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91.
92.
Venous thromboembolism (VTE) is a significant healthcare burden with approximately 900,000 events annually in the United States, over half of which are healthcare-associated. This number is anticipated to double by 2050. Group prophylaxis strategies confined to the inpatient setting appear to have minimal impact on the reduction of post-discharge VTE in medically ill patients due to shortened lengths of stay and a heterogenous population that includes patients at low risk for VTE. In accordance with current guideline recommendations, very few (<5%) medically ill patients are discharged with extended prophylaxis, which potentially creates a clinical gap for at-risk patients as VTE risk has been shown to persist for up to 90 days. Initial studies of extended thromboprophylaxis in acutely ill medical patients with enoxaparin, rivaroxaban and apixaban showed little to no benefit towards VTE reduction that was consistently outweighed by increased bleeding. The more recent APEX study that compared betrixaban to enoxaparin in an enriched patient population at high-risk for VTE was the first study of extended thromboprophylaxis that showed similar efficacy in VTE prevention without an increase in major bleeding. Based on the APEX results, betrixaban recently gained FDA approval for extended thromboprophylaxis in acutely ill medical patients. Recognition that up to half of medically ill patients are not at sufficient risk to warrant thromboprophylaxis has driven extensive research towards development of scientifically derived and validated VTE risk assessment models intended to identify patients who do not warrant prophylaxis, as well as those at high risk who may derive benefit from extended thromboprophylaxis. This article will review prior and ongoing extended thromboprophylaxis studies, VTE and bleed risk assessment models, incorporation of biomarkers in VTE risk assessment and key issues in the paradigm shift towards individualized VTE prophylaxis in acutely ill medical patients. 相似文献
93.
Current performance criteria for analytical methods are often based on recommendations developed many years ago. A common criterion for imprecision requires that two times the standard deviation (s) of the method be less than the allowable total error (TEa). Unfortunately, when this criterion is minimally satisfied, commonly used control procedures cannot achieve reliable detection of medically important errors. Studies of the power functions for statistical quality-control (QC) procedures show that the magnitude of medically important errors must be at least 3s to fall near the plateau of the power curves and be readily detected by current QC procedures. For methods that just meet the precision criterion 2s less than TEa, however, medically important errors will fall on the rising portion of the power curves and typically be detected less than half of the time. From a "reverse engineering" perspective, the 2s less than TEa criterion is inadequate because it does not allow for the known performance limitations (lack of sensitivity) of commonly used control procedures. A strong case can be made for using a criterion of at least '4s less than TEa, which calls for a twofold improvement in imprecision over, the current minimum requirements. This recommendation is consistent with current industrial guidelines for process capability and would lead to more reliable detection of medically important errors. 相似文献
94.
Robert Recker David Dempster Bente Langdahl Hilde Giezek Seth Clark Graham Ellis Tobias de Villiers Ivo Valter Cristiano AF Zerbini Dosinda Cohn Arthur Santora Le T Duong 《Journal of bone and mineral research》2020,35(7):1289-1299
Odanacatib (ODN), a selective oral inhibitor of cathepsin K, was an investigational agent previously in development for the treatment of osteoporosis. In this analysis, the effects of ODN on bone remodeling/modeling and structure were examined in the randomized, double-blind, placebo-controlled, event-driven, Phase 3, Long-term Odanacatib Fracture Trial (LOFT; NCT00529373) and planned double-blind extension in postmenopausal women with osteoporosis. A total of 386 transilial bone biopsies, obtained from consenting patients at baseline (ODN n = 17, placebo n = 23), month 24 (ODN n = 112, placebo n = 104), month 36 (ODN n = 42, placebo n = 41), and month 60 (ODN n = 27, placebo n = 20) were assessed by dynamic and static bone histomorphometry. Patient characteristics at baseline and BMD changes over 5 years for this subset were comparable to the overall LOFT population. Qualitative assessment of biopsies revealed no abnormalities. Consistent with the mechanism of ODN, osteoclast number was higher with ODN versus placebo over time. Regarding bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces were generally similar in ODN-treated versus placebo-treated patients after 2 years of treatment. Regarding periosteal modeling, the proportion of patients with periosteal double labels and the bone formation indices increased over time in the ODN-treated patients compared with placebo. This finding supported the observed numerical increase in cortical thickness at month 60 versus placebo. In conclusion, ODN treatment for 5 years did not reduce bone remodeling and increased the proportion of patients with periosteal bone formation. These results are consistent with the mechanism of action of ODN, and are associated with continued BMD increases and reduced risk of fractures compared with placebo in the LOFT Phase 3 fracture trial. © 2020 American Society for Bone and Mineral Research. 相似文献
95.
Background
Patients with recurrent ischemic priapism have historically been treated with anti-androgen therapy due to the limited available evidence for more targeted therapies to treat the underlying pathophysiologic mechanisms of this condition. We report a case in which anti-androgen therapy caused significant adverse side effects and likely masked this patient’s elevated prostate-specific antigen (PSA) levels, which adversely impacted the timely diagnosis and treatment of his prostate cancer.Case report
A 69-year-old man treated with anti-androgens for priapism initially developed unwanted anti-androgenic side effects such as gynecomastia, erectile dysfunction, and decreased libido. After decreasing his anti-androgen dosage and starting a specified regimen of phosphodiesterase type 5 inhibitor therapy, his serum PSA levels were found to be elevated. He was subsequently diagnosed with adenocarcinoma of the prostate and underwent a radical prostatectomy with the pathologic finding of high-grade, locally progressive disease.Conclusion
Anti-androgen therapy carries significant complication risks, including the potential to alter the diagnosis and treatment of prostate cancer. Clinicians administering this therapy for priapism management should be aware of these possible risks. 相似文献96.
Alcides Chaux Antonio L. Cubilla Michael C. Haffner Kristen L. Lecksell Rajni Sharma Arthur L. Burnett George J. Netto 《Urologic oncology》2014,32(2):171-177
ObjectivesInfection by high-risk human papillomavirus (HR-HPV) plays an important role in the pathogenesis of penile cancer in approximately 50% of the patients. The gold standard for human papillomavirus (HPV) detection is the polymerase chain reaction (PCR) assay. However, technical requirements and associated costs preclude the worldwide use of PCR assays on a routine basis. Herein, we evaluated the predictive abilities of tumor morphology, immunohistochemistry for p16INK4a expression, and in situ hybridization (ISH) for HR-HPV detection in defining HPV status, as established by PCR.Materials and methodsTissue samples from 48 patients with HPV-positive penile squamous cell carcinoma (SCC) were included in 4 tissue microarrays (TMA).ResultsSensitivities and specificities were as follows: tumor morphology, 70% and 68%; p16INK4a immunohistochemistry, 65% and 90%; HR-HPV ISH, 47% and 100%. Regarding combinations of the predictors, the best performance was seen when HR-HPV ISH and p16INK4a immunohistochemistry were combined, regardless of the tumor morphology: sensitivity, 88%; specificity, 64%; area under the receiver-operating characteristic (AUC) curve, 0.83. Combinations of tumor morphology with p16INK4a immunohistochemistry or with HR-HPV ISH performed similarly well.ConclusionsIn penile SCC, both p16INK4a immunohistochemistry and ISH for HR-HPV increase the predictive ability of routine morphology in defining HPV status. These tests can be interpreted differentially, depending on the necessity of a higher sensitivity or a higher specificity. For research/screening studies, we recommend combining tumor morphology, p16INK4a immunohistochemistry, and HR-HPV ISH. To increase sensitivity, positivity in any of these predictors should be considered as indicative of HPV infection. For routine diagnosis of clinical cases, criteria should be more stringent, and, to achieve the highest specificity in classifying a case as HPV-related, all predictors should be consistently positive. The data generated in the present study could be used in algorithms for defining HPV status in penile carcinomas. 相似文献
97.
Summary. Our laboratory demonstrated that seropositivity to hepatitis A virus (HAV) independently predicts risk for coronary artery disease (CAD). As these findings are based only on the presence of HAV-specific antibodies, and not infectious virus, this prompted questions regarding possible effects of HAV vaccines on CAD development. If seropositivity to HAV alone, resulting from HAV vaccination, leads to increased atherogenesis, this raises important issues regarding the benefit of protection against HAV infection vs the risk of developing CAD. This study examines the effect of HAV vaccination on atherosclerosis development in a cholesterol-fed mouse model. Animals either received HAV vaccine, adjuvant, or saline. After 15 weeks, no significant differences were found in lesion area between the groups: HAV vaccine, 13 470 μm2 ; adjuvant, 16 332 μm2 and saline, 14 356 μm2 . Only animals receiving HAV vaccination developed HAV-specific IgG. Thus, in this mouse model, vaccination against HAV does not contribute to the development of atherosclerosis. 相似文献
98.
Ishiguro A; Spirin KS; Shiohara M; Tobler A; Gombart AF; Israel MA; Norton JD; Koeffler HP 《Blood》1996,87(12):5225-5231
99.
The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis 总被引:5,自引:0,他引:5 下载免费PDF全文
van der Holt B Löwenberg B Burnett AK Knauf WU Shepherd J Piccaluga PP Ossenkoppele GJ Verhoef GE Ferrant A Crump M Selleslag D Theobald M Fey MF Vellenga E Dugan M Sonneveld P 《Blood》2005,106(8):2646-2654
To determine whether MDR1 reversal by the addition of the P-glycoprotein (P-gp) inhibitor PSC-833 to standard induction chemotherapy would improve event-free survival (EFS), 419 untreated patients with acute myeloid leukemia (AML) aged 60 years and older were randomized to receive 2 induction cycles of daunorubicin and cytarabine with or without PSC-833. Patients in complete remission were then given 1 consolidation cycle without PSC-833. Neither complete response (CR) rate (54% versus 48%; P = .22), 5-year EFS (7% versus 8%; P = .53), disease-free survival (DFS; 13% versus 17%; P = .06) nor overall survival (OS; 10% in both arms; P = .52) were significantly improved in the PSC-833 arm. An integrated P-gp score (IPS) was determined based on P-gp function and P-gp expression in AML cells obtained prior to treatment. A higher IPS was associated with a significantly lower CR rate and worse EFS and OS. There was no significant interaction between IPS and treatment arm with respect to CR rate and survival, indicating also a lack of benefit of PSC-833 in P-gp-positive patients. The role of strategies aimed at inhibitory P-gp and other drug-resistance mechanisms continues to be defined in the treatment of patients with AML. 相似文献
100.
Storb R; Raff RF; Appelbaum FR; Deeg HJ; Graham TC; Schuening FG; Shulman H; Yu C; Bryant E; Burnett R 《Blood》1994,84(10):3558-3566
Previous studies found that bone marrow (BM) allografts from DLA- identical littermates resulted in survival of two thirds of recipient dogs after otherwise lethal doses of 450 to 600 cGy of total body irradiation (TBI) because of successful allografts or autologous recovery after rejection of the allografts. The current study asked whether survival could be further improved by treating allograft recipients with recombinant canine granulocyte colony-stimulating factor (G-CSF), stem cell factor (SCF), or G-CSF/SCF. Of 21 dogs, 14 (67%) receiving allografts but no growth factors survived, 10 with successful allografts (including 5 mixed chimeras) and 4 with autologous recovery; whereas 7 animals died, 5 from infections during BM aplasia and 2 from acute graft-versus-host disease. By comparison, 30 of 34 dogs (88%) receiving hematopoietic growth factors in addition to the BM graft survived, 17 with successful allografts (including 10 mixed chimeras) and 13 with autologous recovery; whereas 4 died, all with infection related to BM aplasia after rejection of the allograft. Survival was similar for recipients of G-CSF, SCF, or the combination of G-CSF and SCF. Logistic regression analyses, which accounted for possible effects of TBI dose, showed a trend for improved survival in dogs receiving growth factors (P = .09), no change in allogeneic engraftment (P = .74), and a slight increase in autologous recovery (P = .22). In agreement with previous data, we found that grafts of BM from DLA-identical littermates improved survival of recipient dogs exposed to low but otherwise lethal doses of TBI. A further improvement in survival could be achieved by additional treatment with G-CSF, SCF, or G-CSF/SCF. Results suggest that treatment by hematopoietic growth factors along with BM grafts should be considered for victims of radiation accidents. 相似文献