NF-kappaB promotes cell survival against external stress such as radiation. We examined whether NF-kappaB decoy transfection enhances the antiproliferative effects of radiation on vascular smooth muscle cells (VSMCs) in vitro. The irradiation induced activation or nuclear translocation of NF-kappaB p65 in VSMCs was confirmed by immunofluorescence. NF-kappaB decoy transfection resulted in inhibition of the radiation-induced NF-kappaB activation in VSMCs and the subsequent reduction of transcription and translocation of ICAM, iNOS, and TNF-alpha, downstream molecules under the control of NF-kappaB. By using MTT assay, NF-kappaB decoy augmented the antiproliferative effects of radiation, where the effect of low dose radiation (2 and 8-Gy) of the cells transfected with NF-kappaB decoy was equivalent to the high dose (16-Gy) irradiated non-transfected cells at 48 h after irradiation: 1.06+/-0.16, 1.11+/-0.22, 1.20+/-0.25, respectively. The decrease in proliferation and survival of the radiation treated cells by flow cytometry analysis showed that NF-kappaB inhibition did not show any additive effects on the cell cycle of the irradiated VSMCs, while apoptosis was significantly increased after NF-kappaB decoy transfection in the irradiated VSMCs (apoptosis fraction: 13.33+/-2.08% vs. 26.29+/-7.43%, for radiation only vs. radiation+NF-kappaB decoy transfection, P < 0.05). In addition, at 48 h, NF-kappaB decoy transfection dose dependently (10 microM vs. 20 microM) inhibited proliferation of 16Gy-irradiated VSMCs, and showed greater antiproliferative efficacy than 100 microM sulfasalazine, a specific NF-kappaB inhibitor. These results indicate that NF-kappaB inhibition reduces proliferation and survival of irradiated VSMCs, likely by increased apoptosis rather than additive cell cycle arrest and suggest the possibility of adjunctive gene therapy using NF-kappaB decoy to improve efficacy and to decrease the adverse effects of intracoronary radiation therapy.
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The newer 5-ASA preparations were intended to avoid the adverse effects of SASP while maintaining its therapeutic benefits. The efficacy and safety of 5-ASA preparations have been evaluated in numerous clinical trials that have often lacked sufficient statistical power to arrive at definitive conclusions. Previously, it was found that newer 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP in inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the effectiveness, dose-responsiveness, and safety of 5-ASA preparations in terms of more precise outcome measures.
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Articles were selected on the basis of study quality and their significance with regard to treatment of inflammatory bowel disease.
In this Medi-Cal population, with its racial diversity and relatively homogenous socioeconomic status and health care benefits, racial/ethnic differences were found in RA patients receiving biologic DMARDs.
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Olsalazine is a compound consisting of two 5-amino salicylate (5-ASA) molecules linked by an azo bond, which, administered orally, is split by colonic bacteria to liberate 5-ASA. It lacks the sulfapyridine moiety found in sulfasalazine. Using a specific protocol, we conducted a randomized, double-blind, placebo-controlled trial of olsalazine in patients with symptomatic ulcerative colitis. Inclusion criteria included mild to moderate disease with involvement of more than 15 cm of colon, visible blood in stools, and the discontinuation of all other medications prior to and during the study. Patients were given oral olsalazine 3.0 g/day or placebo for 4 wk. Patients were evaluated clinically, by laboratory analysis and by colonoscopic evaluation, at entry and at 4 wk. Additional clinical and laboratory evaluations were performed at 2 wk. Fifteen patients entered the study. Of the seven patients randomized to olsalazine, four (57%) improved clinically and by colonoscopic scoring, one showed no improvement in either, and two (29%) withdrew after developing severe watery diarrhea. Of the eight patients treated with placebo, two (25%) improved clinically but were without colonscopic improvement and six (75%) worsened, of whom four withdrew early because of worsening symptoms of colitis. Seven of eight placebo patients were then treated with olsalazine on an open basis. Of these seven, five (71%) improved clinically and colonoscopically and two (29%) withdrew because of severe watery diarrhea. Overall, of 14 patients treated with Olsalazine, nine (64%) improved, one showed no improvement, and four (29%) discontinued because of persistent watery diarrhea. No other serious side effects were noted. Minor side effects included transient diarrhea, flares of acne, and anxiety attacks which resolved despite continuation of the drug.
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5-Aminosalicylate (mesalazine; 5-AS) represents a new therapeutic strategy in chronic inflammatory bowel disease. The drug (active metabolite of sulfasalazine) has proven its clinical efficacy and safety in numerous controlled studies in adults. However only limited data are available for the pediatric population. This brief review summarises the published spares information on this promising agent. As pharmacokinetic properties of 5-AS are age-independent and since 5-AS has a wide margin of safety clinical studies and use of this drug should be encouraged also in children.
358 patients with rheumatoid arthritis in a double blind trial were randomly allocated to receive either leflunomide 20 mg/day, placebo, or sulfasalazine 2 g/day. Those completing six months of treatment (n=230) were given the option to continue in 12 (n=168) and 24 (n=146) month double blinded extensions; the placebo group switched to sulfasalazine. This report compares efficacy and safety of leflunomide with sulfasalazine in the 6, 12, and 24 month patient cohorts.
All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing oral cyclophosphamide against placebo (or an active drug at a dosage considered to be ineffective) in patients with rheumatoid arthritis.
Ulcerative colitis and Crohn's disease are chronic inflammatory bowel diseases. The most widely prescribed drug for treatment of these diseases, sulfasalazine, has been shown to inhibit the activity of free radicals, as the active moiety of sulfasalazine, 5-aminosalicylic acid, is a radical scavenger. This effect of 5-aminosalicylic acid may be of clinical relevance, as a recent study has shown that 5-aminosalicylic acid reacts with oxygen-derived free radicals formed in the intestine in this disease. Reaction with free radicals does not, however, occur in patients with rheumatoid arthritis treated with the same agent. Furthermore, a significant correlation exists between the activity in the intestine of free radicals, as measured by the rate of lipid peroxidation, and the disease activity.
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Six hundred nineteen SNSA patients (264 AS, 221 PsA, and 134 ReA) were studied. One hundred eighty-seven of these patients had only axial manifestations of their disease, while 432 patients had peripheral articular manifestations. Of the patients with axial disease, 40.2% of the SSZ group and 43.3% of the placebo group met the predefined response criteria (P = 0.67). Of the peripheral articular group, 59.0% of the SSZ-treated patients and 42.7% of the placebo-treated patients showed a response (P = 0.0007).
We compared the effects of intramuscular gold and sulphasalazine on early, active rheumatoid arthritis in 128 consecutive patients. Intramuscular gold was started in the first 70 consecutive patients and sulphasalazine in the subsequent 58 patients. The patient groups were comparable with regard to clinical characteristics. In both groups clinical and laboratory parameters improved, but there was no significant difference between the two groups. The clinical improvement was most pronounced during the first three months. However, despite the clinical improvement a clear progression in radiological changes was observed in both groups, 40% of the patients taking gold and 48% of patients taking sulphasalazine discontinued the treatment because of adverse drug reactions or inefficacy during the one year follow-up. Adverse drug reactions were the main reason in both groups. These findings suggest that intramuscular gold and sulphasalazine seem to have an equal, positive effect on symptoms and clinical variables, but that radiological progression does occur in most patients none the less.
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SP appears to be the active moiety in AS, although there was a trend suggesting a better outcome in the SSZ group compared with the SP group, perhaps suggesting the importance of a common sulfonamide structure for efficacy.
A 28-year-old woman was admitted to our hospital with complaints of mucosanguinous stool and low grade fever. She was diagnosed as a typical chronic continuous type of ulcerative colitis by the findings of barium enema and colonoscopy. Since she had an allergy to sulfasalazine, prednisolone was chosen. She became pregnant during an active stage while being treated with 20 mg of prednisolone a day. Prednisolone was withdrawn to avoid the side-effects of the medicine on the fetal outcome. This resulted in her symptoms becoming far worse and the oral ingestion being discontinued. Total parenteral nutrition (TPN) was required under careful nutritional management. The TPN consisted of glucose, electrolytes, amino acids, vitamins, trace elements and intravenous lipid preparation. Her total energy intake was 2320 kcal a day. Vitamins were administered to her on the bases of the guideline of the American medical association. Rapid turnover proteins, transferrin, vitamins, trace elements and amino acids in addition to routine laboratory tests were measured to estimate her nutritional condition. The data showed that biotin was 10 times lower than the expected value and that other factors were within normal limits. This is the first case in Japan where a woman suffering from an active ulcerative colitis was treated with TPN and delivered of a healthy baby. We concluded that TPN under careful control was useful in the nutritional management and therapy of the pregnant patient who suffered from severe colitis. We believe that the amount of biotin's supplementation should be increased in this type of case because it was 10 times lower than the normal value, although the deficiency symptoms did not develop.
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Nineteen patients (17 females, 2 males) with the mean age of 54.5±7.7 years, with mean disease duration of 141.8±58 months were treated for an average period of 2.9±1.9 years. All the patients were treated with low-dose methotrexate (MTX) up to 15 mg/week alone or with combination of hydroxychloroquine and/or sulfasalazine and 5 mg prednisolone daily. At the end of study period, the value of FN-BMD gr/cm2 decreased by - 4.24% (p=0.12) and LS-BMD gr/cm2 by - 6.57% (p=0.009). The mean FN BMD Z-score increased by +7.66% (p=0.64) and LS-BMD Z-score decreased by - 14.7% (p=0.120).
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The efficacy of 5-aminosalicylic acids (5-ASAs) in ulcerative colitis (UC) has been studied previously in meta-analyses. However, several randomized controlled trials (RCTs) have been published recently, and no previous meta-analysis has studied the effect of 5-ASA dosage used.
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A quarter of the irritable bowel syndrome controls were seropositive for H. pylori. Of the ulcerative colitis patients, 21.6% were currently H. pylori-positive on C13 UBT; 17.6% of the ulcerative colitis patients who had been previously treated with sulphasalazine were positive while 23.1% of the ulcerative colitis patients who had been treated with a non-sulphasalazine 5-ASA drug were positive. Of the Crohn's patients, 11.9% were currently H. pylori-positive; 3.6% of the Crohn's patients who had been previously treated with sulphasalazine were positive while 12.5% of the Crohn's patients who had been treated with a non-sulphasalazine 5-ASA drug were positive.
Drug use during pregnancy is sometimes unavoidable, especially in chronic inflammatory diseases such as rheumatoid arthritis (RA). The use of disease-modifying antirheumatic drugs (DMARDs) often starts in the early stage of RA; therefore, women of reproductive age are at risk for exposure to a DMARD at time of conception as well as during pregnancy. The aim of this paper was to review recent literature about DMARDs used for rheumatic diseases in pregnancy and to describe the type of study designs and results reported.Twenty-nine studies; eight on hydroxychloroquine/chloroquine, thirteen on methotrexate, three on sulfasalazine and six on azathioprine were identified. With respect to hydroxychloroquine, most studies concluded that it could be safely used in systemic lupus erythematosus or RA. The same conclusions were drawn from the azathioprine studies, but the available evidence is scarce. Although the evidence regarding the safety of methotrexate during pregnancy is conflicting, a high rate of pregnancy losses indicates a risk to the fetus. For each individual case it must be decided whether the benefits outweigh the potential risks. No major teratogenic effects of sulfasalazine were seen although teratogenic effects still can not be excluded. For all other DMARDs, the information on their use in pregnancy was limited. This review underscores the gross absence of data on safety and risks of DMARD use during conception and pregnancy. While young women use these drugs in pregnancy, this review stresses the importance of good monitoring and further research.
In the scope of the ECCDS, established to test the efficacy of prednisolone and/or sulfasalazine in Crohn's disease, the relationships of blood chemistry and CDAI to histology of rectal mucosa were studied in 115 patients by means of univariate and multivariate statistical analyses. Laboratory and histologic markers of inflammation tend to be correlated. But these correlations are definitively weak. Thus, the predictive value of histology for blood chemistry or CDAI is very low. Laboratory indices and CDAI are relatively inaccurate means of assessing disease severity at tissue level and vice versa.
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A 21-year-old schizophrenic man developed ulcerative colitis. Because he might have needed steroids, we reviewed the literature on the use of steroids in patients with psychiatric disorders. The pathogenesis of psychiatric symptoms during steroid therapy is unknown. Development of psychiatric complications in patients receiving steroids is probably dose-dependent. The type of psychiatric manifestations is variable, ranging from affective through schizophreniform syndromes. It is unclear whether a history of psychiatric disorders increases the risk for psychiatric problems from steroids. In the majority of patients psychiatric complications remit when the dose of steroids is reduced or discontinued, or when appropriate pharmacotherapy and psychotherapy are administered. Preliminary studies suggest that lithium may prevent development of steroid psychosis.
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The effects of sulfasalazine and its moieties on NF-kappaB signaling were evaluated using electromobility shift, transfection, and immune complex kinase assays. The direct effect of sulfasalazine on IkappaB kinase (IKK) activity was investigated using purified recombinant IKK-alpha and -beta proteins.
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Sinus problems are decreased in patients with RA compared to OA and FM. Slight protective effects on sinus problems are noted with sulfasalazine and leflunomide, and a slight increase in risk of sinus problems is noted with etanercept.
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Both dogs were treated with prednisolone; this was combined with ciclosporin in case 1 and azathioprine in case 2. Case 2 had a more complete response of lesions to treatment and a longer survival time after diagnosis (763 days) than case 1 (81 days).
Nine of the 10 patients had ulcerative colitis poorly controlled on sulfasalazine and prednisolone. Two had associated thromboembolic disease, and one was on no medication. Patients were started on heparin in hospital, taught to self-inject subcutaneously, and discharged to continue on 10,000 U of unfractionated heparin twice daily. Current doses of sulfasalazine were maintained; prednisolone was tapered and stopped. Patients were carefully monitored for adverse side-effects. Sections of colonic mucosa from nine patients were examined for intravascular thrombosis of the mucosal blood vessels.