Adverse Drug Reactions to Antiretroviral Therapy: Frequency, Type, and Risk Factors in Children in Mali.

OBJECTIVE: The aim of our study was to evaluate the frequency, type, and risk factors associated with adverse drug reactions (ADRs) in HIV-positive children with adherence to antiretroviral therapy (ART) at the Unit of Care and Accompaniment for People Living With HIV (USAC) of Bamako. METHODS: A cross-sectional study was conducted at USAC of Bamako from May 1, 2014, to July 31, 2015. We included children aged 1 to 14 years with at least 6 months of ARV treatment initiated at USAC, with or without ADRs. Data collection was based on information collected from parents and clinical/biological assessments. RESULTS: Median age of participants was 36 months and female sex was predominant (54.8%). Poor adherence during the study was observed in 15% of cases. Of patients in the study, 52% had a CD4 count less than 350 cells/mm3 at the time of adverse events. In bivariate analysis, we found that participants with adherence to ART tended to be younger than those with non-adherence to ART (36 vs 72 months, p = 0.093). In multivariable analysis, prophylactic treatment was the only factor marginally associated with ART adherence in HIV patients (p = 0.09). No other adverse biological effects or clinical conditions were associated with ART adherence in this study. CONCLUSIONS: In this study we found that ADRs were frequent in HIV-positive patients but less frequent in ART-adherent HIV-positive children. Therefore, it is essential to regularly monitor children receiving ARVs to detect and treat the complications associated with these therapies according to ART adherence.

Safety and efficacy of aviandr in patients with generalized anxiety disorder: A multicenter, randomized, double-blind, placebo-controlled, dose-finding, pilot study.

Generalized anxiety disorder (GAD) is associated with an imbalance in the functioning of the stimulating neurotransmitter systems in human's brain. We studied the safety and therapeutic efficacy of aviandr, the new noradrenergic and specific serotonergic antidepressant, for GAD patients in the phase II, double-blind, placebo-controlled, randomized, multicenter, pilot trial at 17 clinical sites of the Russian Federation. 129 eligible patients were 18 years and older and met the criteria for GAD diagnosis. The patients were randomly assigned (1:1:1) to receive oral aviandr at daily dose of 40 mg (cohort 1, n = 41) or 60 mg (cohort 2, n = 43) or placebo (cohort 3, n = 43) for 8 weeks. The patients were assessed by the Hamilton anxiety scale (HAM-A), Hamilton Depression Scale (HAM-D), Clinical Global Impression Scale (CGI-S), Visual Analogue Scale and vital signs. At week 8, the decreases of the HAM-A score were achieved in 53∙7%, 47∙7% and 16∙3% in cohorts 1, 2 and 3, respectively. Changes of HAM-A, HAM-D, CGI-S, and CGI-I scores in aviandr-treated patients were superior to placebo (p < 0∙001). The psychic components of anxiety decreased on the first day, throughout the 8 weeks of treatment and on a follow-up week after aviandr discontinuation. Aviandr (40 mg daily dose) reduced drowsiness compared to baseline, was safe, well-tolerated and did not cause serious or severe adverse events or signs of withdrawal syndrome within one week after treatment completion. Aviandr at both 40 and 60 mg daily doses demonstrated therapeutic efficacy in GAD patients over placebo.

COVID-19 mass vaccination campaign for healthcare workers in a low-resource setting: A clinician-driven initiative.

COVID-19 vaccination has been globally accepted as a critical public health response measure to prevent severe disease and death, alleviate strain on healthcare systems, and prevent onward transmission of SARS-CoV-2. The South African Department of Health's plan to vaccinate 1.25 million healthcare workers through the Sisonke Early Access Vaccine Rollout for Healthcare Workers presented both opportunities and challenges in terms of designing and implementing a mass vaccination roll-out in the resource-limited state sector. We present our experiences and challenges from the largest hospital in Africa, and hope that this will assist other institutions with planning successful COVID-19 mass vaccination campaigns.

[The cardiological evaluation in patients undergoing to Day Surgery: when is indicated]. / La consulenza cardiologica nei pazienti da sottoporre ad intervento chirurgico in regime di Day Surgery: quando è indicate.

AIM: Guidelines established preoperative cardiac management of the patient undergoing non-cardiac surgery in hospitalization. Regarding the patients undergoing the surgery in DS, the management is not defined. Aim of this study was to evaluate the appropriateness of the cardiological consultation requested by the patients undergoing surgery with this method. MATERIALS AND METHODS: We examined the request of cardiological evaluation for patient admitted to DS of Sant'Andrea Hospital in Rome. We have considered: age, sex, clinic history, simpthomatology, electrocardiogram, cardiovascular objectivity, hemodynamic stability, comorbidity, therapy, type of the surgery, the motivation of the request. RESULTS: Of 2350 patients, 495 patients (21%) have been undergone the preoperative cardiologic consultation. The request was resulted as unnecessary for 432 (87.2%) patients, appropriate for 63 (12.7%): 4 that had the ischemic heart disease without knowing this, 6 with severe hypertension; 2 with mitral valve prolapse and valvular regurgitation; 34 with congestive heart failure; 6 with the alterations in EKG : 3 with "Brugada pattern"; 1 with Pace Maker (PMK) that had to be reprogrammed before the operation; 3 under dual antiplatelet therapy; 7 that were taking the oral anticoagulant therapy. Cardiac complications occurred just in one case with patient suffering dilated cardiomyopathy, diabetes and hypertension; during the cataract surgery was presented the abrupt increase of blood pressure and left ventricular failure. CONCLUSIONS: Preoperative cardiologic evaluation results as useless in most patients. However, in some particular situations had allowed the diagnosis of heart disease for the patients who did not know to have it.

Gene variants with suicidal risk in a sample of subjects with chronic migraine and affective temperamental dysregulation.

BACKGROUND: Risk factors for suicide are at least partially heritable and functional polymorphisms of targeted genes have been suggested to be implicated in the pathogenesis of this phenomenon. However, other studies examining the association between specific gene variants and suicide revealed inconsistent findings. We aims to evaluate the possible association between MAO-A3, CYP1A2*1F and GNB3 gene variants, hopelessness and suicidal risk in a sample of subjects with chronic migraine and affective temperamental dysregulation. METHODS: 56 women were genotyped for MAO-A3, CYP1A2*1F and GNB3 gene variants. Participants were also assessed using Beck Hopelessness Scale (BHS), the Temperament Evaluation of the Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A), and the Suicidal History Self-Rating Screening Scale (SHSS). RESULTS: Patients with higher total scores on affective dysregulated temperaments are more likely to have higher BHS (11.27+/=5.54 vs. 5.73+/=3.81; t19.20 = -3.57; p < 0.01) and higher SHSS total scores (4.79+/=3.31 vs. 1.05±2.31; t17.74 = -3.90; p < 0.001) than those with lower total scores. 67% of patients in the dysregulated group has BHS total scores >= 9 indicating high levels of hopelessness. No association was found between MAO-A3, CYP1A2*1F and GNB3 gene variants and suicidal risk as assessed by BHS and SHSS. CONCLUSIONS: This study did not sustain the association between MAO-A3, CYP1A2*1F and GNB3 gene variants and increased suicidal risk in patients with chronic migraine and affective temperamental dysregulation. Further studies investigating the gene-environment interaction or focusing on other genetic risk factors involved in suicidal behaviour are needed.  

The role of physical activity in the prevention and treatment of chronic diseases.

The aim of this review is to assess the current evidence in scientific literature that supports the use of physical activity as a fundamental tool for primary and secondary prevention and to encourage its use conscientiously. Observational studies and international guidelines have been examined to evaluate the positive effects of physical activity as primary prevention on some of the most common diseases. We have also evaluated those studies which demonstrate that the association of physical activity with drug therapy in chronic diseases results in a better prognosis. We researched the Cochrane Controlled Trials Register, MEDLINE, PubMed up to January 2009. Furthermore, we screened references in relevant reviews and clinical trials. Sixty four studies were included in the review and cited as giving consistent evidence for the utilization of physical activity to improve health. There is strong evidence that, according to international guidelines, physical activity should be adopted as a tool in the prevention and treatment of many chronic diseases.

[The malignant hemopathies in children: epidemiologic aspects in the Haematology and Medical Oncology Ward of Point G Hospital, Bamako, Mali (1996-2003)]. / Les hemopathies malignes de l'enfant: aspects epidemiologiques dans Le Service D'Hematologie Oncologie Medicale de L'Hopital Du Point G, Bamako, Mali (1996-2003).

Data from developed countries place the malignant hemopathies among the most frequent cancers in children. The epidemiologic and prognostic aspects of these diseases are not well known in developing countries notably in Africa sub-Saharan countries because of lack of registry and clinical collaborative studies. Nevertheless, the good progress in the management of paediatric diseases that were a big concerns in former times authorize to think that in future, these countries will be engaged in programs to fit malignant diseases as major health problems in children. A good knowledge of epidemiologic aspects of these diseases must be therefore an important concern. This study describes epidemiologic and prognosis particularities of malignant hemopathies in children diagnosed in a last referral hospital ward, Bamako, Mali (West Africa) during height years. Fifty-nine cases of malignant hemopathies were diagnosed by January 1996 to December 2003 in 19 females and 40 males. Data were analysed retrospectively with SPSS 11.0. These children were aged from 4 to 15 years and the modal class of age was 6-10 years. The mean recruitment of cases per year was 7.37. Lymphomas were more frequent (70%) particularly the Burkitt lymphoma. The Hodgkin's lymphoma was not observed under 5 years of age but represents 24% of cases over this age and was more frequent in male. This study emphasizes the need to put in place strategies for a better understanding of epidemiological aspects of malignant hemopathies in children and for developing policies to improve management and prevention of cases in Mali.