Global coagulation assays detect an early prothrombotic state in children with acute lymphoblastic leukemia.

Background: Pediatric patients with acute lymphoblastic leukemia (ALL) are at highest risk of venous thromboembolism during the induction therapy (IT). These events are not predictable by conventional coagulation assays.

Objectives: To investigate the utility of global coagulation assays (GCAs) for assessing the hemostatic state in children with ALL during IT.

Exploring grandparents' psychosocial responses to childhood cancer: A qualitative study.

Objective: A childhood cancer diagnosis is a traumatic experience for patients and their families. However, little is known about the effect on grandparents. We aimed to investigate the negative psychosocial impact, coping strategies, and positive outcomes of grandparents of childhood cancer patients in Switzerland.

Decrease in circulating endothelial cell adhesion molecule and thrombomodulin levels during oral iloprost treatment in rheumatoid arthritis patients: preliminary results.

Objective: Rheumatoid arthritis is a chronic inflammatory autoimmune disease with proinflammatory cytokines involved in its pathogenesis. Recently in vitro as well as in vivo studies have shown that iloprost, a stable prostacyclin analogue, can reduce the release of these cytokines. This study was performed to further investigate the anti-inflammatory effects of iloprost by determining plasma adhesion molecules as markers of endothelial cell activation, and plasma thrombomodulin as a parameter of endothelial cell injury in patients with rheumatoid arthritis receiving oral iloprost therapy.

Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis.

Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents.

Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting.

When a DMARD fails, should patients switch to sulfasalazine or add sulfasalazine to continuing leflunomide?

Objective: To evaluate the efficacy and safety of adding sulfasalazine to leflunomide treatment compared with switching to sulfasalazine alone in patients with RA with an inadequate response to leflunomide monotherapy.

Methods: Patients with active RA ((DAS28) >3.2) who were enrolled in the first open label phase of the RELIEF study received leflunomide for 24 weeks.

Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis.

Background: Recent innovations in the pharmaceutical drug discovery environment have generated new chemical entities with the potential to become disease modifying drugs for osteoarthritis (DMOAD's). Regulatory agencies acknowledge that such compounds may be granted a DMOAD indication, providing they demonstrate that they can slow down disease progression; progression would be calibrated by a surrogate for structural change, by measuring joint space narrowing (JSN) on plain X-rays with the caveat that this delayed JSN translate into a clinical benefit for the patient. Recently, new technology has been developed to detect a structural change of the OA joint earlier than conventional X-rays.

The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis.

Background: Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.

Methods: To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years.

Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain.

In this paper we propose guidelines for clinical trials aimed at assessing the efficacy of drugs for acute non-specific low back pain (LBP) with or without radicular pain, preliminary to their approval and registration. To this end, consensus statements were obtained from a group of experts in the fields of rheumatology, clinical medicine, public health and epidemiology. EBM resources were systematically used as references.

Efficacy and safety of leflunomide and predisposing factors for treatment response in patients with active rheumatoid arthritis: RELIEF 6-month data.

Objective: The RELIEF investigation was a 48-week, multicenter, international study comprising 2 phases. Results from the first phase, a 24-week open-label cohort study that evaluated the safety and efficacy of leflunomide, as well as predisposing factors to treatment response, are reported here.

Methods: Patients received leflunomide 100 mg once daily for 3 days, followed by 20 mg once daily thereafter.

Ankylosing spondylitis in the pharaohs of ancient Egypt.

Background: Among the pharaohs of the 18th and 19th dynasty of Old Egypt, at least three had ankylosing spondylitis: Amenhotep (Amenophis) II, Ramses II ("The Great"), and his son Merenptah.

Objective: An illustrated review is given on the radiological indications for their disease, together with the rough history of these pharaohs, the history of their tombs, of the detection of their mummies in the 19th century and of their paleopathological investigation.

Patient and physician satisfaction with aceclofenac: results of the European Observational Cohort Study (experience with aceclofenac for inflammatory pain in daily practice). Aceclofenac is the treatment of choice for patients and physicians in the management of inflammatory pain.

A pan-European study involving 23407 patients with pain due to various inflammatory or degenerative rheumatic diseases was undertaken in Austria, Belgium, Germany and Greece, to evaluate overall pain relief and satisfaction with aceclofenac therapy. Aceclofenac was considered by patients to be a highly efficacious treatment with excellent and fast analgesic activity that was maintained throughout the study period. At the conclusion of the study, assessment of patient status, a parameter encompassing both efficacy against inflammatory pain and tolerability, by both patient and physician, was either much improved or improved in 84% of cases.

A 7-day oral treatment of patients with active rheumatoid arthritis using the prostacyclin analog iloprost: cytokine modulation, safety, and clinical effects.

Objective: The purpose of this study was to investigate the plasma levels of tumor necrosis factor (TNF)-alpha, its soluble p55 and p75 receptors, ex vivo lipopolysaccharide (LPS)-stimulated TNF-alpha production, and plasma levels of interleukin 6, interleukin 1, and interleukin 10 during a 7-day oral administration of iloprost in patients with active rheumatoid arthritis.

Methods: During oral 7-day administration of the prostacyclin analog iloprost, the plasma levels of TNF-alpha, soluble p55, and p75 TNF-alpha receptors, IL-1, IL-6, and IL-10 and C-reactive protein (CRP) in serum were determined on days -1, 1, 3, 4, 6, and 8 and after a treatment-free follow-up on day 15. In addition, the ex vivo TNF-alpha production in whole blood under LPS-stimulated and -unstimulated conditions were measured.

A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis.

Objective: To compare the clinical efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis (RA).

Methods: In this multicentre, double-blind trial, 999 subjects with active RA were randomized to leflunomide (n = 501; loading dose 100 mg/day for 3 days, maintenance dose 20 mg/day) or methotrexate (n = 498; 10-15 mg/week) for 52 weeks. After 1 yr the subjects could choose to stay for a second year of double-blind treatment.

Inhibition of interleukin-8 synthesis by intraarticular methotrexate therapy in patients with rheumatoid arthritis.

5 Patients with definite RA and knee effusions under constant doses of DMARD therapy were treated with up to 6 intraarticular injections of 10 mg methotrexate (MTX) every 3 to 7 days. A matched randomized control group who received a single i.a.

Efficacy and safety of meloxicam in patients with rheumatoid arthritis.

Objective: To evaluate the efficacy and safety of meloxicam, a new acidic enolic nonsteroidal anti-inflammatory drug, at doses of 7.5 and 15 mg once daily in patients with rheumatoid arthritis (RA).

Methods: Meloxicam 15 and 7.

Immunoprinting: various genes are associated with increased risk to develop rheumatoid arthritis in different groups of adult patients.

To identify genes that contribute to the manifestation of rheumatoid arthritis we performed association studies via microsatellite analyses of immunorelevant loci (HLA-DRB, 5 T cell receptor loci, TNFa IL1, IL2, IL5R and CD40L). A total of 183 patients and 275 healthy controls were typed in terms of HLA and grouped according to the known predisposing HLA-DRB1 genes (DRB1*04; relative risk approx. 5; DRB1*01, relative risk approx.