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2.
J Oncol Pharm Pract ; : 10781552241246119, 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38656201

RESUMO

INTRODUCTION: The incidence of invasive fungal diseases (IFDs) has risen in hematologic malignancy patients due to neutropenia. While posaconazole is recommended as the first-line antifungal prophylaxis in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients and voriconazole is an alternative, there is currently no direct comparison data available to assess their relative effectiveness. METHOD: We retrospectively reviewed eligible patient charts from January 2017 to February 2019 to identify breakthrough IFD rates, drug adverse event frequency, and drug acquisition cost in AML/MDS patients. RESULTS: Forty-eight patients received 130 chemo cycles, with 50 (38%) cycles prescribed posaconazole and 80 (62%) prescribed voriconazole as primary IFD prophylaxis. The incidence rates of IFD in the posaconazole group were 8% (4 out of 50), of which two were probable and two were possible infections, while 6.26% (5 out of 80) of patients in the voriconazole group developed IFD, with four possible infections and one probable infection (p = 0.73). A higher percentage of patients in the voriconazole group discontinued prophylaxis due to adverse events, with six patients compared to two patients in the posaconazole group (p = 0.15). The drug acquisition cost of posaconazole is 5.62 times more expensive than voriconazole. CONCLUSION: The use of voriconazole instead of posaconazole for 130 chemo cycles would save $166,584.6. Posaconazole and voriconazole have comparable efficacy and safety in preventing IFD in AML and MDS patients receiving chemotherapy. However, posaconazole is more costly than voriconazole.

3.
Pharm Res ; 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38561579

RESUMO

PURPOSE: Products formulated for intramammary (IMM) infusion are intended for the delivery of therapeutic moieties directly into the udder through the teat canal to maximize drug exposure at the targeted clinical site, the mammary gland, with little to no systemic drug exposure. Currently, to our knowledge, there has been no in-vitro matrix system available to differentiate between IMM formulations. Our goal is to develop A custom tailored in-vitro "Matrix of Chemistry, Manufacturing and Control" (MoCMC) System to be a promising future tool for identifying inequivalent IMM formulations. MoCMC can detect inter and intra batch variabilities, thereby identifying potential generics versus brand product similarities or differences with a single numeric value and a specific & distinctive fingerprint. METHODS: The FDA-approved IMM formulation, SPECTRAMASTⓇ LC, was selected as the reference product for the MoCMC. Twelve in-house test formulations containing ceftiofur hydrochloride were formulated and characterized. The MoCMC was developed to include six input parameters and three output parameters. The MoCMC system was used to evaluate and compare SPECTRAMASTⓇ LC with its in-house formulations. RESULTS: Based on the MoCMC generated parameters, the distinctive fingerprints of MoCMC for each IMM formulations, and the statistical analyses of MCI and PPI values, in-house formulations, F-01 and F-02 showed consistency while the rest of in-house formulations (F-03-F-12) were significantly different as compared to SPECTRAMASTⓇ LC. CONCLUSION: This research showed that the MoCMC approach can be used as a tool for intra batch variabilities, generics versus brand products comparisons, post-approval formulations changes, manufacturing changes, and formulation variabilities.

4.
Biomed Chromatogr ; 38(5): e5845, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38412513

RESUMO

A brompheniramine taste-masked pediatric formulation was developed as part of the National Institutes of Health Pediatric Formulation Initiative to help address low patient compliance caused by the bitter taste of many adult formulations. To confirm that the taste-masked formulation can provide a similar pharmacological effect to the previous marketed adult formulations, a juvenile porcine model was used to screen the model pediatric formulation to compare the bioavailability between the marketed brompheniramine maleate and the taste-masked maleate/tannate formulation. Pigs were dosed orally with both formulations and blood samples were obtained from 0 to 48 h. Plasma samples were prepared and extracted using solid-phase extraction. The mass spectrometer was operated under selected ion monitoring mode. The selected ion monitoring channels were set to m/z 319.1 for brompheniramine and m/z 275.2 for the internal standard chlorpheniramine. Calibration curves were linear over the analytical range 0.2-20 ng/ml (r2 > 0.995) for brompheniramine in plasma. The intra- and inter-day accuracies were between 98.0 and 105% with 5.73% RSD precision. The bioanalytical method was successfully applied to a preclinical bioavailability study. The bioavailability profiles were not significantly different between the two formulations, which demonstrates that taste-masking with tannic acid is a promising approach for formulation modification for pediatric patients.


Assuntos
Disponibilidade Biológica , Bromofeniramina , Animais , Suínos , Bromofeniramina/farmacocinética , Bromofeniramina/química , Bromofeniramina/sangue , Reprodutibilidade dos Testes , Paladar , Modelos Lineares , Extração em Fase Sólida/métodos
5.
BMJ Open Qual ; 13(1)2024 01 29.
Artigo em Inglês | MEDLINE | ID: mdl-38286564

RESUMO

INTRODUCTION: The extensive resources needed to train surgeons and maintain skill levels in low-income and middle-income countries (LMICs) are limited and confined to urban settings. Surgical education of remote/rural doctors is, therefore, paramount. Virtual reality (VR) has the potential to disseminate surgical knowledge and skill development at low costs. This study presents the outcomes of the first VR-enhanced surgical training course, 'Global Virtual Reality in Medicine and Surgery', developed through UK-Ugandan collaborations. METHODS: A mixed-method approach (survey and semistructured interviews) evaluated the clinical impact and barriers of VR-enhanced training. Course content focused on essential skills relevant to Uganda (general surgery, obstetrics, trauma); delivered through: (1) hands-on cadaveric training in Brighton (scholarships for LMIC doctors) filmed in 360°; (2) virtual training in Kampala (live-stream via low-cost headsets combined with smartphones) and (3) remote virtual training (live-stream via smartphone/laptop/headset). RESULTS: High numbers of scholarship applicants (n=130); registrants (Kampala n=80; remote n=1680); and attendees (Kampala n=79; remote n=556, 25 countries), demonstrates widespread appetite for VR-enhanced surgical education. Qualitative analysis identified three key themes: clinical education and skill development limitations in East Africa; the potential of VR to address some of these via 360° visualisation enabling a 'knowing as seeing' mechanism; unresolved challenges regarding accessibility and acceptability. CONCLUSION: Outcomes from our first global VR-enhanced essential surgical training course demonstrating dissemination of surgical skills resources in an LMIC context where such opportunities are scarce. The benefits identified included environmental improvements, cross-cultural knowledge sharing, scalability and connectivity. Our process of programme design demonstrates that collaboration across high-income and LMICs is vital to provide locally relevant training. Our data add to growing evidence of extended reality technologies transforming surgery, although several barriers remain. We have successfully demonstrated that VR can be used to upscale postgraduate surgical education, affirming its potential in healthcare capacity building throughout Africa, Europe and beyond.


Assuntos
Realidade Virtual , Humanos , Uganda , Aprendizagem , Países em Desenvolvimento , Reino Unido
6.
AAPS PharmSciTech ; 25(1): 20, 2024 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-38267637

RESUMO

The aim of this paper was to investigate the effects of formulation parameters on the physicochemical and pharmacokinetic (PK) behavior of amorphous printlets of lopinavir (LPV) manufactured by selective laser sintering 3D printing method (SLS). The formulation variables investigated were disintegrants (magnesium aluminum silicate at 5-10%, microcrystalline cellulose at 10-20%) and the polymer (Kollicoat® IR at 42-57%), while keeping printing parameters constant. Differential scanning calorimetry, X-ray powder diffraction, and Fourier-transform infrared analysis confirmed the transformation of the crystalline drug into an amorphous form. A direct correlation was found between the disintegrant concentration and dissolution. The dissolved drug ranged from 71.1 ± 5.7% to 99.3 ± 2.7% within 120 min. A comparative PK study in rabbits showed significant differences in the rate and extent of absorption between printlets and compressed tablets. The values for Tmax, Cmax, and AUC were 4 times faster, and 2.5 and 1.7 times higher in the printlets compared to the compressed tablets, respectively. In conclusion, the SLS printing method can be used to create an amorphous delivery system through a single continuous process.


Assuntos
Excipientes , Lasers , Animais , Coelhos , Preparações Farmacêuticas , Disponibilidade Biológica , Lopinavir , Impressão Tridimensional
7.
Pak J Med Sci ; 40(1Part-I): 36-40, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38196456

RESUMO

Background and Objective: A thorough insight into the management of hand injuries can shape the approach of a surgeon in order to achieve optimal outcomes for the patients. The aim of this study was to share our experience in reconstruction of the hand and establishing an algorithm for classification and treatment of hand injuries. Methods: This is a descriptive cross sectional study and was conducted from January 2020 to August 2022 at Burns and Plastic Surgery center, Peshawar. Data was collected from medical records about the patient demographics, mechanism of injury and type of procedures done. Defect size was classified into small (<5cm), medium (5cm to 10 cm) and large (>10cm). The defect site and size was cross tabulated against the method of soft tissue reconstruction in order to make the algorithm for reconstruction of hand injuries. Data was analyzed using SPSS. Results: The study population included 41 (75.9%) male and 13 (24.1%) female patients, mean age 31.56±14.1. Machine injuries (33.3%) and electric burns (24.1%) were the most common cause of hand soft tissue defects. The most commonly performed flap was Posterior introsseous artery (PIA) flap, followed by First dorsal metacarpal artery (FDMA) flap. Flap necrosis was observed in three cases (5.6%). Conclusion: This treatment algorithm for coverage of soft tissue defects in hand injuries will help with the decision making process of hand reconstruction and has didactic value for novice surgeons. It will also form the foundation for further work on this aspect of hand injuries.

8.
AAPS PharmSciTech ; 25(1): 19, 2024 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-38267707

RESUMO

Between February 2020 and January 2022, the Food and Drug Administration (FDA) recalled 281 metformin extended-release products due to the presence of N-nitrosodimethylamine (NDMA) above the acceptable daily intake (ADI, 96 ng/day). Our previous studies indicated presence of NDMA levels above ADI in both metformin immediate and extended-release products. When metformin products have NDMA impurities, it is indispensable to check for the same impurities in metformin combination products. Therefore, the objective of the present study was to evaluate in-use stability of commercial metformin combination products for NDMA. For this purpose, metformin products in combination with glyburide (GB1-GB12), glipizide (GP1-GP8), pioglitazone (P1-P3), alogliptin (A1, A2), and linagliptin (L1, L2) were repacked in pharmacy vials, stored at 30°C/75% RH for 3 months, and monitored for NDMA impurity. The NDMA level varied from 0 to 156.8 ± 32.8 ng/tablet initially and increased to 25.4 ± 5.1 to 455.0 ± 28.4 ng/tablet after 3 months of exposure to in-use condition. Initially, 18 products have NDMA level below ADI limit before exposure which decreased to 7 products (GB5, GP3, GP5, A1, A2, L1, and L2) meeting specification. In conclusion, in-use stability study provides quality and safety risk assessment of drug products where nitroso impurities are detected in the probable condition of use.


Assuntos
Metformina , Nitrosaminas , Estados Unidos , Humanos , United States Food and Drug Administration , Dimetilnitrosamina , Comprimidos
9.
BJS Open ; 8(1)2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38284399

RESUMO

BACKGROUND: Textbook outcomes are composite outcome measures that reflect the ideal overall experience for patients. There are many of these in the elective surgery literature but no textbook outcomes have been proposed for patients following emergency laparotomy. The aim was to achieve international consensus amongst experts and patients for the best Textbook Outcomes for non-trauma and trauma emergency laparotomy. METHODS: A modified Delphi exercise was undertaken with three planned rounds to achieve consensus regarding the best Textbook Outcomes based on the category, number and importance (Likert scale of 1-5) of individual outcome measures. There were separate questions for non-trauma and trauma. A patient engagement exercise was undertaken after round 2 to inform the final round. RESULTS: A total of 337 participants from 53 countries participated in all three rounds of the exercise. The final Textbook Outcomes were divided into 'early' and 'longer-term'. For non-trauma patients the proposed early Textbook Outcome was 'Discharged from hospital without serious postoperative complications (Clavien-Dindo ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation or death). For trauma patients it was 'Discharged from hospital without unexpected transfusion after haemostasis, and no serious postoperative complications (adapted Clavien-Dindo for trauma ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation on or death)'. The longer-term Textbook Outcome for both non-trauma and trauma was 'Achieved the early Textbook Outcome, and restoration of baseline quality of life at 1 year'. CONCLUSION: Early and longer-term Textbook Outcomes have been agreed by an international consensus of experts for non-trauma and trauma emergency laparotomy. These now require clinical validation with patient data.


Assuntos
Laparotomia , Sepse , Humanos , Laparotomia/efeitos adversos , Qualidade de Vida , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias
10.
Updates Surg ; 76(2): 677-686, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37839047

RESUMO

Emergency Resuscitative Thoracotomy (ERT) is a lifesaving procedure in selected patients. Outcome mostly in blunt trauma is believed to be poor. The primary aim of this study was to determine the predictors of postoperative mortality following ERT. We retrospectively reviewed 34 patients ≥ 18 years who underwent ERT at San Camillo-Forlanini Hospital (Rome, Italy) between January 2009 and December 2022 with traumatic arrest for blunt or penetrating injuries. Of 34 ERT, 28 (82.4%) were for blunt trauma and 6 (17.6%) were for penetrating trauma. Injury Severity Score (p-value 0.014), positive E-FAST (p-value 0.023), Systolic Blood Pressure (p-value 0.001), lactate arterial blood (p-value 0.012), pH arterial blood (p-value 0.007), and bicarbonate arterial blood (p-value < 0.001) were significantly associated with postoperative mortality in a univariate model. After adjustment, the only independent predictor of postoperative mortality was Injury Severity Score (p-value 0.048). Our experience suggests that ERT is a technique that should be utilized for patients with critical penetrating injuries and blunt trauma in patients in extremis. Our study highlights as negative prognostic factors high values of ISS and lactate arterial blood, a positive E-FAST, and low values of Systolic Blood Pressure, pH arterial blood and bicarbonate arterial blood.


Assuntos
Ferimentos não Penetrantes , Ferimentos Penetrantes , Humanos , Centros de Traumatologia , Estudos Retrospectivos , Toracotomia , Bicarbonatos , Ferimentos Penetrantes/cirurgia , Ferimentos não Penetrantes/cirurgia , Lactatos
11.
Pharm Res ; 41(1): 129-139, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37783927

RESUMO

PURPOSE: Intramammary (IMM) formulations are locally acting and delivered intracisternally into the udder. No pharmacopeial in-vitro release method is available to differentiate between the IMM formulations. Our research aim is to develop in-vitro release methods that discriminate different IMM formulations (SPECTRAMAST® LC and in-house formulations). METHODOLOGY: Different in-house formulations were developed to simulate SPECTRAMAST® LC generics. SPECTRAMAST® LC and the in-house formulations were characterized for physicochemical attributes, such as particle size, rheology, drug content, sedimentation rate, and flocculation rate. The in-vitro release method was optimized by evaluating drug release using USP apparatuses 1, 2 (with and without enhancer/customized cells), and 4. Various test parameters, including medium effect (whole homogenized bovine milk versus aqueous buffer), medium volume (200-900 mL), and rotational speed (50-200 rpm) were investigated. RESULTS: Two potential in-vitro systems can be used as discriminatory methods for IMM formulations: USP apparatus 2 with the IMM formulation loaded into two containers a) customized formulation container (83.1 cm in height and 56.4 cm in width) or b) enhancer cells with their top adapted with mesh #40 (rotation speed:125 rpm and 900 mL of whole homogenized bovine milk). The release profile of SPECTRAMAST® LC at 1 h (99.8%) was not significantly different from formulations with similar physicochemical characteristics F-01 (99.1%) and F-02 (100.5%). Formulation with different physicochemical characteristics F-03 (44.3%) and F-04 (57.2%) showed slower release (1 h) than SPECTRAMAST® LC (98.8%). CONCLUSION: The developed in-vitro release methods can be used as a potential tool for in-vitro comparability evaluations for IMM formulations.


Assuntos
Química Farmacêutica , Água , Animais , Química Farmacêutica/métodos , Liberação Controlada de Fármacos
12.
Surgeon ; 22(1): 37-42, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37652801

RESUMO

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method for temporary hemorrhage control used in haemodynamically unwell patients with severe bleeding. In haemodynamically unwell abdominal trauma patients, laparotomy remains the initial procedure of choice. Using REBOA in patients as a bridge to laparotomy is a novel option whose feasibility and efficacy remain unclear. We aimed to assess the clinical outcome in patients with abdominal injury who underwent both REBOA placement and laparotomy. METHODS: This is a retrospective study, including trauma patients with an isolated abdominal injury who underwent both REBOA placement and laparotomy, during the period 2011-2019. All data were collected via the Aortic Balloon Occlusion Trauma Registry database. RESULTS: One hundred and three patients were included in this study. The main mechanism of trauma was blunt injury (62.1%) and the median injury severity score (ISS) was 33 (14-74). Renal failure and multi-organ dysfunction syndrome (MODS) occurred in 15.5% and 35% of patients, respectively. Overall, 30-day mortality was 50.5%. Post balloon inflation systolic blood pressure (SBP) >80 mmHg was associated with lower 24-h mortality (p = 0.007). No differences in mortality were found among patients who underwent partial occlusion vs. total occlusion of the aorta. CONCLUSIONS: Our results support the feasibility of REBOA use in patients with isolated abdominal injury, with survival rates similar to previous reports for haemodynamically unstable abdominal trauma patients. Post-balloon inflation SBP >80 mmHg was associated with a significant reduction in 24-h mortality rates, but not 30-day mortality. Total aortic occlusion was not associated with increased mortality, MODS, and complication rates compared with partial occlusion.


Assuntos
Traumatismos Abdominais , Oclusão com Balão , Procedimentos Endovasculares , Choque Hemorrágico , Humanos , Estudos Retrospectivos , Aorta/cirurgia , Hemorragia/etiologia , Hemorragia/terapia , Traumatismos Abdominais/complicações , Traumatismos Abdominais/cirurgia , Escala de Gravidade do Ferimento , Ressuscitação/efeitos adversos , Ressuscitação/métodos , Oclusão com Balão/efeitos adversos , Oclusão com Balão/métodos , Sistema de Registros , Procedimentos Endovasculares/efeitos adversos , Choque Hemorrágico/complicações , Choque Hemorrágico/terapia
13.
Trials ; 24(1): 701, 2023 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-37907927

RESUMO

BACKGROUND: Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold standard blade tenotomy technique. METHODS: We will randomize 244 feet into group A: needle tenotomy or group B: blade tenotomy. Randomization will be done using a block randomization with random block sizes and applying a 1:1 allocation to achieve an intervention and control group of the exact same size. Children will be evaluated at 3 weeks and 3 months post-tenotomy for primary and secondary clinical outcomes. The primary clinical outcome will be the range of dorsiflexion obtained the secondary clinical outcomes will be frequency of minor and major complications and Pirani score. The non-inferiority margin was set at 4°, and thus, the null hypothesis of inferiority of the needle technique will be rejected if the mean difference between both techniques is less than 4°. The statistical analysis will use a multi-level mixed effects linear regression model for the primary outcomes and a multi-level mixed effects logistic regression model for the secondary clinical outcomes. The physician performing the evaluations post-tenotomy will be the only one blinded to group allocation. TRIAL REGISTRATION: This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021.


Assuntos
Tendão do Calcâneo , Pé Torto Equinovaro , Criança , Humanos , Lactente , Tenotomia/efeitos adversos , Tenotomia/métodos , Pé Torto Equinovaro/diagnóstico , Pé Torto Equinovaro/cirurgia , Tendão do Calcâneo/cirurgia , Moldes Cirúrgicos , , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Cureus ; 15(9): e45035, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37829939

RESUMO

Objective This cross-sectional study aimed to assess the influence of root canal treatment on the oral-health-related quality of life (OHRQoL) of patients in the Kingdom of Saudi Arabia (KSA). The data on KSA's population are significantly limited, highlighting the significance of additional research to be carried out in this particular field. Methods The study was conducted at the dental clinics of the College of Dentistry, Qassim University, from January to June 2022. A total of 112 patients who had undergone endodontic therapy (ET) for teeth with irreversible pulpitis were included. Demographic data and treatment procedures were recorded. The patients' responses to the OHIP-14 questionnaire were analyzed to assess their OHRQoL. The scores were converted into qualitative categories (good, moderate, poor) for classification. Results The majority of patients (59.8%) reported a good OHRQoL after ET. Physical pain was the only variable where more than 50% of patients reported experiencing pain. Older age and smoking status were significantly associated with a poorer OHRQoL. However, no significant gender differences in OHRQoL were observed. Conclusion ET had a positive impact on the OHRQoL of patients in Saudi Arabia. The study highlights the importance of considering patient-centered outcomes, such as OHRQoL, in assessing the success of root canal treatment. Further research with longitudinal designs and randomized controlled trials is needed to better understand the long-term effects of root canal treatment on patients' OHRQoL and to compare them with other dental treatments.

15.
Biol Trace Elem Res ; 2023 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-37824020

RESUMO

Grass carp (Ctenopharyngodon idella) was exposed to nanoparticles of different concentrations, i.e., copper oxide nanoparticles (CuO-NPs), silver nanoparticles (Ag-NPs), and green synthetic gold nanoparticles (Au-NPs).The administered doses of the three concentration groups were 20mg L-1, 30 mg L-1, and 40mg L-1 each for a period of 14 and 28 days, respectively. The DNA damage in the erythrocytes of grass carp was detected through a comet assay technique. The values of total comet score (TCS) were noted for the exposed concentrations with a significant increasing trend (p < 0.05) and ordered as CuO-NPs > Ag-NPs > Au-NPs. The highest TCS value of the exposed erythrocytes was recorded for CuO-NPs at 40 mg L-1 after 14 days of exposition period. Comparatively, TCS values of erythrocytes exposed to green synthetic Au-NPs at all the concentrations and exposed time were less as compared to the Ag-NPs and CuO-NPs. The study confirmed the adverse effects of nanoparticles on the genetic material of fish cells.

16.
Cureus ; 15(8): e44267, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37772227

RESUMO

Background Fluoropyrimidine-based regimens are used for the management of colorectal cancer, which is the second most common cancer in Saudi Arabia. We aimed to study the incidence of hematological toxicities in colorectal cancer patients treated with fluoropyrimidine and fluoropyrimidine-based regimens at Princess Noorah Oncology Center, King Abdulaziz Medical City- Jeddah, Saudi Arabia.  Methods A retrospective cohort study that included adult colorectal cancer patients who were treated with fluoropyrimidine-based regimens from January 1, 2018 to December 31, 2018 at Princess Noorah Oncology Center, Jeddah, Saudi Arabia was performed. Our primary objective was to determine the incidence of anemia, neutropenia, and thrombocytopenia in colorectal cancer patients treated with fluoropyrimidines and fluoropyrimidine-based regimens. Secondary objectives were to assess the grade of hematological toxicities associated with 5-fluorouracil (5-FU) use and to determine the frequency of unplanned hospital admissions or emergency department (ED) visits after receiving fluoropyrimidine-based regimens. The collected data contained patients' characteristics (weight, height, age, gender, and diagnosis), chemotherapy agents, and hematological toxicity-related findings such as absolute neutrophil count, hemoglobin, platelet count, and number of ED visits or hospital admissions during fluoropyrimidine-based chemotherapy regimens. Results Of the 570 cycles of the fluoropyrimidine-based regimen received by 68 patients, hematological toxicities were observed in 508 (89.1%) cycles, and grade ≥ 3 grade toxicities were found in 46 (8.1%) cycles. The results demonstrated a statistically significant difference in the incidence of grade 3-4 neutropenia between patients who received bolus administration of 5-FU and those who did not (8.5% vs. 2.3% respectively, p=0.025). The incidence of grade 3-4 anemia was higher in the bolus group (11.3%) compared to the group where bolus was omitted (4.6%); however, the difference was not statistically significant (p=0.059). Furthermore, there was no significant difference among the two groups for grade 3 and grade 4 thrombocytopenia (0.0% with bolus given and 0.7% with bolus omission p=1.00). Conclusion Our retrospective study showed that there have been significantly higher grade 3-4 hematological toxicities observed with bolus administration of 5-FU, which confirms the previous reports.

17.
AAPS PharmSciTech ; 24(6): 171, 2023 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-37566167

RESUMO

The aim of this work was to design pediatric-friendly, dose-flexible orally disintegrating drug delivery systems (printlets) of the antiviral drug tenofovir disoproxil fumarate (TDF) by selective laser sintering (SLS) for potential use in hospitals along with other antiviral drugs. In order to obtain a consistent quality of printlets with desired properties, it is important to understand certain critical quality attributes for their main and interactions effect. The printlets were optimized by Box-Behnken's design of the experiment by varying process variables while keeping the composition constant. The composition contained 16.3% TDF, 72.7% polyvinyl pyrrolidone K16-18, 8% magnesium aluminum silicate, 3% Candurin® NXT Ruby Red, and 0.3% colloidal silicon dioxide. The process variables studied were surface (X1), chamber temperatures (X2), and laser scanning speed (X3). The range of variable levels was 75-85°C for X1, 50-70°C for X2, and 200-240 mm/s for X3, respectively. The responses studied were hardness, disintegration time, dissolution, physiochemical, and pharmacokinetic characterization. X-ray powder diffraction indicated partial or complete conversion of the crystalline drug into amorphous form in the printlets. Comparative pharmacokinetics between Viread® (generic) and printlets in rats were superimposable. Pharmacokinetic parameters showed statistically insignificant differences between the two formulations in terms of Tmax, Cmax, and AUC of (p > 0.05). Printlets were bioequivalent to Viread® as per FDA bioequivalence criteria. Thus, the SLS printing method showed the fabrication of dose-flexible printlets with quality, and in vivo performance equivalent to commercial tablets.


Assuntos
Antivirais , Impressão Tridimensional , Ratos , Animais , Tenofovir/farmacocinética , Composição de Medicamentos , Equivalência Terapêutica
18.
J Coll Physicians Surg Pak ; 33(8): 906-909, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37553931

RESUMO

OBJECTIVE: To determine the early surgical outcome of Mulliken's repair technique for bilateral cleft lip. STUDY DESIGN: Descriptive cross-sectional study. Place and Duration of the study: Burns and Plastic Surgery Centre, Hayatabad Medical Complex, Peshawar, Pakistan, from January 2020 to December 2021. METHODOLOGY: This study included 51 patients with bilateral cleft lip deformity. Patients were evaluated preoperatively to exclude any associated congenital anomalies or comorbidities. Then the patients were classified into mild, moderate, severe, and asymmetrical cases. Outcomes were determined immediately and one week postoperatively, as good (score 16-20), fair (score 11-15), and bad (0-10) on the basis of anthropometric measurements on outcome evaluation criteria (OEC). RESULTS: Preoperatively mild, moderate, and severe bilateral cleft lips were observed in 18 (35.3%), 6 (11.85%), and 15 (29.4%), respectively, while 10 (19.6%) were bilateral asymmetrical cleft lips. The postoperative outcome score ranged from 16 to 20 (mean 19.2+1.03) which falls in the good outcome range. Nasal symmetry was good in 64.7% (n=33) cases while 31.4% (n=16) patients had satisfactory scores. CONCLUSION: Although Mulliken's repair is by far the most prevalent type of repair for bilateral cleft lip patients, the results can vary markedly. The early outcome evaluation criteria is an objective tool to measure the outcomes. KEY WORDS: Cleft lip, Bilateral cleft lip, Mulliken, Mulliken's repair, Day care surgery, Outcome.


Assuntos
Fenda Labial , Procedimentos de Cirurgia Plástica , Humanos , Fenda Labial/cirurgia , Estudos Transversais , Nariz/cirurgia , Resultado do Tratamento
19.
Int J Biol Macromol ; 246: 125666, 2023 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-37406904

RESUMO

Hydrophobically associated conductive hydrogels got great attention due to their excellent properties like stretchability, energy dissipation mechanism, and strain sensor. But hydrophobically associated hydrogels have poor mechanical properties and time response to external stimuli. To enhance the mechanical properties and response to stimuli, Acrylamide- co-Butyl acrylate/Gum based conductive hydrogels were prepared. SDS works as a cross-linker and micelle-forming agent while NaCl makes hydrogel as conductive. The results show that our % strain sensing reached up to 400 %, and fracture stress and fracture strain reached to 0.5 MPa and 401 % respectively. Besides this, it's having an excellent response to continuous stretching and unstretching multiple cycles without any fracture up to 180 s and an excellent time response of 190 s. The conductivity of the hydrogel was 0.20 Sm-1. The hydrophobic hydrogels showed a clear and quick response to human motions like finger, wresting, writing, speaking, etc. Interestingly, our prepared hydrogels can detect the mood of the human face. Similarly, the hydrogels were found efficient in bridging the surface of electronic devices with human skin. This indicates that our prepared hydrogels can monitor human body motion and will replace the existing materials used in strain sensors in the near future.


Assuntos
Galactanos , Hidrogéis , Humanos , Mananas , Condutividade Elétrica , Eletrônica
20.
Expert Opin Biol Ther ; 23(8): 679-688, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37503858

RESUMO

INTRODUCTION: The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. AREAS COVERED: We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes. EXPERT OPINION: The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.


Assuntos
Medicamentos Biossimilares , Humanos , Medicamentos Biossimilares/efeitos adversos , Arábia Saudita , Aprovação de Drogas , Acessibilidade aos Serviços de Saúde , Pessoal de Saúde
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