Carotid MR angiography: phase II study of safety and efficacy for MS-325

PURPOSE: To evaluate the safety and efficacy of MS-325 in patients suspected of having carotid arterial disease. MATERIALS AND METHODS: Fifty carotid arteries in 26 patients were imaged with three-dimensional spoiled gradient-recalled-echo magnetic resonance (MR) angiography at 5 and 50 minutes after injection of MS-325. MS-325 was administered intravenously as a single dose of 0.01, 0.03, or 0.05 mmol per kilogram of body weight as determined with a dose randomization scheme for four, nine, and 13 patients, respectively. Safety, including clinical laboratory changes and electrocardiographic monitoring, was assessed until approximately 3 days after injection. Conventional contrast agent-enhanced angiography was used as the standard of reference. Independent readers blinded to the dose interpreted the MR angiographic and conventional images. Images were assessed for location and extent of carotid arterial stenosis. RESULTS: There were no severe or serious adverse events. For the determination of clinically significant stenosis (>70%) on the 5-minute images, sensitivity, specificity, and accuracy (P =.07, three-way comparison) were 100%, 100%, and 100%; 63%, 100%, and 88%; and 40%, 75%, and 55% at 0.01, 0.03, and 0.05 mmol/kg, respectively. Sensitivity and specificity for images at 50 minutes after MS-325 administration showed the same trends as the 5-minute images. CONCLUSION: Overall accuracy for MS-325-enhanced carotid MR angiography performed during steady-state conditions of circulating contrast agent approximately 5 minutes after injection was high (88%-100%) at 0.03 and 0.01 mmol/kg. MS-325 was well tolerated at all evaluated doses.     

The effect of different preparations of hormone therapy on tumor necrosis factor-alpha levels in women with surgical menopause.

The aim of the present prospective controlled study was to examine the influence of 17beta-estradiol and tibolone on tumor necrosis factor-alpha (TNF-alpha) levels in healthy women with surgical menopause. Forty-five surgically menopausal women were included in the study. Thirty women were randomized to receive tibolone 2.5 mg or 17beta-estradiol 2 mg daily for 16 weeks. Fifteen surgically menopausal women who refused hormone therapy served as controls. Serum was collected from the subjects at baseline and at the end of the study for TNF-alpha assay. Neither tibolone nor 17beta-estradiol showed a significant influence on TNF-alpha level at the end of 16 weeks in comparison with baseline. Although tibolone induced a trend toward decreased level of TNF-alpha (3.30 +/- 0.42 vs. 2.56 +/- 1.94 microg/dl), this was non-significant. The slight increase observed in TNF-alpha level in the control group was also insignificant (3.60 +/- 1.20 vs. 4.10 +/- 0.70 microg/dl). Overall, these results demonstrate no significant effects of either tibolone or 17beta-estradiol on circulating TNF-alpha level in surgically menopausal women. However, the significant difference achieved between the tibolone and control group after treatment is promising and needs to be investigated in trials with longer treatment periods.     

Transfemoral venous catheterization through inferior vena caval filters: results in seven cases

Use of the transfemoral route for venous catheterization has been considered contraindicated in patients with inferior vena caval (IVC) filters. The transjugular route has been used instead in such patients when subsequent diagnostic or therapeutic procedures are required. Many radiologists, however, are more accustomed to the transfemoral approach, and may not find the transjugular route a desirable alternative. We describe seven patients with previously placed IVC filters in whom the transfemoral route was used to perform pulmonary arteriography (five patients) or to place additional IVC filters (two patients). After venographic confirmation of caval patency, filters were catheterized under fluoroscopic control and the procedures were performed. All procedures were technically successful; no complications occurred. We believe the transfemoral route to be a safe and feasible approach for performing venous procedures in selected patients with IVC filters, obviating the less familiar and potentially more hazardous transjugular approach.     

Two-year interferon therapy with or without ribavirin in chronic delta hepatitis

The only beneficial agent for the treatment of chronic delta hepatitis (CDH) is interferon (IFN). However, there is no consensus on the best dosage or duration of IFN therapy. As ribavirin (RBV) increases the sustained response when added to IFN in chronic hepatitis C, probably because of its immunomodulatory effect, we aimed to investigate the efficacy of 2-year IFN treatment and whether RBV had any additive effect to IFN in CDH. METHODS: Patients (n = 31) with CDH were randomized with a 1:2 ratio as 10 patients (3 females/7 males, age 39 +/- 9) receiving IFN monotherapy (9 MU IFN-alpha2a three times weekly) and 21 patients (8 females/13 males, age 38 +/- 11) receiving IFN plus RBV for 2 years (IFN at the same dosage and RBV at 1000-1200 mg/day). Alanine transferase normalization and hepatitis delta virus (HDV) RNA negativity at the end of treatment and at the end of the follow-up period (at least 6 months following 2-year treatment) were primary endpoints of the study. In addition, virological response and biochemical response were determined separately. RESULTS: Eight of 31 patients (25%) had cirrhosis in liver biopsies. Six patients from the IFN monotherapy group and 12 patients from the combination group had biochemical response. Five patients from the IFN monotherapy group and 11 patients from the combination group had virological response at the end of therapy. Two patients from the IFN group and five patients from the combination group had sustained biochemical response at the end of the follow-up period. Hepatitis B virus (HBV) activations with HBV DNA positivity were observed in two patients (one from the IFN monotherapy group, one from the combination group). Two patients (20%) in the IFN group and five patients (23.5%) in IFN plus RBV group remained as virological responders at the end of the follow-up period (P > 0.05). None of the patients with liver cirrhosis were responsive at the end of the follow-up period. CONCLUSION: Almost 20% of the patients with CDH were responsive to 2-year IFN treatment at the end of the follow-up period and no additional effect of RBV was observed. Patients with advanced liver disease failed to respond to treatment.     

Patients with Behcet's disease carry a higher risk for microvascular involvement in active disease period

BACKGROUND: Behcet's disease (BD) is characterized with remissions and exacerbations. However, to date, there is no study to investigate a possible association of disease activity (active versus inactive disease period) with cardiovascular complications. METHODS: Forty patients with BD were evaluated in both active and in inactive disease period. For the control group 45 healthy volunteers, age and sex matched, were registered. Subjects with at least a 15-day lesion-free period were regarded in inactive disease period, and subjects with any oral, skin, and/or genital lesion was regarded as in active disease period. In each subject coronary diastolic peak flow velocities (DPFV) were measured at baseline and after dipyridamole infusion (0.84 mg/kg over 6 minutes) using an Acuson Sequoia C256 echocardiography system. Coronary flow reserve (CFR) was defined as the ratio of hyperemic to baseline DPFV. RESULTS: CFR values were significantly lower in BD patients compared to the controls (2.57+/-0.50 versus 2.87+/-0.53, P = 0.006). In active disease period, basal DPFV (24.6+/-7.5 versus 27.3+/-6.6, P = 0.019) was significantly higher than in the inactive disease period. In the active disease period hyperemic DPFV (61.7+/-14.9 versus 56.8+/-16.7, P = 0.015) values decreased significantly. Therefore, in the active disease period CFR significantly decreased from 2.57+/-0.50 to 2.09+/-0.46, P<0.001. The only independent predictor of CFR within the active disease period was the disease duration (beta = -0.384, P = 0.012). CONCLUSION: Within the active disease period, coronary microvascular function is more prominently impaired in BD patients. Therefore, BD patients are possibly more vulnerable to cardiovascular manifestations when they are in an active disease period.     

Efeito de informações por meio de vídeo sobre a ansiedade e satisfação de pacientes submetidos à anestesia espinhal

Background

Providing sufficient information during a preanesthetic interview may help improve patient understanding and decrease anxiety related to spinal anesthesia. We investigated the effect of video‐based education on anxiety and satisfaction in patients about to undergo spinal anesthesia.