A two-year study of chondroitin sulfate in erosive osteoarthritis of the hands: behavior of erosions, osteophytes, pain and hand dysfunction.

The aim of this study was to evaluate the effect of 800 mg/die of chondroitin sulfate (CHS) per os plus naproxen versus naproxen over 2 years in patients with erosive osteoarthritis (EOA) of the hands. Joint count for erosions, Heberden and Bouchard nodes, Dreiser's algofunctional index and physicians' and patients' global assessment of disease activity were studied. A total of 24 consecutive patients (22 women and 2 men, mean age 53.0 +/- 6) suffering from symptomatic OA with radiographic characteristics of EOA were evaluated. The patients were divided into two groups of 12 patients each. The first group took naproxen 500 mg only. The second group was treated with CHS 800 mg orally plus naproxen 500 mg. Joint counts, radiological hand examinations and assessment of disease activity were performed at baseline, at 12 months and at 24 months. In the second year the treated group showed significant worsening in erosion, Heberden, Bouchard and Dreiser scores was recorded. Physician and patient global assessments of disease activity showed no significant difference from baseline scores. The untreated group showed significant worsening in erosion, Heberden and Bouchard nodes, Dreiser index and physician and patient global assessment scores. This study confirms the partial efficacy of oral CHS in improving some aspects of EOA.

Chondroitin sulfate in erosive osteoarthritis of the hands.

The aim of this study was to evaluate the joint count for erosions in patients with erosive osteoarthritis (EOA) of the hands treated with 800 mg/day of orally administered chondroitin sulfate plus naproxen, compared with that of patients administered naproxen only. Twenty-four consecutive patients (22 women and two men, mean age 53.0 +/- 6) suffering from symptomatic OA and with radiographic characteristics of EOA were studied. The patients were divided into two groups of 12 patients each. The first group took naproxen 500 mg/day only. The second group was treated with chondroitin sulfate 800 mg/day orally plus naproxen 500 mg/day. Radiological hand examinations were performed at baseline and again after 12 and 24 months. In both groups, the joint count for erosions showed a general tendency to increase over time. Progression of erosions at 24 months was lower in patients treated with 800 mg/day chondroitin sulfate plus naproxen than in patients taking naproxen only (p <0.05). Chondroitin sulfate failed to stop the usual time-associated progression in the number of finger joints presenting erosions in EOA of the hands. It was, however, associated with a lower increase in the number of finger joints with erosions detected after 2 years of radiological observation.

Clearance kinetics of hepatitis C virus under different antiviral therapies.

Interferon alpha (IFN) has been the standard treatment for hepatitis C virus (HCV) infection. Using the kinetic curves of viral clearance, this study compared three treatment regimes based on IFN alone or in combination with Amantadine or Ribavirin to determine the mechanisms of action and the most suitable way to use these drugs. The early clearance kinetics of HCV were studied in 22 patients with chronic hepatitis C under different antiviral treatments: IFN 3 MU daily (7 pts); IFN 3 MU daily plus Amantadine 200 mg (7 pts); and IFN 3 MU daily plus Ribavirin 1-1.2 gr (8 pts), for 6 months. HCV-RNA was assessed qualitatively and quantitatively on serial samples. The HCV-RNA decay curves suggested a different behaviour of viral clearance induced by the three treatments. While no significant differences were present in the first 6 hours, between 6 to 12 hours Ribavirin induced a rapid decline in the viral load. Amantadine seemed to accelerate it in the third phase (12 to 30 hours) and to provoke a more pronounced viral decline when compared to IFN alone (P < 0.05) or to IFN plus Ribavirin (P < 0.025) (baseline to 30 hours). Thus, while IFN remains the principal antiviral drug, Amantadine upholds the viral decline. Ribavirin, although synergistic with IFN, does not seem to improve the IFN effect during the earliest phase of treatment but probably supports the effects of IFN later on. A new dynamic approach to HCV treatment can therefore be developed.

Sleep related vehicle accidents on Italian highways.

Sleepiness has been identified as a significant risk factor for vehicle accidents, and specific surveys are needed for Italy. The aim of this study was to assess incidence and characteristics of sleep-related vehicle-crashes on Italian highways. The database of the Italian National Institute of Statistics (1993-1997) was the source for the survey (50859 accidents with 1632 (3.2%) ascribed to sleep by the police). The distribution of accidents was evaluated by means of the analysis of variance considering the year, the day of the week, the age and the time of day and their interactions as main factors. The relative risk of sleep-related accidents was also evaluated with reference to the relative traffic density as estimated by the Italian Highways Society. The counts of sleep-related accidents, and even more the relative risk, revealed the presence of peaks and troughs in zones at a higher level of sleepiness and alertness respectively. Death of the driver occurred in 11.4% of sleep related accidents versus 5.6% in general accidents. The great majority of sleep-related accidents occurred to drivers under 35 (61.4%) mainly during the night with an increasing trend in the yearly number of sleep-related accidents, especially on weekends. Therefore sleepiness appears a remarkable risk factor and, in our opinion, its incidence as sole or contributory cause of accidents on Italian highways is still underestimated.

Intravenous clodronate for acute pain induced by osteoporotic vertebral fracture.

Even though newly developed drugs may in the future preserve bone mass and reduce the risk of fracture, patients with osteoporosis will continue to suffer from episodes of painful vertebral fracture for many years to come. For this reason, the treatment of acute pain induced by this pathology is still a clinically important issue. The aim of this study was to assess the effect of intravenous disodium clodronate (300 mg) on three pain conditions (at rest, on pressure and on motion) associated with recent osteoporotic vertebral fractures. The effects of disodium clodronate were compared with those of paracetamol in 30 patients during a 30-day observation period. The results showed higher pain remission rate in patients receiving disodium clodronate intravenously than in those receiving paracetamol. The rapid onset of analgesic activity produced by intravenous administration of disodium clodronate after vertebral fracture represents a definite clinical indication.

[Sleepiness and road accidents among policemen on shif-work on Italian highways: study of the national highway network in the period of 1993-1997]. / Sonnolenza ed incidenti stradali nei turnisti della polizia stradale Italiana: uno studio sulla rete autostradale nazionale nel quinquennio 1993-1997.

Sleep disorders and daytime sleepiness are the most frequent disturbances reported by shift-workers. Sleepiness and fatigue can increase the risk of human errors and accidents especially during night work. In order to evaluate the time distribution and the possible role of sleepiness on road accidents in policemen on shift-work on highway patrols over 24 hours, we analyzed 1218 car accidents that occurred on the Italian highway network in the period 1993-1997. Accidents occurring during day shifts were significantly correlated with traffic density while accidents occurring during night shifts were not. During the 19:00-01:00 h shift the number of accidents showed a progressively increasing trend with two significant peaks around 23:00 and 01:00 h. Accidents occurring during the 01:00-07:00 h shift did not show significant trends. Information about sleep habits before starting night shifts were obtained by means of telephone interviews. While 85% of the subjects usually took a nap (30-90 min) before the 01:00-07:00 h shift only 15% took a short nap (< 30 minutes) before the 19:00-01:00 h shift. The data can be interpreted as a balance between circadian factors, homeostasis and fatigue related influences and spontaneously adopted counteracting strategies to increase the level of vigilance during night work hours. While a long nap seems to reduce the risk of accidents during the 01:00-07:00 h shift, policemen seem to underestimate the risk of sleepiness during the shift 19:00-01:00 h shift.

[Sleep disorders and day sleepiness in a population of shift workers of the State Police]. / Disturbi del sonno e sonnolenza diurna in una popolazione di turnisti operatori della Polizia di Stato.

UNLABELLED: Policemen are workers exposed to risk from both shiftwork and delicate tasks. This study aims to investigate sleep habits, prevalence of sleep disturbance, sleepiness and hypnotic drug intake in the whole population of Italian State Policemen working in the Genoa district. Italian literature is completely lacking of such data. The study has been carried out by means self administered and assisted questionnaires. Eighty-five percent of the population accepted and answered the questionnaire. Here we focus on the differences between 540 not-shiftworkers, NS, (413 males, 127 females), and 575 shiftworkers, S, (483 males, 92 females). A higher prevalence of difficulties in falling asleep, sleep-latency longer than 20 min. and early awakenings was found in S. No significative differences in daytime sleepiness and drug intake were found between the two groups. Concerning the self-evaluation of the numbers of hours slept during the night and during the 24 hours a higher quantity of sleep was reported by S. CONCLUSIONS: Data seem to indicate a low quality of sleep in S without any evidence of increased daytime sleepiness or increased hypnotic drugs assumption. Shiftworkers seem to compensate their poor quality of sleep with a greater amount of time spent sleeping in the 24 hour period. Such a condition could be the expression of a prolonged recovery from the shift effects.

Quantitative analyses of plasma opsonizing activity and polymorphonuclear cell response during phagocytosis: standardisation of a chemiluminescent method.

Although measurement of chemiluminescence has become a widespread tool in the study of phagocytosis of peripheral neutrophils, several problems linked to spontaneous fluctuation in chemiluminescence and the number of variables involved have occasionally either limited its usefulness for clinical and experimental purposes or compelled operators to take particular care when using the technique. In the present paper, sources of variability are investigated and most of the parameters involved are thoroughly analysed and step-by-step normalised. A stochastic calibration procedure for validation of the method is applied and a monofunctional test protocol for quantitative evaluation of plasma opsonizing activity in whole blood chemiluminescence is suggested. With regard to the goal of proposing a reverse monofunctional test, we discuss the reasons why further studies aimed at standardised evaluation of the cellular components are needed.

Behavior of soluble HLA class I antigens in patients with chronic hepatitis C during interferon therapy: an early predictor marker of response?

Soluble HLA class I antigens (sHLA-I), beta 2-microglobulin (beta 2-mu) and alanine aminotransferase (ALT) serum levels have been evaluated in 16 patients affected by chronic hepatitis C treated for six months with recombinant interferon-alpha (rIFN-alpha, 3 MU three times a week). The predictor role of sHLA-I and ALT modifications with respect to the response to rIFN-alpha therapy was also evaluated. Six patients responded (group 1), five patients relapsed followed in initial responses (group 2), and five did not respond to rIFN-alpha treatment (group 3). The baseline serum levels of sHLA-I and beta 2-mu were significantly higher in all three groups of HCV-positive patients with respect to HCV-negative controls (P < 0.05). A significant increase of sHLA-I serum level with respect to baseline value (P < 0.001) was observed in group 1 patients after two weeks of rIFN-alpha treatment. sHLA-I serum level then decreased, although remaining steadily and significantly increased with respect to baseline (P values ranging from 0.05 to 0.01) in the following five months and then returned to baseline one month after the end of rIFN-alpha administration. No significant variations of beta 2-mu serum levels were detected throughout the observation period. In group 1 patients ALT serum levels significantly decreased after two weeks of rIFN-alpha treatment (P < 0.001) and then remained in the normal range throughout the observation period. In the other two groups of patients no relevant variations of sHLA-I and beta 2-mu serum levels were found during and after rIFN-alpha therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessment of growth hormone insulin like growth factor-I axis in Down's syndrome.

As GH therapy has been reported to increase growth velocity in children with Down's syndrome (DS), we studied the GH-IGF-I axis in some DS patients affected by growth retardation without serious congenital malformation, malnutrition or pathological thyroid or adrenal function. IGF-I and IGF-II were evaluated in 39 patients in basal conditions. The patients were subsequently divided into two groups with respect to the IGF-I basal value: Group 1 (GR 1) consisting of patients with abnormally low basal IGF-I concentration as compared to age matched control subjects, group 2 (GR 2) consisting of patients with IGF-I in the normal range. In 6 GR 1 patients and 12 GR 2 patients we evaluated GH and IGF-I concentrations after stimulation with arginine (0.5 g/kg bw), and recombinant GH (4 IU im). In the same patients, GH radioreceptor assay and serum GH-binding protein were evaluated. In all patients IGF-II proved normal (534 +/- 23 ng/ml; mean +/- SE), while IGF-I was pathological in 36% of subjects. The cause of the defective IGF-I secretion in these patients does not seem to depend on an impaired GH axis, as no significant difference in arginine-stimulated GH peak values was seen between GR 1 (29.6 +/- 5.3 ng/ml) and GR 2 (15.1 +/- 2.24 ng/ml). IGF-I concentration evaluated 12, 24, and 48 h after arginine stimulation was significantly increased only in GR 2 patients (peak value: 0.95 +/- 0.1, p = 0.0003 vs baseline; GR 1: 0.34 +/- 0.05 U/ml).(ABSTRACT TRUNCATED AT 250 WORDS)

Ammonia-independent modifications of the background EEG signal and paradoxical enhancement of epileptic abnormalities in EEG after acute administration of valproate to epileptic patients.

The effects on the background quantitative EEG (power spectral analysis) and concentration of valproate in plasma were studied after single-dose (14.3-33.3 mg/kg) oral administration in 12 epileptic patients with generalized nonconvulsive or partial seizures. An increase of the amplitude of the background EEG (diffuse and preponderant on anterior scalp areas) and a decrease of the 12.5-32.0 Hz relative power (limited to the posterior electrode deviations) were observed; the increase in the EEG total power was paralleled by a definite increment in incidence of epileptic phenomena in the EEG. Both effects proved unrelated to shifts in vigilance or changes in the concentration of ammonia or serum glucose in plasma and confirm previous observations from superimposable study designs. These findings are qualitatively opposite to those observed during long-term treatment at comparable doses and are suggested to reflect a direct CNS action of acute administration of valproate.

Human flash-VEP and quantitative EEG are independently affected by acute scopolamine.

Scopolamine in acute intramuscular doses of 0.25-0.75 mg reduced the P2-N3 flash-VEP amplitude and, in the quantitative EEG, the 8.5-12.0 Hz power and total power in 8 healthy young male volunteers. The effects on flash-VEP and EEG total power were dose dependent and were evident 30 min and 90 min respectively after drug administration, regardless of dose. The reduction in 8.5-12.0 Hz power was limited to the 0.50 and 0.75 mg doses. No systematic effects on the pattern-VEP were observed. Possible interferences with flash- or pattern-VEP amplitude of the scopolamine-induced EEG changes were identified and removed by regression analysis and computation of VEP residuals from the regression function. The P2-N3 flash-VEP residuals proved EEG independent and showed relationships with dose and time after drug administration that were superimposable on those of the original data, with comparable significance levels at the drug/placebo and pre/postdrug statistical comparisons. The results indicate that VEP estimates of drug effects which are independent from EEG changes can be identified in human studies and allow some inference on the cholinergic specificity of the systems affecting late flash-VEP components. The statistical approach used in this study is suitable for application in VEP studies when effects of interacting factors are to be expected.

Placebo effects in standard human neuropharmacological studies: effects of physiological variations of blood glucose and ammonia concentration on the electrophysiology of the visual system.

The effects on retinal and cortical visual evoked phenomena of the stimulus intensity/spatial frequency and of the spontaneous, physiological blood glucose/ammonia fluctuations were investigated comparatively in a pilot study on young male volunteers. Flash ERG and flash OPs to 5 different stimulus intensities and pattern VECP to 3 spatial frequencies were recorded at 2-hour intervals during a standard acute pharmaco-EEG experimental session (8 h) with administration of placebo; glucose and ammonia blood concentration levels were assessed concomitantly. The effects of the stimulus intensity/spatial frequency were statistically defined for each amplitude/latency measure by nonlinear regression analysis and were removed by computing the residuals from the regression function, which were then tested separately versus the glucose/ammonia concentration by linear regression. Glucose/ammonia statistically significant effects on the visual system were detected at concentration levels within the range of normality and were representative of a nonnegligeable portion of the data overall variance. These effects were selective on retinal/cortical evoked phenomena and it is conceivable that physiological or pathological metabolic changes might account for a still underestimated source of individual variability in human neuropharmacological studies otherwise adequately controlled.

The relative contribution of androgens and insulin in determining abdominal body fat distribution in premenopausal women.

To investigate the relative contribution of insulin and sex hormones in determining the abdominal pattern of fat distribution in premenopausal women, five groups of age-matched subjects were examined: Group 1 consisted of 14 normal weight eumenorrheic women (NO); Group 2 of 9 obese eumenorrheic women (OB); Group 3 of 14 normal weight hyperandrogenic women with polycystic ovary syndrome (NO-HA); Group 4 of 10 obese hyperandrogenic women with polycystic ovary syndrome (OB-HA) and, finally, Group 5 of 10 obese hyperandrogenic women with polycystic ovary syndrome and acanthosis nigricans (OB-HA-AN). Both the two normal weight groups and the three obese groups were matched for body mass index values. Sex hormone pattern showed significantly higher LH and testosterone levels in hyperandrogenic women with respect to NO and OB women but obese hyperandrogenic groups (OB-HA and OB-HA-AN) presented significantly lower LH concentrations than NO-HA. Fasting and glucose-stimulated insulin levels were significantly higher in OB than NO, in OB-HA and OB-HA-AN than in OB and NO-HA, and in OB-HA-AN than in OB-HA, without any significant difference between OB and NO-HA. Body fat distribution, expressed by the waist to hip ratio (WHR), showed progressively higher values (p less than 0.01) from NO to OB, NO-HA, OB-HA and, particularly, OB-HA-AN women. Determination coefficients r2 obtained from simple regression analysis showed that the sum of insulin values during the glucose tolerance test and testosterone levels had a more significant power in determining WHR variability.(ABSTRACT TRUNCATED AT 250 WORDS)

Ouham-Pendé: a new endemic goiter area in the Centroafrican Republic (CAR): epidemiological survey on 7621 subjects.

The authors report epidemiological observations about a new endemic goiter area in the North western region of the Centro-African Republic (CAR). The research was carried out in 7 quarters of the chief-town (Bocaranga) and in 8 rural villages; 7621 people were examined by the same three of the present Authors who filled in a sample individual form (proposed by WHO) with the generalities and the goiter grading. The data were analyzed according to sex, age and place of residence by means of the common position parameters and the cumulative frequencies, taking into account the goiter grading of each group. The goiter prevalences observed in the rural areas varied from 70.9% (males) to 82.6% (females), whereas in the chief-town they varied from 29.3% (males) to 57.9% (females). Neurological and myxedematous cretins were seen to constitute 3.4% of the visited population. The M/F goitrous ratio was near unity under the age of 6; above this age, females are more widely and severely affected than males. An important fall in goiter prevalence was observed in adult males after the age of 16. The gradings observed in the rural villages, in both females and males of different ages (0-5; 6-15; 16-45; greater than 45 ys.) were significantly more severe than those observed in the chief town (P less than 0.01). The results obtained confirm those of a preliminary survey which the Authors previously carried out on a sample of school children living in the same region of CAR.

Ouham-Pendè: a new endemic goiter area in Centro-African Republic (C.A.R.). Preliminary observations on school children.

In this work, the Authors make several epidemiological observations and report a series of biohumoral data relative to a new endemic goiter area in the north-western region of the Centro-African Republic (CAR). In this province whose chief-town is Bocaranga, living conditions are very poor and primitive, manioca being the staple food. The survey was carried out in 11 rural schools and in 2 schools in the chief-town; 4009 subjects were examined; 2839 were males, 1170 females. The goiter prevalence observed in the whole sample population was 79.75%. The prevalence for each step of the grading were: 34.6% for 1a; 32.9% for 1b; and 11.8% for 2. In the schools of the chief town the goiter prevalence was found to be significantly lower than in the rural schools (71.9% versus 83.6% with P less than 0.01). Being the goitrous F/M ratio equal to 1.041, the goiter prevalences and gradings in females were higher and more severe than in males. After calculating these differences by means of the cumulated frequencies and the Kolmogorov Smirnov test, they were found to be significant. In 45 goitrous subjects, high TSH (7.19 microU/ml +/- 5.1), T3 (1.65 ng/ml +/- 0.56), and TG serum levels (410 ng/ml +/- 280) were found; however, low normal levels were observed for rT3 (8.97 ng/dl +/- 7.5) and fT4 (0.50 ng/ml +/- 0.51). In 42 casual urine samples, iodine excretion was 23.2 micrograms/l +/- 12.8; thyocianate excretion was 9.72 mg/l +/- 6 with a I/SCN ratio = 2.38.(ABSTRACT TRUNCATED AT 250 WORDS)

[Biometrico-statistical evaluation of a biological sample]. / Valutazioni biometrico-statistiche su un campionatore biologico.

The total animal population percentage composition, found during period May-August 1979 on tunny-fishing coco-fibres nets in Camogli (Genoa), has been valued in relation to the depth. In particular, connections between population and presence of some fish species draughted has been studied, considering ecological, reproductive and trophic habits of fishes, in order to value relations between the influence these populations exert on fishing and biological characteristics of the quantitatively more meaningful fish species.

[Percent composition of fatty acids in Tigriopus fulvus from rocky pools on the Ligurian coast (Copepoda harpacticoida)]. / Rapporto di composizione percentuale degli acidi grassi nel Tigriopus fulvus delle pozze di scogliera della costa Ligure (Copepoda harpacticoida).

The study concerns the Tigriopus fulvus specimens fatty acid composition, sampled in Ligurian coast rockpools from September 1980 to June 1981. By the study of frequency distribution it was observed that the fatty acid found in greater quantity was the palmitic one, followed by the palmitoleic, the oleic and stearic acids. Short and long chain fatty acids are less frequent. Investigation about each fatty acid concentration shows that the seasonal trends between males and females are different and the trend of some fatty acids (e.g. linolenic and stearic acid) is characteristic.

Clinical and hormonal characteristics of obese amenorrheic hyperandrogenic women before and after weight loss.

We studied a group of obese hyperandrogenic amenorrheic women to determine the effects of weight loss on anthropometry, hormonal status, menstrual cycles, ovulation, and fertility. Fourteen women had polycystic ovaries, two the hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, one hirsutism of adrenal origin, and three idiopathic chronic anovulation. The duration of amenorrhea before the study ranged from 3-17 months [mean, 8.6 +/- 4.5 (+/- SD)]. All women ate a hypocaloric diet for a period of 8.0 +/- 2.4 months. Weight loss ranged from 4.8 to 15.2 kg (mean, 9.7 +/- 3.1 kg; 1.35 +/- 0.56 kg/month) and the waist to hip ratio, which was used as a measurement of body fat distribution, decreased from 0.86 +/- 0.1 to 0.81 +/- 0.06 (P less than 0.0001). The women's mean plasma testosterone and LH concentrations decreased significantly (P less than 0.001 and P less than 0.005, respectively). A significant positive correlation was found between the decreases in plasma testosterone levels and the decreases in glucose-stimulated insulin levels. Moreover, the decreases in the waist to hip ratio correlated positively with the decreases in glucose-stimulated insulin levels and inversely with the decreases in plasma 17 beta-estradiol. No relationships were found between weight loss and the changes in plasma insulin, steroid, and gonadotropin concentrations. The responsiveness to the weight reduction program was evaluated by comparing the number of menstrual cycles during the study period with the number reported before it. Eight women had significantly improved menstrual cyclicity (responders), while 12 did not (nonresponders). The clinical characteristics and hormone values were similar in responder and nonresponder women. In the group as a whole, 33% of the menstrual cycles during the study were ovulatory, and 4 pregnancies occurred. Hirsutism improved significantly in more than half of the women, as did acanthosis nigricans when present. We conclude that weight loss is beneficial in all obese hyperandrogenic women regardless of the presence of polycystic ovaries, the degree of hyperandrogenism, and the degree and distribution of obesity.