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Efficacy of Vitamin K2 for Glucocorticoid-induced Osteoporosis in Patients with Systemic Autoimmune Diseases.
Shikano, K, Kaneko, K, Kawazoe, M, Kaburaki, M, Hasunuma, T, Kawai, S
Internal medicine (Tokyo, Japan). 2016;(15):1997-2003
Abstract
Objective Vitamin K2 (menatetrenone) is an effective treatment for patients with postmenopausal osteoporosis. We herein performed a subanalysis of patients with systemic autoimmune diseases undergoing glucocorticoid therapy in our previous prospective study. Methods Sixty patients were categorized into a group with vitamin K2 treatment (n=20, Group A) and a group without vitamin K2 treatment (n=40, Group B). All patients were treated with bisphosphonates. Results Serum levels of osteocalcin and undercarboxylated osteocalcin decreased significantly after the start of glucocorticoid therapy in both groups, while the serum osteocalcin level was significantly higher in Group A than Group B during the third (p=0.0250) and fourth weeks (p=0.0155). The serum level of the N-terminal peptide of type I procollagen, a bone formation marker, decreased during glucocorticoid therapy, but was significantly higher in Group A than Group B during the fourth week (p=0.0400). The bone mineral density and fracture rate showed no significant differences between the two groups. Conclusion Although vitamin K2 improves bone turnover markers in patients with osteoporosis on glucocorticoid therapy, it has no significant effect on the bone mineral density and fracture rate after 1.5 years of treatment.
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2.
Pharmacokinetics of enteric-coated mycophenolate sodium: comparative study in patients with autoimmune disease and renal allograft.
Neumann, I, Fuhrmann, H, Kanzler, M, Fang, IF, Jaeger, A, Graf, H, Bayer, P, Kovarik, J
Expert opinion on pharmacotherapy. 2008;(6):879-86
Abstract
BACKGROUND Recently, mycophenolic acid drugs have gained interest in the treatment of autoimmune diseases. However, only limited pharmacokinetic data are available on enteric-coated mycophenolate sodium in non-transplant indications. OBJECTIVE This study compared the pharmacokinetics of mycophenolic acid from enteric-coated mycophenolate sodium in patients with autoimmune disease and renal transplant recipients. METHODS Twelve autoimmune disease patients (mainly with antineutrophil cytoplasmic antibody-associated vasculitis) and 11 stable renal transplant patients, all of whom had been on enteric-coated mycophenolate sodium for > or = 10 weeks, received an oral dose of enteric-coated mycophenolate sodium of 720 mg under fasting conditions. Blood samples for the determination of mycophenolic acid in the plasma were collected over 24 h. RESULTS Overall, no significant difference was found between both groups for their 0 - 12 h and 0 - 24 h areas under the concentration-time curve, C(max), T(max), C(0 h), C(12 h) and C(24 h), although the mean C(max) was numerically higher by 39% in the autoimmune disease patients (autoimmune disease 27.3 +/- 17.4 mg/l and renal transplant 19.6 +/- 15.7 mg/l). Patients on concomitant ciclosporin tended to have a lower mycophenolic acid exposure than patients on a non-ciclosporin regimen. The intersubject variabilities in the mycophenolic acid pharmacokinetics were high in both patient populations (around 40% for the area under the curve values). Both groups exhibited a weak and non-significant correlation between their mycophenolic acid trough (C(12 h)) levels and mycophenolic acid 0 - 12 h area under the curve (autoimmune disease r = 0.482 and renal transplant r = 0.138), whereas in the autoimmune disease group the mean C(1.5 h) and C(2 h) concentrations provided a satisfactory association with the 0 - 12 h area under the curve (for both r > 0.7 and p < 0.001). CONCLUSION These data suggest that mycophenolic acid exposure (in terms of the area under the curve) from enteric-coated mycophenolate sodium is comparable in autoimmune disease and renal transplant patients. The mycophenolic acid trough levels did not reflect the systemic exposure to mycophenolic acid adequately; a limited sampling strategy for estimating mycophenolic acid exposure in autoimmune disease patients should include times around C(1.5 h) and/or C(2 h) reflecting T(max) if further studies confirm its usefulness.
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3.
Treatment of refractory blistering autoimmune diseases with mycophenolic acid.
Marzano, AV, Dassoni, F, Caputo, R
The Journal of dermatological treatment. 2006;(6):370-6
Abstract
BACKGROUND Immunosuppressive drugs are used as steroid-sparing agents in the management of blistering autoimmune diseases. Mycophenolic acid (MPA) is a relatively new adjuvant drug that selectively inhibits T and B lymphocyte proliferation by suppressing de novo purine synthesis. OBJECTIVE To evaluate the efficacy of MPA in refractory blistering autoimmune diseases and the safety profile of a recent formulation, enteric-coated mycophenolate sodium (EC-MPS), in comparison with mycophenolate mofetil (MMF). PATIENTS AND METHODS Twelve patients with various bullous dermatoses (three pemphigus vulgaris, one pemphigus herpetiformis, three bullous pemphigoid (BP), two cicatricial pemphigoid (CP) and three epidermolysis bullosa acquisita (EBA)) were enrolled in the study. In 10 cases, MPA was administered in combination with systemic corticosteroids, while in two patients with severe diabetes mellitus MPA was employed as monotherapy. The total time on MPA varied from 2 to 8 months. Four patients were given MMF (2,000 mg daily), seven received EC-MPS (1,440 mg daily) and one received both sequentially. RESULTS Complete remission, lasting for a mean time of 6.1 months, was achieved in 10 patients. Partial remission was obtained in two patients with disseminated CP and EBA. Both MMF and EC-MPS were well tolerated, but the latter was better in terms of gastrointestinal adverse effects. CONCLUSIONS MPA may be proposed as a first-line adjuvant agent for pemphigus as well as for refractory BP and CP. MPA monotherapy has to be considered in selected cases of BP and pemphigus. The highly promising results obtained in EBA suggest a future key role for MPA in the management of this disease.
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Restoration of immune-mediated sensorineural hearing loss with sodium enoxaparin: a case report.
Mora, R, Mora, F, Passali, FM, Cordone, MP, Crippa, B, Barbieri, M
Acta oto-laryngologica. Supplementum. 2004;(552):25-8
Abstract
The aim of the study was to assess the efficacy of sodium enoxaparin in the treatment of autoimmune sensorineural hearing loss. A small number of patients with unilateral sensorineural hearing loss were selected and divided randomly into two numerically equal groups (groups A and B) if they fulfilled the inclusion criteria, i.e. being between 20 and 65 years of age, had been affected by systemic lupus erythematosus, had presented with a hearing loss of at least 30 dB of audibility threshold involving the medium frequencies (2000-4000 Hz), and had provided informed consent. Group A received sodium enoxaparin while group B (control) received placebo. In group A, all patients except one showed an improvement in hearing after sodium enoxaparin treatment. In group B, no patients showed an improvement in auditory function. In conclusion, our results underline the important role of sodium enoxaparin in the therapeutic management of this disease. The low number of patients suggests that further studies are required to confirm this initial data but this study suggests that sodium enoxaparin provides encouraging results in the treatment of autoimmune sensorineural hearing loss.
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Normal renal function 8 to 13 years after cyclosporin A therapy in 285 diabetic patients.
Assan, R, Blanchet, F, Feutren, G, Timsit, J, Larger, E, Boitard, C, Amiel, C, Bach, JF
Diabetes/metabolism research and reviews. 2002;(6):464-72
Abstract
BACKGROUND Cyclosporin A (CyA) may induce acute nephrotoxicity. The question has been raised of the possible long-term unfavorable course of CyA-induced lesions. Advantage was taken of a large cohort of diabetic patients treated for several months using moderate CyA dosage to evaluate the long-term evolution of renal function in such patients. METHODS Two hundred and eighty five recently diagnosed type 1 diabetic patients having received CyA for a mean of 19.9 months were monitored for 13 years, in parallel with 100 similar patients treated with insulin alone. RESULTS In the CyA-treated group, a transient increase in creatininemia levels occurred during the first 18 months of treatment associated with a transient increase in renal vascular resistance. Both effects disappeared later on: creatininemia levels then remained normal. Inulin and p-aminohippurate (PAH) clearances remained normal throughout follow-up. Neither permanent renal failure nor progressive deterioration of renal function occurred in either group or in individual patients. A 10 to 12% increase in inulin and PAH clearance was elicited by IV amino acid infusion at 7 to 10 years, a finding consistent with a normal renal functional reserve. Patients with moderate kidney lesions on biopsy at 1 year had normal and stable clearance values at 7 to 13 years. The prevalence of arterial hypertension and retinopathy was lower in the CyA-treated group than in the control group, possibly because of the tighter metabolic control obtained in the CyA group. CONCLUSION These results suggest that low-dose CyA treatment combined with thorough monitoring does not result in long-term renal dysfunction.
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Transplantation osteoporosis and corticosteroid-induced osteoporosis in autoimmune diseases: experience with alfacalcidol.
Dequeker, J, Borghs, H, Van Cleemput, J, Nevens, F, Verleden, G, Nijs, J
Zeitschrift fur Rheumatologie. 2000;:53-7
Abstract
The effect of alfacalcidol therapy on bone mineral density at the spine and proximal femur was evaluated in 112 transplant recipients (59 heart, 26 liver and 27 lung); 45 transplant cases served as controls (included in a randomised way in a placebo group) and in 42 rheumatoid arthritis cases. Liver and lung transplantation cases had before transplantation a lower bone density at the spine and femur compared to heart transplant cases. Heart transplant cases lost considerably more bone immediately after transplantation than liver and lung transplant recipients. A positive effect of 2 years alfacalcidol treatment (0.5-1 microgram/day) on bone loss was observed in all treated groups. Alfacalcidol was particularly effective against trabecular bone loss at the spine in rheumatoid arthritis patients and transplant recipients. There is a manifest difference in evolution between organ transplant groups and bone sites measured. Liver and lung transplant recipients respond better to therapy than cardiac recipients.
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Infection-triggered anorexia nervosa in children: clinical description of four cases.
Sokol, MS
Journal of child and adolescent psychopharmacology. 2000;(2):133-45
Abstract
BACKGROUND Anorexia nervosa (AN) is a serious illness with no definitive treatment. Clinical and research evidence led to the hypothesis that some children with AN may have a pediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS), similar in pathogenesis to other hypothesized PANDAS disorders. METHODS Four youngsters (ages, 11-15 years) with PANDAS AN were treated with an open trial of antibiotics, in addition to conventional treatment. They were evaluated for eating disorder and obsessive-compulsive symptoms, and for weight gain. Evidence of streptococcal infection came from clinical evaluation, throat cultures, and two serological tests: anti-deoxyribonuclease B (anti-DNase B) and anti-streptolysin O (ASO) titers. The "rheumatic" marker D8/17 was also measured. This B-cell alloantigen is associated, in several publications, with poststreptococcal autoimmunity: Rheumatic fever (RF), Sydenham's chorea (SC), and possibly PANDAS obsessive compulsive disorder (OCD) and tic disorders. RESULTS There was clinical evidence of possible antecedent streptococcal infection in all four patients, two of whom had comorbid OCD, with possible infection-triggered AN. All four had the rheumatic marker: A percentage of D8/17-positive B cells of 28-38%, with a mean of 33% (12% or more is considered positive for the marker). The patients responded to conventional treatment plus antibiotics with weight restoration and decreased eating disorder and obsessive-compulsive symptoms. Three needed to gain weight and did so. CONCLUSIONS There may be a link between infectious disease and some cases of AN, which raises the possibility of new treatment.