Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: A randomized control trial

A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri (L. reuteri). In the present study, the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated. A randomized group of 131 subjects received a dose of 2.9 × 10⁹ CFU L. reuteri NCIMB 30242 capsules (n = 67) or placebo capsules (n = 64) twice daily for 9 weeks. Clinical chemistry and hematological parameters of safety were analyzed. The frequency, duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results. The frequency and intensity of AEs was similar in the two groups. These results demonstrate that administration of a twice daily dose of 2.9 × 10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks.     

医务人员自我和谐与智力效率的相关研究

目的了解医务人员自我和谐状况,以及与智力效率发挥的关系。方法采用自我和谐量表（SCCS）和智力效率量表（Ie）对我院一线医务人员进行调查,收回有效问卷135份进行统计、相关及回归分析。结果医务人员自我与经验的不和谐得分低于大学生常模（P〈0．01）,自我的刻板性得分高于大学生常模（P〈0．05）,Ie得分高于全国成年人常模（P〈0．01）;以年龄段、医／护、学历为界划分比较,SCCS各因子均无统计学差异;以不同学历背景划分比较Ie得分,本科组Ie得分高于专科组和中专组;Ie得分与SCCS各因子得分相关分析显示,Ie得分与自我与经验的不和谐呈负相关（r=-0．3067,P〈0．001）,与自我的刻板性呈负相关（r=-0．2226,P〈0．05）;逐步回归分析显示,自我与经验的不和谐、自我的刻板性对智力效率的发挥有影响。结论自我不和谐会影响医务人员智力效率的发挥,倡导外向、善良及良好的处世态度对促进医务人员自我和谐有帮助,进而提高智力效率。     

Myocardial infarction: psychosocial aspects, gender differences and impact on pre-hospital delay

Title.  Myocardial infarction: psychosocial aspects, gender differences and impact on pre-hospital delay.
Aim.  This paper is a report of a study to explore gender differences in psychosocial aspects in the year prior to first-time myocardial infarction, and the association between these aspects and pre-hospital delay.
Background.  The time from symptom onset to hospital admission is critical for patient survival; therefore influences on pre-hospital delay are of interest. The prevalence of stressful psychosocial factors is higher among patients before acute myocardial infarction than among healthy controls.
Method.  Patients diagnosed with first-time acute myocardial infarction were recruited from five Norwegian hospitals over a 13-month period in 2003–2004. Of 738 eligible patients, 149 women and 384 men completed a self-administered questionnaire (response rate 72%).
Findings.  Depression, high family stress, high work stress and major life events had no statistically significant impact on patient delay or total pre-hospital delay. Depression, sleep disturbances and high family stress were reported among more women than men in the year prior to the event. Women and men aged 65 years and younger were more likely to report major depression and major life events than those older than 65. Low education and low partner education predicted prolonged patient delay in men but not in women. Low partner education also predicted prolonged total pre-hospital delay in men.
Conclusion.  The process between symptom onset and hospital admittance is complex, and more knowledge about factors influencing this process is vital to reduce pre-hospital delay. Significant others should be included in information-giving in relation to myocardial infarction as they seem to play a vital role in patients' decision-making processes.     

Chronic clozapine treatment in female rats does not induce weight gain or metabolic abnormalities but enhances adiposity: implications for animal models of antipsychotic-induced weight gain

The ability of clozapine to induce weight gain in female rats was investigated in three studies with progressively lowered doses of clozapine. In an initial preliminary high dose study, clozapine at 6 and 12 mg/kg (i.p., b.i.d.) was found to induce weight loss. In a subsequent intermediate dose study, we obtained no evidence for clozapine-induced weight gain despite using identical procedures and doses of clozapine (1-4 mg/kg, i.p., b.i.d.) with which we have observed olanzapine-induced weight gain, hyperphagia, enhanced adiposity and metabolic changes [Cooper G, Pickavance L, Wilding J, Halford J, Goudie A (2005). A parametric analysis of olanzapine-induced weight gain in female rats. Psychopharmacology; 181: 80-89.]. Instead, clozapine induced weight loss without alteration in food intake and muscle mass or changes in levels of glucose, insulin, leptin and prolactin. However, these intermediate doses of clozapine enhanced visceral adiposity and elevated levels of adiponectin. In a final study, low doses of clozapine (0.25-0.5 mg/kg, i.p, b.i.d.) induced weight loss. These data demonstrate that clozapine-induced weight gain can be much more difficult to observe in female rats than olanzapine-induced weight gain. Moreover, these findings contrast with clinical findings with clozapine, which induces substantial weight gain in humans. Clozapine-induced enhanced adiposity appears to be easier to observe in rats than weight gain. These findings, along with other preclinical studies, suggest that enhanced adiposity can be observed in the absence of antipsychotic-induced weight gain and hyperphagia, possibly reflecting a direct drug effect on adipocyte function independent of drug-induced hyperphagia [e.g. Minet-Ringuet J, Even P, Valet P, Carpene C, Visentin V, Prevot D, Daviaud D, Quignard-Boulange A, Tome D, de Beaurepaire R (2007). Alterations of lipid metabolism and gene expression in rat adipocytes during chronic olanzapine treatment. Molecular Psychiatry; 12: 562-571.]. These and other findings which show that the results of studies of antipsychotic treatment in animals do not always mimic clinical findings have important implications for the use of animal models of antipsychotic-induced weight gain. With regard to weight gain the results obtained appear to depend critically on the experimental procedures used and the specific drugs studied. Thus such models are not without limitations. However, they do consistently demonstrate the ability of various antipsychotics to enhance adiposity.     

Rat behavior after chronic variable stress and partial lesioning of 5-HT-ergic neurotransmission: effects of citalopram

Deficits in serotonergic (5-HT-ergic) neurotransmission and stressful life events have been implicated in affective disorders, and chronic variable stress (CVS) can elicit behavioral changes reminiscent of increased emotionality, anxiety and atypical depression after partial 5-HT depletion. This study examined the effect of chronic citalopram treatment (10 mg/kg daily) on these changes. Parachloroamphetamine (PCA) (2 mg/kg) reduced the levels of 5-HT and 5-hydroxyindoleacetic acid (5-HIAA) in the frontal cortex, increased anxiety in the social interaction test, and increased activity in the open field. CVS reduced social activity in the social interaction test and immobility time in the forced swimming test. Reduction of excrements left during immobilization indicated partial adaptation with the CVS. Specific stressors had different effects on body weight gain, shorter lasting stressors having a smaller effect in general than those that lasted longer. Combination of CVS and PCA increased sucrose intake after two weeks of stress. In addition, combination of the two treatments reduced diving in the forced swimming test. Citalopram prevented the increase in sucrose consumption in the PCA+CVS rats, and in 5-HT-depleted animals blocked the increase in struggling and reduced the number of defecations in the forced swim test. In conclusion, citalopram treatment prevented several effects of either 5-HT depletion or combined PCA+CVS treatment, suggesting that these behavioral changes could be used in studies on the neural mechanisms underlying emotional behavior that may have relevance to the neurobiology of depression.     

Not just right experience: is it influenced by feelings of guilt?

Individuals with obsessive–compulsive disorder (OCD) experience increased guilt. Further, these individuals often report uncomfortable sensations of things being not quite right (“not just right experiences”—NJREs). As to the relation between these psychological phenomena, it was hypothesized that feelings of guilt may enhance NJRE. In two experiments, we demonstrated that the induction of a guilty emotion resulted in increased NJRE, and this finding was qualified by an interaction with trait guilt. Induced guilt was followed by stronger feelings of things being not just right only in high-trait-guilt participants. In the low-trait-guilt participants NJRE was weaker. Moreover, we found a meaningful relationship between both NJRE and trait guilt and OCD features.     

The relationship between various parameters of complete denture quality and patients’ satisfaction

BackgroundPatients’ appreciation of their conventional complete dentures might be affected by the quality of the dentures.MethodsA random sample of 33 edentulous patients who were rehabilitated by means of conventional complete dentures participated in the study. Three independent investigators who underwent technique calibration evaluated the dentures on the basis of seven clinical criteria by using a validated examination form. The patients filled out a validated denture satisfaction scale. The author used Pearson product-moment correlation and analysis of covariance to identify possible correlations.ResultsThe study results showed that most patients were between “reasonably satisfied” and “very satisfied” with their dentures. The author found nominally higher satisfaction among those receiving both mandibular and maxillary dentures and significant positive correlations between the overall denture satisfaction score and the stability of the mandibular denture (P = .039) and retention of the mandibular denture (P = .005). In contrast, esthetic lip support and lower lip line, occlusion, and maxillary stability and retention were not correlated with participants’ overall satisfaction level (P > .064).ConclusionsThe results of this study show that a clinically stable mandibular denture was the most important determinant of patients’ satisfaction.Practical ImplicationsThe study findings highlight the most important denture quality parameters that can aid clinicians in meeting their patients’ expectations.     

Bulevirtide for patients with compensated chronic hepatitis delta: A review

Chronic hepatitis delta (CHD) affects approximately 10–20 million people worldwide and represents the most severe form of chronic viral hepatitis, as it is characterized by high rates of progression to cirrhosis and its complications (end-stage liver disease, hepatocellular carcinoma). In the last 30 years, the only treatment option for CHD has been represented by the off-label administration of Interferon (or Pegylated Interferon)-alpha: antiviral treatment, however, resulted in suboptimal (20–30%) virological response and was burdened by several side effects, de facto contraindicating Interferon (IFN) administration in patients with more advanced liver disease. Recently, Bulevirtide (BLV), a first-in-class HBV-HDV entry inhibitor blocking Na⁺-taurocholate co-transporting polypeptide (NTCP), has provided very promising efficacy data in Phase II and Phase III (interim analysis) trials as well as in preliminary real-life reports. In July 2020, BLV has granted conditional approval by EMA for treatment of compensated CHD, at the dose of 2 mg/day by self-administered subcutaneous injections. In Phase II and Phase III trials, BLV was evaluated at different doses (2 vs. 10 mg/day) for 24 or 48 weeks, either in monotherapy or in combination with PegIFN. Administration of BLV monotherapy for 24 or 48 weeks resulted in 50%–83% virological response (HDV RNA ≥ 2 Log decline) rates and 45%–78% ALT normalization. Combination therapy with PegIFN provided synergistic effects. These results were replicated in real-life studies and confirmed also in patients with advanced cirrhosis and clinically significant portal hypertension. BLV treatment was optimally tolerated, resulting only in an asymptomatic increase of bile acids.