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1.
Gynecol Oncol Rep ; 38: 100871, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34646930

RESUMO

OBJECTIVES: To assess telemedicine readiness of gynecologic oncology patients, particularly those at risk for care access disparities (increased distance to care, rural populations.). METHODS: Patients at all disease/treatment stages completed an anonymous survey during in-person outpatient appointments at an academic comprehensive cancer center from 1/6/2020 to 2/28/2020, conducted prior to the COVID-19 pandemic, before the introduction of telemedicine in this practice. RESULTS: Of 180 patients approached, 170 completed the survey (94.4%). Mean age was 59.6 years; 73.4% identified as White, 23.7% Black, and 2.9% other race. Ovarian cancer was most common (41.2%), followed by endometrial (27.1%), cervical (20.6%), and vaginal/vulvar (7.1%). Most patients traveled > 50 miles for appointments (63.8%); they were more likely from rural counties with significantly higher travel costs/visit ($60.77 vs $37.98, p = 0.026.) The majority expressed interest in using telemedicine (75.7%) or a smartphone app (87.5%) in their care. The majority of patients with difficulty attending appointments (88.9 vs 70.2%, p = 0.02) or from rural counties (88.7% vs 69.6%, p = 0.03) were interested in telemedicine; those with both characteristics reported 100% interest. The majority in both urban and rural counties had home internet access, and reported similarly high rates of daily use (79% vs 75%). Race and age were not associated with differences in internet access or use or telemedicine interest. CONCLUSIONS: Telemedicine is attractive to the majority of patients and may offer financial/logistical advantages. Patients have high internet use rates and comfort with using technology for healthcare. Telemedicine should be incorporated into standard practice beyond the COVID-19 pandemic to reduce healthcare access disparities.

3.
Transplant Proc ; 51(3): 692-700, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30979452

RESUMO

BACKGROUND: Adequate kidney donor management after donation is increasingly emphasized due to concerns of renal function impairment after nephrectomy with increasing life expectancy. In this study, the clinical impact of a protocolized kidney donor follow-up system by nephrologists was evaluated. METHODS: A total of 427 living kidney donors underwent nephrectomy from January 2010 to December 2014 and were followed for at least 2 years at the Samsung Medical Center. Donors were followed-up by nephrologists after the establishment of a donor clinic with systemized protocols in January 2013. The primary outcomes were incidence of post-donation low estimated glomerular filtration rate (eGFR) and renal function adaptability. Secondary outcomes were changes in compliance and incidence of hyperuricemia and microalbuminuria. RESULTS: The patients were divided into 2 groups according to the time of nephrectomy: the pre-donor clinic period (n = 182) and the donor clinic period (n = 172). Preoperative eGFR in patients in the pre-donor clinic period was higher than that in patients in the donor clinic period. After donation, poor renal adaptation was less frequent in the donor clinic period compared to the pre-donor clinic period. Low eGFR tended to be less common during the donor clinic period. Shorter mean outpatient clinic visit intervals with more visits within 6 months after donation and earlier detection of de novo hyperuricemia were found during the donor clinic period. CONCLUSION: A protocolized donor clinic run by nephrologists may improve post-nephrectomy renal outcomes and compliance and facilitate better management of potential risk factors of chronic kidney disease in donors.


Assuntos
Doadores Vivos , Nefrectomia/efeitos adversos , Adulto , Albuminúria/epidemiologia , Albuminúria/etiologia , Estudos de Coortes , Feminino , Seguimentos , Taxa de Filtração Glomerular , Humanos , Hiperuricemia/epidemiologia , Hiperuricemia/etiologia , Rim/fisiopatologia , Transplante de Rim/efeitos adversos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/etiologia , Estudos Retrospectivos , Fatores de Risco
4.
AJR Am J Roentgenol ; 212(3): W45-W54, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30673334

RESUMO

OBJECTIVE: The purpose of this study is to evaluate the clinical, pathologic, and multimodality cross-sectional imaging features of a cohort of 94 patients with desmoplastic small round cell tumor (DSRCT). MATERIALS AND METHODS: This retrospective study of 94 patients with pathologically verified DSRCT was conducted at a tertiary cancer center between 2001 and 2013. Epidemiologic, clinical, pathologic, and imaging findings were recorded. Tumor size, location, and shape and the distribution pattern of metastases at presentation were analyzed. RESULTS: DSRCT most often occurred in young patients (median age, 21.5 years; range, 5-53 years), showing a marked predominance in male patients (86 male patients vs eight female patients). Eighty nine-patients (95%) were white (defined in this study as white or Hispanic), four were African American, and one was of Asian descent. Most patients had symptoms, with abdominal pain noted as the most common symptom. At initial presentation, 85 patients (90%) had multifocal disease, nodular disease, diffuse omental and peritoneal disease, or a combination of these conditions. Thirty-eight patients (40%) had diaphragmatic involvement. Thirty-two patients (34%) had liver metastases, and 49 patients (52%) had retroperitoneal involvement in the form of implants, tumoral extension, or nodal involvement. With regard to thoracic findings, 33 patients (35%) had nodal disease, 17 (18%) had pleural effusions, and only two (2%) had lung metastases at presentation. Twelve patients (13%) had calcified lesions. CONCLUSION: DSRCT is a rare, multifocal peritoneal malignancy with frequently disseminated abdominal disease at presentation. In the abdomen, disease most commonly involves the omentum and peritoneum, followed by the retroperitoneum. The liver is the most common solid visceral metastatic site. A substantial number of patients have diaphragmatic involvement. In the thorax, nodal and pleural involvement is more common than lung involvement.


Assuntos
Neoplasias Abdominais/diagnóstico por imagem , Tumor Desmoplásico de Pequenas Células Redondas/diagnóstico por imagem , Neoplasias Abdominais/patologia , Neoplasias Abdominais/cirurgia , Adolescente , Adulto , Criança , Pré-Escolar , Tumor Desmoplásico de Pequenas Células Redondas/patologia , Tumor Desmoplásico de Pequenas Células Redondas/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Sexuais
5.
Transplant Proc ; 49(9): 1999-2006, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29149951

RESUMO

BACKGROUND: Despite compensatory hyperfiltration in remaining nephrons following donor nephrectomy, some donors show impaired renal adaptation and low estimated glomerular filtration rate (eGFR). We investigated the factors predicting early renal adaptation after nephrectomy and identified kidney donors at risk of inadequate renal adaptation. METHODS: A total of 265 living kidney donors from 2010 to 2013 were retrospectively analyzed. Renal function was serially followed for 6 months after the operation. Regression analyses were performed to identify the independent predictors of low eGFR (eGFR <60 mL/min/1.73 m2) and impaired renal adaptation (%Modification of Diet in Renal Disease [MDRD] <66% of baseline eGFR). RESULTS: A total of 148 donors belonged to the low eGFR group, and changes in eGFR (ΔeGFR) at postoperative (PO) 1 day and 1 month were identified as independent predictors of low eGFR. Impaired renal adaptation was related to age, ΔeGFR PO 2-3 days, and ΔeGFR PO 1 month. Early renal adaptation was associated with age, male gender, and residual kidney computerized tomography angiography (CTA) volume. The best sensitivity and specificity were obtained with a cutoff value of ΔeGFR 31 at PO 1 day and 1 month for predicting low eGFR and with a value of ΔeGFR 27 at PO 2-3 days and 1 month for predicting impaired renal adaptation. CONCLUSIONS: Our study showed that the degree of early renal adaptation determines subsequent renal function in kidney donors. Closer monitoring and management may be required in old or male donors with small residual CTA kidney volume as well as donors with persistent ΔeGFR >27 within 1 month of nephrectomy.


Assuntos
Adaptação Fisiológica , Rim/fisiologia , Doadores Vivos , Adolescente , Adulto , Fatores Etários , Idoso , Feminino , Taxa de Filtração Glomerular , Humanos , Transplante de Rim , Masculino , Pessoa de Meia-Idade , Nefrectomia , Néfrons/fisiopatologia , Período Pós-Operatório , Análise de Regressão , Insuficiência Renal/etiologia , Estudos Retrospectivos , Coleta de Tecidos e Órgãos/efeitos adversos
6.
Transplant Proc ; 48(3): 820-6, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27234744

RESUMO

Antibody-mediated rejection (AMR) is one of the major causes of poor outcomes in ABO-incompatible kidney transplantation (ABOi KT). Studies investigating AMR risk factors found that anti-ABO titer is a major issue. However, the significance of antibody titer has been debated. This retrospective study analyzed AMR risk factors in 59 patients who underwent ABOi KT between August 2010 and January 2015. We also analyzed AMR risk factors in recipients with high anti-ABO baseline titers (≥1:64 on dithiothreitol at 37°C phase or ≥1:256 on antihuman globulin phase). The 2-year patient survival rate was 95.8%, and the 2-year graft survival rate was 94.9%. Nine patients (15.3%) experienced clinical (6 of 59 [10.2%]) or subclinical (3 of 59 [5.1%]) AMR. One patient experienced graft loss from hyperacute rejection. AMR risk factor analysis revealed that baseline antibody titer was associated with incidence of AMR. In patients with high baseline titers, low doses of rituximab (200-mg single-dose), an antibody against CD20, was predictive for AMR. Six patients who received pretransplant intravenous immunoglobulin did not experience AMR even when they had high baseline antibody titers. Our results indicate that a high baseline antibody titer affected the incidence of AMR. ABOi KT candidates with high baseline titers need to undergo an intensified preconditioning protocol, including high-dose rituximab (375 mg/m(2)) and intravenous immunoglobulin.


Assuntos
Sistema ABO de Grupos Sanguíneos/imunologia , Anticorpos/sangue , Incompatibilidade de Grupos Sanguíneos , Rejeição de Enxerto/sangue , Transplante de Rim , Doadores Vivos , Adulto , Feminino , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Fatores Imunológicos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Rituximab/uso terapêutico , Condicionamento Pré-Transplante
7.
Pediatr Surg Int ; 32(1): 71-3, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26500075

RESUMO

PURPOSE: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have been used in adults with ovarian carcinoma proving overall survival benefit in randomized trials, but measured in months. Diffuse peritoneal disease from pediatric type ovarian tumors is rare. We applied CRS and HIPEC to pediatric girls with diffuse peritoneal disease as part of a clinical trial. METHODS: In all patients complete cytoreduction was followed by HIPEC using 100 mg/m2 of cisplatin for 90 min in a closed technique. All received neoadjuvant chemotherapy. Patients with disease outside of the abdominal cavity were excluded. RESULTS: Of 101 pediatric CRS and HIPEC operations, 8 had ovarian primary tumors and multifocal peritoneal disease. There were three yolk sac tumors (germ cell, mixed teratoma), one Sertoli­Leydig, one PNET of the ovary, one choriocarcinoma, one juvenile granulosa cell tumor and one adenocarcinoma. Age ranged 4­18 years. Three of the 8 (37 %) recurred and died. The remaining 63 % are disease free 2­6 years post HIPEC. Overall survival and relapse-free survival in this cohort was 64 and 62 %, respectively [CI 0.64 (0.34, 1); 0.62 (0.37, 1)]. CONCLUSIONS: This is the first report of CRS and HIPEC in pediatric ovarian tumors. HIPEC may be effective in pediatric-type ovarian tumors. More study is needed in a larger cohort.


Assuntos
Procedimentos Cirúrgicos de Citorredução , Hipertermia Induzida , Neoplasias Ovarianas/complicações , Neoplasias Ovarianas/terapia , Doenças Peritoneais/complicações , Adolescente , Antineoplásicos/uso terapêutico , Quimioterapia Adjuvante , Cisplatino/uso terapêutico , Terapia Combinada , Feminino , Humanos , Terapia Neoadjuvante , Ovário/cirurgia , Cavidade Peritoneal , Doenças Peritoneais/terapia , Peritônio , Análise de Sobrevida , Resultado do Tratamento
8.
Br J Cancer ; 112(2): 278-82, 2015 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-25422914

RESUMO

BACKGROUND: Late relapse and solitary lesion are positive prognostic factors in recurrent osteosarcoma. METHODS: We reviewed the records of 39 patients treated at three major centres for recurrent osteosarcoma with a single pulmonary metastasis more than 1 year after diagnosis. We analysed their outcomes with respect to clinical factors and treatment with chemotherapy. RESULTS: Median age at diagnosis was 14.6 years. Relapse occurred at a median of 2.5 years (range, 1.2-8.2 years) after initial diagnosis. At relapse, all patients were treated by metastasectomy; 12 (31%) patients also received chemotherapy. There was no difference in time to recurrence or nodule size between the patients who received or did not receive chemotherapy at relapse. Sixteen patients had no subsequent recurrence, 13 of whom survive without evidence of disease. The 5-year and 10-year estimates of post-relapse event-free survival (PREFS) were 33.0±7.5% and 33.0±9.6%, respectively, and of post-relapse survival (PRS) 56.8±8.6% and 53.0±11.0%, respectively. There was a trend for nodules <1.5 cm to correlate positively with PREFS (P=0.070) but not PRS (P=0.49). Chemotherapy at first relapse was not associated with PREFS or PRS. CONCLUSION: Approximately half of the patients with recurrent osteosarcoma presenting as a single pulmonary metastasis more than 1 year after diagnosis were long-term survivors. Metastasectomy was the primary treatment; chemotherapy did not add benefit.


Assuntos
Neoplasias Ósseas/terapia , Neoplasias Pulmonares/terapia , Recidiva Local de Neoplasia/prevenção & controle , Osteossarcoma/terapia , Adolescente , Neoplasias Ósseas/epidemiologia , Neoplasias Ósseas/patologia , Criança , Intervalo Livre de Doença , Feminino , Humanos , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/secundário , Masculino , Recidiva Local de Neoplasia/epidemiologia , Osteossarcoma/epidemiologia , Osteossarcoma/secundário , Prognóstico , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
9.
Transplant Proc ; 46(10): 3396-9, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25498058

RESUMO

INTRODUCTION: Renal transplantation is the best treatment modality for end-stage renal disease. We investigated the effects of donor source on renal allograft and patient survival in deceased donor transplants. METHODS: We analyzed retrospectively 190 cadaver kidney transplants performed in our center from January 2000 to December 2009. Of these, 136 kidneys were harvested in our transplantation center and 54 were from external donors. Primary outcome of graft survival was assessed with the Kaplan-Meier method and the significance of possible variables was determined with the Cox proportional hazard model. RESULTS: There was no difference between groups in the age of donor and recipient, recipient body mass index, duration of dialysis, or panel reactive antibody >30%. Twenty recipients lost their grafts (14 from external donors and 6 from internal donors). Graft survival at 1, 3, and 5 years was 99.2%, 97.3%, and 95.5% for in-center donors and 98.1%, 88.9%, and 86.2% for external donor transplants (P = .01). There was no difference in patient survival rates between the groups. Acute rejection episodes (hazard ratio [HR], 13.2; P < .001) and external hospital donor (HR, 9.3; P = .008) were independent factors associated with failure. Higher age of recipient was associated with increased patient death rate (HR, 1.2; P = .02). CONCLUSION: Graft survival of cadaveric transplants from in-center donors was better than that of transplants from external center donors. Acute rejection episodes and location of harvest were significant factors for graft survival. Further study is needed to evaluate the effects of center-level factors on allograft outcomes.


Assuntos
Sobrevivência de Enxerto , Transplante de Rim , Coleta de Tecidos e Órgãos , Adulto , Feminino , Sobrevivência de Enxerto/imunologia , Humanos , Falência Renal Crônica , Transplante de Rim/mortalidade , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Diálise Renal , Estudos Retrospectivos
10.
Intern Med J ; 44(12a): 1217-22, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25266773

RESUMO

BACKGROUND: Reduction in renal mass after unilateral nephrectomy causes functional and structural changes in the remaining kidney. AIM: We aimed to investigate the association between pre-donation serum uric acid (SUA) concentration and the change in renal function after living kidney donation. METHODS: This retrospective study included 413 living kidney donors from a single centre. We collected medical history and laboratory findings at baseline and 6 months after donation. Renal function was assessed by calculating the estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration equation. Main outcomes were the percentage change in eGFR from before to 6 months after donation and the percentage of patients whose eGFR decreased by >25% after donation compared with the pre-donation baseline value. RESULTS: Mean age was 40 ± 11 years, and eGFR was 106 ± 14 mL/min/1.73 m(2). In women, the SUA concentration was linearly associated with the change in eGFR after donation independently of baseline eGFR (standardised coefficient - 0.16, P = 0.04). Multiple logistic analysis showed that a 59.5 µmol/L increase in baseline SUA concentration was associated with a 1.7-fold higher risk of a > 25% decrease in eGFR after donor nephrectomy (95% confidence interval, 1.2-2.5; P = 0.007) in women. In contrast, SUA concentration was not an independent risk factor of decrease in eGFR after donor nephrectomy in men. CONCLUSIONS: Pre-donation SUA concentration is associated independently with the change in renal function after donor nephrectomy in women but not in men.


Assuntos
Seleção do Doador/métodos , Transplante de Rim , Rim/fisiopatologia , Doadores Vivos , Nefrectomia , Ácido Úrico/sangue , Adulto , Biomarcadores/sangue , Feminino , Taxa de Filtração Glomerular , Humanos , Transplante de Rim/métodos , Valor Preditivo dos Testes , Período Pré-Operatório , Estudos Retrospectivos
11.
Drug Res (Stuttg) ; 64(12): 651-5, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24549963

RESUMO

Imatinib mesylate is effective for chronic myeloid leukaemia and gastrointestinal tumours. We aimed to evaluate the pharmacokinetics of a 200-mg imatinib tablet compared to 2×100-mg imatinib tablets in order to meet the regulatory requirements for marketing in Korea.An open-label, randomized, single-dose, 2-period, 2-treatment cross-over study was conducted in 28 healthy Korean male volunteers. Subjects were administered a 200-mg imatinib tablet and 2×100-mg imatinib tablets under a fasting state according to a randomly assigned order with a 2-week wash-out period. Serial blood samples were collected up to 72 h post-dose. The pharmacokinetic parameters were calculated using non-compartmental methods.A total of 28 subjects were enrolled and 23 subjects completed the study. There were no serious adverse events during the study. 23 mild to moderate adverse events were reported (11 events with 200-mg imatinib vs. 12 events with 2×100-mg imatinib) and subjects recovered without sequelae. The Cmax value was 922.8±318.8 µg/L at 3.15 h for 200-mg imatinib tablet, and 986.3±266.0 µg/L at 2.91 h for the 2×100-mg imatinib tablet. The AUClast of 200-mg and 2×100-mg tablets were 13 084.3±39.1 and 14 131.7±3 826.2 h · µg/L, respectively. The geometric mean ratios (90% confidence intervals) for Cmax and AUClast were 0.9121 (0.8188, 1.0161) and 0.9558 (0.8685, 1.0519), respectively.A newly developed 200-mg imatinib tablet was bioequivalent to 2×100-mg imatinib tablets in healthy Korean subjects. A single-dose of either of the 2 formulations was generally well tolerated.


Assuntos
Benzamidas/administração & dosagem , Benzamidas/farmacocinética , Piperazinas/administração & dosagem , Piperazinas/farmacocinética , Pirimidinas/administração & dosagem , Pirimidinas/farmacocinética , Adulto , Área Sob a Curva , Química Farmacêutica/métodos , Estudos Cross-Over , Humanos , Mesilato de Imatinib , Masculino , República da Coreia , Comprimidos/administração & dosagem , Comprimidos/farmacocinética , Equivalência Terapêutica , Voluntários
12.
Gynecol Oncol ; 132(3): 531-6, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24472410

RESUMO

OBJECTIVE: To develop a nomogram to predict overall survival (OS) in women with recurrent ovarian cancer treated with bevacizumab and chemotherapy. METHODS: A multicenter retrospective study was conducted. Potential prognostic variables included age; stage; grade; histology; performance status; residual disease; presence of ascites and/or pleural effusions; number of chemotherapy regimens, treatment-free interval (TFI) prior to bevacizumab administration, and platinum sensitivity. Multivariate analysis was performed using Cox proportional hazards regression. The predictive model was developed into a nomogram to predict five-year OS. RESULTS: 312 women with recurrent ovarian cancer treated with bevacizumab and chemotherapy were identified; median age was 59 (range: 19-85); 86% women had advanced stage (III-IV) disease. The majority had serous histology (74%), high grade cancers (93.5%), and optimal cytoreductions (69.5%). Fifty-one percent of women received greater than two prior chemotherapeutic regimens. TFI (AHR=0.98, 95% CI 0.97-1.00, p=0.022) was the only statistically significant predictor in a multivariate progression-free survival (PFS) analysis. In a multivariate OS analysis, prior number of chemotherapy regimens, TFI, platinum sensitivity, and presence of ascites were significant. A nomogram to predict five-year OS was constructed and internally validated (bootstrap-corrected concordance index=0.737). CONCLUSION: Our multivariate model identified prior number of chemotherapy regimens, TFI, platinum sensitivity, and the presence of ascites as prognostic variables for OS in women with recurrent ovarian cancer treated with bevacizumab combined with chemotherapy. Our nomogram to predict five-year OS may be used to identify women who may benefit from bevacizumab and chemotherapy, but further validation is needed.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Epiteliais e Glandulares/tratamento farmacológico , Nomogramas , Neoplasias Ovarianas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/administração & dosagem , Bevacizumab , Carcinoma Epitelial do Ovário , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Análise de Sobrevida , Adulto Jovem
13.
Pediatr Blood Cancer ; 61(2): 238-44, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23997016

RESUMO

PURPOSE: This non-randomized, patient-access protocol, assessed both safety and efficacy outcomes following liposomal muramyl-tripeptide-phosphatidylethanolamine (L-MTP-PE; mifamurtide) in patients with high-risk, recurrent and/or metastatic osteosarcoma. METHODS: Patients received mifamurtide 2 mg/m(2) intravenously twice-weekly ×12 weeks, then weekly ×24 weeks with and without chemotherapy. Serum concentration-time profiles were collected. Adverse events within 24 hours of drug administration were classified as infusion-related adverse events (IRAE); other AEs and overall survival (OS) were assessed. RESULTS: The study began therapy in January 2008; the last patient completed therapy in October 2012. Two hundred five patients were enrolled; median age was 16.0 years and 146/205 (71%) had active disease. Mifamurtide serum concentrations declined rapidly in the first 30 minutes post-infusion, then in a log-linear manner 2-6 hours post-dose; t1/2 was 2 hours. There were no readily apparent relationships between age and BSA-normalized clearance, half-life, or pharmacodynamic effects, supporting the dose of 2 mg/m(2) mifamurtide across the age range. Patients reported 3,679 IRAE after 7,482 mifamurtide infusions. These were very rarely grade 3 or 4 and most commonly included chills + fever or headache + fatigue symptom clusters. One- and 2-year OS was 71.7% and 45.9%. Patients with initial metastatic disease or progression approximated by within 9 months of diagnosis (N = 40) had similar 2-year OS (39.9%) as the entire cohort (45.9%) CONCLUSIONS: Mifamurtide had a manageable safety profile; PK/PD of mifamurtide in this patient access study was consistent with prior studies. Two-year OS was 45.9%. A randomized clinical trial would be required to definitively determine impact on patient outcomes.


Assuntos
Acetilmuramil-Alanil-Isoglutamina/análogos & derivados , Neoplasias Ósseas/tratamento farmacológico , Fatores Imunológicos/farmacologia , Recidiva Local de Neoplasia/tratamento farmacológico , Osteossarcoma/tratamento farmacológico , Fosfatidiletanolaminas/farmacologia , Acetilmuramil-Alanil-Isoglutamina/administração & dosagem , Acetilmuramil-Alanil-Isoglutamina/farmacocinética , Acetilmuramil-Alanil-Isoglutamina/farmacologia , Adolescente , Adulto , Neoplasias Ósseas/mortalidade , Neoplasias Ósseas/patologia , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Seguimentos , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/farmacocinética , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Metástase Neoplásica , Recidiva Local de Neoplasia/mortalidade , Recidiva Local de Neoplasia/patologia , Osteossarcoma/mortalidade , Osteossarcoma/patologia , Fosfatidiletanolaminas/administração & dosagem , Fosfatidiletanolaminas/farmacocinética , Prognóstico , Segurança , Taxa de Sobrevida , Distribuição Tecidual , Adulto Jovem
14.
J Clin Pharm Ther ; 39(2): 192-5, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24325365

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Sarpogrelate is a selective 5-hydroxytryptamine receptor subtype 2A antagonist that inhibits platelet aggregation and vasoconstriction. The aim of this study was to compare the pharmacokinetics of a sarpogrelate controlled-release formulation (CR) with those of the immediate-release formulation (IR). The effect of food on the pharmacokinetics of CR sarpogrelate was also evaluated. METHODS: A randomized, open-label, 3-period, 3-treatment crossover study was conducted in 50 healthy male subjects. Subjects were allocated into one of six sequence groups. In one period, a 100-mg IR formulation was administered three times at 6-h intervals, and in the other two periods, a 300-mg CR formulation was administered once to fasting and once to fed subjects. Each period was separated by a 7-day washout period. Serial blood samples were collected up to 24 h after the first drug administration in each period. The plasma concentrations of sarpogrelate were analysed by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were calculated by non-compartmental methods. RESULTS AND DISCUSSION: After the administration of the IR formulation, the plasma concentration reached a peak at 0·48 h and the drug was eliminated with a half-life (t1/2 ) of 0·7 h. After administration of the CR formulation, the plasma concentration reached a peak at 0·5 h and the drug was eliminated with a t1/2 of 3·23 h. The geometric mean ratios (CR/IR) for sarpogrelate area under the plasma concentration-time curve (AUC) and the maximum plasma drug concentration (Cmax) were 1·2040 (90% confidence interval (CI): 1·0992-1·3188) and 0·9462 (90% CI: 0·8504-1·0529). When CR was administered to fed subjects, the time to peak concentration was prolonged to 3·97 h and t1/2 was shortened to 1·45 h. The geometric mean ratios (fasting/fed) for sarpogrelate AUC and Cmax were 0·8573 (90% CI: 0·7687-0·9561) and 0·6452 (90% CI: 0·5671-0·7341). WHAT IS NEW AND CONCLUSION: After the administration of CR and IR formulations of the same daily dose of sarpogrelate hydrochloride, the overall systemic exposure was slightly higher for the CR than for the IR formulation, whereas peak concentration was comparable between the two formulations. Food reduced the bioavailability of sarpogrelate CR.


Assuntos
Interações Alimento-Droga , Inibidores da Agregação Plaquetária/farmacocinética , Succinatos/farmacocinética , Adulto , Área Sob a Curva , Disponibilidade Biológica , Cromatografia Líquida , Estudos Cross-Over , Preparações de Ação Retardada , Esquema de Medicação , Meia-Vida , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Biológicos , Inibidores da Agregação Plaquetária/administração & dosagem , Succinatos/administração & dosagem , Espectrometria de Massas em Tandem , Adulto Jovem
15.
Transplant Proc ; 45(8): 2914-8, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24157003

RESUMO

We investigated the effect of the donor kidney weight (Kw) to recipient body weight (Rw) ratio (Kw/Rw) on long-term graft function. To investigate the impact of the Kw/Rw ratio on the graft function, we retrospectively collected data from 213 kidney transplant recipients at least 5 years Post-transplantations. Renal function showed a positive correlation with the Kw/Rw ratio until 5 years after transplantation (at 60 months after transplantation, R = 0.158, P = .023); however, this ratio does not affect graft survival (P = .794). We used the mixed-effect model to identify the factors that affect the estimated glomerular filtration rate (eGFR) over time. In univariate analysis, donor age, BSA, kidney weight, and Kw/Rw ratio were associated with eGFR. To identify independent factors that affect to the eGFR, multivariate analysis using a mixed model was applied. Donor age (P < .001) and Kw/Rw ratio (P < .001) were independent factors that affected the eGFR. To identify the cutoff values of the Kw/Rw ratio and donor age that affect long-term graft function, multiple testing using a mixed model was applied. The cutoff value for the Kw/Rw ratio was 3.16 (P = .0104) and the cutoff value of donor age was 44 years (P = .0001). Based on our results, we conclude that the Kw/Rw ratio and donor age are important factors for the long-term function of graft.


Assuntos
Peso Corporal , Sobrevivência de Enxerto , Transplante de Rim , Rim/patologia , Doadores Vivos , Tamanho do Órgão , Adulto , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
16.
Transplant Proc ; 45(8): 2984-7, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24157018

RESUMO

INTRODUCTION: We studied the incidence of vesicoureteral reflux (VUR) in the graft kidney and its effect on the occurrence of urinary tract infection (UTI) and long-term graft function. METHODS: We performed a retrospective analysis of 64 adult kidney transplant recipients based upon voiding cystourethrography at 12 months post-transplantation. Patients underwent analysis of survival, incidence of UTIs beyond 1 year, and graft function. RESULTS: Thirty-seven male and 27 female patients in the study populations showed a mean age 42 years. VUR in the transplanted kidney at 12 months post-transplant occurred among 78.1% (50/64) of subjects: grade I (n = 6), grade II (n = 30), or grade III (n = 14) reflux. Patients followed for a median 61 months (range 44-74s) showed 11 cases of UTIs in 9 subjects. There were no significant differences in clinical characteristics or incidence of, UTIs according to the presence or severity of VUR (P = .81) or the Serum creatinine and estimated glomerular filtration rate values at 12, 36, 48, or 60 months post-transplantation. CONCLUSIONS: VUR present in 78.1% of patients after kidney transplantation affected neither graft functions or graft survival. The incidence of UTI did not differ according to the presence of VUR.


Assuntos
Sobrevivência de Enxerto , Transplante de Rim , Refluxo Vesicoureteral/fisiopatologia , Adulto , Feminino , Humanos , Imunossupressores/administração & dosagem , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença
17.
Transplant Proc ; 44(3): 740-3, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22483482

RESUMO

BACKGROUND: End-stage renal disease is associated with severe abnormalities in reproductive function. However, the abnormalities are reversed by successful kidney transplantation. The aim of the present study was to compare hormonal levels between recipients with successful kidney transplantations and healthy women with the same gynecologic conditions. METHODS: The study group consisted of 31 women of reproductive age with end-stage renal disease who underwent successful kidney transplantation. The ratio of the control group, composed of healthy woman, to the study group was 3:1 matched for age and symptoms. RESULTS: Abnormal bleeding (n = 14) and infertility were the most common gynecologic conditions in kidney transplant recipients. The levels of estrogen (E2) and follicle-stimulating hormone (FSH) in the study group were higher than in the control group, but the levels of progesterone (P4) and luteinizing hormone (LH) were lower in the study group than in the control group. There were no significant differences in prolactin and thyroid-stimulating hormone between the two groups. The incidence of infertility in patients who receive steroid was higher than those with no steroid use (P = .007). CONCLUSIONS: Compared with healthy age- and symptom-matched women, female kidney transplant recipients have increased levels of E2 and FSH and decreased levels of P4 and LH. These differences in hormone profiles may predispose kidney transplant recipients to increased risk of gynecologic pathologies.


Assuntos
Estrogênios/sangue , Hormônio Foliculoestimulante/sangue , Infertilidade Feminina/fisiopatologia , Transplante de Rim , Hormônio Luteinizante/sangue , Distúrbios Menstruais/fisiopatologia , Progesterona/sangue , Estudos de Casos e Controles , Feminino , Humanos , Imunossupressores/administração & dosagem
18.
Transplant Proc ; 44(1): 167-70, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22310606

RESUMO

BACKGROUND: Induction therapy is used to reduce the incidence of acute rejection and to prevent or treat delayed graft function. We compared basiliximab with rabbit antithymocyte globulin (ATG) as induction therapies for kidney transplant recipients. METHODS: We retrospectively analyzed the clinical data from 514 patients who received ATG or basiliximab. The patients in the ATG group (n = 152) received ATG (1.5 mg/kg/d) for 5-7 days and those in the basiliximab group (n = 362) were given 2 doses of basiliximab (20 mg) on posttransplantation days 0 and 4. All patients received standard triple immunosuppressive therapy with calcineurin inhibitors, mycophenolate mofetil, and steroids. RESULTS: There were statistically significant differences in the incidences of delayed graft function, 1-year acute rejection rate, death-censored graft survival, and patient survival between the 2 groups, even though the ATG group had more kidney transplants from deceased donors, higher levels of panel reactive antibodies, and more retransplantations. The incidences of cytomegalovirus (CMV) infection and parvovirus infection in the ATG group were higher than those in the basiliximab group. However, there was no statistically significant difference in the incidence of CMV disease between the 2 groups. CONCLUSIONS: ATG is safe and efficacious for use in kidney transplant recipients. Our results suggest that ATG should be considered for induction therapy in high-risk patients, such as those who have a kidney allograft from a deceased donor, high levels of panel reactive antibodies, and are undergoing retransplantation.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Soro Antilinfocitário/uso terapêutico , Imunossupressores/uso terapêutico , Transplante de Rim , Proteínas Recombinantes de Fusão/uso terapêutico , Adulto , Animais , Basiliximab , Biomarcadores/sangue , Creatinina/sangue , Infecções por Citomegalovirus/virologia , Função Retardada do Enxerto/sangue , Função Retardada do Enxerto/etiologia , Função Retardada do Enxerto/prevenção & controle , Feminino , Rejeição de Enxerto/sangue , Rejeição de Enxerto/imunologia , Rejeição de Enxerto/prevenção & controle , Sobrevivência de Enxerto/efeitos dos fármacos , Humanos , Transplante de Rim/efeitos adversos , Transplante de Rim/imunologia , Masculino , Pessoa de Meia-Idade , Infecções por Parvoviridae/virologia , Coelhos , República da Coreia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo
19.
Clin Nephrol ; 76(2): 117-23, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21762643

RESUMO

BACKGROUND/AIMS: Recent studies have suggested that urinary angiotensinogen (AGT) reflects the activity of the intrarenal renin angiotensin system (RAS), which is involved in tissue injury in patients with chronic kidney disease. In this study, we investigated whether urinary AGT directly reflected the severity of histopathology in such patients. METHODS: AGT was measured using a sandwich enzyme-linked immunosorbent assay (ELISA) on urine and plasma samples obtained from 58 patients on the day of renal biopsy. We measured the urinary transforming growth factor (TGF)-beta1, a representative cytokine of fibrogenic property, and analyzed the correlation among urinary TGF-beta1, urinary AGT, and the severity of renal injury. Mesangial proliferation, glomerulosclerosis, tubular atrophy and interstitial fibrosis were scored for the biopsied tissues. RESULTS: Urinary AGT levels correlated positively with proteinuria, urinary TGF-beta1 levels and diastolic blood pressure, but negatively with the estimated glomerular filtration rate (GFR). Urinary AGT concentrations were increased in patients with severe glomerulosclerosis, tubular atrophy and interstitial fibrosis. CONCLUSION: Urinary AGT levels correlated with the deterioration of renal function in patients with chronic kidney disease and reflected the histological severity of renal injury.


Assuntos
Angiotensinas/urina , Rim/patologia , Fragmentos de Peptídeos/urina , Insuficiência Renal Crônica/urina , Fator de Crescimento Transformador beta1/urina , Biomarcadores/urina , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Masculino , Proteinúria , Insuficiência Renal Crônica/patologia
20.
Clin Nephrol ; 75(6): 511-7, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21612754

RESUMO

BACKGROUND/AIMS: Refractory nephrotic syndrome (NS) is problematic because the optimal therapy for this disease is unclear and because persistent NS progresses eventually to end-stage renal disease. We report our experience using a combination of corticosteroid, cyclosporine A (CsA), and mycophenolate mofetil (MMF) to treat 10 refractory NS patients. METHODS: Ten refractory NS patients, who showed resistance to corticosteroid and CsA, were treated with triple immunosuppressive therapy. Cyclophosphamide and MMF had been used previously in 6 patients, but had failed to induce remission. RESULTS: Triple immunosuppressive therapy was discontinued after 4 months in 1 patient because of progressive azotemia. Partial remission was achieved in 9 of the 10 patients after 10 months, and remission was maintained during the treatment (urine protein to creatinine ratio, mg/mg, baseline vs. 12th month; 5.7 ± 1.8 vs. 1.4 ± 0.7). Renal function was preserved in these 9 patients (estimated GFR, ml/min/1.73 m2, baseline vs. 12th month; 71.4 ± 29.1 vs. 68.9 ± 31.5). Of the 7 patients who discontinued triple immunosuppressive therapy, remission and renal function were maintained in 4 patients. CONCLUSION: Triple immunosuppressive therapy significantly reduced proteinuria and preserved renal function in refractory NS patients, indicating a promising role of this therapy for refractory NS.


Assuntos
Corticosteroides/uso terapêutico , Ciclosporina/uso terapêutico , Imunossupressores/uso terapêutico , Ácido Micofenólico/análogos & derivados , Síndrome Nefrótica/tratamento farmacológico , Adolescente , Adulto , Idoso , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ácido Micofenólico/uso terapêutico , Proteinúria/tratamento farmacológico , Indução de Remissão , Estatísticas não Paramétricas , Resultado do Tratamento
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