ABSTRACT
BACKGROUND: In patients with aneurysmal subarachnoid haemorrhage, short-term antifibrinolytic therapy with tranexamic acid has been shown to reduce the risk of rebleeding. However, whether this treatment improves clinical outcome is unclear. We investigated whether ultra-early, short-term treatment with tranexamic acid improves clinical outcome at 6 months. METHODS: In this multicentre prospective, randomised, controlled, open-label trial with masked outcome assessment, adult patients with spontaneous CT-proven subarachnoid haemorrhage in eight treatment centres and 16 referring hospitals in the Netherlands were randomly assigned to treatment with tranexamic acid in addition to care as usual (tranexamic acid group) or care as usual only (control group). Tranexamic acid was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first). The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin Scale, dichotomised into a good (0-3) or poor (4-6) clinical outcome. Both primary and safety analyses were according to intention to treat. This trial is registered at ClinicalTrials.gov, NCT02684812. FINDINGS: Between July 24, 2013, and July 29, 2019, we enrolled 955 patients; 480 patients were randomly assigned to tranexamic acid and 475 patients to the control group. In the intention-to-treat analysis, good clinical outcome was observed in 287 (60%) of 475 patients in the tranexamic acid group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66-1·12). Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the tranexamic acid and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48-1·04). Other serious adverse events were comparable between groups. INTERPRETATION: In patients with CT-proven subarachnoid haemorrhage, presumably caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale. FUNDING: Fonds NutsOhra.
Subject(s)
Antifibrinolytic Agents/administration & dosage , Subarachnoid Hemorrhage/drug therapy , Tranexamic Acid/administration & dosage , Aged , Female , Humans , Male , Middle Aged , Netherlands , Prospective Studies , Subarachnoid Hemorrhage/mortality , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: In 10-20% of patients with subacute-onset idiopathic inflammatory myopathy (IIM), muscle biopsy is normal or shows nonspecific findings. MRI can be used as a triage test before muscle biopsy and as an add-on test if the biopsy is nondiagnostic. METHODS: MRI scans of skeletal muscles and muscle biopsies were evaluated prospectively in 48 patients suspected to have IIM. The interpretations of MRI and muscle biopsy were compared with the definite diagnosis (based on European Neuromuscular Centre criteria and response to corticosteroids). RESULTS: The false negative rate (FNR) of all muscle biopsies was 0.23. Biopsies of a muscle showing hyperintensity on MRI (as triage test) had an FNR of 0.19. The result of MRI as an add-on test in patients with a nondiagnostic muscle biopsy decreased the FNR from 0.23 to 0.06. CONCLUSIONS: We recommend both MRI and muscle biopsy in patients suspected of having IIM.
Subject(s)
Biopsy/methods , Magnetic Resonance Imaging/methods , Muscle, Skeletal/pathology , Myositis/diagnosis , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myositis/epidemiology , Myositis/physiopathology , Predictive Value of Tests , Retrospective Studies , Sensitivity and Specificity , Thigh/physiology , Upper Extremity/pathologyABSTRACT
The aim of this work is to evaluate disease-related mortality and the course of the disease including functional outcome and quality of life. We did a follow-up study on a large prospective cohort of 62 patients with subacute-onset idiopathic inflammatory myopathy (IIM) (dermatomyositis (n = 24), nonspecific myositis (n = 34), necrotizing autoimmune myopathy (n = 4)) after treatment with corticosteroids only (randomized controlled trial comparing daily high-dosage prednisone with pulse therapy of dexamethasone). Development of connective tissue disease (CTD) or malignancy, disease course and mortality, functional outcome and quality of life were evaluated. After a mean follow-up of 3 years (SD 1.5), 22 % had developed a CTD and 17 % a malignancy. Disease-related mortality was 15 %. A monophasic disease course was found in 27 %. Most patients had a chronic (35 %) or polyphasic disease (35 %) course and experienced single or multiple relapses. Sixteen patients (33 %) were off medication after a mean of 1 year of treatment. Disability scores improved particularly in the first 18 months. At follow-up, 68 % still perceived disabilities. Quality of life scores as measured by the short-form (SF)-36 improved in the first 18 months. After 18 months, scores remained stable during the next years of follow-up and remained low compared to a normal population. (1) Two-thirds of the patients with an IIM have a polyphasic or chronic disease course and need maintenance treatment. (2) The impact on functional outcome and quality of life is considerable and does not improve further after 18 months.
