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Vaccinating HIV patients against excessive levels of interferon alpha may prevent some complications of AIDS. Interferon alpha is a naturally occurring immune system protein, but excessive levels produced during HIV infection are believed to be damaging. Researchers gave 242 HIV patients three doses of an anti-inferferon alpha vaccine or a placebo at one-month intervals, followed by booster shots every three months. Only 33% of the patients who received the vaccine developed an immune response that would control their interferon alpha levels. The vaccine did not seem to affect the progression of HIV infection, but reduced the rate of complications.

A vaccine against interferon-alpha (IFN-alpha) may slow the progression of HIV infection. An over-production of interferon-alpha has been implicated in the progression of AIDS early in HIV infection. In a follow-up study of 27 HIV-infected patients who were vaccinated against IFN-alpha, no further signs of deterioration from HIV infection or decreasing CD4+ count were recorded. Eleven of the patients were in the advanced stage of infection.

Musicco M, Emberti L, Nappi G, Caltagirone C, for the Italian Multicenter Study on Outcomes of Rehabilitation of Neurological Patients. Early and long-term outcome of rehabilitation in stroke patients: the role of patient characteristics, time of initiation, and duration of interventions. Arch Phys Med Rehabil 2003;84:551-8. Objective: To determine whether and how patient characteristics and the time of initiation and duration of rehabilitation influence early and long-term patient outcome after cerebrovascular accident. Design: A cohort study. Setting: Twenty rehabilitation hospitals and wards located throughout Italy. Participants: A total of 1716 stroke patients (874 men, 842 women) consecutively admitted to Italian hospital rehabilitation centers in 1997 and 1998. Patients had moderate to severe disability (FIM^T^M instrument score, [le]90). Interventions: Not applicable. Main Outcome Measures: Three negative patient outcomes were considered: death, early failure (premature, unwanted interruption of rehabilitation program; absence of any improvement at hospital discharge), and late failure in terms of severe disability (Barthel Index score, [lt]40) or poor quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey; questionnaire score, [lt]80) 6 months after admission. The strength of the association between the considered variables and the outcomes was calculated with the odds ratio (OR). Results: The less disabled and younger patients had better survival and early and long-term outcomes. The presence of dementia and pressure ulcers on admission was associated with worse outcomes (OR for any failure or death[equals]1.31; 95% confidence interval [lsqb]CI[rsqb], 1.03-1.67; OR[equals]1.63; 95% CI, 1.12-2.37, respectively). Patients who initiated the rehabilitative procedures early (within 7d after stroke) had better long-term outcomes than did those who initiated the rehabilitation after more than 1 month (OR[equals]2.12; 95% CI, 1.35-3.34) or from 15 to 30 days after the acute cerebrovascular event (OR[equals]2.11; 95% CI, 1.37-3.26). Conclusions: This study[apos]s results support the idea that recovery after stroke is greatly influenced by the clinical and demographic characteristics of the patients and that early rehabilitation intervention may have a relevant role. role.

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Observational studies suggest that the sooner treatment is started after the onset of seizures the better is the outcome of the disease. However, when to start antiepileptic treatment is still debated and this may explain the different behaviour of practising physicians. For these reasons, a multicenter randomized controlled trial comparing the treatment of the first seizure and the treatment of the recurrences (the two most common strategies in clinical practice) has been started in Italy. The scientific background, the study rationale and design, and the general characteristics of the study population (498 patients) are presented here.

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On the long term Parkinson Disease (PD) treatment is often complicated by the occurrence of motor fluctuations. To find out whether early treatment of PD with levodopa, dopaminoagonists or 1-deprenyl is associated with any difference in motor fluctuations occurrence, the Italian Parkinson Study Groups initiated a multicenter, randomized study. Since November 1988, 475 patients cequiring effective treatment for idiopathic PD have been randomized to receive levodopa, dopoamine agonists or deprenyl. After 2 months of therapy, all patients evaluated with the Unified Parkinson Disease Rating Scale showed a significant amelioration. Daily living activities were more impaired in patients treated with deprenyl. Study design is presented and first resuts are discussed.

This prospective, multicenter, epidemiological study was carried out in 99 Italian ICUs, distributed throughout the country, from April 1993 to March 1994. In the study, we applied the new ACCP/SCCM classification system for sepsis (SIRS, sepsis, severe sepsis and septic shock) and determined the prevalence, incidence, evolution and outcome of these categories in critically ill patients. The preliminary analysis of 1101 patients showed that on admission SIRS accounted for about half of the diagnoses (52%) with sepsis, severe sepsis and septic shock accounting for 4.5%, 2.1% and 3% of patients, respectively. Patients with severe sepsis or septic shock more frequently had high SAPS scores than patients without sepsis. Mortality rates were similar in patients with SIRS (26.5%) and without SIRS or infection (24%), but rose to 36% in patients with sepsis, to 52% in those with severe sepsis and to 81.8% in those with septic shock. Sepsis, severe sepsis and septic shock were more common in patients with medical diagnoses, and neither severe sepsis nor septic shock was observed in trauma patients. With respect to evolution, the incidence of septic shock was progressively higher in patients admitted with more severe “sepsis-related” diagnoses, while only a trivial difference in rates of incidence was observed between SIRS patients and those admitted without SIRS or any septic disorder (nil). The breakdown of the various ACCP/SCCM “sepsis-related” diagnoses at any time during the study was: SIRS in 58% of the population, sepsis in 16.3%, severe sepsis in 5.5% and septic shock in 6.1%. It seems reasonable to expect from the final evaluation of our study answers to the questions raised by the ACCP/SCCM Consensus Conference about the correlations between “sepsis-related” diagnosis, severity score, organ dysfunction score and outcome.

Abstract: Oxidative damage by free radicals may contribute to the etiology of Parkinson's disease (PD), and increased oxidative stress in the nigral cells of PD patients may occur following L-dopa treatment, prompting suggestions that L-dopa therapy should be delayed as long as possible. Bilirubin is a potent antioxidantin vitro, even when bound to albumin, suggesting a physiological role as an antioxidant. Calculations indicate that bilirubin can pass the blood-brain barrier in sufficient quantity to exert a significant antioxidant effect in the brain. We have found a highly significant (about 20%) increase in plasma bilirubin in 162 PD patients on chronic L-dopa treatment compared to 93 untreated parkinsonians and 224 non-parkinsonian controls. We propose that L-dopa-induced increase in nigral oxidative stress in PD may be effectively counteracted by increased bilirubin levels. The mechanism by which plasma bilirubin is increased in patients receiving L-dopa is at present unknown.

We evaluated the possible influence of early levodopa treatment on the mortality of Parkinson's disease (PD). One hundred forty-five consecutive parkinsonian patients initiated treatment with levodopa between 1970 and 1983. Ninety-eight of those started levodopa therapy 2 or more years after symptom onset, while 47 received levodopa within the 1st 2 years of the disease. At the end of follow-up, in December 1985, 49 patients had died. Mortality was 2.5 times higher among patients who delayed initiation of levodopa therapy 2 or more years than among those who initiated the therapy earlier. Age and disease severity were the most significant predictors of survival after initiation of levodopa treatment. The risk of death was 10 higher every year of age increase and was 2 and 4 times higher, respectively, for patients at Hoehn and Yahr stages II and III than for patients at Hoehn and Yahr stage I. When we controlled for the effect of age and disease severity on mortality, the cumulative death probability was no longer significantly higher among patients who delayed levodopa treatment than among patients treated within 2 years from disease onset. As far as mortality is concerned, the results show that the time of levodopa treatment initiation during PD has no influence and the drug can be introduced as soon as indicated by the severity of the disease progression.

Two groups of patients with transient ischaemic attack and minor stroke without detectable haemodynamic stenotic lesions were evaluated by neuropsychological tests and compared with a control group. The mean values of the scores adjusted for age and educational background demonstrated that (a) the patients with transient ischaemic attack did not have a worse performance than normal subjects in any of the tests, (b) the patients with minor stroke had a worse performance than normals, particularly in Rey's figure-copying test (P<0.025), and (c) the latter test was not affected by educational background or age of the subjects. The results are discussed with reference to other case series, and the importance of age and cerebral damage in causing intellectual impairment evaluated by neurophysiological tests is stressed.

In a series of patients with TIA or minor stroke we have investigated the possibility of a different distribution of risk factors according to the presence or absence of angiographic lesions of the cerebral arterial circulation. The differences observed, though not statistically significant, argue for a more severe and widespread atherosclerotic process in patients with positive angiography. A significant proportion of these patients present associated insufficiency of the coronary circulation, demonstrated indirectly by exercise testing. The exercise test presents a positive predictive power of 41% for cerebral angiographic lesions.

The aim of the present study, a multicentre trial of didanosine (ddI) compassionate use, was to identify factors associated with a better outcome in patients given ddI monotherapy. Enrolled were 1047 HIV-positive patients intolerant of and/or unresponsive to zidovudine (ZDV) therapy, with CD4+ cell counts of < 200/μl or AIDS. Didanosine was given at a dose of 250 mg b.i.d. (patients ≥ 60 kg) or 167 mg b.i.d. (patients < 60 kg). Clinical examinations and laboratory tests were performed every two months. Endpoints included death, the occurrence of a new AIDS-defining disease, or permanent discontinuation of ddI for a severe adverse event. At entry, the median CD41 cell count was 47/μl and the median duration of prior ZDV treatment 19 months; 446 patients (43%) were classified as having AIDS. Severe toxicity occurred in 143 subjects (14%); the frequency of pancreatitis was very low (0.2%), The benefit in terms of CD4+ cell counts was greater for patients whose counts exceeded 100/μl at entry and remained at this level until month 12 in those patients still receiving treatment. Death and/or new AIDS-defining events were observed in 374 cases (36%) over a median follow-up of eight months. AIDS dementia was observed in 11 patients (1 %). Multivariate analysis of survival without disease progression showed that the factors associated with a worse outcome include the severity of immunodepression, a diagnosis of AIDS at entry, and a history of both intolerance of and clinical resistance to ZDV. Surprisingly, the patients who had received previous prolonged treatment with ZDV had a better outcome. In conclusion, severely immunodepressed patients previously administered long-term monotherapy may receive a short-term benefit from being switched to another antiretroviral drug.

To evaluate the role of parenteral and sexual transmission of human immunodeficiency virus, we studied seronegative intravenous drug users recruited from 25 drug dependence treatment centers in northern Italy. All attending intravenous drug users were asked for their consent and screened for antibodies to human immunodeficiency virus; those who were seronegative were enrolled, interviewed about their habits, and invited to follow-up visits. Between 1987 and 1989, 1,195 seronegative intravenous drug users were enrolled, 635 were followed up (mean duration, 11.9 months), and 35 seroconversions were observed. The incidence rate ratios were 3.3 (95% confidence interval (CI) 1.4-7.5) for subjects aged less than 20 years, 2.4 (95% CI 1.2-4.7) for less than 2 years of intravenous drug use, 2.2 (95% CI 0.9-5.5) for syringe sharing, and 1.0 for subjects with a sexual partner who had tested positive for human immunodeficiency virus. A case-control approach, using logistic regression and adjusting for sex, age, area, and prevalence, showed odds ratios of 13.2 (95% CI 3.1-56.8) for frequent syringe sharing and 4.0 (95% CI 1.5-10.4) for sexual contacts with seropositive partners; frequent use of condoms was associated with a reduction in risk that did not reach statistical significance. Parenteral transmission is the most important route of infection with the human immunodeficiency virus among intravenous drug users, and sexual transmission plays a relevant, additive role.

During 1983 and 1984, 240 newly diagnosed cases of brain glioma and 742 controls (465 non-glioma nervous system tumors and 277 patients with other neurologic diseases) were recruited and interviewed in the neurologic and neurosurgical departments of two hospitals in Milan, Italy. The occupational histories of cases and controls were compared, and relative risk estimates, adjusted for sex, age, residence, and socioeconomic status, were computed using the Mantel-Haenszel method. A statistically significant risk increase was found for farmers (relative risk (RR) = 1.6, p = 0.0025). This risk increase was attributable to those farmers who reported the use of chemicals (insecticides or fungicides, herbicides, and fertilizers). Among the three groups of investigated agrochemicals, only the use of insecticides or fungicides was associated with a significant increase in relative risk (RR = 2.0, p = 0.006). Many farmers exposed to fungicides reported the use of commercial compounds of copper sulfate. Some of these compounds contain methyl urea, which has a specific carcinogenic effect on the nervous system in animals. These data suggest that the occupational exposure of farmers to agrochemicals might be responsible for the observed excess risk of brain glioma in farmers.

Patients with gliomas of the central nervous system hospitalized during the period January 1979--March 1980 at the Neurological Institute C. Besta of Milan were compared with controls admitted to the Institute in the same period for nonneoplastic neurologic diseases or benign tumors. The comparison was based on occupational history, smoking habits, and alcohol consumption. Two analyses were carried out: the first by case-control pairs matched for age, sex, and residence; the second by age, sex, and residence stratification. Patients with glioma were more likely than controls to have worked in agricultural activities and showed a relative risk of 5.0 (p = 0.043) in the matched analysis and 1.9 (p = 0.113) in the analysis by stratification. This high risk was confined to those who performed agricultural work after 1960, suggesting a possible etiologic role of exposure to organic pesticides, fertilizers, and herbicides, which have only recently been commonly used in Italy. No significant difference was observed between cases and controls in regard to other analyzed occupations and habits.