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1.
BMC Surg ; 24(1): 84, 2024 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-38448841

RESUMO

BACKGROUND: Conversional surgery is common after laparoscopic sleeve gastrectomy (LSG) because of suboptimal weight loss (SWL) or poor responders and gastroesophageal reflux disease (GERD). Roux-en-Y gastric bypass (RYGB) is the most common conversional procedure after LSG. METHODS: A retrospective cohort study analyzed patients who underwent primary RYGB (PRYGB) or conversional RYGB (CRYGB) at three specialized bariatric centers between 2008 and 2019 and tested for weight loss, resolution of GERD, food tolerance (FT), early and late complications, and the resolution of associated medical problems. This was analyzed by propensity score matching (PSM). RESULTS: In total, 558 (PRYGB) and 155 (CRYGB) completed at least 2 years of follow-up. After PSM, both cohorts significantly decreased BMI from baseline (p < 0.001). The CRYGB group had an initially more significant mean BMI decrease of 6.095 kg/m2 at 6 months of follow-up (p < 0.001), while the PRYGB group had a more significant mean BMI decrease of 5.890 kg/m2 and 8.626 kg/m2 at 1 and 2 years, respectively (p < 0.001). Food tolerance (FT) improved significantly in the CRYGB group (p < 0.001), while CRYGB had better FT than PRYGB at 2 years (p < 0.001). A GERD resolution rate of 92.6% was recorded in the CRYGB (p < 0.001). Both cohorts had comparable rates of early complications (p = 0.584), late complications (p = 0.495), and reoperations (p = 0.398). Associated medical problems at 2 years significantly improved in both cohorts (p < 0.001). CONCLUSIONS: CRYGB is a safe and efficient option in non- or poor responders after LSG, with significant weight loss and improvement in GERD. Moreover, PRYGB and CRYGB had comparable complications, reoperations, and associated medical problem resolution rates.


Assuntos
Derivação Gástrica , Refluxo Gastroesofágico , Laparoscopia , Humanos , Estudos de Coortes , Pontuação de Propensão , Estudos Retrospectivos , Gastrectomia , Refluxo Gastroesofágico/cirurgia , Redução de Peso
2.
BMC Oral Health ; 24(1): 505, 2024 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-38684974

RESUMO

BACKGROUND: The stability of resin-dentin interfaces is still highly questionable. The aim of this study was to evaluate the effect of Salvadora persica on resin-dentin bond durability. MATERIALS AND METHODS: Extracted human third molars were used to provide mid-coronal dentin, which was treated with 20% Salvadora persica extract for 1 min after acid-etching. Microtensile bond strength and interfacial nanoleakage were evaluated after 24 h and 6 months. A three-point flexure test was used to measure the stiffness of completely demineralized dentin sticks before and after treatment with Salvadora persica extract. The hydroxyproline release test was also used to measure collagen degradation by endogenous dentin proteases. Statistical analysis was performed using two-way ANOVA followed by post hoc Bonferroni test and unpaired t-test. P-values < 0.05 were considered statistically significant. RESULTS: The use of Salvadora persica as an additional primer with etch-and-rinse adhesive did not affect the immediate bond strengths and nanoleakage (p > 0.05). After 6 months, the bond strength of the control group decreased (p = 0.007), and nanoleakage increased (p = 0.006), while Salvadora persica group showed no significant difference in bond strength and nanoleakage compared to their 24 h groups (p > 0.05). Salvadora persica increased dentin stiffness and decreased collagen degradation (p < 0.001) compared to their controls. CONCLUSION: Salvadora persica extract pretreatment of acid-etched dentin preserved resin-dentin bonded interface for 6 months. CLINICAL SIGNIFICANCE: Durability of resin-dentin bonded interfaces is still highly questionable. Endogenous dentinal matrix metalloproteinases play an important role in degradation of dentinal collagen within such interfaces. Salvadora persica may preserve resin-dentin interfaces for longer periods of time contributing to greater clinical success and longevity of resin composite restorations.


Assuntos
Condicionamento Ácido do Dente , Colagem Dentária , Infiltração Dentária , Dentina , Extratos Vegetais , Salvadoraceae , Resistência à Tração , Humanos , Dentina/efeitos dos fármacos , Extratos Vegetais/farmacologia , Colagem Dentária/métodos , Colágeno , Adesivos Dentinários/química , Teste de Materiais , Hidroxiprolina , Análise do Estresse Dentário , Resinas Compostas/química , Fatores de Tempo , Cimentos de Resina/química
3.
HPB (Oxford) ; 26(5): 682-690, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38342647

RESUMO

BACKGROUND: Minimally Invasive thermal ablation (MITA) of liver tumors is a commonly performed procedure, alone or in combination with liver resection. Despite being a first-option strategy for small lesions, it is technically demanding, and many concerns still exist about local disease control. METHODS: Consecutive patients undergoing MITA from 1-2019 to 12-2022 were retrospectively enrolled. Risk factors of local recurrence were investigated through univariate and multivariable cox regression analysis. RESULTS: At the multivariable analysis of the 207 nodules undergoing MITA, RFA was associated with worse local Recurrence Free Survival (lRFS) than MWA (HR 2.87 [95 % CI 0.96-8.66], p = 0.05), as well as a concomitant surgical resection (HR 3.89 [95 % CI 1.06-9.77], p = 0.02). A concomitant surgical resection showed worse lRFS in the subgroup analysis of both HCC (HR 3.98 [95 % CI 1.16-13.62], p = 0.02) and CRLM patients (HR 2.68 [95 % CI 0.66-5.92], p = 0.04). Interestingly, a tumor size between 30 and 40 mm was not associated to worse lRFS. CONCLUSION: MWA may reduce the risk of local recurrence in comparison to RFA, while MITA associated to liver resection may face an increased risk of local recurrence. Further prospective studies are needed to confirm such results.


Assuntos
Neoplasias Hepáticas , Recidiva Local de Neoplasia , Humanos , Neoplasias Hepáticas/cirurgia , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/patologia , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Idoso , Hepatectomia/efeitos adversos , Carcinoma Hepatocelular/cirurgia , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/patologia , Procedimentos Cirúrgicos Minimamente Invasivos , Resultado do Tratamento , Ablação por Cateter/efeitos adversos , Ablação por Radiofrequência/efeitos adversos , Medição de Risco
4.
Liver Transpl ; 29(2): 172-183, 2023 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-36168270

RESUMO

Precise graft weight (GW) estimation is essential for planning living donor liver transplantation to select grafts of adequate size for the recipient. This study aimed to investigate whether a machine-learning model can improve the accuracy of GW estimation. Data from 872 consecutive living donors of a left lateral sector, left lobe, or right lobe to adults or children for living-related liver transplantation were collected from January 2011 to December 2019. Supervised machine-learning models were trained (80% of observations) to predict GW using the following information: donor's age, sex, height, weight, and body mass index; graft type (left, right, or left lateral lobe); computed tomography estimated graft volume and total liver volume. Model performance was measured in a random independent set (20% of observations) and in an external validation cohort using the mean absolute error (MAE) and the mean absolute percentage error and compared with methods currently available for GW estimation. The best-performing machine-learning model showed an MAE value of 50 ± 62 g in predicting GW, with a mean error of 10.3%. These errors were significantly lower than those observed with alternative methods. In addition, 62% of predictions had errors <10%, whereas errors >15% were observed in only 18.4% of the cases compared with the 34.6% of the predictions obtained with the best alternative method ( p < 0.001). The machine-learning model is made available as a web application ( http://graftweight.shinyapps.io/prediction ). Machine learning can improve the precision of GW estimation compared with currently available methods by reducing the frequency of significant errors. The coupling of anthropometric variables to the preoperatively estimated graft volume seems necessary to improve the accuracy of GW estimation.


Assuntos
Transplante de Fígado , Aprendizado de Máquina , Adulto , Criança , Humanos , Transplante de Fígado/métodos , Doadores Vivos , Tamanho do Órgão
5.
Surg Endosc ; 37(2): 1303-1315, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36197519

RESUMO

BACKGROUND: One-stage revision Roux-en-Y gastric bypass (RRYGB) after Laparoscopic adjustable gastric banding (LAGB) is widely adopted, but its safety is still debated. OBJECTIVE: This study aimed to compare outcomes between primary Roux-en-Y gastric bypass (PRYGB and RRYGB after LAGB. METHOD: A retrospective record-based cohort study of patients who underwent PRYGB and RRYGB for failed LAGB and completed at least 2 years of follow-up from 2008 to 2019. Propensity score matching (PSM) analysis was conducted to obtain a balanced sample of patients with RRYGB and PRYGB interventions by adjusting for baseline covariates including age and sex. RESULTS: Patients with PRYGB (n = 558) and RRYGB (n = 156) were included. PSM identified 98 patients for RRYGB and 98 patients for PRYGB. Both cohorts exhibited significant reductions in BMI compared to baseline values (p < 0.001), but reductions were significantly higher in PRYGB compared to those in RRGYB at 6 months (- 10.55 ± 8.54 vs. - 8.38 ± 5.07; p = 0.032), 1-year (- 21.50 ± 8.19 vs. 16.14 ± 6.93; p < 0.001), and 2 years (- 24.02 ± 7.85 vs. - 18.93 ± 6.80; p < 0.001), respectively. A significant improvement in food tolerance from the 1st to the 2nd year was seen after RYGB (p < 0.001). The rates of early and late complications were similar in both cohorts (p = 0.537, p = 1.00). Overall re-intervention rates were 5.1 and 3.1% for RRYGB and PRYGB p = 0.721). Both cohorts exhibited significant improvement in comorbidities after 2 years (p < 0.001). CONCLUSIONS: One-stage RRYGB for failed LAGB is safe and effective with comparable rates of complications, re-interventions, and resolution of associated comorbid conditions compared to PRYGB.


Assuntos
Derivação Gástrica , Gastroplastia , Laparoscopia , Obesidade Mórbida , Humanos , Obesidade Mórbida/cirurgia , Estudos de Coortes , Estudos Retrospectivos , Pontuação de Propensão , Redução de Peso , Resultado do Tratamento , Reoperação
6.
Am J Transplant ; 22(1): 14-23, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34783439

RESUMO

Living donation in many countries is the main resource of organs. Healthy, volunteering individuals deserve the highest safety standards possible in addition to the least invasive technique to procure the organs. Since the introduction of living donor liver transplantation, many efforts have been made to minimize the surgical trauma inherent to living donor surgery. The journey started with a large Mercedes incision and evolved to reverse L-shaped and small upper midline incisions before the introduction of minimally invasive laparoscopic techniques originated. The technical difficulties of the laparoscopic approach due to suboptimal instrumentation, challenging ergonomics, and the long learning curve limited the application of the fully laparoscopic approach to a few centers. The recent introduction of the robotic platform with its superb optical system and advanced instruments allows for the first time, a genuine emulation of open donor surgery in a closed abdomen, thus allowing all liver donors to benefit from minimally invasive surgery (better cosmesis, less pain and morbidity, and better quality of life) without compromising donor safety. This attribute in combination with the ubiquitous presence of the robot in major transplant centers may well lead to the desired endpoint of this technology, namely, the widespread dissemination of minimally invasive donor surgery.


Assuntos
Laparoscopia , Transplante de Fígado , Procedimentos Cirúrgicos Robóticos , Robótica , Hepatectomia , Humanos , Fígado , Doadores Vivos , Qualidade de Vida , Coleta de Tecidos e Órgãos
7.
Liver Transpl ; : 172-183, 2022 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-37160073

RESUMO

ABSTRACT: Precise graft weight (GW) estimation is essential for planning living donor liver transplantation to select grafts of adequate size for the recipient. This study aimed to investigate whether a machine-learning model can improve the accuracy of GW estimation. Data from 872 consecutive living donors of a left lateral sector, left lobe, or right lobe to adults or children for living-related liver transplantation were collected from January 2011 to December 2019. Supervised machine-learning models were trained (80% of observations) to predict GW using the following information: donor's age, sex, height, weight, and body mass index; graft type (left, right, or left lateral lobe); computed tomography estimated graft volume and total liver volume. Model performance was measured in a random independent set (20% of observations) and in an external validation cohort using the mean absolute error (MAE) and the mean absolute percentage error and compared with methods currently available for GW estimation. The best-performing machine-learning model showed an MAE value of 50 ± 62 g in predicting GW, with a mean error of 10.3%. These errors were significantly lower than those observed with alternative methods. In addition, 62% of predictions had errors <10%, whereas errors >15% were observed in only 18.4% of the cases compared with the 34.6% of the predictions obtained with the best alternative method ( p < 0.001). The machine-learning model is made available as a web application ( http://graftweight.shinyapps.io/prediction ). Machine learning can improve the precision of GW estimation compared with currently available methods by reducing the frequency of significant errors. The coupling of anthropometric variables to the preoperatively estimated graft volume seems necessary to improve the accuracy of GW estimation.

8.
Surg Endosc ; 36(12): 9146-9155, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35764843

RESUMO

BACKGROUND: Long-term weight regain (WR) after sleeve gastrectomy (SG) is a major challenge. Laparoscopic banded SG (BSG) was introduced to overcome pouch dilation and, consequently, WR; however, its mid-and long-term outcomes have not been sufficiently demonstrated. OBJECTIVE: This study retrospectively evaluated the mid-term weight loss efficacy and morbidity over at least a 4-year follow-up after laparoscopic banded SG using a MiniMizer Gastric Ring® and laparoscopic non-banded SG. METHOD: The data of 1586 bariatric surgeries were retrospectively evaluated. To ensure homogeneity in our study cohort, propensity score matching (PSM) was performed. RESULTS: The final cohort comprised 1392 patients: the non-banded SG (n = 1260) and BSG (n = 132) groups. In our matched cohort (SG, n = 655 and BSG, n = 132), WR was noted in 4 (3.0%) and 71 (10.8%) patients in the BSG and SG groups, respectively. Gastric band erosion or slippage was not noted in the BSG cohort. The levels of cholesterol and triglyceride were similar in the two groups. Postoperative glycemic control was significantly reduced in the BSG group. CONCLUSION: Although the percentage of weight loss achieved in the BSG group was low in the first year postoperatively, the mid-term (sustained) weight loss associated with BSG was superior to that associated with non-banded SG. BSG is a safe procedure with no significant mid-term band-related morbidity; its impact on the resolution of comorbidities is equivalent and perhaps superior to SG.


Assuntos
Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Humanos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Gastrectomia/métodos , Redução de Peso , Aumento de Peso , Inocuidade dos Alimentos , Resultado do Tratamento , Laparoscopia/métodos
9.
Langenbecks Arch Surg ; 407(6): 2337-2346, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35486149

RESUMO

PURPOSE: The primary objective of the current study is to determine whether bariatric surgery reversed the negative impact of obesity on the serological response after the COVID-19 vaccination. This objective is achieved in two steps: (a) quantifying the negative impact of obesity on the serological response after COVID-19 vaccination if it is present, and (b) testing whether bariatric surgery reversed this impact. The secondary objective was to monitor the occurrence of adverse events. METHODS: This is a prospective cohort study between May 2021 and August 2021 on the strength of serological response after COVID-19 vaccination. Patients were classified into three groups. Group A (controls with normal or overweight), Group B (bariatric patients pre-operative), and Group C (bariatric patients post-operative). Quantitative antibodies against SARS­CoV­2 RBD with a strong neutralizing capacity were quantified from sera after at least 2 weeks post-vaccination. RESULTS: Of the 276 participants, Group A had n = 73, Group B had n = 126, and Group C had n = 77 patients. Overall, a strongly positive vaccine serological response was observed among 86% in group A, 63% in Group B, and 88% in Group C. Group C showed 5.33 times [95% CI 2.15 to 13.18] higher immune response than group B. Mild to moderate adverse events occurred in 30.1% [95% CI 24.7 to 35.9] of the study samples. Adverse events with the whole virus, mRNA, and vector vaccines occurred in 25%, 28%, and 37%, respectively. CONCLUSION: Vaccinating and bariatric surgery are safe and effective treatments in the serological response in patients who suffer from obesity.


Assuntos
Cirurgia Bariátrica , COVID-19 , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Humanos , Obesidade/complicações , Obesidade/cirurgia , Estudos Prospectivos , SARS-CoV-2 , Vacinação
10.
Medicina (Kaunas) ; 58(10)2022 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-36295508

RESUMO

Background and Objectives: Migraine is caused by genetic susceptibility that is triggered by environmental as well as biological factors, and it is also linked to many somatic comorbidities, including clinical and subclinical hypothyroidism. We aimed to estimate the potential association between subclinical hypothyroidism (ScH) and migraine in children at our tertiary hospital. Materials and Methods: Using a case−control strategy, 200 children and adolescents were assigned to two equal groups: a case group (patients with migraine) of 100 patients and a control group of 100 patients without migraine. Clinical and biochemical parameters (TSH, FT4) were compared between the groups using statistical analysis. Results: Thyroid function comparison between the groups showed higher TSH but normal FT4 among children with migraine headache compared to the control group, which means more frequent ScH cases among the migraine group relative to the control (17% vs. 2%, p < 0.001). Obesity and overweight were more frequent among patients with migraine than the control group (8 and 5% vs. 2 and 1%, respectively). The (overweight/obese) patients with migraine had about 77% ScH and 15.4% overt hypothyroidism compared to 8% ScH and no overt hypothyroidism among normal body weight migraine patients (p < 0.001). No significant difference in the prevalence of nodular goiter between patients with migraine and controls was found. Conclusions: Based on our results, subclinical hypothyroidism is significantly linked to childhood migraine. Obesity and being overweight are more frequent among patients with migraine. Therefore, it may be logical to test the thyroid function in migraineur children, especially those with high BMI. Further studies are recommended to discover the mechanism of this association in children.


Assuntos
Hipotireoidismo , Transtornos de Enxaqueca , Adolescente , Humanos , Criança , Sobrepeso , Hipotireoidismo/complicações , Hipotireoidismo/epidemiologia , Obesidade , Transtornos de Enxaqueca/complicações , Transtornos de Enxaqueca/epidemiologia , Tireotropina , Fatores Biológicos
11.
Clin Transplant ; 35(6): e14301, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33783041

RESUMO

BACKGROUND: The coupling of increased life expectancy and improvements in both quality and access to chronic liver disease care, is culminating in an expanding population of septuagenarians (≥70 years) in need of liver transplantation (LT). The objective of this study is to partially alleviate this knowledge deficit and to add clarity to the current status and role of LDLT in this recipient population. METHODS: Of 295 adult patients underwent LDLT between January 1, 2011 and December 31, 2016. Twelve (4%) of these patients were septuagenarians and this group was compared to younger cohort (n = 283). RESULTS: Comorbidity profiles between the two groups were similar and no statistically significant differences were noted in warm/cold ischemia times, operative duration, or blood product utilization. ICU and total hospital stays were comparable. Septuagenarian 1-and 5-year graft and patient survivals were identical at 91.7%. Their younger counterparts had 1-and 5-year patient survivals of 91.1% and 84.0 % accompanied by 1-and 5-year graft survivals of 89.8% and 82.7%, respectively. CONCLUSION: Our study highlights a recognition that LDLT can afford highly-selected elderly patients to access to transplant with equivalent outcomes to those realized by younger recipients.


Assuntos
Transplante de Fígado , Adulto , Idoso , Estudos de Coortes , Sobrevivência de Enxerto , Humanos , Tempo de Internação , Doadores Vivos , Resultado do Tratamento
12.
Pediatr Transplant ; 25(6): e14044, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34076330

RESUMO

BACKGROUND: There are still controversies in using the large left lateral segment in pediatrics LT, with the possibility of the problem of LFS grafts, and the use of monosegmental or reduced liver grafts in small infants. This study aimed to evaluate our experience with LFSG in pediatrics LT. METHODS: A cohort retrospective analysis was conducted including pediatric recipients who underwent LT between January 2011 and October 2019. We compared recipients with GRWR ≥ 4% (LFS) vs GRWR < 4% as an average for size grafts. RESULTS: There were 331 pediatric LT, 74 patients with GRWR ≥ 4%, and 257 patients with GRWR < 4%. In the group of LFS grafts, temporary abdominal closure by silicon patch was done in 39 patients (52.7%), 2 patients (2.7%) had postoperative HAT, 3 patients (4.1%) early PVT, 1 patient (1.3%) bile leak, and 3 patients (4.1%) had wound infection, with no significant difference in these complications between the 2 groups. In patients with LFS- grafts, the 1-, 3-, 5-, and 7-year patients survival rates were 94.6%, 91.7%, 91.7%, and 91.7%, respectively, while the survival rates in patients of the other group were 96.1%, 92.6%, 91.9%, and 91.9%, respectively, with no significant difference (p = .85). CONCLUSION: Using LFS graft by left lateral segment in pediatric LT with potential delayed abdominal closure is a safe and feasible option with good outcomes and unnecessary need for graft reduction if performed by an experienced multidisciplinary team.


Assuntos
Transplante de Fígado , Fígado/anatomia & histologia , Tamanho do Órgão , Criança , Pré-Escolar , Feminino , Sobrevivência de Enxerto , Humanos , Lactente , Masculino , Complicações Pós-Operatórias , Estudos Retrospectivos
13.
Liver Transpl ; 26(11): 1455-1464, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32542956

RESUMO

Robotic right lobe donor hepatectomy (RRLDH) is rarely performed, and data concerning its safety and efficacy are lacking. Here we compare our series of RRLDHs with a similar cohort undergoing open right lobe donor hepatectomy (ORLDH) with a propensity score-matched (PSM) analysis. Among 263 consecutive adult patients undergoing right lobe living donor hepatectomy from January 2015 until July 2019, 35 RRLDHs were matched to 70 ORLDHs. A 1:2 PSM analysis was performed to make the groups comparable for donor sex, age, and body mass index (BMI) and for recipient sex, age, BMI, Model for End-Stage Liver Disease score, and indication for transplant. Operative time was longer in RRLDHs compared with ORLDHs (504 ± 73.5 versus 331 ± 65.1 minutes; P < 0.001) but significantly decreased with the number of patients (P < 0.001). No conversions occurred. First warm ischemia time was longer and blood loss significantly less in RRLDHs (P = 0.001 and 0.003, respectively). Overall donor complications were similar: 2 (6%) in RRLDHs versus 12 (17%) in ORLDHs (P = 0.13). Biliary leak occurred in 1 (3%) patient receiving a robotic procedure and 2 (3%) patients receiving the conventional approach. Donors undergoing robotic surgery required less patient-controlled analgesia and had a shorter hospital stay compared with the open surgery group (P < 0.001 and P = 0.001, respectively). No significant differences in graft anatomical data and recipient outcomes were recorded. RRLDH is feasible, safe, and reproducible, with significantly decreased blood loss and a shorter hospital stay compared with the open procedure. The first 35 patients receiving the robotic procedure showed a substantial reduction in operative time, reflecting a rapid shortening of the learning curve.


Assuntos
Doença Hepática Terminal , Laparoscopia , Transplante de Fígado , Procedimentos Cirúrgicos Robóticos , Adulto , Doença Hepática Terminal/cirurgia , Hepatectomia/efeitos adversos , Humanos , Tempo de Internação , Transplante de Fígado/efeitos adversos , Doadores Vivos , Complicações Pós-Operatórias , Pontuação de Propensão , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Índice de Gravidade de Doença
14.
AAPS PharmSciTech ; 21(2): 40, 2020 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-31897805

RESUMO

There is a need to develop in vitro dissolution methods that discriminate for particle size of the manipulated abuse deterrent formulation (ADF) and that can be used for in vivo predictive models since dissolution methods developed for intact formulation might not be suitable for manipulated ones. A vertical diffusion cell (VDC) and United States Pharmacopeia (USP) Apparatus 1, 2, and 4 were evaluated for measuring the dissolution of intact and manipulated metoprolol succinate tablets with abuse deterrent-like properties. These tablets were physically manipulated to produce fine (106-500 µm) and coarse (500-1000 µm) powder samples. The VDC method was not able to discriminate the effect of particle size on drug release with varied stirring rate (200 to 800 rpm), molecular weight cut-off (MWCO, 3-5 kDa to 12-14 kDa) of the diffusion membrane, or composition and ionic strength (0.45% and 0.9%) of receiver medium. Standard and modified USP Apparatus 1 and 2 methods were assessed; however, large variations (RSD > 20%) were observed with USP Apparatus 1 for manipulated product dissolution and floating powder samples caused failure of auto-sampling when using standard USP Apparatus 2. For the USP Apparatus 4 dissolution method, packing configuration (1, 3, 8 layers and blend), ionic strength of dissolution medium (0.017, 0.077, and 0.154 M additional NaCl), and flow rate (4, 8, 16 mL/min) were studied to discriminate the effect of particle size on release. The USP Apparatus 4 dissolution method was optimized by using a packaging configuration of 8 layers with 8 mL/min flow rate which exhibited low variability and complete drug release and it could be used for in vivo predictive models. The dissolution method variables can be optimized for a specific product for desirable reproducibility and discriminatory power when using USP Apparatus 4.


Assuntos
Formulações de Dissuasão de Abuso , Composição de Medicamentos/métodos , Liberação Controlada de Fármacos , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Difusão , Metoprolol/administração & dosagem , Metoprolol/química , Modelos Teóricos , Peso Molecular , Tamanho da Partícula , Pós , Solubilidade , Comprimidos
15.
AAPS PharmSciTech ; 20(8): 331, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31677012

RESUMO

Because spray-dried dispersion (SDD) performance depends on polymer selection and drug load, time- and resource-sparing methods to screen drug/polymer combinations before spray drying are desirable. The primary objective was to assess the utility of films to anticipate the effects of drug load and polymer grade on dissolution performance of tablets containing SDDs of itraconazole (ITZ). A secondary objective was to characterize the solid-state attributes of films and SDDs to explain drug load and polymer effects on dissolution performance. SDDs employed three different grades of hypromellose acetate succinate (i.e., either HPMCAS-L, HPMCAS-M, or HPMCAS-H). Solid-state characterization employed differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and solid-state nuclear magnetic resonance (ssNMR) spectroscopy. Results indicate that films correctly anticipated the effects of drug load and polymer on dissolution performance. The best dissolution profiles were observed under the following conditions: 20% drug loading performed better than 30% for both films and SDDs, and the polymer grade rank order was HPMCAS-L > HPMCAS-M > HPMCAS-H for both films and SDDs. No dissolution was detected from films or SDDs containing HPMCAS-H. Solid-state characterization revealed percent crystallinity and phase miscibility as contributing factors to dissolution, but were not the sole factors. Amorphous content in films varied with drug load (10% > 20% > 30%) and polymer grades (HPMCAS-L > HPMCAS-M > HPMCAS-H), in agreement with dissolution. In conclusion, films anticipated the rank-order effects of drug load and polymer grade on dissolution performance from SDDs of ITZ, in part through percent crystallinity and phase miscibility influences.


Assuntos
Portadores de Fármacos/síntese química , Portadores de Fármacos/metabolismo , Itraconazol/síntese química , Itraconazol/metabolismo , Metilcelulose/análogos & derivados , Antifúngicos/síntese química , Antifúngicos/metabolismo , Varredura Diferencial de Calorimetria , Dessecação , Metilcelulose/síntese química , Metilcelulose/metabolismo , Polímeros , Solubilidade , Comprimidos , Difração de Raios X/métodos
16.
Ann Plast Surg ; 81(6): 688-693, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30325840

RESUMO

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory disease affecting the apocrine glands of the axillary, groin, and mammary regions with significant physical and psychosocial sequelae. Surgical excision of the affected tissue is the criterion standard treatment. Advanced cases of axillary HS are associated with high rates of recurrence and require extensive surgical resection with challenging reconstruction associated with risk of postoperative complications. The most effective method for reconstruction of the axilla after excision of HS is yet to be identified. OBJECTIVES: The aim of the study was to evaluate the results of the use of pedicled thoracodorsal artery perforator (TDAP) flap as a method of reconstruction for axillary efect result from wide surgical excision as a line of treatment for stage II and III HS of the axilla. PATIENT AND METHODS: The study included 20 patients with stage II and III (Hurley staging system) HS of the axilla, 18 male and 2 women treated by wide local excision and reconstruction by rotational TDAP flap. At the end of follow-up, outcome is judged by complete remission of disease, comparing preoperative shoulder function (using Constant-Murley shoulder outcome score), and quality of life (using dermatology life quality index) with postoperative results after 1 year, plus durability of reconstruction, donor site morbidity, overall aesthetic outcome, and patient's satisfaction. RESULTS: The mean ± SD follow-up period was 30 ± 5.2 months (range = 12-60 months). Four patients (20%) were treated for their right side, 8 patients (40%) for their left side, and 8 patients (40%) were treated bilaterally, so we perform 28 operations for 20 patients. The treated patients with stage II disease were 16 (57.14%) and with stage III disease were 12 (42.85%). The size of the defects was usually approximately 10 × 15 cm. By the end of follow-up period, all patient showed complete remission of the disease with improvement in both shoulder function and quality of life, whereas 1 flap (3.57%) was complicated by bleeding treated by reoperation, 2 flaps (7.14%) complicated by wound infection that was treated conservatively, 3 other flaps (10.71%) showed wide scare at insight of the flaps, and 1 flap (3.57%) developed hypertrophic scare at donor site of the flap. CONCLUSIONS: Surgical treatment of stage II and III HS of axilla and reconstruction by rotational TDAP flap provides good aesthetic and functional results with 100% success rate in eradicating and complete remission of the disease during follow-up period and accepted complication rate.


Assuntos
Axila/cirurgia , Hidradenite Supurativa/cirurgia , Músculos Peitorais/irrigação sanguínea , Músculos Peitorais/transplante , Retalho Perfurante/irrigação sanguínea , Retalho Perfurante/transplante , Adulto , Avaliação da Deficiência , Estética , Feminino , Humanos , Masculino , Satisfação do Paciente , Qualidade de Vida
17.
J Contemp Dent Pract ; 19(9): 1129-1134, 2018 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-30287716

RESUMO

AIM: The objective of this study is to compare the bulk-fill resin composite to a conventional one, as regards; water sorption, solubility, and their effect on color stability. MATERIALS AND METHODS: This study was conducted using two types of composites: Bulk-fill composite (Filtek Bulk-Fill) and nanohybrid composite for control (Filtek Z250 XT). Specimens were prepared using a ring mold, 10 from each material. Specimens were desiccated, then weighed in a digital balance until a stable mass was acquired. For water sorption test, specimens were immersed in distilled water and placed in a lightproof incubator at 37 ± 1°C and the mass was measured weekly for 8 weeks. For solubility test, specimens were desiccated again in the desiccator until a stable mass was achieved. A spectropho-tometer was used to record the baseline color measurements prior to water immersion and weekly for 8 weeks. RESULTS: Bulk-fill composite showed higher water sorption value and lower water solubility values compared with that of the conventional one. No statistically significant difference was found for water sorption (p = 0.104) or water solubility (p = 0.098) between groups. The mean ΔE was lower in bulk-fill than conventional composite, and results showed a statistically significant difference (p = 0.009). CONCLUSION: Bulk-fill resin composite yielded better color stability and similar water sorption and solubility values. CLINICAL SIGNIFICANCE: Bulk-fill resin composite can be used in esthetically concerned patients.


Assuntos
Resinas Acrílicas , Cor , Resinas Compostas , Teste de Materiais , Poliuretanos , Água , Estética Dentária , Solubilidade
18.
Clin Transplant ; 31(2)2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27888549

RESUMO

BACKGROUND: Despite the technical and medical improvements in the recent years, hepatic artery thrombosis (HAT) remains a devastating complication after living donor liver transplantation (LDLT). We described our surgical techniques and monitoring protocols for hepatic artery reconstruction. We reported one of the lowest incidence rates of HAT in the literature. METHODS: Between 2008 and 2015, a total of 325 LDLTs performed at our institute were retrospectively analyzed. Under microscope assistance, all hepatic artery anastomosis were performed in a risk-free and back-wall first manner. We collected donors' and recipients' demographics, operative procedures, and outcome. RESULTS: A total of 325 adult LDLTs were enrolled in the study. Of these, 297(91.4%) were right liver graft. The mean diameter of the hepatic arteries of the graft was 1.9 ± 0.3 mm. A single HA anastomosis was performed in 310 patients (95.4%). The 1-, 3-, and 5-year overall patient survival rates were 84.8%, 76.8%, and 75.2%, respectively. Only one (0.3%) episode of HAT was encountered in our series. The patient was treated successfully with nonsurgical management. CONCLUSION: Our study showed that the occurrence of HAT is avoidable. Identifying risk factors associated with HAT, meticulous surgical techniques, and careful routine flow monitoring are mandatory to avoid disastrous complications.


Assuntos
Artéria Hepática/cirurgia , Transplante de Fígado , Doadores Vivos , Microscopia/métodos , Procedimentos de Cirurgia Plástica/métodos , Trombose/prevenção & controle , Procedimentos Cirúrgicos Vasculares/métodos , Adulto , Anastomose Cirúrgica , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida
19.
Drug Dev Ind Pharm ; 43(9): 1450-1459, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28420295

RESUMO

Dermal drug delivery system which localizes methotrexate (MTX) in the skin is advantageous in topical treatment of psoriasis. The aim of the current study was to understand dilution effects and formulation variability for the potential formation of niosomes from proniosome gels of MTX. Box-Behnken's design was employed to prepare a series of MTX proniosome gels of Span 40, cholesterol (Chol-X1) and Tween 20 (T20-X2). Short chain alcohols (X3), namely ethanol (Et), propylene glycol (Pg) and glycerol (G) were evaluated for their dilution effects on proniosomes. The responses investigated were niosomal vesicles size (Y1), MTX entrapment efficiency percent (EE%-Y2) and zeta potential (Y3). MTX loaded niosomes were formed immediately upon hydration of the proniosome gels with the employed solvents. Addition of Pg resulted in a decrease of vesicular size from 534 nm to 420 nm as Chol percentage increased from 10% to 30%, respectively. In addition, increasing the hydrophilicity of the employed solvents was enhancing the resultant zeta potential. On the other hand, using Et in proniosomal gels would abolish Chol action to increase the zeta potential value and hence less stable niosomal dispersion was formed. The optimized formula of MTX loaded niosomes showed vesicle size of 480 nm, high EE% (55%) and zeta potential of -25.5 mV, at Chol and T20 concentrations of 30% and 23.6%, respectively, when G was employed as the solvent. Hence, G was the solvent of choice to prepare MTX proniosomal gels with a maintained stability and highest entrapment.


Assuntos
Colesterol/química , Sistemas de Liberação de Medicamentos/métodos , Géis/química , Hexoses/administração & dosagem , Hexoses/farmacocinética , Lipossomos/química , Lipossomos/metabolismo , Metotrexato/administração & dosagem , Metotrexato/farmacocinética , Pele/metabolismo , Solventes/química , Tensoativos/química , Administração Cutânea , Administração Tópica , Química Farmacêutica , Colesterol/metabolismo , Hexoses/química , Metotrexato/química , Solubilidade
20.
Pharm Dev Technol ; 22(2): 173-183, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26811031

RESUMO

Through the integration of orthogonal central composite design and desirability function, this work aimed to explore the potential of quality by design in understanding the formulation of phospholipid-stabilized tacrolimus nanodispersions by microfluidization. The influence of homogenization pressure, microfluidization time and phospholipid concentration (X1-X3) on nanodispersion performance was studied. Nanodispersions were characterized by differential scanning calorimetric (DSC), X-ray diffractometer (XRD) and Fourier transform infrared (FTIR) analysis. Moreover, masking the unpalatable taste of tacrolimus and reducing the gastric complications were also evaluated. FTIR analysis indicated its interaction with phospholipid. DSC and XRD analysis revealed the amorphous transformation of tacrolimus within nanodispersions. The dissolution was enhanced by 35 folds and 15 folds after 0.5 and 2 h, respectively. Maximum tacrolimus content, yield, polydispersity index, percentages dissolved after 0.5 and 2 h of 99.3%, 100%, 0.864, 39.7% and 95.3%, respectively, with particle size of 160 nm were obtained at X1, X2 and X3 values of 20 000 psi, 6 min and 30%, respectively. The Euclidean distance values demonstrated masking the unpalatable taste and taste perversion to stimuli of tacrolimus in its optimized nanodispersion. Moreover, the ulcerative indices following raw tacrolimus and its optimized nanodispersion oral administration were 6.73 and 2.45, respectively, to indicate that nanodispersion was significantly less irritating to the gastric mucosa.


Assuntos
Composição de Medicamentos/métodos , Excipientes/química , Trato Gastrointestinal/efeitos dos fármacos , Imunossupressores/química , Fosfolipídeos/química , Tacrolimo/química , Percepção Gustatória/efeitos dos fármacos , Animais , Nariz Eletrônico , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/metabolismo , Masculino , Ratos Sprague-Dawley , Solubilidade , Tacrolimo/efeitos adversos , Tacrolimo/metabolismo , Paladar/efeitos dos fármacos
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