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61.
An available supply of intravenous immunoglobulin (IVIG) is essential for individuals with primary humoral immunodeficiency. A shortage in 1997 prompted the Food and Drug Administration (FDA) to revise guidelines for the licensure, production, and distribution of new IVIG products, including the standardization of United States clinical trials regarding endpoints for safety, efficacy, and pharmacokinetics. The following review is intended to present current information and results of clinical trials in patients with primary immunodeficiency treated with IVIG products currently licensed or awaiting licensure in the United States. The data presented are compiled from published clinical trials and prescribing information generated by manufacturers. 相似文献
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Dougherty MJ Calligaro KD Schindler N Raviola CA Ntoso A 《Journal of vascular surgery》1999,30(6):1016-1023
PURPOSE: The objective of this study was to compare clinical outcome and costs for two widely used treatment strategies for hemodialysis graft thrombosis. METHODS: During a 4-year period, 80 patients with thrombosed dialysis grafts were randomly assigned to surgical thrombectomy with or without graft revision (SURG) or thrombolytic therapy with urokinase with the pulse-spray technique (ENDO), with adjunctive percutaneous transluminal angioplasty as indicated. All the procedures were performed in an endovascular operating suite with fistulography. The clinical and cost data were tabulated, and the outcome was analyzed with the life-table method. RESULTS: Fifty-six women and 24 men ranged in age from 33 to 90 years (mean, 63.7 years). The patients had undergone a mean of 2.8 prior access procedures in the ipsilateral extremity. All the grafts were upper extremity expanded polytetrafluoroethylene grafts. Lesions that were presumed to be the primary cause of graft thrombosis were identified in 73 of 80 grafts, and 60 of these were at the venous anastomosis. The procedure time averaged 99 minutes for the patients in the SURG group and 113 minutes for the patients in the ENDO group (P =.12). Eleven patients in the ENDO group crossed over to surgical revision as compared with two patients in the SURG group who required adjunctive percutaneous transluminal angioplasty (P =.005). The mean cost of treatment (including room and supply costs but not professional fees) was significantly higher for the ENDO group than for the SURG group ($2945 vs $1512; P <.001). There were no procedure-related complications in either group. At a median follow-up time of 24 months, there was no difference in primary or assisted primary patency between groups, which averaged 6 and 7 months, respectively. CONCLUSION: Although thrombolytic therapy combined with endovascular treatment can extend the life of dialysis grafts with results similar to surgical revision, there is a high rate of technical failure necessitating surgery and a substantially higher cost for thrombolysis. 相似文献
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Kara M. Christopher Nosayaba Osazuwa-Peters Rebecca Dougherty Sarah A. Indergaard Christina Popp Ronald Walker Mark A. Varvares 《American journal of otolaryngology》2017,38(2):168-173
Purpose
The objective of this pilot study was to determine how different treatment modalities (surgery, radiation, and chemotherapy) impact quality of life (QOL) in a population of head and neck cancer (HNC) survivors.Methods
Fifty-nine newly diagnosed, biopsy-confirmed HNC patients were recruited between 2007-2012. They completed the EORTC Quality of Life Questionnaire and Head & Neck Module at 5 intervals pre- and post-treatment. Participants were grouped into four categories based on modality: surgery only, surgery/radiation, chemoradiation, or surgery/chemoradiation. Repeated measures ANOVA examined effect of treatment modality on QOL over time.Results
Xerostomia symptoms were significantly associated with chemoradiation (F(2.47, 59.27) = 3.57, p = 0.03), lowest at pretreatment and highest 6 months post-treatment. Time was significantly associated with head and neck pain, F(2.95,67.89) = 3.39, p = 0.02.Conclusions
HNC survivors exhibit different QOL related symptoms depending on combined treatment modalities, and time post-treatment. It is important to understand QOL differences based upon treatment modalities when developing treatment plans for HNC patients. 相似文献66.
Robert E. Davis Erin Dougherty Colin McArthur Qiu Sue Huang Michael G. Baker 《Influenza and other respiratory viruses》2016,10(4):310-313
The relationship between weather and influenza and pneumonia mortality was examined retrospectively using daily data from 1980 to 2009 in Auckland, New Zealand, a humid, subtropical location. Mortality events, defined when mortality exceeded 0·95 standard deviation above the mean, followed periods of anomalously cold air (ta.m. = ?4·1, P < 0·01; tp.m. = ?4·2, P < 0·01) and/or anomalously dry air (ta.m. = ?4·1, P < 0·01; tp.m. = ?3·8, P < 0·01) by up to 19 days. These results suggest that respiratory infection is enhanced during unusually cold conditions and during conditions with unusually low humidity, even in a subtropical location where humidity is typically high. 相似文献
67.
Z P Bernstein B D Wilson A R Oseroff C M Jones S E Dozier J S Brooks R Cheney L Foulke T S Mang D A Bellnier T J Dougherty 《AIDS (London, England)》1999,13(13):1697-1704
OBJECTIVE: Kaposi's sarcoma, the most common malignancy in AIDS patients, often presents with painful cutaneous lesions that are difficult to treat effectively despite a wide variety of therapeutic approaches. We used photodynamic therapy in an attempt to provide effective palliative treatment for this disease. METHODS: Photodynamic therapy utilizes the activation by light of a photosensitizing drug that preferentially accumulates in tumor tissue such as Kaposi's sarcoma. We enrolled 25 patients who received 1.0 mg/kg of Photofrin 48 h before exposure to 100-400 J/cm2 of 630 nm light. RESULTS: Of the 348 lesions treated, 289 were evaluable: 32.5% had complete clinical response, 63.3% had partial clinical response and 4.2% were clinical failures. There was a strong correlation between response and light dose: 54% of lesions achieved a complete clinical response at optimum light dose (> 250 J/cm2). There was no correlation of response with CD4 cell count nor was there a change in CD4 cell count post-treatment. At 400 J/cm2 full field scabbing and necrosis occurred in 90% of the treated fields. Thus, the maximum tolerated dose was determined to be 300 J/cm2. At light doses of 250 J/cm2 and below the toxicities were limited to erythema and edema in the treatment field. Forty-three biopsies were taken 0.5 h to 4 months post-treatment. These showed little change in the B and T cell infiltrates identified. Kaposi's sarcoma cells disappeared post-treatment in certain lesions. CONCLUSION: Photofrin is effective palliative treatment for HIV-associated Kaposi's sarcoma. 相似文献
68.
Gabapentin is an anti-epileptic drug (AED) that was approved in 1993 for the adjunct treatment of complex partial seizures (CPS) with and without generalization. Although the mechanism of action of gabapentin has not been fully elucidated, it has been shown to be effective not only as an adjunct AED in patients with CPS, but also in children with epilepsy, many pain syndromes (most notably neuropathic pain), and several other neurological diseases. The efficacy of the drug as an AED In both adults and children has been mostly seen when used as an adjunct with other AEDs. When used as monotherapy, it has been most effective for CPS in adults at higher doses. Gabapentin as monotherapy in children has not been shown to be as beneficial as in adults. Also, the dosing of the drug in children has been complicated by negative behavioral adverse effects. Overall, gabapentin has a low incidence of adverse effects, a pharmacokinetic profile that limits its drug interactions, and limited effects on cognition when compared to traditional AEDs. The dosing of the drug is dependent on the disease state targeted, the number of specific therapeutic drugs used, and the renal function of the patient. 相似文献
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70.
Hypertension is usually managed on a case-finding basis, and yet continued blood pressure control can be inadequate. Furthermore, hypertension is often a ‘silent’ condition until comorbid events, target organ damage and subsequent heart failure become manifest, leading to a reactive rather than a proactive approach. Management of the hypertension syndrome becomes complex, because blood pressure control may not be just an isolated concern. This review considers the various options, in addition to existing guidelines, that can help to reduce hypertension-related morbidity and mortality. 相似文献