Interferon-alpha combined with ketoprofen as treatment of naïve patients with chronic hepatitis C: a randomized controlled trial.

In this randomized controlled study, we evaluated the efficacy and safety of interferon-alpha combined with ketoprofen to that of interferon-alpha alone in naïve patients with chronic hepatitis C. Forty patients were randomized to receive Interferon-alpha2a (3 million units three times a week) and ketoprofen (150 mg twice a day) and 40 to receive only interferon-alpha2a at the same dose. Patients were treated for 6 months and followed up for 6 months. Response was defined by undetectable HCV-RNA in serum at the end-of-treatment and after 6 months from the completion of therapy (long term response). At the end of treatment the response was similar in the two group. However, combination treatment showed significantly higher efficacy than monotherapy in achieving long term response (10%vs 32.5%; P = 0.014). Overall adverse events were similar in the two groups. 'Flu-like syndrome was significantly less common in the ketoprofen plus interferon group which experienced a significantly higher incidence of epigastric pain'. Our results indicate that the combination of ketoprofen plus interferon is significantly more effective than interferon alone in the treatment of naïve patients with chronic hepatitis C and is well tolerated. However this combined treatment appears to be less effective than the association of pegylated IFN and ribavirin which represent the current standard treatment. Thus, the role of ketoprofen in the treatment of chronic hepatitis C needs to be further evaluated against such a treatment.

[Use of thermomagnetic bandages and belts in cervical and lumbar pain syndromes. Experimental study with double blind method versus placebo]. / Impiego di fasce e cinture termomagnetiche nelle sindromi dolorose cervicali e lombari. Studio sperimentale con il metodo della doppia cecità vs. placebo.

OBJECTIVE: To assess the antalgic activity of thermomagnetic bandages and belts in cervical and lumbar pain syndrome (respectively CPS and LPS), compared with non-magnetic devices (placebo). PATIENTS AND METHODS: It was a double-blind study on two groups of 30 patients suffering from chronic back pain (15 cervical and 15 lumbar in each group). Patients had to stop any previous analgesic or antiinflammatory drug treatment at least 8 days prior to entering the study. Each subject included in the study had to wear the bandage/belt for 8 hours a day for 14 consecutive days. Before the start, every subject underwent an initial assessment of his/her current pain level and functional status through the use of two visual analogue scales (pain and functional status) and one verbal scale (pain). After the end of the study, a final assessment was made using the same tools. RESULTS: 93 and 97% (respectively in the CPS and LPS group) were the percentages of patients in the actively-treated arm who showed an improvement both in pain level and in functional status. This improvement was statistically significant vs. the correspondent placebo-treated groups (respectively, 20 and 23% in the CPS and in the LPS). No adverse events associated to treatment were signalled. CONCLUSIONS: The use of thermomagnetic bandages and belts (which are, virtually in all cases, free of contraindications) allows us a more rational and easy management of the patient suffering from chronic back pain.

Effects of cyclosporin on joint damage in rheumatoid arthritis. The Italian Rheumatologists Study Group on Rheumatoid Arthritis.

According to the most recent literature, few antirheumatic drugs can claim disease-controlling properties over the anatomical joint damage in rheumatoid arthritis (RA). A small number of studies have favored one or another of the available agents, in particular parenteral gold salts, sulphasalazine and methotrexate, but the evidence regarding their efficacy is not convincing when analysed using methodological criteria known to be important in evaluating radiologic evidence of joint damage. The radiologic results in long-standing RA patients have shown that CsA may be of benefit in reducing disease progression. Data from the second year of a clinical trial designed to compare the disease-controlling, anti-rheumatic properties of CsA with those of conventional disease-modifying anti-rheumatic drugs (DMARDs) in early RA support the hypothesis that CsA may be useful in delaying the appearance of new joint erosion.

Polyarticular pigmented villonodular synovitis associated with multiple congenital anomalies. A case of Noonan-like/multiple giant cell lesion syndrome.

A case of polyarticular pigmented villonodular synovitis associated with many congenital phenotypic peculiarities (such as shortness, blue sclerae, flattened nose, low-set ears, hypertelorism, curly hair and pulmonary stenosis) is described. The presence of many of the typical signs of the Noonan syndrome and the histological finding of giant cells on the synovial biopsy led to the diagnosis of Noonan-like/multiple giant cell lesion syndrome.

[Clinical experience with the use of piroxicam in fast-dissolving sublingual capsules in acute recurrent osteoarthritis]. / Esperienza clinica sull'impiego del piroxicam compresse sublinguali a rapida dissoluzione nell'osteoartrosi riacutizzata.

Open, non comparative study to evaluate the efficacy and safety of piroxicam Fast Dissolving Dosage Form (FDDF) for sublingual administration in treatment of reacutized osteoarthritis. Fifty-four patients with flare-ups of osteoarthritis involving various joints were enrolled in the study. They were treated with 20 mg/die piroxicam sublingual tablets for a total of 4 weeks. Drug efficacy was evaluated on the basis of the variation of spontaneous pain, pain on passive motion, functional limitation and capacity of performing a specific activity. Intensity of spontaneous pain on the first day showed a statistically significant improvement (p < 0.0001) only 15 minutes after the drug administration. This improvement in pain intensity increased until day 3. All other efficacy parameters showed a statistically significant improvement (p < 0.0001) 7 days after the beginning of treatment. Local and systemic tolerability was good. No patient showed local side effects; only 6 patients experienced systemic side effects. In conclusion, piroxicam sublingual tablets for treatment of osteoarthritis flare-ups showed analgesic efficacy already 15 minutes after drug administration, and good anti-inflammatory efficacy with good local and systemic tolerability.

Expression of CD69 antigen on synovial fluid T cells in patients with rheumatoid arthritis and other chronic synovitis.

OBJECTIVES: The expression of the CD69 antigen on synovial fluid and peripheral blood lymphocytes was studied in 12 patients with rheumatoid arthritis (RA), five subjects with other forms of chronic synovitis, and on the peripheral blood lymphocytes of 15 patients with systemic lupus erythematosus (SLE) and immune vasculitis. METHODS: The CD69 antigen and other activation markers (HLA-DR, interleukin 2 receptor (IL-2R), transferrin receptor) were measured by cytometric analysis. In patients with RA soluble IL-2R was determined by enzyme linked immunosorbent assay (ELISA). RESULTS: The percentage of T cells bearing CD69 was significantly increased in synovial fluid from patients with RA (30.3 (13)%) and other chronic synovitis (18 (9)%). The expression of CD69 on peripheral blood lymphocytes of patients with RA, other chronic synovitis, and SLE and immune vasculitis was within the normal range 2.1 (1.2)%. According to previously published work, a high proportion of synovial fluid T cells are HLA-DR positive (64.2 (12.4)% in synovial fluid from patients with RA and 61 (1.2)% in synovial fluid from patients with other chronic synovitis). Transferrin receptor expression on synovial fluid was up-regulated compared with that on peripheral blood. The increase of IL-2R expression on synovial fluid lymphocytes v peripheral blood was not significant; the quantitative determination of soluble IL-2R levels gave a mean value of 921 (351) U/ml in synovial fluid of patients with RA, 672 (229) U/ml in the serum of the same patients, and 273 (100) U/ml in serum from normal subjects. CONCLUSIONS: Synovial fluid lymphocytes are in a different functional state than peripheral blood lymphocytes. CD69 antigen is an interesting cellular marker which should be studied in patients with chronic synovitis. The unusual expression of the activation antigens and the sequence of their appearance require further study.

Meta-analysis of three double-blind comparative trials with sustained-release etodolac in the treatment of osteoarthritis of the knee.

A meta-analysis was done with the final data from three trials that provided the first results relating to efficacy and safety of the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis (OA) of the knee. The studies were 4-week, double-blind, randomized, parallel-group comparisons of etodolac SR 600 mg (119 patients) against diclofenac SR 100 mg (54 patients), tenoxicam 20 mg (46 patients), or piroxicam 20 mg (18 patients). The primary efficacy parameters (assessed after 2 and 4 weeks of treatment) were physicians' and patients' overall assessments of patients' condition, night pain, and pain intensity. All patients had radiographic and clinical evidence of OA of the knee. For the meta-analysis, the data from the individual etodolac SR studies were pooled and compared with the pooled data for diclofenac SR, tenoxicam, and piroxicam. The homogeneity of the treatments across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance, including "study," "treatment," and "center within treatment" effects and their interaction. The analysis for the efficacy parameters was based on the final assessment during therapy (last visit). At baseline, the two treatment groups were comparable. Improvement rates were high in both groups (range, 68-81%), indicating that treatments were effective for most patients. No significant treatment difference was observed for the patients' overall assessment, night pain, or pain intensity. Both etodolac SR and the reference preparations were well tolerated. No clinically significant changes were noted in the laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)

Meta-analysis of two double-blind comparative studies with the sustained-release form of etodolac in rheumatoid arthritis.

A meta-analysis was done with the data from two studies that provided the first efficacy and safety results for the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs in patients with rheumatoid arthritis (RA). The studies were 4-week, double-blind, multicenter, randomized, parallel-group comparisons of etodolac SR 600 mg (102 patients) with either diclofenac SR 100 mg (65 patients) or piroxicam 20 mg (35 patients). The data for etodolac SR were pooled and compared with the pooled data for the comparators. The primary efficacy assessments (weeks 2 and 4) were physician and patient overall evaluation of the patient's condition, number of painful/tender joints, and number of swollen joints. Patients met at least five of the American Rheumatism Association diagnostic criteria and were within Steinbrocker progression stage I, II, or III and functional class I, II, or III. The homogeneity of the treatment groups across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance including "study," "treatment," and "center within treatment" factors and their interaction. The efficacy analysis was based on the final assessment during therapy (last visit). The patients in the etodolac SR group were older than those in the comparators group (P = 0.032), and there were more patients over 65 years of age in the etodolac SR group than in the comparators group (31% versus 14%, respectively; P = 0.004).(ABSTRACT TRUNCATED AT 250 WORDS)

Prevalence and clinical associations of anticardiolipin antibodies in systemic lupus erythematosus: a prospective study.

The main objectives of the present study were to determine the prevalence of IgG and IgM anticardiolipin antibody (aCL) isotypes in systemic lupus erythematosus (SLE) in order to analyze their possible association with the clinical manifestations of the disease. Clinical features of 64 consecutive and unselected SLE patients were prospectively studied. Sera from the same patients taken during each clinical manifestation were tested for the presence of aCL. The prevalence of aCL was 43.75% for the IgG isotype and 9.4% for the IgM isotype. A strong linkage between the presence of these antibodies and the occurrence of both thrombosis and abortions was found: a weaker association with neurological events and thrombocytopenia was also demonstrated. The titre of aCL appeared to be linked with the probability of having the clinical manifestations associated with these autoantibodies. Our results suggest that thrombosis and abortion, and possibly thrombocytopenia and central nervous system involvement, may be associated with the presence of aCL at the time when these clinical events develop in SLE patients.

HLA antigens in Italian patients with systemic lupus erythematosus: evidence for the association of DQw2 with the autoantibody response to extractable nuclear antigens.

In order to verify the hypothesis that Italian patients with systemic lupus erythematosus (SLE) may be immunogenetically distinct from SLE patients born in other regions, we investigated the HLA class I and II antigens and their relation with the various autoantibodies characteristic of the disease in an Italian SLE population. Forty-four SLE patients were typed for HLA-A, -B, -C, -DR and -DQ antigens; sera from the same patients were tested for the presence of antibodies to the nuclear or cytoplasmic antigens Ro/SSA, La/SSB, Sm and RNP (ENA). Results of HLA typing showed that the frequencies of DR3 and DQw2 were increased in patients compared with controls. Analysis of the correlations between HLA antigens and anti-ENA antibodies showed that both DQw2 and DR3 were increased in patients with anti-Ro and/or antiLa antibodies, while in patients with anti-Sm and/or antiRNP antibodies the DQw2 and DR4 were found to be increased. Only DQw2 was found to be significantly increased in anti-ENA positive patients. These results might suggest that Italian patients with SLE are, at least in part, different from lupus patients living in other geographical areas and suggest the association of DQw2 with the autoantibody response to ENA in SLE.

Immune imbalance in the synovial fluid of rheumatoid arthritis patients: effects of intra-articular injection of thymopentin.

T cell subsets in the synovial fluid (SF) and peripheral blood (PB) of RA patients and controls suffering from different forms of chronic synovitis have been investigated. The immunological evaluation showed a reduction of CD4 subsets in RA-SF compared to RA-PB (p less than 0.001), and an almost complete absence of the suppressor-inducer/naive T cells in RA-SF compared to RA-PB and SF from patients with other forms of chronic synovitis. The CD8 subpopulation showed an increased proportion of cytotoxic cells only in RA-SF. On the basis of these results, an intra-articular immunomodulating treatment with thymopentin has been performed: its effects were characterized by an increase of CD8+CD11b+ T cells in the CD8 subset parallel to the enhancement of the suppressor-inducer/naive T cells in the CD4 subset with a statistically significant correlation. The enhanced levels of soluble CD8 decreased after treatment in RA-SF, whereas the soluble IL-2R levels were not significantly modified. Clinical evaluation showed a significative amelioration in all considered parameters.

[Clinical manifestations correlated with anticardiolipin antibodies in systemic lupus erythematosus: preliminary results of a prospective study]. / Manifestazioni cliniche correlate agli anticorpi anticardiolipina nel lupus eritematoso sistemico: risultati preliminari di uno studio prospettico.

Antiphospholipid antibodies (aPL) have been linked to various clinical manifestations in systemic lupus erythematosus (SLE), mainly thrombosis, repeated abortions and thrombocytopenia. Despite the large number of studies which have been published in the recent years, there is still some debate on this matter, and no firm conclusion has been reached as yet. Among the various aPL, anticardiolipin antibodies (aCL) have received more attention, mostly because they can be easily detected by means of immunoenzymatic assays. The main objective of the present study was to determine the prevalence of IgG and IgM aCL isotypes in SLE in order to compare their possible association with the clinical manifestations of the disease. Clinical features of 40 consecutive and unselected SLE patients (35 female and 5 male) were prospectively studied. Sera from the same patients were tested for the presence of aCL, using a standardised ELISA assay, and the presence of aCL was correlated with the various clinical events. Results showed that the prevalence of aCL was 42.5% for the IgG isotype and 10% for the IgM isotype. Regarding the clinical associations of aCL, we found a strong linkage between the presence of these antibodies and the occurrence of both thrombosis and abortions; a weaker association with neurological events was also demonstrated. These results, if confirmed on larger series, suggest that aCL should be searched in patients with SLE in order to identify those who are at greater risk of developing some severe clinical problems and could benefit by prophylactic treatment.