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Biomedical subjects

I Caruso

Publications and source records attributed to I Caruso.

At least 37 records · Page 2Linked to original sources

Sulglycotide in the prevention of nonsteroidal anti-inflammatory drug-induced gastroduodenal mucosal injury. A controlled double-blind, double-dummy, randomized endoscopic study versus placebo in rheumatic patients.

The aim of this double-blind, randomized placebo-controlled trial was to evaluate whether sulglycotide prevents the onset of gastroduodenal mucosal injury in patients with rheumatic disease treated with nonsteroidal anti-inflammatory drugs (NSAIDs). One hundred patients, free from endoscopically detectable lesions of the gastroduodenal mucosa, affected either by rheumatoid arthritis or osteoarthritis, and candidates for NSAID therapy, were randomly allocated either to 200 mg sulglycotide three times daily (n = 50) or to an indistinguishable placebo (n = 50) for 4 weeks, together with standard NSAID administration (50 mg diclofenac three times daily (n = 50); 50 mg indomethacin three times daily (n = 50)). Upper gastrointestinal endoscopy was repeated at the end of the study. It was possible to evaluate 86 patients after treatment (sulglycotide = 42, placebo = 44); diclofenac = 45, indomethacin = 41). Six of 42 patients (14%) in the sulglycotide group and 15 of 44 (34%) in the placebo group had developed gastric or duodenal ulcerative lesions (p = 0.02). These data suggest that sulglycotide prophylaxis may be useful for the prevention of gastric and duodenal ulcer associated with NSAID therapy in rheumatic patients.

Adolescent↗

Multiple intra-articular treatment of rheumatoid arthritis: a randomized prospective study comparing rifamycin SV with pefloxacin.

In a randomized, prospective study the efficacy and tolerability of extensive multiple intra-articular administrations of two antibiotics, rifamycin SV and pefloxacin, were evaluated in 40 patients with classical or definite rheumatoid arthritis. Total weekly doses of 525 mg rifamycin or 560 mg pefloxacin were given for 10 weeks, and 12 months after treatment all clinical indices, erythrocyte sedimentation rate and C-reactive protein improved significantly in the rifamycin group. Some of the treatment indices (morning stiffness, severity of pain by visual analogue scale, grip strength and Ritchie's index) were already improved when the treatment ended, whereas others (erythrocyte sedimentation rate, C-reactive protein, number of painful and swollen joints) improved progressively during the follow-up. In the pefloxacin treatment group all indices except C-reactive protein and severity of pain determined using a visual analogue scale were significantly improved 12 months after treatment. Comparison of the two treatments showed a significant difference in erythrocyte sedimentation rate (P less than 0.047), Ritchie's index (P less than 0.036) and C-reactive protein (P less than 0.028) in favour of rifamycin.

Aged↗

Prevention of appearance of radiological lesions in early rheumatoid arthritis: a randomized, single-blind study comparing intra-articular rifamycin with auranofin.

In a prospective, randomized, single-blind study of 116 patients with early rheumatoid arthritis (mean disease duration 7 months), therapeutic activity of intra-articular rifamycin SV (525 mg/week) infiltration into each peripheral joint over 10 weeks was compared with that of 3 mg auranofin given orally twice daily. The incidence of side-effects was lower in rifamycin-treated patients. At the end of follow-up, the clinical variables and erythrocyte sedimentation rate showed a significant and persistent improvement both in 16 patients who continued the auranofin treatment regularly and in 55 treated with rifamycin who had completed the therapeutic cycle 62.5 months before; the latex test decreased only in the rifamycin group. In patients treated with auranofin or who changed to other commonly used antirheumatic agents, 57% of those with an initially negative radiological picture developed new radiological lesions in at least one of the small joints compared with 9% in the rifamycin group. Although the number of patients treated with rifamycin was small and the follow-up relatively short, the results of the study indicated that treatment with intra-articular rifamycin SV may prevent the appearance of radiological lesions in patients with early rheumatoid arthritis and normal radiographs initially.

Administration, Oral↗

Clinical improvement in ankylosing spondylitis with rifamycin SV infiltrations of peripheral joints.

In an open study, a new treatment modality was evaluated in 22 patients with active ankylosing spondylitis and compared with oral treatment. Patients were given a 10-week course of rifamycin SV infiltrations to all large peripheral joints, whether or not affected, and were followed for up to 12 months after the end of treatment. Clinical improvements observed at the end of the 10-week treatment cycle persisted for 12 months: morning stiffness (P less than 0.02); subjective pain (P less than 0.0001); Schober's test (P less than 0.006); hand-ground distance (P less than 0.001); erythrocyte sedimentation rate (P less than 0.001); and C-reactive protein (P less than 0.04). The number of painful joints became significantly lower at 6 (P less than 0.01) and 12 months (P less than 0.02) of the follow-up period. Oral administration of rifampin at three times the intra-articular dosage was devoid of any therapeutic activity. It is not known how treatment of peripheral joints influenced the inflammatory process at the level of the axial skeleton. These results must be considered preliminary due to the small number of patients and the short follow-up period, and because it was an open study.

Administration, Oral↗

Primary fibromyalgia syndrome and 5-hydroxy-L-tryptophan: a 90-day open study.

The efficacy and tolerability of 5-hydroxy-L-tryptophan (5-HTP) were studied in an open 90-day study in 50 patients affected by primary fibromyalgia syndrome. When all the clinical variables studied throughout the trial (number of tender points, anxiety, pain intensity, quality of sleep, fatigue) were compared with baseline results, they all showed a significant improvement (P less than 0.001). The overall evaluation of the patient condition assessed by the patient and the investigator indicated a 'good' or 'fair' clinical improvement in nearly 50% of the patients during the treatment period. A total of 15 (30%) patients reported side-effects but only one patient was withdrawn from the treatment for this reason. No abnormality in the laboratory evaluation was observed. It is concluded that 5-HTP is effective in improving the symptoms of primary fibromyalgia syndrome and that it maintains its efficacy throughout the 90-day period of treatment.

5-Hydroxytryptophan↗

A double-blind gastroscopic evaluation of the effects of etodolac and naproxen on the gastrointestinal mucosa of rheumatic patients.

The aim of this clinical, endoscopical study was to evaluate the therapeutic efficacy and the gastric tolerability of etodolac, a new anti-inflammatory, non-steroidal drug, compared with naproxen. The study was conducted on 48 patients suffering from rheumatoid arthritis. 44 of whom completed the trial. After an initial oesophagogastroduodenoscopy to exclude the presence of gastric mucosal lesions, patients were randomly allocated to double-blind treatment with either etodolac 200 mg b.i.d. or naproxen 500 mg b.i.d. for a period of 4 weeks. Endoscopic control followed this treatment period. Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosal lesions were observed in 15% of etodolac-treated patients and in 46% of patients treated with naproxen (P less than 0.05) (95% CI 0.01-0.60). Painful dyspepsia was observed in 15% of patients treated with etodolac vs. 38% of patients on naproxen therapy. This study demonstrates that etodolac is at least as active as naproxen in relieving rheumatic symptoms, and its administration results in a significantly lower degree of gastric damage.

Anti-Inflammatory Agents, Non-Steroidal↗

Imidazole salicylate versus piroxicam in the treatment of arthrosis in elderly patients. A double-blind clinical and endoscopic trial.

The clinical efficacy and gastroduodenal tolerability of imidazole salicylate (imidazole 2-hydroxybenzoate, ITF 182), a new synthetic drug with an anti-inflammatory action, was evaluated endoscopically in comparison with those of piroxicam in elderly patients suffering from osteoarthrosis. Of the 41 patients entering the trial, only 38 completed the protocol (6 men and 32 women; mean age, 71; range, 65-80 years). After upper gastrointestinal endoscopy for the purpose of excluding gastric and duodenal mucosal lesions, the patients were allocated at random, according to a double-blind, double-dummy protocol, to treatment either with imidazole salicylate 750 mg three times daily or with piroxicam 20 mg once daily for a period of 4 weeks. Imidazole salicylate proved active in controlling a number of the pain symptoms caused by arthrosis, although its efficacy was inferior to that of piroxicam. Grade 2 gastric mucosal lesions were detected in 1 of 20 patients (5%) treated with imidazole salicylate; lesions corresponding to grades 2, 3, and 4 were found in 6 of 18 (33%) of those treated with piroxicam (P = .034). Painful dyspepsia was reported by 15% of the patients in the imidazole salicylate group and by 28% of those in the piroxicam group. On the basis of these results and under the experimental conditions adopted in this trial, the authors concluded that imidazole salicylate is characterized by good gastric tolerability and can thus be used in the treatment of rheumatic diseases in the elderly.(ABSTRACT TRUNCATED AT 250 WORDS)

Activities of Daily Living↗

Clinical, laboratory and radiographic features in early rheumatoid arthritis.

We evaluated disease status in relation to age, sex and disease duration using some short term indices of disease activity, laboratory tests, and radiological features in 315 patients with rheumatoid arthritis of duration varying from 3 to 36 months (mean 12 months). No differences were observed among various age groups in disease duration, female/male ratio, incidence of radiologic lesions and other indices of disease process. Some clinical markers of the disease process such as involvement of the flexor tendons of the hands and Ritchie's index (score greater than 9) were significantly more frequent in the women (p less than 0.0013 and p less than 0.04, respectively). In the patients with disease of recent onset women were slightly more numerous (56%) than men; however, in those with disease duration of 36 months there were significantly more women (72%) (p less than 0.039), suggesting a greater tendency to chronic disease in this sex. Radiological lesions of the small joints of the hands, feet, and/or wrists were found in 37% of the cases with disease duration of up to 4 months and in 91% at 36 months (p less than 0.0001). The lesions were associated significantly more frequently with Ritchie index (p less than 0.02) and with laboratory indices of inflammatory activity (erythrocyte sedimentation rate greater than or equal to 25 mm/h) (p less than 0.001) and immune response (latex test greater than or equal to 80) (p less than 0.0001). Logistic regression analysis showed that the duration of illness is the most important factor correlating with radiologic lesions.

Adolescent↗

Italian double-blind multicenter study comparing S-adenosylmethionine, naproxen, and placebo in the treatment of degenerative joint disease.

In a double-blind study, the efficacy and tolerability of S-adenosylmethionine (SAMe) were evaluated in comparison with those of placebo and naproxen in the treatment of osteoarthritis of the hip, knee, spine, and hand. Thirty-three centers, 18 rheumatologic and 15 orthopedic, participated in this study. A total of 734 subjects, including 582 with coxarthrosis (hip osteoarthritis) or gonarthrosis (knee osteoarthritis), were enrolled. SAMe administered orally at a dose of 1,200 mg daily was shown to exert the same analgesic activity as naproxen at a dose of 750 mg daily. Both drugs were more effective than placebo (p less than 0.01). Tolerability of SAMe was significantly better than that of naproxen, both in terms of physicians' (p less than 0.025) and patients' (p less than 0.01) judgments and in terms of the number of patients with side effects (p less than 0.05). There was no difference between SAMe and placebo in the number of side effects. Ten patients in the SAMe group and 13 in the placebo group withdrew from the study because of intolerance to the drug.

Anti-Inflammatory Agents, Non-Steroidal↗

[Endoscopic evaluation of the effects of diacerhein and naproxen on the gastroduodenal mucosa].

The potential capacity of diacerheine (DAR), a new drug known to have no anti-prostaglandin effect and therefore a different action mechanism from the standard non-steroid anti-inflammatory drugs, to cause damage to the gastroduodenal mucosa was compared with that of a well-known NSAID, naproxene. Gastroscopic examination of 10 + 10 patients before and 4 weeks after treatment showed that DAR produced endoscopic lesions without subjective symptoms in 10% of the patients whereas naproxene produced lesions of varying size in 50%, with or without symptoms.

Anthraquinones↗

Why are non-steroidal anti-inflammatory drugs important in peptic ulceration?

The pathogenetic role of non-steroidal anti-inflammatory drugs (NSAIDs) in peptic ulcer disease is reviewed, on the basis of available experimental and epidemiological knowledge. In addition, original clinical data are provided concerning the prophylactic and therapeutic role of the H2-receptor antagonists ranitidine and cimetidine, and colloidal bismuth subcitrate, in the treatment of NSAID-associated peptic lesions in rheumatic patients.

Animals↗

Multicenter double-blind randomized clinical trial of imidazole salicylate versus ibuprofen in patients with osteoarthrosis.

Imidazole salicylate (750 mg t.i.d.) was compared with ibuprofen (400 mg t.i.d.) in a 30-day multicenter double-blind clinical trial in patients with osteoarthrosis. Both drugs were effective in relieving joint pain and in reducing the duration of morning stiffness. A statistically significant reduction of the severity of these symptoms was observed already one week after the start of treatment, lasting until the end of the study. No significant differences in efficacy were demonstrated between the two drugs throughout the trial. The systemic tolerability, assessed by changes in tests of hematological, liver and kidney function, was excellent with both treatments. The incidence of side effects (mostly gastrointestinal complaints) was fairly low in both groups, and lower in the group treated with imidazole salicylate.

Adult↗