant reduction in radial PWV [7.7 (6.9-9.2) vs. 6.5 (5.5-8.4) m/s] at 9 month, while in the control presented a significant increase in mean central systolic blood pressure (BP) (106.8 ± 11.2 vs. 117.6 ± 16.5 mmHg) and in central diastolic BP (90.4 ± 9.8 vs. 103.3 ± 12.5 mmHg) at 9 months. The left ventricular mass (LVM)/body surface presented a significant reduction in the control (109.6 ± 30.8 vs. 101.2 ± 28.9 g/m2) and BIS group (107.7 ± 24.9 vs. 96.1 ± 27.0 g/m2) at 9 months. Conclusion: The results suggest BIS is superior than the clinical evaluation plus SF-BIA for the fluid control of PD patients. Clinical trial registration: [https://www.ClinicalTrials.gov], identifier [RBR-10k8j3bx].

9.
J Bras Nefrol ; 44(3): 308-309, 2022.
Artigo em Inglês, Português | MEDLINE | ID: mdl-36095127
10.
Vaccine ; 40(47): 6722-6729, 2022 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-36055876

RESUMO

INTRODUCTION: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. METHODS: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. RESULTS AND DISCUSSION: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Brasil/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Programas de Imunização , Pandemias/prevenção & controle , Vacinação/efeitos adversos , Vacinas/efeitos adversos
11.
J. bras. nefrol ; 44(3): 308-309, July-Sept. 2022.
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1405392
12.
BMC Nephrol ; 23(1): 289, 2022 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-35982404

RESUMO

BACKGROUND: Restriction of sodium intake is routinely recommended for patients with chronic kidney disease (CKD). Whether or not sodium intake is associated with the progression of CKD and mortality remains uncertain. We evaluated the association between urinary sodium excretion (as a surrogate for sodium intake) with the occurrence of renal failure and mortality in patients with non-dialytic CKD. METHODS: We conducted a retrospective study of patients followed at a CKD clinic care hospital from October 2006 to March 2017. Adult patients with non-dialytic CKD were included. Using a time-to-event analysis, we examined the association of urinary sodium excretion as a categorical variable (categorized as quintiles: 1st quintile: 0.54-2.51 g; 2nd quintile: 2.52-3.11 g, 3rd quintile: 3.12-3.97 g, 4th quintile: 3.98-5.24 g and 5th quintile: 5.26-13.80 g) and the outcomes of interest. The primary outcome was defined as progression to end-stage renal disease requiring any type of renal replacement therapy. The secondary outcome was mortality. RESULTS: Two hundred five patients were included in the study (mean follow up of 2.6 years) with a mean eGFR of 26 (19-41) ml/min/1.73m2. 37 patients (18%) required renal replacement therapy and 52 (25,3%) died. There was association between urinary sodium excretion and need for renal replacement therapy (adjusted HR 0.245; 95%CI 0.660-0.912). There was no association between urinary sodium excretion and mortality in adjusted models. CONCLUSION: Moderate sodium intake was associated with a lower risk of renal failure.


Assuntos
Falência Renal Crônica , Insuficiência Renal Crônica , Insuficiência Renal , Adulto , Progressão da Doença , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Insuficiência Renal/complicações , Insuficiência Renal Crônica/complicações , Estudos Retrospectivos , Sódio
13.
Front Nutr ; 9: 912642, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35990362

RESUMO

Introduction: The phase angle (PhA) has been used as a nutritional marker and predictor of mortality in patients on peritoneal dialysis (PD). The coronary artery calcium (CAC) score has shown to predict the incidence of acute myocardial infarction and death from cardiovascular disease in these patients. However, the association between PhA and CAC score in patients with PD is not well-established, which is the objective of this study. Materials and methods: Cross-sectional study with patients on PD, followed up at a University Hospital, between March 2018 and August 2019. PhA was evaluated by unifrequency bioimpedance (BIA). The CAC score was calculated based on cardiovascular computed tomography, considering positive when greater than or equal to 100 Agatston and negative when less than 100 Agatston. Results: We evaluated 44 patients on dialysis, with a mean age of 56 years and median time on dialysis therapy was 11.7 months. In the statistical analysis, a significant association was only observed between the CAC score and the PhA. Conclusion: The PhA is associated with a positive CAC score in patients with PD, and despite other factors, may be useful as a risk marker for coronary artery disease in this population.

14.
Chronobiol Int ; 39(9): 1220-1225, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35786235

RESUMO

In diabetes kidney disease (DKD), orthostatic hypotension and supine hypertension often coexist, which, when uncontrolled, contributes to the progression of proteinuria and renal dysfunction. Chronotherapy and elevation of the head of the bed during sleep are feasible clinical measures and could contribute to the control of supine hypertension and proteinuria in this group of patients. This study consists of a series of cases, in which nine consecutive patients with DKD, dysautonomia and supine hypertension (intervention group) were instructed to use chronotherapy and inclination of the head of the bed in six degrees during sleep. These patients were compared with a historical control group. The primary outcome was proteinuria behavior. The intervention group had a significant drop in proteinuria levels, while there was an increase in proteinuria in the control group (variation in the proteinuria/creatininuria index in an isolated sample from the intervention group: -6.60 ± 3.90 g/g; variation in the group control: +1.70 ± 7.10 g/g, p = 0.008). Chronotherapy and six-degree inclination of the head of the bed during sleep were associated with a significant decrease in proteinuria in patients in the intervention group, with conversion of nephrotic into non-nephrotic proteinuria in most of these patients.


Assuntos
Diabetes Mellitus , Nefropatias Diabéticas , Hipertensão , Disautonomias Primárias , Ritmo Circadiano , Nefropatias Diabéticas/complicações , Humanos , Hipertensão/complicações , Disautonomias Primárias/complicações , Proteinúria/complicações
15.
PLoS One ; 17(6): e0270214, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35749444

RESUMO

BACKGROUND: We tested if fatigue in incident Peritoneal Dialysis associated with an increased risk for mortality, independently from main confounders. METHODS: We conducted a side-by-side study from two of incident PD patients in Brazil and the United States. We used the same code to independently analyze data in both countries during 2004 to 2011. We included data from adults who completed KDQOL-SF vitality subscale within 90 days after starting PD. Vitality score was categorized in four groups: >50 (high vitality), ≥40 to ≤50 (moderate vitality), >35 to <40 (moderate fatigue), ≤35 (high fatigue; reference group). In each country's cohort, we built four distinct models to estimate the associations between vitality (exposure) and all-cause mortality (outcome): (i) Cox regression model; (ii) competing risk model accounting for technique failure events; (iii) multilevel survival model of clinic-level clusters; (iv) multivariate regression model with smoothing splines treating vitality as a continuous measure. Analyses were adjusted for age, comorbidities, PD modality, hemoglobin, and albumin. A mixed-effects meta-analysis was used to pool hazard ratios (HRs) from both cohorts to model mortality risk for each 10-unit increase in vitality. RESULTS: We used data from 4,285 PD patients (Brazil n = 1,388 and United States n = 2,897). Model estimates showed lower vitality levels within 90 days of starting PD were associated with a higher risk of mortality, which was consistent in Brazil and the United States cohorts. In the multivariate survival model, each 10-unit increase in vitality score was associated with lower risk of all-cause mortality in both cohorts (Brazil HR = 0.79 [95%CI 0.70 to 0.90] and United States HR = 0.90 [95%CI 0.88 to 0.93], pooled HR = 0.86 [95%CI 0.75 to 0.98]). Results for all models provided consistent effect estimates. CONCLUSIONS: Among patients in Brazil and the United States, lower vitality score in the initial months of PD was independently associated with all-cause mortality.


Assuntos
Falência Renal Crônica , Diálise Peritoneal , Adulto , Brasil/epidemiologia , Fadiga/etiologia , Humanos , Falência Renal Crônica/terapia , Diálise Peritoneal/efeitos adversos , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Estados Unidos/epidemiologia
16.
Artigo em Inglês | MEDLINE | ID: mdl-35721790

RESUMO

The innovation timeline is expensive, risky, competitive, time-consuming, and labor-intensive. In order to overcome such challenges and optimize financial resources, pharmaceutical companies nowadays hire contract development and manufacturing organizations (CDMO) to help them. Based on the experience acquired first from the development of two biopharmaceuticals, the Heterologous Fibrin Sealant and the Apilic Antivenom, and more recently, during their respective clinical trials; the Center for the Study of Venoms and Venomous Animals (CEVAP) proposed to the Ministry of Health the creation of the first Brazilian CDMO. This groundbreaking venture will assist in converting a candidate molecule - from its discovery, proof of concept, product development, up to pilot batch production - into a product. The CDMO impact and legacy will be immense, offering service provision to the public and private sector by producing validated samples for clinical trials and academic training on translational research for those seeking a position in pharmaceutical industries and manufacturing platforms.

17.
Pathogens ; 11(2)2022 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-35215161

RESUMO

(1) Background: Peritonitis due to nonfermenting Gram-negative bacilli (NF-GNB) is a dramatic complication of peritoneal dialysis (PD) with bad outcomes. Previous studies of PD-related peritonitis due to Pseudomonas species have shown a low-resolution rate, without a high resistance rate to antipseudomonal antibiotics. This suggests that bacterial virulence factors can act and influence peritonitis evolution. This study aimed to describe the microbiological characteristics of NF-GNB causing PD-related peritonitis and analyze their influence on the outcome. (2) Methods: We analyze the 48 isolates from NF-GNB peritonitis, which were stored in our culture collection regarding bacterial resistance, biofilm, and other virulence factors' production, and clonal profile. Additionally, we collected data on treatment and outcomes from patients' clinical registers. (3) Results: The etiologies were species of Pseudomonas (50%), Acinetobacter (36%), and other NF-GNB (14%). There was a high (75%) proportion of biofilm producer lineages. The in vitro susceptibility rate of Pseudomonas spp. to amikacin, ciprofloxacin, and ceftazidime was significantly greater than that of Acinetobacter spp. and other species; however, there was a similar low-resolution rate (<45%) among the episodes attributable to them. Pseudomonas species have a polyclonal profile, while we found a clone of five multiresistant Acinetobacter baumannii over an 8-year interval (2000-2008), which suggest an origin from the healthcare environment. (4) Conclusions: We are not able to identify any predictor of outcome, but it is possible that biofilm and others virulence factors can act in concert and contribute to the bad outcome.

18.
J. venom. anim. toxins incl. trop. dis ; 28: e20220017, 2022. graf
Artigo em Inglês | LILACS, VETINDEX | ID: biblio-1386130

RESUMO

The innovation timeline is expensive, risky, competitive, time-consuming, and labor-intensive. In order to overcome such challenges and optimize financial resources, pharmaceutical companies nowadays hire contract development and manufacturing organizations (CDMO) to help them. Based on the experience acquired first from the development of two biopharmaceuticals, the Heterologous Fibrin Sealant and the Apilic Antivenom, and more recently, during their respective clinical trials; the Center for the Study of Venoms and Venomous Animals (CEVAP) proposed to the Ministry of Health the creation of the first Brazilian CDMO. This groundbreaking venture will assist in converting a candidate molecule - from its discovery, proof of concept, product development, up to pilot batch production - into a product. The CDMO impact and legacy will be immense, offering service provision to the public and private sector by producing validated samples for clinical trials and academic training on translational research for those seeking a position in pharmaceutical industries and manufacturing platforms.(AU)


Assuntos
Produtos Biológicos/análise , Proposta de Concorrência/organização & administração , Protocolo de Ensaio Clínico , Brasil , Boas Práticas de Fabricação
19.
PLoS One ; 16(10): e0257140, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34653195

RESUMO

Peritoneal dialysis (PD) modalities affect solute removal differently. However, the impacts of switching PD modalities on serum levels of biomarkers of different sizes are not known. Our objective was to analyze whether a change in the PD modality associates with the levels of two routine biochemical laboratories. In this multicentric prospective cohort study. we selected all patients who remained on a PD modality for at least 6 months and switched PD modality. Patients were also required to be treated with the same PD modality for at least 3 months before and after the modality change. The primary outcome was change in potassium and phosphate serum levels. We identified 737 eligible patients who switched their PD modality during the study. We found mean serum phosphate levels increased during the 3 months after switching from CAPD to APD and conversely decreased after switching to from APD to CAPD. In contrast, for potassium the difference in the mean serum levels was comparable between groups switching from CAPD to APD, and vice versa. In conclusion, CAPD seems to be as efficient as APD for the control of potassium serum levels, but more effective for the control of phosphate serum levels. The effect of a higher removal of middle size molecules as result of PD modalities in terms of clinical and patient-reported outcomes should be further explored.


Assuntos
Diálise Peritoneal , Fosfatos/sangue , Potássio/sangue , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Diálise Peritoneal Ambulatorial Contínua , Estudos Prospectivos
20.
Transplant Proc ; 53(7): 2162-2167, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34429191

RESUMO

BACKGROUND: Kidney transplantation (KT) has the advantage of providing a better quality of life and freedom for the patient. However, nutritional changes can occur, with clinical repercussions. The aim of the study was to compare the nutritional status in the initial and late post-KT period. METHODS: A cross-sectional study was conducted involving 169 outpatients post-KT. Clinical, demographic, biochemical, food intake, handgrip strength (HGS), and anthropometric data were collected from medical records for the first nutritional care after KT. Statistical tests were performed to compare the groups according to the time of KT: early (≤1 year) and late (>1 year). The level of significance adopted was 5%. RESULTS: The median age of the patients was 46 years (range, 38-57), 50.3% were men, and it was observed that 66.9% underwent KT with a deceased donor. There was a higher prevalence of diabetes mellitus (42.6% vs 23.5%; P = .011), and higher body mass index (28.80 ± 7.26 vs 26.51 ± 6.62 kg/m2; P = .046), arm muscle circumference (25.84 ± 4.63 vs 24.09 ± 3.36 cm; P = .019), and HGS (26.97 ± 10.70 vs 20.21 ± 10.83 kg; P = .010) in patients with late KT. Linear regression analysis showed that at each log of time, there was an increase of 1.90 kg in HGS (P = .045) and 0.48 cm (P = .036) in mid-arm muscle circumference. CONCLUSION: The present study demonstrated that late kidney transplantation was associated with higher values of body mass index, mid-arm muscle circumference, and HGS.


Assuntos
Transplante de Rim , Adulto , Índice de Massa Corporal , Estudos Transversais , Força da Mão , Humanos , Masculino , Pessoa de Meia-Idade , Estado Nutricional , Qualidade de Vida
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