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1.
J Clin Immunol ; 43(6): 1414-1425, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37160610

RESUMO

PURPOSE: To achieve reductions in infusion time, infusion sites, and frequency, a prospective, open-label, multicenter, Phase 3 study evaluated the safety, efficacy, and tolerability of subcutaneous immunoglobulin (SCIG) 16.5% (Cutaquig®, Octapharma) at enhanced infusion regimens. METHODS: Three separate cohorts received SCIG 16.5% evaluating volume, rate, and frequency: Cohort 1) volume assessment/site: up to a maximum 100 mL/site; Cohort 2) infusion flow rate/site: up to a maximum of 100 mL/hr/site or the maximum flow rate achievable by the tubing; Cohort 3) infusion frequency: every other week at twice the patient's weekly dose. RESULTS: For Cohort 1 (n = 15), the maximum realized volume per site was 108 mL/site, exceeding the currently labeled (US) maximum (up to 40 mL/site for adults). In Cohort 2 (n = 15), the maximum realized infusion flow rate was 67.5 mL/hr/site which is also higher than the labeled (US) maximum (up to 52 mL/hr/site). In Cohort 3 (n = 34), the mean total trough levels for every other week dosing demonstrated equivalency to weekly dosing (p value = 0.0017). All regimens were well tolerated. There were no serious bacterial infections (SBIs). Most patients had mild (23.4%) or moderate (56.3%) adverse events. The majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens and reported that switching to SCIG 16.5% was easy. CONCLUSIONS: SCIG 16.5% (Cutaquig®), infusions are efficacious, safe, and well tolerated with reduced infusion time, fewer infusion sites, and reduced frequency. Further, the majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens.


Assuntos
Síndromes de Imunodeficiência , Doenças da Imunodeficiência Primária , Adulto , Humanos , Imunoglobulinas Intravenosas/efeitos adversos , Estudos Prospectivos , Síndromes de Imunodeficiência/diagnóstico , Síndromes de Imunodeficiência/tratamento farmacológico , Infusões Subcutâneas , Imunoglobulina G/uso terapêutico , Doenças da Imunodeficiência Primária/tratamento farmacológico , Avaliação de Resultados da Assistência ao Paciente
2.
Surg Technol Int ; 28: 19-28, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27042779

RESUMO

INTRODUCTION: Haemostasis is a critical part of surgery. Haemostatic agent selection is based upon a number of factors including surgeon's experience and choice. This post-marketing survey determined surgeons' intraoperative use and perception of Hemopatch® (Baxter Healthcare Corporation, Deerfield, IL), a resorbable collagen-based sealing haemostat. METHODS AND PARTICIPANTS: A one-arm questionnaire was distributed to European general, cardiac, pulmonary, and urologic surgeons who used Hemopatch® to achieve haemostasis in situations where bleeding control by pressure, ligature, or conventional procedures had been ineffective or was impractical. Responses were summarized for patient characteristics, surgical procedures/techniques, and surgeons' assessment of Hemopatch® regarding their overall satisfaction and utilization characteristics of Hemopatch®. RESULTS: Of 1028 responses received from seven European countries, the majority were from Germany (47.3%) or Italy (36%). Most cases were in males (60.7%), 50-75 years of age (61.8%), performed by an open approach (82.5%), with 52.7% general-, 16.2% cardiac-, 7.5% lung, 19.5% urologic-type procedures and 3.7% other/unknown. Successful haemostasis after two minutes of approximation occurred in 93.3% of patients (86.8%-96.9% across surgical subtypes), with similar rates by approach (93.1% open; 94.1% minimally-invasive), and patient's use of anticoagulant and/or antiplatelet agents (87.9% - 93.1%). Over 92% of surgeon's rated Hemopatch® as "excellent" or "good" in assessments of overall satisfaction, haemostasis efficacy, ease of preparation, ease of handling, flexibility/pliability, and tissue adherence. These characteristics were rated as excellent or good by 81% or more of surgeons in analyses by surgical subspecialty and surgical approach of open or minimally invasive. CONCLUSIONS: Hemopatch® provides effective haemostasis across a variety of surgical procedures, both in open- and minimally-invasive, as well as in patients receiving anticoagulant and/or antiplatelet agents. Surgeon's generally rated their overall satisfaction with Hemopatch®, its haemostatic efficacy, and other characteristics as "much better" or "better" than their previously used haemostat.


Assuntos
Atitude do Pessoal de Saúde , Perda Sanguínea Cirúrgica/prevenção & controle , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Hemostáticos/administração & dosagem , Cuidados Intraoperatórios/estatística & dados numéricos , Cirurgiões/estatística & dados numéricos , Adulto , Idoso , Bandagens , Embolização Terapêutica/instrumentação , Embolização Terapêutica/métodos , Embolização Terapêutica/estatística & dados numéricos , Europa (Continente)/epidemiologia , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Cuidados Intraoperatórios/instrumentação , Cuidados Intraoperatórios/métodos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Prevalência , Resultado do Tratamento , Revisão da Utilização de Recursos de Saúde , Adulto Jovem
3.
J Med Econ ; 17(9): 670-6, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24927164

RESUMO

OBJECTIVE: Improved health outcomes can result in economic savings for hospitals and payers. While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated, evaluations of their economic benefit are limited. This study quantifies the cost consequences to hospitals, based on clinical outcomes, from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery. RESEARCH DESIGN AND METHODS: Applying clinical outcomes from a prospective randomized clinical trial, a cost consequence framework was utilized to model the economic impact of comparator groups. From that study, clinical outcomes were obtained and analyzed for a flowable hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation) vs non-flowable topical hemostats (SURGICEL Nu-Knit, Ethicon-Johnson & Johnson; GELFOAM, Pfizer). Costing analyses focused on the following outcomes: complications, blood transfusions, surgical revisions, and operating room (OR) time. Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data. Comparator group variability in cost consequences (i.e., cost savings) was calculated based on annualized impact and scenario testing. RESULTS: RESULTS suggest that if a flowable hemostatic matrix (rather than a non-flowable hemostat) was utilized exclusively in 600 mixed cardiac surgeries annually, a hospital could improve patient outcomes by a reduction of 33 major complications, 76 minor complications, 54 surgical revisions, 194 transfusions, and 242 h of OR time. These outcomes correspond to a net annualized cost consequence savings of $5.38 million, with complication avoidance as the largest contributor. CONCLUSIONS: This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents. These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix, rather than a non-flowable topical hemostat, in cardiac surgery.


Assuntos
Procedimentos Cirúrgicos Cardíacos/economia , Procedimentos Cirúrgicos Cardíacos/métodos , Economia Hospitalar , Hemostáticos/economia , Hemostáticos/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Análise Custo-Benefício , Custos e Análise de Custo , Hemostáticos/classificação , Humanos , Modelos Econômicos , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Resultado do Tratamento
4.
Arch Surg ; 145(1): 28-33, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20083751

RESUMO

OBJECTIVE: To compare outcome parameters for good-risk patients with classic signs, symptoms, and laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE) or endoscopic retrograde cholangiopancreatography sphincterotomy plus laparoscopic cholecystectomy (ERCP/S+LC). DESIGN: Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique. SETTING: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California. PATIENTS: We randomized 122 patients (American Society of Anesthesiologists grade 1 or 2) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before 1 or both procedures were completed. INTERVENTIONS: Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE. MAIN OUTCOME MEASURES: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary end points were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores. RESULTS: The baseline characteristics of the 2 randomized groups were similar. Efficacy of stone clearance was likewise equivalent for both groups. The time from first procedure to discharge was significantly shorter for LC+LCBDE (mean [SD], 55 [45] hours vs 98 [83] hours; P < .001). Hospital service and total charges for index hospitalization were likewise lower for LC+LCBDE, but the differences were not statistically significant. The professional fee charges for LC+LCBDE were significantly lower than those for ERCP/S+LC (median [SD], $4820 [1637] vs $6139 [1583]; P < .001). Patient acceptance and quality of life scores were equivalent for both groups. CONCLUSIONS: Both ERCP/S+LC and LC+LCBDE were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. However, the overall duration of hospitalization was shorter and physician fees lower for LC+LCBDE. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00807729.


Assuntos
Colecistolitíase/cirurgia , Coledocolitíase/cirurgia , Ducto Colédoco/cirurgia , Cálculos Biliares/cirurgia , Adulto , Procedimentos Cirúrgicos do Sistema Biliar/métodos , Colangiopancreatografia Retrógrada Endoscópica , Colecistectomia Laparoscópica , Feminino , Cálculos Biliares/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Esfinterotomia Endoscópica
5.
J Immunol ; 180(8): 5275-82, 2008 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-18390708

RESUMO

The maintenance of T cell tolerance in the periphery proceeds through several mechanisms, including anergy, immuno-regulation, and deletion via apoptosis. We examined the mechanism underlying the induction of CD8 T cell peripheral tolerance to a self-Ag expressed on pancreatic islet beta-cells. Following adoptive transfer, Ag-specific clone 4 T cells underwent deletion independently of extrinsic death receptors, including Fas, TNFR1, or TNFR2. Additional experiments revealed that the induction of clone 4 T cell apoptosis during peripheral tolerance occurred via an intrinsic death pathway that could be inhibited by overexpression of Bcl-2 or targeted deletion of the proapoptotic molecule, Bim, thereby resulting in accumulation of activated clone 4 T cells. Over-expression of Bcl-2 in clone 4 T cells promoted the development of effector function and insulitis whereas Bim-/- clone 4 cells were not autoaggressive. Examination of the upstream molecular mechanisms contributing to clone 4 T cell apoptosis revealed that it proceeded in a p53, E2F1, and E2F2-independent manner. Taken together, these data reveal that initiation of clone 4 T cell apoptosis during the induction of peripheral tolerance to a cross-presented self-Ag occurs through a Bcl-2-sensitive and at least partially Bim-dependent mechanism.


Assuntos
Proteínas Reguladoras de Apoptose/metabolismo , Autoantígenos/imunologia , Linfócitos T CD8-Positivos/imunologia , Tolerância a Antígenos Próprios , Animais , Apresentação de Antígeno , Apoptose , Proteínas Reguladoras de Apoptose/imunologia , Linfócitos T CD8-Positivos/citologia , Linfócitos T CD8-Positivos/metabolismo , Deleção Clonal , Cloridrato de Fingolimode , Glucose/análise , Imunossupressores/farmacologia , Células Secretoras de Insulina/imunologia , Camundongos , Camundongos Endogâmicos BALB C , Camundongos Transgênicos , Propilenoglicóis/farmacologia , Receptores Tipo I de Fatores de Necrose Tumoral/metabolismo , Receptores Tipo II do Fator de Necrose Tumoral/metabolismo , Esfingosina/análogos & derivados , Esfingosina/farmacologia , Receptor fas/metabolismo
6.
Ann N Y Acad Sci ; 1103: 63-8, 2007 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-17376835

RESUMO

Several publications describing the use of anti-CD40L monoclonal antibodies (anti-CD40L) for the treatment of type 1 diabetes in non-obese diabetic (NOD) mice have reported different treatment responses to similar protocols. The Entelos Type 1 Diabetes PhysioLab platform, a dynamic large-scale mathematical model of the pathogenesis of type 1 diabetes, was used to study the effects of anti-CD40L therapy in silico. An examination of the impact of pharmacokinetic variability and the heterogeneity of disease progression rate on therapeutic outcome provided insights that could reconcile the apparently conflicting data. Optimal treatment protocols were identified by exploring the dynamics of key pathophysiological pathways.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Ligante de CD40/imunologia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/imunologia , Animais , Simulação por Computador , Esquema de Medicação , Humanos , Camundongos , Camundongos Endogâmicos NOD , Modelos Biológicos
7.
Immunity ; 17(1): 73-81, 2002 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-12150893

RESUMO

Memory T cells differ from naive T cells in that they respond more rapidly and in greater numbers. In addition, memory T cells are generally believed to be less susceptible to tolerance induction than naive T cells. In this study, we show that this is not the case. Using two different methods of tolerance induction, peptide-induced tolerance and crosstolerance, we present evidence that memory CD8(+) T cells are as susceptible to tolerance as naive cells. These results have a direct impact on manipulating T cell responses to self-antigens in order to improve immunotherapy of cancer and autoimmune diseases.


Assuntos
Tolerância Imunológica , Memória Imunológica , Linfócitos T Citotóxicos/imunologia , Animais , Animais Recém-Nascidos , Autoantígenos/imunologia , Linhagem Celular , Células Clonais , Diabetes Mellitus/imunologia , Genes Codificadores dos Receptores de Linfócitos T , Hemaglutininas/imunologia , Hemaglutininas/metabolismo , Linfonodos/imunologia , Camundongos , Camundongos Endogâmicos BALB C , Pâncreas/imunologia , Peptídeos/imunologia
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