Outbreak of Salmonella Newport associated with internationally distributed raw goats' milk cheese, France, 2018.

Raw milk cheeses are commonly consumed in France and are also a common source of foodborne outbreaks (FBOs). Both an FBO surveillance system and a laboratory-based surveillance system aim to detect Salmonella outbreaks. In early August 2018, five familial FBOs due to Salmonella spp. were reported to a regional health authority. Investigation identified common exposure to a raw goats' milk cheese, from which Salmonella spp. were also isolated, leading to an international product recall. Three weeks later, on 22 August, a national increase in Salmonella Newport ST118 was detected through laboratory surveillance. Concomitantly isolates from the earlier familial clusters were confirmed as S. Newport ST118. Interviews with a selection of the laboratory-identified cases revealed exposure to the same cheese, including exposure to batches not included in the previous recall, leading to an expansion of the recall. The outbreak affected 153 cases, including six cases in Scotland. S. Newport was detected in the cheese and in the milk of one of the producer's goats. The difference in the two alerts generated by this outbreak highlight the timeliness of the FBO system and the precision of the laboratory-based surveillance system. It is also a reminder of the risks associated with raw milk cheeses.

Unusual increase in reported cases of paratyphoid A fever among travellers returning from Cambodia, January to September 2013.

From January to September 2013, a marked increase in notifications of Salmonella Paratyphi A infections among travellers returning from Cambodia occurred in France. An investigation revealed 35 cases without a common source: 21 in France, five in Germany, three in the Netherlands, one in Norway, one in the United Kingdom, four in New-Zealand. Data suggest an ongoing event that should trigger further investigation. Travellers to Cambodia should observe preventive measures including good personal hygiene and food handling practices.

Avaliação do impacto do tempo de espera para admissão em Unidade de Terapia Intensiva no desfecho clínico do paciente crítico / Assessment of the impact of waiting time until admission in the Intensive Care Unit on the clinical outcome of critical patients

RESUMO: Este estudo tem por base a premissa de que com um maior número de leitos de Unidade de Terapia Intensiva (UTI) disponíveis o tempo de espera para admissão em UTI é menor, o que resulta no melhor desfecho clínico, justifi-cando, portanto, a importância do presente estudo. Objetivo: Avaliar se o tempo de espera no Departamento de Emergência até a admissão em UTI tem influência no desfecho clínico do paciente crítico. Metodologia: Estudo ob-servacional, retrospectivo, do tipo antes e depois, realizado em um hospital público do município de Joinville/SC no ano de 2019. Foram incluídos os dados referentes aos pacientes adultos admitidos na UTI com até 72 horas de es-pera no Departamento de Emergência desde a chegada ao hospital. Comparou-se o último trimestre de 2017 (fase 1), período durante o qual havia 14 leitos de UTI no hospital, e último trimestre de 2018 (fase 2), período durante o qual havia 30 leitos de UTI. Resultados: Analisaram-se 173 prontuários elegíveis de 2017 e 2018. Houve diferen-ça estatisticamente significativa no tempo decorrido na emergência até a admissão em UTI entre 2017 e 2018 (me-diana de 22 vs. 15; p=0,0002). A diferença estatística também foi relevante para a mortalidade em até 24 horas após a admissão em UTI, comparando-se os dois anos em questão (9,61% vs. 2,47%; p=0,04). Não houve diferen-ça estatística significante na mortalidade hospitalar entre 2017 e 2018 (34,6% vs. 35,5%; p=0,57). Também não houve diferença estatisticamente relevante entre os demais parâmetros analisados. Conclusão: Comparando-se 2017 a 2018, percebeu-se que o tempo de espera pelo leito de UTI diminuiu, bem como a mortalidade em até 24h da admissão intensiva. No entanto, isto não se refletiu na mortalidade hospitalar. (AU)

ABSTRACT: The premise that underpins this study is that the more Intensive Care Unit (ICU) beds available, the shorter the waiting time for ICU admission, resulting in better clinical outcomes, which justifies the relevance of this study. Objective: Assess if the waiting time in the Emergency Room until ICU admission influences on the clinical outcome of critical patients. Methods: An observational longitudinal retrospective study performed in a public hospital in Joinville/SC in 2019. This study analyzed data from patients admitted to the ICU with up to 72h of waiting time in the Emergency Room. It compares Q4'2017 (phase 1), when there were 14 ICU beds in the hospital vs. Q4'2018 (phase 2), when there were 30 ICU beds. Results: 173 medical records were analyzed in 2017-2018. There was a statistically significant difference in the time for ICU admission between 2017 and 2018 (median 22h vs. 15h; p=0.0002). There was also a statistically significant difference for mortality rates up to 24h of admission (9.61% vs. 2.47%; p=0.04). There was no statistically significant difference for hospital mortality rates (34.6% vs. 35.5%; p=0.57). There was also no statistically significant difference between the other parameters analyzed. Conclusion:Comparing 2017 and 2018, waiting time for an ICU bed was shorter in 2018, and the mortality rates up to 24 hours of ICU admission were lower. However, waiting time in the Emergency Room until ICU admission did not show as-sociation with hospital mortality rates. (AU)

[Spectral analysis of the electroencephalogram in children with systemic lupus erythematosus]. / Análisis espectral del electroencefalograma en niños con lupus eritematoso sistémico.

INTRODUCTION: Systemic lupus erythematosus (SLE) is an autoimmune disease that affects different systems and organs, including the central nervous system (CNS). It has been suggested that about 40% of the cases of neuropsychiatric lupus (NPSLE) develop before SLE is diagnosed or at the same time it is being carried out, and 63% appear during the first year following diagnosis. AIMS: The aim of this study was to check the hypothesis that the electroencephalogram (EEG) may be sensitive to the damage to the CNS in children with SLE in whom there is still no clinical evidence of NPSLE. PATIENTS AND METHODS: EEG recordings were performed in 30 children with a diagnosis of SLE with or without signs of a neuropsychiatric syndrome. The results of the EEG were evaluated visually and analysed quantitatively. RESULTS: The visual inspection of the EEG showed the presence of alterations in 44.5% of the children with SLE and in 76.9% of those with NPSLE. There were significant differences in Student's t test (p = 0.0055) between the two groups for the analysis of the broadband spectral measurements. The narrow band analysis revealed a significant increase in the theta and delta frequencies in children with SLE as compared to standard values, whereas in children with NPSLE significant differences were found in the fast bands in frontal regions. CONCLUSIONS: Spectral analysis of the narrow band could help to confirm diagnoses of NPSLE, while anomalies in the slow bands could be an early marker of damage to the CNS although there are still no symptoms of the disease.

Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo.

In a 6-week, randomized, double-blind, multicenter trial, sertraline 50 mg, 100 mg, or 200 mg, or placebo, was administered once daily to 369 patients with DSM-III-defined major depression. Efficacy variables included changes from baseline scores for total Hamilton Rating Scale for Depression (HAMD), HAMD Bech Depression Cluster, Clinical Global Impressions (CGI) Severity, CGI Improvement, and Profile of Mood States Depression/Dejection Factor. For the evaluable-patients analysis, all sertraline groups showed significantly (p < 0.05 or better) greater improvements in all efficacy variables except one when compared with the placebo group. For the all-patients analysis, all efficacy variables in the 50 mg group were statistically significantly (p < 0.05) better than placebo. Side effects increased with increasing dosage but were usually mild and well tolerated. The results of this study show that sertraline 50 mg once daily is as effective as higher dosages for the treatment of major depression with fewer side effects and therapy discontinuations.

Placebo-controlled study of the D4/5-HT2A antagonist fananserin in the treatment of schizophrenia.

OBJECTIVE: The authors' objective was to assess the potential efficacy of fananserin (RP62203), a potent antagonist at the D4 and serotonin2A (5-HT2A) receptors, on symptoms of schizophrenia. METHOD: A double-blind, placebo-controlled study was conducted in 97 patients. Doses of fananserin reached 250 mg b.i.d. over 28 days, starting with an 8-day escalation. Most of the patients were men with paranoid schizophrenia; they were approximately 38 years old. The primary outcome measure was the total Positive and Negative Syndrome Scale score. The patients' mean score on the Positive and Negative Syndrome Scale at entry was 91.8 (SD=16.5). A low dropout rate was observed in both groups of patients (19 [30%] of those given fananserin and nine [27%] of those given placebo). RESULTS: The total Positive and Negative Syndrome Scale score of the patients given fananserin decreased at endpoint by a mean of 4.2 points (SD=15.4); the score of the patients given placebo decreased by 6.7 points (SD=19.6). No differences between treatments were found on secondary measures such as the Clinical Global Impression, Positive and Negative Syndrome Scale subscores or individual items, and Brief Psychiatric Rating Scale total score. The patients' extrapyramidal symptoms did not worsen during the trial, but the patients given fananserin had an increase in akathisia. The safety profile was good in both groups of patients. CONCLUSIONS: The results of this study do not support the prediction that a selective D4 antagonist associated with strong 5-HT2A antagonism will exhibit an antipsychotic effect.

Trazodone dosing regimen: experience with single daily administration.

Efficacy being constant, antidepressant choice is dictated by side effect profile, patient acceptance, and safety. Trazodone has been shown to be safe in overdose, and the side effect profile is mild, with sedation the most common side effect. Sleep electroencephalogram and clinical studies have shown trazodone effective in improving sleep in normal subjects, insomniac patients, and patients with major depression. Tolerance and rapid eye movement rebound on discontinuation do not occur. The 3- to 9-hour half-life of trazodone and its pharmacokinetics favors a dose weighted at bedtime. Studies comparing multiple daytime dosing to single dosing at bedtime have shown equal efficacy in relieving depression. At treatment onset, a single nighttime dose is more productive of sleep with less daytime drowsiness. These differences between single nighttime dosing and multiple daily dosing disappear with continued administration. Geriatric patients respond similarly. Trazodone is best dosed at 150 mg given predominantly (but not necessarily all) at bedtime and increased as needed to 200 to 300 mg for full antidepressant efficacy.

Buspirone in the management of major depression: a placebo-controlled comparison.

One hundred forty outpatients with major depression were admitted to an 8-week, placebo-controlled, double-blind study of buspirone. Entry criteria included a Hamilton Rating Scale for Depression (25-item [HAM-D]) score of greater than or equal to 18 and a Hamilton Rating Scale for Anxiety (HAM-A), score of greater than or equal to 18. A flexible dose schedule ranging from 5-90 mg/day was employed. The mean dose of buspirone was 41-54 mg/day from Week 2 to the end of the study. Sixty-four percent of buspirone patients and 50% of placebo patients were melancholic; 64% of buspirone patients and 74% of placebo patients discontinued treatment before the end of the study. Extender data analysis showed that buspirone patients had significant (p less than .05) HAM-D score reductions compared with the placebo group at Weeks 2, 3, 4, and 6. The HAM-D retardation factor trended toward significance over placebo at Weeks 3, 4, and 6. HAM-D change scores for the subgroup of melancholic patients taking buspirone were significantly (p less than .02) better than those of the placebo-treated melancholic subjects at Weeks 2, 3, 4, and 6. Most other efficacy parameters also favored the buspirone-treated group over the placebo-treated group. The most common adverse experiences for the buspirone group were CNS effects (74% in the buspirone group vs. 21% in the placebo group) and gastrointestinal effects (55% in the buspirone group vs. 37% in the placebo group). Side effects consisted of dizziness, light-headedness, nausea, and headache. No serious or unexpected adverse effects occurred.(ABSTRACT TRUNCATED AT 250 WORDS)

Treatment of depression in outpatients: a controlled comparison of the onset of action of amoxapine and maprotiline.

In a 4-week double-blind study, amoxapine and maprotiline were compared in the treatment of 76 outpatients with moderate to severe depressive illness. Mean maximum daily dosages were 230 mg for amoxapine and 165 mg for maprotiline. The data suggest that in these dosages amoxapine and maprotiline are equally effective overall. However, significant differences favored amoxapine at Days 4 and 7, in agreement with other studies showing early onset of therapeutic action of amoxapine.

A 6-week, double-blind trial of paroxetine, imipramine, and placebo in depressed outpatients.

Paroxetine is a novel antidepressant that selectively inhibits neuronal reuptake of serotonin. Results are reported from a 6-week, double-blind trial of paroxetine, imipramine, and placebo in 120 outpatients with DSM-III major depression. Paroxetine was significantly superior to placebo on almost all measures. This included the main outcome variable, the Hamilton Rating Scale for Depression (HAM-D), and its factor scores, anxiety-somatization, cognitive disturbance, psychomotor retardation, and sleep disturbance. There were no significant differences between paroxetine and imipramine on the same scales. Imipramine-treated patients were significantly more likely than those taking placebo to report one or more adverse effects, which were predominantly anticholinergic in nature. There was no significant difference in the number of paroxetine and placebo patients who reported one or more adverse effects. The results of this and similar studies indicate that paroxetine is an effective treatment in major depression and has a favorable side effect profile.

Depressive symptoms and intellectual functioning in anxiety patients treated with clorazepate.

The combined data from two 1970s anxiety studies that used clorazepate and placebo as controls were reanalyzed statistically with a focus on intellectual functioning and depressive symptoms. For the 176 patients given either clorazepate or placebo, significant improvement was observed on the mean scores of the intellectual item and the depressive item of the Hamilton Rating Scale for Anxiety; the clorazepate group was significantly more improved than the placebo group. Similar results were observed in patients' self-ratings. The authors conclude that clorazepate is effective in treating depressive symptoms and improving intellectual functioning in patients with generalized anxiety disorder.

A fixed-dose clinical trial of fluoxetine in outpatients with major depression.

Fixed daily doses of 20 mg, 40 mg, or 60 mg of fluoxetine, a highly specific serotonin reuptake inhibitor, were given to 84 depressed outpatients in a double-blind, placebo-controlled, randomized 6-week trial. The 20-mg dose produced improvement of depression in the moderate-severe depression group as expressed in significant reductions of scores on the Hamilton Rating Scale for Depression (p greater than or equal to .007) and the Patient Global Impressions scale (p greater than or equal to .011), and the 20-mg dose caused fewer side effects than did the higher doses. A mildly depressed group of patients showed no improvement at any dose level of fluoxetine.

Long-term therapy for depression with trazodone.

Trazodone and imipramine were compared in a two-center double-blind study of moderately to severely depressed outpatients. Results for 44 patients who have completed the 12-month comparison showed superior efficacy of trazodone at endpoint on all efficacy measures. Significant differences were also seen on individual Hamilton Depression Rating Scale items, with lower anxiety scores at 5 evaluation points for the trazodone group. Clinical Global Impressions ratings also favored trazodone treatment. Anticholinergic effects and tremor were significantly more frequent in imipramine-treated patients, whereas drowsiness was more frequent with trazodone. No significant changes were seen in blood pressure or ophthalmologic exams; 2 trazodone patients and 1 imipramine patient developed slight ECG changes during therapy; these may have been age-related. Continued clinical benefit has been seen in 12 patients who have received open-label trazodone for additional periods of up to 3 years. These findings show trazodone to be clearly effective in long-term treatment of moderate to severe depression; the drug may be of particular benefit when atropine side effects pose serious problems, as in the elderly and patients with cardiovascular disorders.

Comparative efficacy and safety of nortriptyline and fluoxetine in the treatment of major depression: a clinical study.

The safety and efficacy of nortriptyline and fluoxetine were compared in a double-blind, randomized, multicenter 5-week trial involving 205 outpatients with acute major depression of moderate severity. Seventy-two nortriptyline and 84 fluoxetine patients completed at least 2 weeks of medication and were included in the efficacy analysis; all patients were evaluated for side effects. Average total scores on the Hamilton Rating Scale for Depression (HAM-D) for both treatment groups declined from 22-23 at baseline to 11.5 at the conclusion of the 5-week period. At Week, 5, 71% of nortriptyline patients and 65% of fluoxetine patients were much or very much improved. Fluoxetine was associated more frequently with nausea (p less than .05), while nortriptyline was associated more frequently with dry mouth (p less than .05). These results are discussed in the context of selecting between nortriptyline and fluoxetine for a particular depressed patient.

A multicenter evaluation of bupropion versus placebo in hospitalized depressed patients.

Bupropion, a new antidepressant with a novel structure and neurochemical profile, was compared to placebo in a three-center evaluation. Seventy-five depressed inpatients, 48 on bupropion and 27 on placebo, participated for up to 28 days. At dosages of 300-600 mg/day, bupropion was significantly more active than placebo in reducing depressive and anxious symptomology, beginning at the 3-week evaluation. Bupropion was particularly efficacious in more severely ill and older patients. Symptoms reflecting cognitive disturbance, somatic anxiety, and psychomotor retardation were most improved; sleep disturbances showed less marked effects. Appetite and diurnal variation were not markedly influenced. Adverse effects were minimal, with no significant cardiovascular or clinical laboratory findings. Three patients developed a skin rash. There was a notable absence of sedative, anticholinergic, and cardiovascular-related side effects. Bupropion has demonstrated antidepressant effects and a spectrum of activity that holds promise for a difficult subgroup: the older depressed patient with retardation and cognitive disturbance.

A randomized, placebo-controlled, dose-response trial of venlafaxine hydrochloride in the treatment of major depression.

BACKGROUND: We examined the efficacy and safety of three different dosages of venlafaxine hydrochloride (75, 225, and 375 mg/day) in a multicenter, randomized, double-blind, placebo-controlled, four-group study. METHOD: Outpatients, 18 to 65 years old, who met DSM-III criteria for major depression were included (N = 358 randomized; 194 completed). Of the total patients completing the trial, 59%, 56%, 51%, and 51% were in the placebo, 75-mg, 225-mg, and 375-mg groups, respectively. The primary outcome measures were the Hamilton Rating Scale for Depression (HAM-D21) total, HAM-D21 depression item, Montgomery-Asberg Depression Rating Scale total, and Clinical Global Impressions scale. RESULTS: Each dosage of venlafaxine was associated with statistically significant improvement as compared with placebo, based on the intent-to-treat sample. The two higher dosages were associated with a modestly greater antidepressant response than was the 75-mg dosage. Nausea, dizziness, somnolence, and anorexia were the most common adverse events attributable to venlafaxine. Since headache occurred at a similar frequency in both the drug and placebo groups, we did not consider it to be attributable to venlafaxine use. Withdrawal from the study due to adverse events occurred in 5%, 17%, 24%, and 30% of the patients in the placebo, 75-mg, 225-mg, and 375-mg groups, respectively. CONCLUSION: Venlafaxine, at dosages of 75-375 mg/day, is an effective and well-tolerated antidepressant. With increasing dosage, greater efficacy and possibly more adverse effects will occur.

Multi-clinic double-blind comparison of triazolam (Halcion) and placebo administered for 14 consecutive nights in outpatients with insomnia.

In this multi-clinic double-blind study, patients suffering from insomnia were treated with triazolam 0.5 mg (Halcion) or placebo for 14 days. Four investigators treated 239 patients, 122 on triazolam and 117 on placebo. Thirty-nine patients, 10 on triazolam and 29 on placebo, dropped out for ineffectiveness of the medication and 32 patients, 16 in each group, dropped out for side effects. Analysis of pooled efficacy data showed that triazolam was significantly better than placebo on all efficacy parameters measured, including how much the medication helped the patients sleep, onset of sleep, duration of sleep, duration compared to usual, number of nocturnal awakenings, and feeling of restfulness in the morning. Triazolam did not produce evidence of tolerance development after 2 weeks of treatment. The same variety of side effects occurred on each treatment and primarily included drowsiness, grogginess, headaches, impaired coordination nausea, and dizziness.

Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.

Two hundred forty-one elderly depressed patients entered the 8-week, double-blind phase of this parallel-group, multicenter study; 161 patients were randomized to receive sertraline (50-200 mg/day) and 80 were randomized to receive amitriptyline (50-150 mg/day). Among evaluable patients, there were no statistically significant differences between treatments in any of the primary efficacy variables: change in total Hamilton Rating Scale for Depression (HAM-D) score (17 items), percentage change in HAM-D score, change in HAM-D Item 1, change in Clinical Global Impressions (CGI) Severity score, change in the Depression Factor of the 56-item Hopkins Symptom Checklist, and the CGI Improvement score at the last visit. Similar results were obtained using data from all patients (intention-to-treat analysis), except that amitriptyline was superior in HAM-D Total score (p = .044). The two drugs produced a similar degree of response: on the basis of the HAM-D criterion, 69.4% of sertraline patients and 62.5% of amitriptyline patients responded, and, on the basis of CGI criterion, 79.5% of sertraline and 73.4% of amitriptyline patients responded. Twenty-eight percent of the sertraline patients withdrew from the study because of a treatment-related side effect and 2.5% (4) because of a laboratory abnormality. In comparison, 35% of the amitriptyline patients withdrew because of treatment-related side effects. Sertraline was associated with a statistically lower frequency of somnolence, dry mouth, constipation, ataxia, and pain and a higher frequency of nausea, anorexia, diarrhea/loose stools, and insomnia; thus, anticholinergic effects were less common and gastrointestinal effects were more common with sertraline than with amitriptyline.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparative efficacy and safety of bupropion and placebo in the treatment of depression.

This was a 4-week, three-center, double-blind, randomized, parallel, placebo-controlled evaluation of the efficacy and safety of bupropion in hospitalized depressed patients. Results from 27 placebo and 48 bupropion-treated patients were analyzed for efficacy and safety. Assessments of efficacy and safety were made at baseline and weekly during the study. Preliminary and secondary measures of efficacy included the Clinical Global Impressions for severity (CGI-S) and improvement (CGI-I) of illness, Hamilton Depression and Hamilton Anxiety Scales, and the Zung Self-Rating Scales for depression and anxiety. Assessments of safety included vital signs, electrocardiogram, clinical laboratory tests, and adverse experiences. Dosages of bupropion were 300-600 mg/day. Results showed that bupropion was significantly (P less than 0.01) more effective than placebo at termination of study on the CGI-S, CGI-I, Hamilton Depression and Hamilton Anxiety Scales. On the Zung Self-Rating Depression and Anxiety Scales, statistical trends favored bupropion at termination of study over placebo (P less than 0.10). Adverse events in the bupropion and placebo groups were minimal with notable absence of sedation and anticholinergic- and cardiovascular-related side effects. We conclude that bupropion was significantly more effective than placebo in treating depression and accompanying anxiety in depressed inpatients.