[Quality of life and associated clinical distress in fibromyalgia]. / Fibromialgia: qualità di vita e sindromi associate.

OBJECTIVES: Fibromyalgia (FM) is a syndrome characterized by chronic, diffuse musculoskeletal pain and by a low pain threshold at specific anatomical points (tender points). Numerous other conditions (Irritable bowel syndrome, tension-type headache, migraine headaches, etc.) may overlap with FM. Aim of this study was to evaluate the quality of life and associated clinical distress in patients with FM. METHODS: 53 females affected by primary fibromyalgia and 40 healthy females were examined were examined by an experienced rheumatologist and interviewed using the Fibromyalgia Impact Questionnaire (FIQ). Clinical monitoring included Visual Analogue Scale for pain and pain pressure threshold measurements. RESULTS: Mean FIQ scores were 66.39+/-14.94 in FM patients and 13.15+/-5.37 in control subjects and the difference was statistically significant. Among associated clinical distress higher frequencies have been found for paraesthesia (87%), sleep disturbance (72%), tension type headache (70%), oto-vestibule syndrome (72%) and irritable colon (60%). An R.O.C. bend was developed in the presence of paraesthesias and oto-vestibule syndromes at the same time. This allowed us to identify a FIQ cut off value of 66.85 so FM patients were divided into 2 groups according to their FIQ scores: severe degree and mild or slight degree. CONCLUSIONS: Based on our data, it would appear possible to use a FIQ value equal to or higher than 66.85 for the clinical picture of FM to be classified as severe.

Tolerability of tiaprofenic acid in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked genetic disorder which can lead to acute haemolytic anaemia following ingestion of fava beans and the administration of certain drugs, mainly in subjects with bacterial or viral infections. It is common in the Mediterranean region and many variants are found in Sardinia. The aim of this study was to evaluate in vivo if treatment with tiaprofenic acid 600 mg daily for 15 days would reduce erythrocyte GSH (reduced glutathione) concentrations and thus produce erythrocytolysis (assessed by evaluation of 51Cr-labelled erythrocyte survival) in subjects with G6PD deficiency. GSH concentrations were also evaluated in vitro after incubation of G6PD-deficient erythrocytes with increasing doses of tiaprofenic acid (20, 50, 100, 150 and 200 mg/L) and with acetylphenylhydrazine 5 mg. The results obtained both in vitro and in vivo confirmed the absence of any oxidative action of tiaprofenic acid on the erythrocytes of G6PD-deficient subjects.

Double-blind comparison of glucametacin and ketoprofen in chronic arthropathies.

A new, non-steroidal anti-inflammatory agent, glucametacin, was compared with ketoprofen in a double-blind, crossover trial. The drugs were given in total daily doses of 420 mg glucametacin and 300 mg ketoprofen for 20 days to 30 patients with chronic arthropathies of an inflammatory or degenerative nature. Both drugs were well tolerated and resulted in significant improvements in a number of criteria of disease assessment. Although there were no significant differences between results seen with the two drugs, there appeared to be trends in favour of glucametacin in respect to both efficacy and tolerance.

Development of arthritis and hypothyroidism during alpha-interferon therapy for chronic hepatitis C.

Alpha-interferon (alpha-IFN) therapy may induce, reveal or exacerbate various autoimmune-related disorders. The most common is the development of autoantibodies, while clinically overt autoimmune diseases are rare. We describe a 49-year-old woman who developed seronegative rheumatoid-like arthritis and autoimmune hypothyroidism after 7 months of human lymphoblastoid alpha-IFN therapy given for hepatitis C virus-related chronic active hepatitis (CAH-HCV). There was no family or personal history of autoimmune, thyroid or articular diseases. Our patient required continuous therapy for arthritis and hypothyroidism despite discontinuation of alpha-IFN. This suggests that alpha-IFN therapy may induce the contemporary appearance of two different persistent autoimmune-related diseases in the same patient. However, chronic HCV infection may play an important adjuvant role in the development of these diseases.

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.

Quality of life assessment during six months of NSAID treatment [Gonarthrosis and Quality of Life (GOAL) Study].

OBJECTIVE: To identify the time point of the greatest degree of improvement in daily living activities, pain and depression in patients with osteoarthritis (OA) of the knee during 6 months of treatment with NSAIDs, in order to define compliance and drop-out rate. METHODS: 107 patients were recruited into a multicentre, prospective, randomized, controlled trial comparing two treatments, piroxicam-beta-cyclodextrin (PBCD) and slow release diclofenac (DCL). RESULTS: The greatest improvement in quality of life occurred in both groups after 3 months, with a slight further gain observed by the end of treatment. The Stanford Health Assessment Questionnaire score improved (p < 0.05 vs baseline) at 3 and 6 months with PBCD and at 6 months with DCL. The Arthritis Impact Measurement Scale score improved (p < 0.05 vs baseline) after 6 months in both groups. Significant (p < 0.05 vs baseline) improvement in other psychological and pain scores were recorded in both groups after 3 and 6 months. Compliance with treatment at 3 months was 73% for PBCD and 72% for DCL, and was 60% in both groups at 6 months. CONCLUSIONS: The results of this study indicate that the optimal length of time for an NSAID trial in OA patients is 3 months, when assessment of daily living activities is considered as the main outcome criterion.

A 12-week double-blind study of the efficacy, safety and tolerance of pirazolac b.i.d. compared with indomethacin t.i.d. in patients with ankylosing spondylitis.

A 12-week trial was carried out to compare the efficacy of pirazolac (300-600 mg b.i.d.) with that of indomethacin (25-50 mg t.i.d.) in patients with ankylosing spondylitis. A total of 119 patients completed the treatment period, with 32 drop-outs. Both therapies showed significant improvements in clinical symptoms.

Peripheral red blood cell survival invariance during pefloxacin treatment in subjects with glucose-6-phosphate dehydrogenase deficiency.

In order to evaluate the possible damaging effect of pefloxacin on erythrocytes in subjects with G-6-PD deficiency, a trial on red-cell survival was carried out using a 51Cr-labelled peripheral red blood cell technique. Eight men, aged 52 to 64 years, with osteoarthrosis and G-6-PD deficiency (Mediterranean type) were treated with 800 mg/day pefloxacin. Pefloxacin did not modify red cell survival in the subjects under study. In all subjects erythrocyte GSH levels were investigated in baseline conditions and also after incubation with increasing doses of pefloxacin. No significant change in erythrocyte GSH levels was observed after incubation with therapeutic doses of pefloxacin.

Somatostatin 14 and joint inflammation: evidence for intraarticular efficacy of prolonged administration in rheumatoid arthritis.

Previous studies with intraarticular administration of somatostatin (SST14) in rheumatoid arthritis showed an antiinflammatory and analgesic effect. The aim of the present study was to demonstrate the efficacy and tolerability of SST14 in rheumatoid arthritis (RA) patients for a longer period of treatment than previously scheduled. Forty-one patients with RA of the knee were treated with a cycle of intraarticular injection of 750 micrograms of SST14, every 15 days. The efficacy of SST14 was evaluated by determining acute phase parameters (erythrocyte sedimentation rate, C-reactive protein [CRP]) and by clinical assessment (pain at rest and on movement, joint tenderness, morning stiffness, spontaneous pain). Additionally, telethermography was performed to evaluate the intensity of the joint inflammation. The tolerability of the treatment was also assessed both by patients and physicians. SST14 produced a reduction in all parameters; this was already statistically significant after the second injection in terms of pain at rest and on movement, and after the third injection for all other symptoms. The treatment showed an excellent tolerability, both local and systemic. Our results indicate the analgesic property of SST14 and demonstrate its capacity to reduce progressively joint inflammation confirmed by thermography and by reduction of pain, after a month of therapy.

Double-blind comparison of the efficacy and safety of etodolac SR 600 mg u.i.d. and of tenoxicam 20 mg u.i.d. in elderly patients with osteoarthritis of the hip and of the knee.

Etodolac SR is the sustained-release formulation of etodolac, an effective anti-inflammatory drug used in the treatment of various rheumatic diseases. The efficacy and safety of etodolac SR were compared with those of tenoxicam in 120 elderly patients with radiographic and clinical evidence of active osteoarthritis (OA) of the knee and/or the hip. This was a double-blind, double-dummy, randomized, parallel-group, multicentre study conducted at 4 Italian rheumatic-disease units. Sixty patients received 600 mg of etodolac SR once daily (u.i.d.) for 8 weeks; the remaining 60 patients received 20 mg of tenoxicam u.i.d. Significant improvements in all 6 efficacy parameters (viso-analogic scale of the global pain, pain at active movements, night pain, joint tenderness, joint motility, and Lequesne's algofunctional index) were observed within each of the treatment groups even after the first 2 weeks of therapy. There were no significant differences in the therapeutic response between the two groups for any efficacy parameters. Adverse reactions, mostly regarding the G-I tract, were significantly more frequent in the tenoxicam group than in the etodolac group: 23.3% vs 8.3% respectively, albeit in the majority of the cases they were not considered to be so severe as to cause the interruption of the study. There were no clinically important changes from baseline in laboratory tests performed during the study. Endoscopy of the upper G-I tract was performed both at baseline and after 8 weeks of therapy in 30 patients per treatment group in order to obtain a reliable comparative evaluation of the G-I safety of the two drugs. Both drugs were found to be well tolerated; only 2 ulcers were observed after therapy in both groups, but minor lesions were more frequently detected in the mucosa of the stomach in the patients who received tenoxicam. The cumulative endoscopic index that reflected both the erosive and the haemorrhagic lesions found in the stomach taken as a whole was significantly (p < 0.03) higher after therapy in the tenoxicam group. These results indicate that 600 mg of etodolac SR u.i.d. for 8 weeks is as effective as 20 mg of tenoxicam u.i.d. in the treatment of OA of the knee and/or of the hip. Both the overall and the G-I specific safety profiles were found to be more favourable in patients treated with etodolac SR. Renal function was not substantially affected in either treatment group.(ABSTRACT TRUNCATED AT 250 WORDS)

Safety of flurbiprofen in subjects with G-6-PD deficiency. In vivo and in vitro results.

The safety of flurbiprofen, a new non-steroidal anti-inflammatory drug was tested in individuals with G-6-PD deficiency. The study was carried out in vitro evaluating the erythrocyte levels of reduced glutathione under basal conditions and after incubation with the drug or acetylphenyl-hydrazine. In the red cells marked with 51Cr, survival was evaluated in vivo before and during flurbiprofen administration. The study shows that flurbiprofen has no oxidating activity in carriers of the G-6-PD Mediterranean variant.

Ipriflavone-treatment of senile osteoporosis: results of a multicenter, double-blind clinical trial of 2 years.

Eighty-four out of 100 enrolled female patients affected by osteoporosis completed a double-blind, randomized trial, using ipriflavone (IP) in a dose of 3 x 200 mg/day (41 patients) or placebo (P)(43 patients). All patients received 1 g/day oral calcium supplementation. Inclusion criteria were: age over 65 years; at least one vertebral fracture in the past; bone mineral density measured at the distal tenth of the radius lower than the normal average -2 x S.D. The trial period was between June 1990 and November 1993. Patients of the IP group showed a significant increase in bone mineral density (P < 0.05) compared with the starting values during the whole study period. Pain decreased rapidly, intake of analgesics dropped, and often significant decreases in calciuria, hydroxyprolinuria, alkaline phospatase, osteocalcin and parathormone values were observed. Only two new fractures occurred during the trial in the IP group. Patients of the P group at the end of the study displayed decreased bone mineral densities (P < 0.05), increased pain, greater consumption of analgesics, and often significant increases in the bone metabolism parameters listed for the IP group. In the

Tolmetin and G-6-PD erythrocyte deficiency: research in vitro.

In thirty-two patients, divided into four groups: normal, G-6-PD deficient, beta-thalaxemic heterozygote and carriers of both anomalies, the variations in erythrocyte GSH were studied after incubation with APH and a non-steroidal anti-inflammatory drug: tolmetin sodium. The results obtained show a considerable fall in GSH after incubation with APH above all in the G-6-PD deficient patients and in the carriers of both anomalies. On the other hand, after incubation with the drug under examination there were no significant variations in the erythrocyte GSH.

Indoprofen in rheumatic patients with acute episodes: a multicentre trial.

The results are reported of an open multicentre trial in 228 rheumatic patients with flare-ups. Fourteen centres adopting the same investigational protocol collaborated in the study. Indoprofen was administered for 1 week at a daily dosage of 1000 mg according to a treatment schedule used with success in acute gouty arthritis: a 400 mg i.v. bolus was followed by 200 mg (1 tablet) t.i.d. Subjective (pain) and objective variables were used for reliable assessment of activity. Marked reduction of pain intensity was already noticeable on day 1 of treatment and was followed by progressive improvement in subjective and objective variables for all the diagnoses considered. According to the patients' own overall assessments, results were good or very good in more than 50% of cases. The best outcomes were obtained in low back pain, acute gout and psoriatic arthritis. At the end of treatment only 7.4% of patients experienced no change or deterioration of symptoms. Adverse reactions, consisting mostly of mild and reversible gastrointestinal disturbances, were reported by 9.2% of patients, but only in 1.8% was treatment discontinued. Indoprofen administered according to the above schedule is an appropriate treatment for acute episodes of rheumatic diseases.

[Double-blind cross-over comparison of flurbiprofen and indomethacin in osteoarthritis of the knee and hip]. / Confronto a doppia cecità cross-over tra flurbiprofen e indometacina nelle osteoartrosi del ginocchio e dell'anca.

A randomised double blind cross-over study was conducted in order to compare the therapeutic efficacy and tolerability of flurbiprofen and indomethacin in 16 patients with osteoarthrosis of the knee or hip. 300 mg per diem flurbiprofen and 150 mg per diem indomethacin were given for 14 days. Both treatment were very effective against pain whether spontaneous, under pressure or in movement and against functional limitations, joint mobility and on ESR. Undesirable side effects were noted in 4 flurbiprofen and 5 indomethacin cases.

[Familial Mediterranean fever. Description of a case observed by us]. / La febbre familiare mediterranea. Descrizione di un caso di nostra osservazione.

Familial mediterranean fever (FMF) is an hereditary disorder characterized by attacks of febrile serosal inflammation involving pleura or peritoneum and synovium, followed usually by insidious onset of amyloidosis. In other patients amyloidosis of AA-type is the only finding of the disease. This disorder is common in Jews of Sephardi and Ashkenazi ancestry, Arabs, Armenians and Turks. In this work the clinico-biological features and the therapeutical aspects of a patient, suffering from FMF, of Italian ancestry are presented.

[Collateral effects of 9-alpha-fluor-prednisolone acetate and kanamycin, administered by nasal spray. Clinical experience and experimental data]. / Effetti collaterali da 9-alfa-fluor-prednisolone acetato e kanamicina, somministrati mediante spray nasale. Esperienze cliniche e dati sperimentali.

Iatrogenic pathology due to treatment with steroid drugs used by systemic route is well known. On the contrary iatrogenic pathology due to topical use of these drugs is rarely reported. Two cases of abuse of 9-alpha- fluor-prednisolone and kanamycin administered by endonasal route are reported. The same treatment has been carried out in patients and rabbits. Clinical and bio-humoral data in patients and anatomo-pathological findings in rabbits are reported. The risks, sometimes underestimated, of an overdose of corticosteroid and antibiotic drugs used by endonasal route are pointed out.

Efficacy and tolerability of ketoprofen 200 mg controlled-release cps vs indomethacin 50 mg cps in patients with symptomatic hip osteoarthritis. A multicentre study.

BACKGROUND: An open-label, randomised, multicentre study was carried out to compare the efficacy and tolerability of indomethacin capsules and ketoprofen controlled-release capsules in the symptomatic treatment of coxarthrosis. MATERIALS AND METHODS: 113 out-patients were enrolled: 57 were assigned to receive indomethacin 50 mg twice daily and 56 ketoprofen 200 mg once daily for 4 weeks. RESULTS: Indomethacin and ketoprofen proved equally effective in relieving osteoarticular pain and stiffness and in improving the quality of life of patients. There was essentially no difference as to gastrointestinal adverse events which occurred in 25% of patients on indomethacin and in 27% of those on ketoprofen. Indomethacin caused more non-gastrointestinal untoward effects, especially CNS effects (headache and dizziness: 11%) which were not observed with ketoprofen. Indomethacin was discontinued because of adverse events in a larger proportion of patients (20%) than ketoprofen (11%).

[Safety of lornoxicam in G-6-PDH deficiency]. / Sicurezza terapeutica di lornoxicam in soggetti G-6-PDH carenti.

OBJECTIVE: To assess the safety of lornoxicam in subjects with G-6-PDH deficiency. METHODS: Open controlled 2-week in vivo study on lornoxicam 8 mg bid in subjects with G-6-PDH deficiency suffering from rheumatic diseases. RESULTS: In 8 male patients with the Mediterranean form of G-6-PDH deficiency (mean age +/- SD, 54.3 years +/- 7.2) lornoxicam showed no influence on red blood cells (RBC) survival curve. The RBC half-life was the same before and after two weeks of treatment. CONCLUSIONS: Lornoxicam caused no RBC damage and evidenced favourable safety in subjects with G-6-PDH deficiency, suffering from rheumatic diseases.

[Spinal cord and cauda equina compression in 2 patients with beta-thalassemia intermedia]. / Compression médullaire et de la queue de cheval chez deux patients atteints de béta-thalassémie intermédiaire.

Spinal cord compression as a consequence of mass lesions due to extramedullary hematopoiesis is a well described but rare syndrome occurring in thalassemia and some other hematologic conditions. The authors report two cases of patients with a genetic variant of beta-thalassemia, who suffered from a progressive compression of the spinal cord in one case, of the cauda equina in the other caused by epidural hematopoietic tissue. The first patient recovered after partial surgical removal of this tissue and subsequent radiotherapy. The second one recovered after only radiotherapy.