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Selected AbstractsMesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitisINFLAMMATORY BOWEL DISEASES, Issue 3 2001Dr. Per G. Farup Abstract Background High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. Methods Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index; UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than ,1 UC-DAI score unit. Results Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. Conclusion Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing. [source] Effect of ipriflavone on pain due to recent osteoporotic vertebral crush fractureINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 1 2002Mohammad M. Rahman Abstract Aim:,Ipriflavone conserves bone mass in postmenopausal osteoporosis. Salmon calcitonin and alendronate, two other anti-resorptive drugs, have been found to have analgesic effects in osteoporotic acute vertebral fracture. This study aimed to determine if ipriflavone also possesses such an effect. Methods:,Thirty-two women with recent osteoporotic vertebral fractures were randomly assigned to ipriflavone treatment or placebo groups. Ipriflavone was given at the dose of 200 mg three times a day. Non-steroidal anti-inflammatory drugs were given ad libitum in both groups. Calcium carbonate (1 g daily) was administered to all subjects. Intensity of pain at rest, on movement and on pressure, pain rating on a 10-point visual analogue scale, degree of mobility impairment, and supplementary analgesic were assessed at the end of a 3-month period in both groups to assess the analgesic effect of ipriflavone. Results:,Fourteen subjects in the ipriflavone group and 12 in the placebo group completed the trial. After 3 months, all pain variables had decreased significantly in both groups. Intensity of pain at rest and on pressure and supplementary analgesic use were significantly lower in the ipriflavone group compared to the placebo group. Conclusion:,The study shows that ipriflavone has an analgesic adjuvant effect in acute osteoporotic vertebral fracture. [source] Effects Of a One-Month Treatment With PTH(1,34) on Bone Formation on Cancellous, Endocortical, and Periosteal Surfaces of the Human Ilium,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 4 2007Robert Lindsay MD Abstract Using bone histomorphometry, we found that a 1-month treatment with PTH(1,34) [hPTH(1,34)] stimulated new bone formation on cancellous, endocortical, and periosteal bone surfaces. Enhanced bone formation was associated with an increase in osteoblast apoptosis. Introduction: The precise mechanisms by which hPTH(1,34) increases bone mass and improves bone structure are unclear. Using bone histomorphometry, we studied the early effects of treating postmenopausal women with osteoporosis with hPTH(1,34). Materials and Methods: Tetracycline-labeled iliac crest bone biopsies were obtained from 27 postmenopausal women with osteoporosis who were treated for 1 month with hPTH(1,34), 50 ,g daily subcutaneously. The results were compared with tetracycline-labeled biopsies from a representative control group of 13 postmenopausal women with osteoporosis. Results: The bone formation rate on the cancellous and endocortical surfaces was higher in hPTH(1,34),treated women than in control women by factors of 4.5 and 5.0, respectively. We also showed a 4-fold increase in bone formation rate on the periosteal surface, suggesting that hPTH(1,34) has the potential to increase bone diameter in humans. On the cancellous and endocortical surfaces, the increased bone formation rate was primarily caused by stimulation of formation in ongoing remodeling units, with a modest amount of increased formation on previously quiescent surfaces. hPTH(1,34),stimulated bone formation was associated with an increase in osteoblast apoptosis, which may reflect enhanced turnover of the osteoblast population and may contribute to the anabolic action of hPTH(1,34). Conclusions: These findings provide new insight into the cellular basis by which hPTH(1,34) improves cancellous and cortical bone architecture and geometry in patients with osteoporosis. [source] Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthmaALLERGY, Issue 7 2010N. Scichilone To cite this article: Scichilone N, Battaglia S, Sorino C, Paglino G, Martino L, Paterṇ A, Santagata R, Spatafora M, Nicolini G, Bellia V. Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma. Allergy 2010; 65: 897,902. Abstract Background:, Airway inflammation in asthma involves both large and small airways, and the combination of inhaled corticosteroids (ICS) and long acting beta-2 agonists (LABA) is the mainstay of therapy. Available inhaled combinations differ in terms of drug delivery to the lung and the ability to reach small airways. Aim:, To evaluate whether treatment with an extra-fine inhaled combination provides additional effects vs a nonextra-fine combination on airway function. Methods:, After a 1- to 4-week run-in period, patients with asthma were randomized to a double blind, double dummy, 12-week treatment with either extra-fine beclomethasone/formoterol (BDP/F) 400/24 ,g daily or fluticasone propionate/salmeterol (FP/S) 500/100 ,g daily. Methacholine (Mch) bronchoprovocation challenge and single breath nitrogen (sbN2) test were performed. Results:, Thirty patients with asthma (15 men), mean age 43, mean forced expiratory volume in the first second (FEV1) 71.4% of predicted, were included. A significant increase (P < 0.01) versus baseline was observed in predose FEV1 in both BDP/F and FP/S groups (0.37 ± 0.13 l and 0.36 ± 0.12 l, respectively). PD20FEV1 Mch improved significantly from 90.42 (±30.08) ,g to 432.41 (±122.71) ,g in the BDP/F group (P = 0.01) but not in the FP/S group. A trend toward improvement vs baseline was observed for BDP/F in closing capacity (CC), whereas no differences were recorded in other sbN2 test parameters. Conclusion:, The findings of this pilot study suggest that an extra-fine inhaled combination for the treatment of asthma has beneficial effects on both large and small airways function as expressed by Mch and sbN2 tests. [source] The estimated benefits of vitamin D for GermanyMOLECULAR NUTRITION & FOOD RESEARCH (FORMERLY NAHRUNG/FOOD), Issue 8 2010A. Zittermann Abstract This article gives an overview of the vitamin D status in Germany, provides evidence for an independent association of vitamin D deficiency with various chronic diseases, and discusses preventive measures for improving vitamin D status in Germany. The prevalence of vitamin D insufficiency is 40,45% in the general German population. An additional 15,30% are vitamin D deficient. Vitamin D can prevent falls and osteoporotic fractures in older people. There is also accumulating evidence that vitamin D may prevent excess mortality and may probably prevent some chronic diseases that occur in early life such as type 1 diabetes and multiple sclerosis. Adherence to present sun safety policy (avoidance of the sun between 11 am and 3 pm) and dietary recommendations (5,10,,g daily for adults) would, however, definitively lead to vitamin D deficiency. The estimated cost saving effect of improving vitamin D status in Germany might be up to 37.5 billion , annually. It should be the goal of nutrition and medical societies to erase vitamin D deficiency in Germany within the next 5,10 years. To achieve this goal, the daily production of at least 25,,g of vitamin D in the skin or an equivalent oral intake should be guaranteed. [source] PC-SPES, a dietary supplement for the treatment of hormone-refractory prostate cancerBJU INTERNATIONAL, Issue 4 2000B.L. Pfeifer Objective To assess the effectiveness of PC-SPES, a dietary supplement containing eight herbal extracts, which is a popular alternative therapy among patients with hormone-refractory prostate cancer; anecdotal reports claim that this agent provides relief of metastatic pain, improvements in quality of life and reduction of prostatic specific antigen (PSA) level. Patients and methods Sixteen men treated for advanced metastatic prostate cancer (stage D3) with either orchidectomy or a luteinizing-hormone releasing hormone agonist, with or without anti-androgen, were enrolled into a prospective clinical trial to evaluate the possible toxic and beneficial effects of PC-SPES. After hormone-ablative therapy had failed, and with established disease progression, all patients received supplemental treatment with PC-SPES (2.88 g daily) for 5 months. Hormonal therapy was continued throughout the trial to avoid the known withdrawal effect of anti-androgen on PSA levels. Results The supplemental intake of PC-SPES was associated with significant (P < 0.05,0.01) improvements in quality-of-life measures, reductions in patient's pain ratings (P < 0.05,0.01), and a decline in PSA levels (P < 0.01), with no major side-effects. Conclusions These results support the anecdotal reports of the beneficial effects of PC-SPES as a comparable alternative to current management regimens in hormone-refractory prostate cancer. However, no conclusions can be drawn about the long-term effects of this new herbal therapy. [source] Successful treatment of subacute cutaneous lupus erythematosus with mycophenolate mofetilBRITISH JOURNAL OF DERMATOLOGY, Issue 1 2002S. Schanz Summary Mycophenolate mofetil (MMF) is an immunosuppressive agent that has been shown to be effective in transplant patients. Some case reports and pilot studies have suggested efficacy against systemic lupus erythematosus (LE), particularly in the case of lupus nephritis. Reports on MMF treatment of skin manifestations of LE are still anecdotal. We report two cases with extensive skin lesions owing to subacute cutaneous LE (SCLE). Both patients had been treated with azathioprine and antimalarials without effect. Finally both patients were given highly dosed glucocorticosteroids, which were also ineffective but led to vertebral fractures because of long-term steroid treatment in one patient and steroid-induced psychosis in the other. MMF 2 g daily caused the skin manifestations to disappear within a few weeks in both patients. One patient was followed up for more than 24 months, and showed good toleration of MMF treatment. The skin remained stable over this period when at least 1 g MMF per day was administered. In conclusion, MMF appears to be an attractive treatment option in skin manifestations of SCLE, and seems to be beneficial for patients with steroid-refractory lesions that are also resistant to treatment with immunosuppressants or antimalarials. The observations suggest that further evaluation of this route in randomized controlled trials is warranted. [source] Cutaneous larva migrans: clinical features and management of 44 cases presenting in the returning travellerBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2001V. Blackwell Background Cutaneous larva migrans (CLM) is the result of a nematode infection, and shows a characteristic creeping eruption. As travel to the tropics increases, many British citizens may be returning with this infection, which is often misdiagnosed or treated incorrectly. Objectives To perform a retrospective survey of 44 cases of CLM presenting to the Hospital for Tropical Diseases in London over the last 2 years. Methods Cases were reviewed with regard to patient characteristics, source of infection, source of referral, clinical features and therapy. Results Most infections were acquired in Africa (32%), the Caribbean (30%) and South-east Asia (25%), but also in Central and South America. There was a history of exposure to a beach in 95% of patients and the median duration of symptoms was 8 weeks (range 1,104). Lesions mainly affected the feet (39%), buttocks (18%) and abdomen (16%), but the lower leg, arm and face were also affected. Multiple lesions were seen in seven of 44 cases (16%). Laboratory abnormalities were absent in all patients. Of 44 patients seen, four needed no treatment, 28 were cured by a single course of treatment, 11 required a second course of therapy and one patient was treated three times. Thirty-one patients received oral albendazole 400 mg daily for 3,5 days and 24 were cured (77%). Five patients received 10% thiabendazole cream topically for 10 days and four were cured (80%). Four patients received oral thiabendazole 1·5 g daily for 3 days and all required further therapy. Conclusions In view of the range of treatment regimens recorded, a randomized controlled trial comparing topical and systemic therapies is warranted. [source] A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infectionsCLINICAL MICROBIOLOGY AND INFECTION, Issue 8 2010S. Towfigh Clin Microbiol Infect 2010; 16: 1274,1281 Abstract Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI). The present study comprised a multicentre, open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or CTX (2 g once daily) plus MET (1,2 g daily), for 4,14 days. The primary endpoint was the clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with CTX/MET (95% CI ,13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores ,10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The microbiologic response was similar between the two treatment arms, with microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated subjects and 71.5% (98/137) of CTX/MET-treated subjects. ( The most frequently reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and comparator-treated subjects, respectively. The results obtaned in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI. [source] Monitoring of vancomycin serum levels for the treatment of staphylococcal infectionsCLINICAL MICROBIOLOGY AND INFECTION, Issue 1 2006M. D. Kitzis Abstract Vancomycin serum concentrations were determined for 1737 patients treated with either 2 × 1 g of vancomycin or 4 × 500 mg daily (780 patients), according to current nomograms, or by continuous infusion (957 patients) with a loading dose (1 g) and a total of 2,6 g daily. Trough serum concentrations were determined after 36,48 h. Adequate serum levels for the treatment of a normal methicillin-resistant Staphylococcus aureus (MRSA) and a glycopeptide-intermediate S. aureus (GISA) were observed in 81% and 20.9% of patients, respectively. The data support theoretical arguments that higher and more sustained serum levels of vancomycin, obtained by continuous infusion, may enhance clinical efficacy. [source] | ||||||||||