Month 0 Research Articles

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies. TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain. These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS. ClinicalTrials.gov identifier, NCT04221191.

Variation of Biological and Biochemical Parameters in Patients Receiving Antiretroviral Treatment at the Maradi Regional Hospital during 2021-2022

Aims: To follow the variation of some biological and biochemical parameters in HIV-infected patients under antiretroviral treatment at the Maradi Regional Hospital.&#x0D; Study Design: Retrospective and prospective study&#x0D; Study Location and Duration: Maradi Regional Hospital; from August 2021 to April 2021, a duration of 9 months.&#x0D; Methodology: We followed the variation of some immunological and biochemical parameters in patients living with HIV, evaluated the CD4+ T cell counts, the viral load, the leukocyte count, and carried out the measurement of haemoglobin, glycaemia, creatinemia, and ALAT levels in the blood at the follow-up visits (month 0 (M0), month 3 (M3), and month 6 (M6)), except for the viral load and CD4+ T-cell counts, which were measured at M0 and M6, and the HBsAg test at M0.&#x0D; Results: 99 patients were included in this study. The sex ratio was 2.6 in favour of females. At enrolment, 63.6% of patients had a CD4+ T-cell count &lt; 200/mm³, 56.6% had anaemia, 40.4% had hypoglycaemia and there was a significant increase in patients with an undetectable viral load from enrolment to the last visit at M6. At the end of the study, we observed an improvement in CD4+ T-cell counts, haemoglobin, glycaemia and viral load at each subsequent visit. We did not observe any significant evolution of creatinemia and alanine aminotransferase rate.&#x0D; Conclusion: At the end of the study, we observed an improvement in CD4+ T-cell count, glycaemia, haemoglobin and viral load. We did not observe any particular change in the biochemical parameters of creatinemia and ALAT levels. This shows the non-toxicity of the antiretroviral treatments. Finally, we observed some difficulties in our study which deserve to be improved.

Microbiota and Resistome Analysis of Colostrum and Milk from Dairy Cows Treated with and without Dry Cow Therapies.

This study investigated the longitudinal impact of methods for the drying off of cows with and without dry cow therapy (DCT) on the microbiota and resistome profile in colostrum and milk samples from cows. Three groups of healthy dairy cows (n = 24) with different antibiotic treatments during DCT were studied. Colostrum and milk samples from Month 0 (M0), 2 (M2), 4 (M4) and 6 (M6) were analysed using whole-genome shotgun-sequencing. The microbial diversity from antibiotic-treated groups was different and higher than that of the non-antibiotic group. This difference was more evident in milk compared to colostrum, with increasing diversity seen only in antibiotic-treated groups. The microbiome of antibiotic-treated groups clustered separately from the non-antibiotic group at M2-, M4- and M6 milk samples, showing the effect of antibiotic treatment on between-group (beta) diversity. The non-antibiotic group did not show a high relative abundance of mastitis-causing pathogens during early lactation and was more associated with genera such as Psychrobacter, Serratia, Gordonibacter and Brevibacterium. A high relative abundance of antibiotic resistance genes (ARGs) was observed in the milk of antibiotic-treated groups with the Cephaguard group showing a significantly high abundance of genes conferring resistance to cephalosporin, aminoglycoside and penam classes. The data support the use of non-antibiotic alternatives for drying off in cows.

Characterisation of gut microbiota composition in patients with axial spondyloarthritis and its modulation by TNF inhibitor treatment

ObjectiveTo assess whether gut microbiota composition is associated with patient characteristics and may have predictive value on the response to TNF inhibitor (TNFi) treatment in axial spondyloarthritis (AxSpA).MethodsThe study involved...

Cumulative incidence of SARS-CoV-2 infection and associated risk factors among frontline health care workers in Paris: the SEROCOV cohort study

With the COVID-19 pandemic, documenting whether health care workers (HCWs) are at increased risk of SARS-CoV-2 contamination and identifying risk factors is of major concern. In this multicenter prospective cohort study, HCWs from frontline departments were included in March and April 2020 and followed for 3 months. SARS-CoV-2 serology was performed at month 0 (M0), M1, and M3 and RT-PCR in case of symptoms. The primary outcome was laboratory-confirmed SARS-CoV-2 infection at M3. Risk factors of laboratory-confirmed SARS-CoV-2 infection at M3 were identified by multivariate logistic regression. Among 1062 HCWs (median [interquartile range] age, 33 [28–42] years; 758 [71.4%] women; 321 [30.2%] physicians), the cumulative incidence of SARS-CoV-2 infection at M3 was 14.6% (95% confidence interval [CI] [12.5; 16.9]). Risk factors were the working department specialty, with increased risk for intensive care units (odds ratio 1.80, 95% CI [0.38; 8.58]), emergency departments (3.91 [0.83; 18.43]) and infectious diseases departments (4.22 [0.92; 18.28]); current smoking was associated with reduced risk (0.36 [0.21; 0.63]). Age, sex, professional category, number of years of experience in the job or department, and public transportation use were not significantly associated with laboratory-confirmed SARS-CoV-2 infection at M3. The rate of SARS-CoV-2 infection in frontline HCWs was 14.6% at the end of the first COVID-19 wave in Paris and occurred mainly early. The study argues for an origin of professional in addition to private life contamination and therefore including HCWs in the first-line vaccination target population. It also highlights that smokers were at lower risk.Trial registration The study has been registered on ClinicalTrials.gov: NCT04304690 first registered on 11/03/2020.

Long-term evolution of humoral immune response after SARS-CoV-2 infection

ObjectiveWe aimed to characterize the evolution of humoral immune response up to 1 year after SARS-CoV-2 infection in healthcare workers (HCWs) during the first wave of COVID-19 in Paris. MethodsSerum samples from 92 HCWs were tested at month 0 (M0), M6, and M12 after SARS-CoV-2 infection for IgG targeting the nucleocapsid (N), IgG targeting the receptor-binding domain (RBD) of spike (S) protein, IgA targeting S, and anti-RBD neutralizing antibodies. After M6, 46 HCWs received a single dose of COVID-19 vaccine. ResultsWe observed a significant decrease in all SARS-CoV-2 immunologic markers at M6 post-infection: median decreases were 0.26 log binding antibody units/mL (M0: 1.9 (interquartile range (IQR) 1.47–2.27); M6: 1.64 (IQR 1.22–1.92)) for anti-RBD IgG; 4.10 (index) (M0: 4.94 (IQR 2.72–6.82); M6: 0.84 (IQR 0.25–1.55)) for anti-N IgG; 0.64 (index) (M0: 2.50 (IQR 1.18–4.62); M6: 1.86 (IQR 0.85–3.54)) for anti-S IgA; and 24.4% (M0: 66.4 (IQR 39.7–82.5); M6: 42.0 (IQR 16.8–68.8)) inhibition activity for the RBD neutralizing antibodies. Between M6 and M12, anti-RBD IgG level, anti-S IgA index, and anti-RBD neutralizing activity significantly increased among COVID-19 vaccinated HCWs, whereas they remained stable among unvaccinated HCWs. Anti-N IgG index significantly decreased between M6 and M12 among both vaccinated (median: 0.73 (IQR 0.23–1.11) at M6 and 0.52 (IQR 0.20–0.73) at M12) and unvaccinated HCWs (median: 0.79 (IQR 0.21–4.67) at M6 and 0.34 (IQR 0.24–2.78) at M12). DiscussionA steady decline in the anti-N IgG response was observed during the first year after SARS-CoV-2 infection among HCWs, whereas the anti-RBD IgG and the anti-S IgA responses remained stable and could be enhanced by COVID-19 vaccination.

The longitudinal changes of anxiety and depression, their related risk factors and prognostic value in colorectal cancer survivors: a 36-month follow-up study

ObjectiveThis study was to investigate the longitudinal change of post-operative anxiety and depression, their related risk factors and prognostic value in colorectal cancer (CRC) patients after resection. MethodsTotally, 302 CRC patients who underwent resection were consecutively recruited. Their anxiety and depression were assessed by hospital anxiety and depression scale (HADS) at Month 0 (M0) and then every 3 months till Month 36 (M36). ResultsWithin 36-month follow-up period, HADS-A score (from 8.3 ± 3.3 at M0 to 8.8 ± 3.4 at M36, P = 0.179) exhibited an upward trend with time but without statistical significance; while anxiety rate (from 46.4% at M0 to 52.6% at M36, P = 0.019) was increased steadily with time longitudinally. Meanwhile, both HADS-D score (from 7.4±3.0 at M0 to 9.2±3.5 at M36, P < 0.001) and depression rate (from 33.8% at M0 to 57.9% at M36, P < 0.001) were elevated greatly with time longitudinally. Furthermore, multivariate logistic regression revealed that female and tumor size (≥5 cm) were common independent risk factors for baseline/1-year/2-year/3-year anxiety (all P < 0.05); meanwhile, female, marry status (single/divorced/widowed vs. married) and advanced TNM stage were common independent risk factors for baseline/1-year/2-year/3-year depression (all P < 0.05). As for new-onset anxiety and depression, no independent factor associated with new-onset anxiety was observed; meanwhile, female and TNM stage were independent risk factors for new-onset depression (both P < 0.05). Additionally, baseline/1-year anxiety and baseline/1-year/2-year/3-year depression were associated with lower accumulating OS (all P < 0.05). ConclusionPost-operative anxiety and depression are highly prevalent and continuously progress, which also correlate with worse survival prognosis in CRC patients.

Cumulative Incidence of SARS-CoV-2 Infection and Associated Risk Factors Among Frontline Health Care Workers in Paris, France: The SEROCOV Prospective Cohort Study

Background: With the COVID-19 pandemic, documenting whether health care workers (HCWs) are at increased risk of SARS-CoV-2 contamination and identifying risk factors is of major concern.Methods: In this multicenter prospective cohort study, HCWs from COVID-19 frontline departments were included in March and April 2020 and followed for 3 months. SARS-CoV-2 serology was performed at month 0 (M0), M1, and M3 and RT-PCR in case of symptoms. The primary outcome was laboratory-confirmed SARS-CoV-2 infection (positive serology and/or positive RT-PCR result) at M3. Secondary outcomes were positive serology for SARS-CoV-2 at M0, M1 and M3. Risk factors of laboratory-confirmed SARS-CoV-2 infection at M3 were identified by multivariate logistic regression.Findings: Among 1,062 HCWs (median [interquartile range] age, 33 [28-42] years; 758 [71.4%] women; 321 [30.2%] physicians), the cumulative incidence of SARS-CoV-2 infection at M3 was 14.6% (95% confidence interval [CI] [12.5; 16.9]). Seroprevalence at M0, M1, and M3 was 5.9% [4.7; 7.5], 12.9% [10.9; 15.1] and 13.0% [11.1; 15.2], respectively. Risk factors were the working department specialty, with increased risk for intensive care units (odds ratio 1.80, 95%CI [0.38; 8.58]), emergency departments (3.91 [0.83; 18.43]) and infectious diseases departments (4.22 [0.92; 18.28]); active smoking was associated with reduced risk (0.36 [0.21; 0.63]). Age, sex, professional category, number of years of experience in the job or department, and public transportation use were not significantly associated with laboratory-confirmed SARS-CoV-2 infection at M3.Interpretation: The rate of SARS-CoV-2 infection in frontline HCWs was 14.6% at the end of the first COVID-19 wave in Paris and occurred mainly early. Seroprevalence in May was higher than in the general population. The study argues for an origin of professional in addition to private life contamination and therefore including HCWs in the first-line vaccination target population. It also highlights that smokers were at lower risk.Trial Registration: The study is registered on ClinicalTrials.gov: NCT04304690Funding Statement: The sponsor of the study was Assistance Publique-Hôpitaux de Paris (AP-HP), with study management by URC Pitié-Salpêtrière. This study was funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique) and the French Agency for Research (Fond d’amorçage de l’Agence National pour la Recherche).Declaration of Interests: None to declare. Ethics Approval Statement: The SEROCOV study was approved by the ethics committee (CPP Sud-Ouest et Outre-Mer I, approval no. 2-20-023 id7257) and all participants signed informed consent before inclusion.

Reminiscence therapy-based care program relieves post-stroke cognitive impairment, anxiety, and depression in acute ischemic stroke patients: a randomized, controlled study.

Cognitive and mental impairments are common health problems in acute ischemic stroke (AIS) patients. In this study, we aimed to assess the benefit of a reminiscence therapy-based care (RTBC) program on cognitive impairment restoration, anxiety, and depression reduction in AIS patients. Totally 130 AIS patients were recruited in this randomized, controlled study and randomly assigned to the RTBC group or control group in 1:1 ratio for 12-month intervention. Mini-Mental State Examination (MMSE), Montreal cognitive assessment (MoCA), Hospital Anxiety and Depression Scale for anxiety/depression (HADS-A/HADS-D), and Zung self-rating anxiety/depression scale (SAS/SDS) were assessed at month 0 (M0), M3, M6, M9, and M12. Meanwhile, patients' satisfaction was also evaluated at M3, M6, M9, and M12. RTBC increased MMSE score and MoCA score and reduced cognitive impairment patients' percentage assessed by MoCA score at M12 compared with control. RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control. RTBC reduced HADS-D score at M9 and M12 (while statistically non-significant), but not depression patients' percentage or severity by HADS-D at M12; it decreased SDS score at M9 and M12, but not depression patients' percentage or severity by SDS at M12 compared with control. Additionally, RTBC obsessed higher patients' satisfaction at M3, M6, and M12 compared with control. RTBC could help reduce cognitive impairment, anxiety, and depression in post-stroke management for AIS patients.

Use of a mobile application for self-management of pancreatic enzyme replacement therapy is associated with improved gastro-intestinal related quality of life in children with Cystic Fibrosis

BackgroundMost patients with cystic fibrosis (CF) suffer from pancreatic insufficiency (PI), leading to fat malabsorption, malnutrition, abdominal discomfort and impaired growth. Pancreatic enzyme replacement therapy (PERT) is effective, but evidence based guidelines for dose adjustment are lacking.A mobile app for self-management of PERT was developed in the context of the HORIZON 2020 project MyCyFAPP. It contains an algorithm to calculate individual PERT-doses for optimal fat digestion, based on in vitro and in vivo studies carried out in the same project.In addition, the app includes a symptoms diary, educational material, and it is linked to a web tool allowing health care professionals to evaluate patient's data and provide feedback. MethodsA 6-month open label prospective multicenter interventional clinical trial was performed to assess effects of using the app on gastro-intestinal related quality of life (GI QOL), measured by the CF-PedsQL-GI (shortened, CF specific version of the Pediatric Quality of Life Inventory, Gastrointestinal Symptoms Module). ResultsOne hundred and seventy-one patients with CF and PI between 2 and 18 years were recruited at 6 European CF centers. Self-reported CF-PedsQL-GI improved significantly from month 0 (M0) (84.3, 76.4–90.3) to month 6 (M6) (89.4, 80.35–93.5) (p< 0.0001). Similar improvements were reported by parents. Lower baseline CF-PedsQL-GI was associated with a greater improvement at M6 (p < 0.001). ConclusionsThe results suggest that the MyCyFAPP may improve GI QOL for children with CF. This tool may help patients to improve self-management of PERT, especially those with considerable GI symptoms.

Plasma miR-126 expression correlates with risk and severity of psoriasis and its high level at baseline predicts worse response to Tripterygium wilfordii Hook F in combination with acitretin

BackgroundTreatment of psoriasis is always difficult, which requires intensive scientific research. ObjectiveTripterygium wilfordii Hook F (TwHF) with acitretin(TwHF + acitretin) is normally used in treating psoriasis. This study aimed to investigate the correlation of plasma miR-126 expression with risk and severity of psoriasis, and its predictive value of response to TwHF + acitretin treatment in psoriasis. MethodsMiRNA-126(MiR-126) expression in plasma was analyzed in psoriasis patients at month 0 (M0), M1, M3 and M6 and in health controls (HCs) at enrollment by qPCR. Psoriasis-affected body surface area (BSA) and Psoriasis Area and Severity Index (PASI) score were used to assess severity and treatment response. ResultsPlasma miR-126 levels were decreased in psoriasis patients compared with HCs (P < 0.001), with area under the curve (AUC) of 0.771. MiR-126 expression was negatively correlated with PASI score (P = 0.001), and negatively associated with psoriasis-affected BSA (P = 0.825). At M6, 65.3% and 36.1% patients achieved PASI 50 and 75, respectively. MiR-126 increased at M1, M3 and M6 after TwHF + acitretin treatment when comparing with M0 (all P < 0.001). Meanwhile, miR-126 expression baseline in PASI 50 group declined when comparing with non-PASI 50 group (P < 0.001). Additionally, data revealed that the cause of high miR-126 baseline level was due to unsuccessfully achieving PASI 50 at M6 after TwHF + acitretin treatment (P < 0.001). However, miR-126 baseline expression was not a predictive factor for PASI 75 achievement (P > 0.05). ConclusionPlasma miR-126 expression is negatively correlated with psoriasis risk and severity, and its high baseline level can be used as a biomarker to predict worse clinical response to TwHF + acitretin treatment in psoriasis.

Depression Symptoms Predict Worse Clinical Response to Etanercept Treatment in Psoriasis Patients

Background/Aims: This study aimed to investigate the predicting values of depression and anxiety symptoms for clinical response to etanercept treatment in psoriasis patients. Methods: A total of 85 psoriasis patients who received 6 months of etanercept treatment were consecutively enrolled in this prospective cohort study. The Psoriasis Area and Severity Index (PASI) score was evaluated at month 0 (M0), M1, M3, and M6, and the corresponding PASI 75/90 response at each visit was assessed. Also, anxiety and depression symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS) at M0, M1, M3, and M6. Results: Depression symptoms were observed to correlate with female gender (p = 0.004), longer disease duration (p = 0.018), and higher PASI score (p < 0.001), and anxiety symptoms were seen to be associated with female gender (p = 0.017), larger psoriasis-affected body surface area (p = 0.049), and higher PASI score (p = 0.017) in psoriasis patients. After etanercept treatment, HADS-Depression (HADS-D) and HADS-Anxiety (HADS-A) scores were both decreased at M1, M3, and M6 (all p < 0.001) compared with M0. Most importantly, baseline depressed patients presented with a lower PASI 75 response rate at M3 (p = 0.014) and M6 (p = 0.005), and a reduced PASI 90 response rate at M6 (p = 0.045) compared with baseline non-depressed patients. Furthermore, multivariate logistic regression analyses revealed that depression symptoms at baseline were an independent predictive factor for the lower possibility of both PASI 75 response (p = 0.048) and PASI 90 response (p = 0.048) achievements at M6 in psoriasis patients. However, no correlation of baseline anxiety symptoms with PASI 75/90 responses was observed. Conclusion: Depression symptoms at baseline independently predict a worse clinical response to etanercept treatment in psoriasis patients.

L’activité physique, un facteur protecteur cardiovasculaire et métabolique chez les patients porteurs d’une insuffisance rénale terminale

ObjectiveThe aim of the study was to test the effectiveness of Physical Activity (PA) during haemodialysis as a protective treatment against cardiovascular (CV) diseases. MethodsEighty volunteer patients were included in this multicentric prospective study and followed for two years: 40 patients in the Exercise group (EX), 40 patients in the Control group (Ctrl). CV risk factors: Total Cholesterol, HDL Cholesterol (HDL-c), LDL cholesterol (LDL-c), Triglycerides (TG) and Hemoglobin (Hb), and Prealbumin, Albumin, Parathormon, 25-OH Vitamin D, were checked at Month 0 (M0) and Month 24 (M24). The number of antihypertensive treatments and the Erythropoietin Stimulating Agent (ESA) required doses were collected. We noted for each group during the follow-up the number of hospitalizations for CV reasons. After two years, we compared 31 patients in EX and 35 in Ctrl. ResultsWe observed a significant decrease of total cholesterol EX group: 1.86±0.49g/L at M0 versus 1.64±0.38g/L at M24 (P<0.05). HDLc and but LDL-c remained stable in both groups. TG decreased significantly in EX: 1.76±0.89g/L vs 1.44±0.69g/L (P<0.05). The number of antihypertensive drugs per patient decreased significantly (P<0.05) in the EX group between M0 and M24 (1.61±1.28 at M0 and 0.74±0.85 at M24). The EX patients were three times less frequently hospitalized for cardiovascular reasons. There were five hospital stays versus 14 for the Ctrl group. ConclusionOur study demonstrates that an intradialytic aerobic cycling training program promotes beneficial effects on cardiovascular protection. Physical activity reduced the number of CV events in our population during two years follow-up.

Suicidal risk among patients enrolled in methadone maintenance treatment: HCV status and implications for suicide prevention (ANRS Methaville)

BackgroundSuicide is a critical issue among opioid users. The aim of this study was to assess the relationship between HCV status and suicidal risk in patients receiving methadone treatment. MethodsWe used data from Methaville, a multicenter, pragmatic randomized trial designed to evaluate the feasibility of methadone induction in primary care compared with induction in specialized centers. Suicidal risk was assessed at enrollment and after one year of methadone treatment using the suicidality module in the MINI International Neuropsychiatric Interview. Socio-demographic characteristics, drug and alcohol consumption, behavioral and personality factors, history of drug use and health indicators were also assessed. ResultsA total of 195 individuals were enrolled from January 2009 to December 2010. Suicidal risk assessment was available at month 0 (M0) and M12 for 159 (72%) and 118 (73%) individuals, respectively. Forty-four (28%) were at risk of suicide at M0 and 17 (14%) at M12 (p=0.004). One patient attempted suicide by overdose during the one-year follow-up. The following three factors were associated with suicidal risk: hepatitis C virus (HCV) positive status (OR [95%CI]=17.25 [1.14–161.07]; p=0.04), receiving food assistance (OR [95%CI]=0.05 [0.00–1.05]; p=0.05) and a higher number of health problems (OR [95%CI]=1.24 [1.08–1.44]; p=0.003). ConclusionsSpecial attention should be given to HCV-positive patients through suicidal risk prevention strategies and routine suicide assessment as part of a comprehensive approach to prevention and care for opioid users. Our results represent a new and powerful argument for the expansion of access to HCV treatment to drug users with chronic infection.

Exercise as a Protective Cardiovascular Factor in ESRD Patients

Objective: The aim of the study was to show the effectiveness of Physical Activity (PA) during dialysis as a protective treatment against cardiovascular (CV) diseases. Methods: Eighty volunteer patients were included in this multicentric prospective study and followed for one year: 40 patients in the Exercise group (EX), 40 patients in the Control group (CON). CV risk factors: Total Cholesterol, HDL Cholesterol (HDL-c), LDL cholesterol (LDL-c), Triglycerides (TG) and Hemoglobin (Hb), were checked. The number of antihypertensive treatments and the Erythropoietin Stimulating Agent (ESA) required doses were collected. We noted for each group during the follow-up the number of hospitalizations for CV reasons. Results: We observed a slight decrease of total cholesterol in both groups, more important for EX (1.82 ± 0.47 at M0 (Month 0), 1.74 ± 0.51 at M12 (Month 12) than for CON (1.60 ± 0.26 at M0; 1.63 ± 0.45 at M12). HDL-c increased in both groups, but LDL-c decreased in EX and increased in CON. The TG decreased in both groups after one year. The Hb level remained more stable in the EX group (11.70 ± 1.17 to 12.06 ± 1.11, p < 0.05) than in the CON group (11.79 ± 1.01 (M0) and 11.35 ± 1.21 (M12)). There was a significant difference between EX and CON at M12 (respectively 12.06 ± 1.11 vs. 11.35 ± 1.21). At the same time, the required doses of Erythropoietin Stimulating Agent (ESA) decreased in EX and increased in CON. The number of antihypertensive drugs per patient decreased significantly (p < 0.05) in the EX group between M0 and M12 (1.85 ± 1.08 at M0 and 1.55 ± 0.85 at M12). The EX patients were 3 times less frequently hospitalized for cardiovascular reasons. There were 3 hospital stays versus 20 for the CON group. Conclusion: Our study demonstrates that an intradialytic aerobic cycling training program promotes beneficial effects on cardiovascular protection: Lipids control, HTA control and Hb stability. Physical Activity although reduced the CV events in our population during one year follow-up.

Implications of combined ovariectomy and glucocorticoid (dexamethasone) treatment on mineral, microarchitectural, biomechanical and matrix properties of rat bone.

Osteoporosis is one of the deleterious side effects of long-term glucocorticoid therapy. Since the condition is particularly aggressive in postmenopausal women who are on steroid therapy, in this study we have attempted to analyse the combined effect of glucocorticoid (dexamethasone) treatment and cessation of oestrogen on rat bone. The dual aim was to generate osteoporotic bone status in a short time scale and to characterise the combination of glucocorticoid-postmenopausal osteoporotic conditions. Sprague Dawley rats (N = 42) were grouped randomly into three groups: untreated control, sham-operated and ovariectomized-steroid (OVX-Steroid) rats. Control animals were euthanized with no treatment [Month 0 (M0)], while sham and OVX-Steroid rats were monitored up to 1 month (M1) and 3 months (M3) post laparotomy/post OVX-Steroid treatment. Histology, dual-energy X-ray absorptiometry (DXA), micro-computed tomography (micro-CT), and biomechanical and mRNA expression analysis of collagenous, non-collagenous matrix proteins and osteoclast markers were examined. The study indicated enhanced osteoclastogenesis and significantly lower bone mineral density (BMD) in the OVX-Steroid rats with Z-scores below -2.5, reduced torsional strength, reduced bone volume (BV/TV%), significantly enhanced trabecular separation (Tb.S), and less trabecular number (Tb.N) compared with sham rats. Osteoclast markers, cathepsin K and MMP 9 were upregulated along with Col1α1 and biglycan with no significant expression variation in fibronectin, MMP 14, LRP-5, Car II and TNC. These results show higher bone turnover with enhanced bone resorption accompanied with reduced torsional strength in OVX-Steroid rats; and these changes were attained within a short timeframe. This could be a useful model which mimics human postmenopausal osteoporosis that is associated with steroid therapy and could prove of value both in disease diagnosis and for testing generating and testing biological agents which could be used in treatment.

Adherence as a Predictor of Sexual Behaviors in People Living with HIV/AIDS during the First Year of Antiretroviral Therapy in Rural Cameroon: Data from Stratall ANRS 12110/ESTHER Trial

ObjectiveThis study aims to investigate the time pattern of inconsistence condom use (ICU) during the first year of antiretroviral therapy (ART) and its relationship with treatment adherence in naïve HIV-infected adult patients.MethodsData collection was nested within a longitudinal trial on HIV treatment. ICU was defined as reporting to have “never”, “sometimes” or “nearly always” used condoms with one’s main or casual partner(s) - either HIV-negative or of unknown HIV status in the three previous months. Adherence was defined as taking 100% of their ART prescribed doses in the 4 days before the visit and “not having interrupted treatment”, even once, for more than two consecutive days during the 4 previous weeks. Mixed logistic regression was used to study the relationship between adherence and ICU.ResultsAmong the 459 patients enrolled, 212 (46%) during 334 visits reported to have had sexual intercourse at least once with their partner(s) – either HIV-negative or of unknown HIV status- during the first 12 months of ART. The proportion of ICU was 76%, 50% and 59% at month 0 (M0), month 6 (M6) and month 12 (M12), while 60% and 66% of patients were ART-adherent at M6 and M12, respectively. After adjustment for the frequency of sexual activity, type of sexual partner(s), perceived social class and desire for a child, patients adherent to ART were less likely to report ICU when compared with baseline (AOR [95% CI]: 0.38 [0.19–0.76]; P = 0.006).ConclusionsAdherence to ART is associated with a lower risk of ICU but this result needs to be interpreted carefully. As adherence behaviors are not only determined by problems with the healthcare systems but also by social barriers encountered by patients in their daily life, counseling should not only be ART adherence-centered but also patient-centered, including sexual risk minimization and psychosocial support.

Optimized Antiretroviral Therapy with Darunavir/Ritonavir, Etravirine and/or Raltegarvir: A Salvage Therapy Option in HIV-1 Infected Patients with Long-Term Therapeutic Failures, about 23 Cases

Objectives: The aims of this study was to analyze the immuno-virologic response after optimised background antiretroviral therapy (OBT) associated to new active antiretroviral treatment (ART) in HIV-1 infected patients with chronic virologic failure. Methods: We conducted a descriptive analysis of the immuno-virologic responses in HIV-1 adult infected patients: 1) harbouring multiple therapeutic failures with ART; 2) with no virologic response obtained over 10 years (1997-2008); and 3) treated with OBT combined with new drugs including at least 1 of the 3 active ART among darunavir/ritonavir, etravirine and raltegravir; 4) observed between month 0 (M0), before new ART to month 12 (M12) after new ART initialisation. Results: Twenty three patients were included in the study. After OBT, the proportion of patients with undetectable viral load was significantly higher at M6 and M12 than M0 (86% and 73% versus 0%, p = 0.03, respectively). At the same period, the median HIV viral load decreased significantly in 19/23 (83%) patients from 4.3 to 1.69log10 HIV-1 RNA copies/ml (p 3 [0 - 604] to 449/mm3 [130 - 964] between M0 and M12 (p 3 decreased from 57% to 23% (p = 0.02). Tolerability was good and no death was recorded during the 12-month' follow-up. Conclusions: These results show that the combination of OBT with the new ART can offer a salvage therapy in patients presenting a long-term history of virologic failures.

Prospective clinical and electrophysiological follow-up on a multiple sclerosis population treated with interferon beta-1 a

Objective To analyse transcranial magnetic stimulation (TMS) variables in a prospective six-month follow-up pilot study on patients suffering from relapsing-remitting multiple sclerosis (RRMS), satisfying inclusion criteria for interferon (IFN) beta-1a treatment. Background So far, no predictive factors are available as to the course of RRMS treated with IFN beta-1 a. Design/methods Fifteen RRMS patients were studied before (month 0 (M0)) and after IFN beta-1a onset (M3, M6). The parameters analysed were motor functional score (mFS), Expanded Disability Status Scale (EDSS), and TMS variables - central motor conduction time (CMCT) and amplitude ratio (AR). Results Four of the six patients with no motor signs at inclusion, subsequently showed signs of pyramidal dysfunction. All had abnormal M0_TMS variables. The number of M0_TMS abnormalities per patient was greatest in the group that showed mFS worsening, and was significantly correlated with M6_EDSS. The M0_CMCT was significantly correlated with M6_EDSS. During follow-up, the number of patients with abnormal TMS variables decreased from 12/15 to 4/15, and the total number of abnormalities decreased from 33.3 to 16.7%. Conclusions TMS variables might be predictive of disease progression. The improvement observed here in the TMS variables may reflect an improvement in MS patients undergoing IFN beta treatment. Multiple Sclerosis 2007; 13: 348-356. http://msj.sagepub.com

Health-related quality of life in Crohn's disease: a prospective longitudinal study in 231 patients.

The aim of this work was to assess the quality of life (QoL) of patients with Crohn's disease (CD) prospectively over 1 yr and to determine factors of influence. A total of 231 CD patients were included. At month 0 (M0), M3, M6, M9, and M12, patients were given a validated QoL questionnaire (self-administered) to fill in and a clinical form referring to the period of 3 months before the visit. The QoL questionnaire was made up of the Short-Form-36 and the Rating Form of Inflammatory Bowel Disease Patients Concerns. The impact on QoL of the following factors was analyzed: age, gender, CD duration and localization, presence of extradigestive manifestations or concomitant disease, disease course, medical treatments, and surgery. We studied the correlations between QoL and disease activity assessed by both patients and investigators by a visual analog scale. At M0, all the scores of the Short-Form-36 were significantly lower than those of a standard population, nevertheless improving between M0 and M12. Patients' main worries were first "having an ostomy bag" followed by "uncertain nature of the disease," "energy level." and finally "having surgery." QoL was better correlated with assessment of disease course by the patient than by the investigator. Significant factors of impairment in QoL were female gender, tobacco, active CD, involvement of the colon, hospitalization, corticoid treatment, and surgery in the past 3 months. Conversely, intake of immunosuppressors improved QoL. Patients' QoL is impaired by CD and is underestimated by doctors. Tobacco, hospitalization, and use of corticoids have a negative impact on QoL. Conversely, the use of immunosuppressors is associated with a better QoL.