The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation.

BACKGROUND: Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need. METHODS: The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD. CONCLUSION: INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.

The bioaccumulation and effects of selenium in the oligochaete Lumbriculus variegatus via dissolved and dietary exposure routes.

Aquatic organisms take up selenium from solution and from their diets. Many questions remain regarding the relative importance of selenium accumulation from these sources and resulting effects in benthic invertebrates. The present study addressed the toxicity and accumulation of Se via dissolved and dietary exposures to three different Se species, in the freshwater oligochaete Lumbriculus variegatus. Worms were exposed to 20µg/g dry weight of selenite (Se(IV)), selenate (Se(VI)), or seleno-l-methionine (Se-Met) in their diet (sediment) or to 15µg/L dissolved Se in water-only exposures. While the dissolved and sediment Se levels differed greatly, such levels may co-occur at a Se-contaminated site. Se accumulation, worm population growth, lipid peroxidation (as TBARS), and Na(+)/K(+)-ATPase activity were quantified at the end of the 2-week exposure. The sediment Se-Met exposure caused 100% mortality, while worm densities were reduced by the other exposures except the Se(VI) one. Se bioaccumulation was generally higher for the sediment-Se exposure than the dissolved-Se ones, and was higher for Se(IV) than Se(VI) in the dissolved-Se exposure but not the sediment-Se one. The Se accumulation was highest for Se-Met. The oligochaetes that accumulated Se had higher levels of lipid peroxidation and reduced Na(+)/K(+)-ATPase activity. The present study's findings of differences in Se accumulation and toxicity for the three Se species, with effects generally but not exclusively a function of Se body burdens, underscore the need for research on these issues in invertebrates. Moreover, the results imply that the dietary uptake route is the predominant one for Se accumulation in L. variegatus.

Antimicrobial efficacy of green synthesized drug blended silver nanoparticles against dental caries and periodontal disease causing microorganisms.

Development of biologically inspired green synthesis of silver nanoparticles is evolving into an important branch of nano-biotechnology. In the present investigation, we report the green synthesis of silver nanoparticles (AgNPs) employing the leaf extract of Justicia glauca. Water-soluble organics present in the leaf extract are mainly responsible for the reduction of silver nitrate (AgNO3) solution to AgNPs. The AgNPs are 10-20nm in dimensions as determined by TEM images. The antimicrobial activities of green synthesized AgNPs and drug blended AgNPs have been evaluated against the dental caries and periodontal disease causing microorganisms such as Streptococcus mutans, Staphylococcus aureus, Lactobacillus acidophilus, Micrococcus luteus, Bacillus subtilis, Escherichia coli, Pseudomonas aeruginosa and Candida albicans. The AgNPs and drug blended AgNPs show a significant antibacterial and antifungal activity. Minimum inhibitory concentration (MIC) value of AgNPs determined against the selected dental caries and periodontal disease causing microorganisms are noticeable between the range of 25-75µg/mL.

Green synthesis of silver nanoparticles from leaf extract of Mimusops elengi, Linn. for enhanced antibacterial activity against multi drug resistant clinical isolates.

Green synthesis of metallic silver nanoparticles has attracted nowadays and alternative to physical and chemical approaches. In the present study, silver nanoparticles (AgNPs) were synthesized from leaf extract of Mimusops elengi, L. at room temperature. Formation of stable AgNPs at 1mM concentrations of silver nitrate (AgNO3) typically gave spherical shape particles with diameter range from 55 to 83nm. The kinetic properties of particle formation were proportional to the effect of concentration of AgNO3 solution. In order to identify the compounds responsible for the bioreduction of Ag(+) ion and the stabilization of AgNPs produced, the functional group present in Mimusops elengi, L. leaf extract was investigated using FTIR. The formation of nanoparticle was confirmed using the surface plasmon resonance band shown in UV-vis spectrophotometer. The topography and morphology of the particles were determined using scanning electron microscopy. The crystalline nature of nanoparticles was confirmed from the XRD pattern. Furthermore these green synthesized AgNPs were found to show higher antimicrobial efficacy against multi drug resistant clinical isolates.

Use of complementary and alternative medicine by cancer patients at the University of Nigeria Teaching Hospital, Enugu, Nigeria.

BACKGROUND: The use of Complementary and Alternative Medicine (CAM) by cancer patients is very common and varies between populations. The referenced English literature has no local study from Africa on this subject. This study was conducted to define the prevalence, pattern of use, and factors influencing the use of CAM by cancer patients at the University of Nigeria Teaching Hospital Enugu (UNTH-E), Nigeria METHOD: Face-to-face interviews using semi-structured questionnaire were used to determine the use of CAM by cancer patients. All consenting cancer patients were interviewed as they presented at the core surgical units of the UNTH- E, from June 2003 to September 2005. RESULTS: 160 patients were interviewed; 68 (42.5%) were males and 94 (57.5%) were females. Ages ranged from 13-86 years. Breast, urogenital system, gastrointestinal system, and soft tissue cancers predominated. One hundred and four patients (65.0%) have used CAM at some time during their current cancer illness; 56 (35.0%) patients have not used any form of CAM. There were more females than males among the non-CAM users. The use of CAM was not affected by age, marital status, level of education, religious affiliation, or socioeconomic status. The most frequently used CAMs were herbs (51.9%), faith/prayer healing (49.4%), aloe vera (23.1%), Forever Living Products (16.3%), medicinal tea (14.4%), and Blackstone (12.5%). Over 23% of those who used CAM were satisfied, but 68.3% were disappointed. Most users (67.3%) did not see any benefit from the CAM, but 25% could describe some specific benefits. More than 21% of users reported various unwanted effects. While 86.5% of CAM users will use orthodox medicine instead of CAM in the future, 9.6% will use the two together to help each other. Most users (79.8%) will not repeat CAM or recommend its use for cancer. The majority of patients (55.8%) did not mention their use of CAM to their doctors - mostly because the doctor did not ask. CONCLUSION: CAM use is common among cancer patients in Nigeria. Most users do not obtain the expected benefits, and adverse events are not uncommon. Every clinician in the field of oncology should ask his/her patients about the use of CAM; this knowledge will enable them to better counsel the patients.