Efficacy and safety of concurrent training in systemic sclerosis

Pinto, ALS, Oliveira, NC, Gualano, B, Christmann, RB, Painelli, VS, Artioli, GG, Prado, DML, and Lima, FR. Efficacy and safety of concurrent training in systemic sclerosis. J Strength Cond Res 25(5): 1423-1428, 2011-The optimal training model for patients with systemic sclerosis (SSc) is unknown. In this study, we aimed to investigate the effects of a 12-week combined resistance and aerobic training program (concurrent training) in SSc patients. Eleven patients with no evidence of pulmonary involvement were recruited for the exercise program. Lower and upper limb dynamic strengths (assessed by 1 repetition maximum [1RM] of a leg press and bench press, respectively), isometric strength (assessed by back pull and handgrip tests), balance and mobility (assessed by the timed up-and-go test), muscle function (assessed by the timed-stands test), Rodnan score, digital ulcers, Rayland`s phenomenon, and blood markers of muscle inflammation (creatine kinase and aldolase) were assessed at baseline and after the 12-week program. Exercise training significantly enhanced the 1RM leg press (41%) and 1RM bench press (13%) values and back pull (24%) and handgrip strength (11%). Muscle function was also improved (15%), but balance and mobility were not significantly changed. The time-to-exhaustion was increased (46.5%, p = 0.0004), the heart rate at rest condition was significantly reduced, and the workload and time of exercise at ventilatory thresholds and peak of exercise were increased. However, maximal and submaximal (V)over dotO(2) were unaltered (p > 0.05). The Rodnan score was unchanged, and muscle enzymes remained within normal levels. No change was observed in digital ulcers and Raynaud`s phenomenon. This is the first study to demonstrate that a 12-week concurrent training program is safe and substantially improves muscle strength, function, and aerobic capacity in SSc patients.

In Vivo Xylitol Primary Dermal Irritation and Phototoxicity Evaluation

Xylitol is a widely studied sugar with therapeutic properties and is effective against microorganisms. Despite a variety of toxicological data being available about this compound, dermal toxicological tests cannot be found. Here, the aim was to carry out in vivo assays to verify xylitol skin application safety. Primary dermal irritation studies were done with rabbits using 5 and 10% (w/w) xylitol, in either cream or gel form. Phototoxicity assays were also performed with guinea pigs, using only 10% (w/w) xylitol, in both forms. Primary dermal irritation studies revealed that xylitol topically used (5 and 10%) did not induce erythema or edema formation, but did show phototoxicity properties. Xylitol is an adequate alternative compound to be applied for skin disease control, since this application will be done together with sunscreen.

Adverse drug events in an intensive care unit of a university hospital

Purpose Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated. Methods This cross-sectional study investigated 299 medical records of patients hospitalized for 5 or more days in an ICU. ADEs were identified through intensive monitoring adopted in hospital pharmacovigilance and also ADE triggers. Adverse drug reactions (ADR) causality was classified using the Naranjo algorithm. Data were analyzed through descriptive analysis, and through univariate and multiple logistic regression. Results The most frequent ADEs were ADRs type A, of possible causality and moderate severity. The most frequent ADR was drug-induced acute kidney injury. Patients with ADEs related to DIs corresponded to 7% of the sample. The multiple logistic regression showed that length of hospitalization (OR = 1.06) and administration of cardiovascular drugs (OR = 2.2) were associated with the occurrence of ADEs. Conclusion Adverse drug reactions of clinical significance were the most frequent ADEs in the ICU studied, which reduces patient safety. The number of ADEs related to drug interactions was small, suggesting that clinical manifestations of drug interactions that harm patients are not frequent in ICUs.

Evaluation of three brands of drug interaction software for use in intensive care units

Objective To evaluate drug interaction software programs and determine their accuracy in identifying drug-drug interactions that may occur in intensive care units. Setting The study was developed in Brazil. Method Drug interaction software programs were identified through a bibliographic search in PUBMED and in LILACS (database related to the health sciences published in Latin American and Caribbean countries). The programs` sensitivity, specificity, and positive and negative predictive values were determined to assess their accuracy in detecting drug-drug interactions. The accuracy of the software programs identified was determined using 100 clinically important interactions and 100 clinically unimportant ones. Stockley`s Drug Interactions 8th edition was employed as the gold standard in the identification of drug-drug interaction. Main outcome Sensitivity, specificity, positive and negative predictive values. Results The programs studied were: Drug Interaction Checker (DIC), Drug-Reax (DR), and Lexi-Interact (LI). DR displayed the highest sensitivity (0.88) and DIC showed the lowest (0.69). A close similarity was observed among the programs regarding specificity (0.88-0.92) and positive predictive values (0.88-0.89). The DIC had the lowest negative predictive value (0.75) and DR the highest (0.91). Conclusion The DR and LI programs displayed appropriate sensitivity and specificity for identifying drug-drug interactions of interest in intensive care units. Drug interaction software programs help pharmacists and health care teams in the prevention and recognition of drug-drug interactions and optimize safety and quality of care delivered in intensive care units.

Antimicrobial drug administration errors identified in Brazilian multicentric study

Medication administration errors (MAE) are the most frequent kind of medication errors. Errors with antimicrobial drugs (AD) are relevant because they may interfere inpatient safety and in the development of microbial resistance. The aim of this study is to analyze the AD errors detected in a Brazilian multicentric study of MAE. It was a devcriptive and explorotory study carried out in clinical units in five Brazilian teaching hospitals. The hospitals were investigated during 30 days. MAE were detected by observation technique. MAE were classified in categories: wrong route(WR), wrong patient(WP), wrong dose(WD) wrong time (WT) and unordered drug (UD). AD with MA E were classified by Anatomical-Therapeutical-Chemical Classification System. AD with narrow therapeutic index (NTI) wet-e identified A descriptive statistical analysis was performed using SPSS version 11.5 software. A total of 1500 errors were observed, 277 (18.5%) of them were error with AD. The hopes of AD error were: WT87.7%, QD 6.9%, WR 1.5%, UD 3.2% and WP 0.7%. The number of AD found was 36. The mostly ATC class were fluoroquinolones 13.9%, combinations of penicillin 13.9%, macrolides 8.3% and third-generation cephalosporines 5.6%. The parenteral drug dosage form was associated with 55.6% of AD. 16.7% of AD were NTI. 47.4% of WD and 21.8% WT were with NTI drugs. This study shows that these errors should be considered potential areas for improvement in the medication process and patient safety plus there is requirement to develop rational drug use of AD.

A safety assessment methodology applied to CNS/ATM-based air traffic control system

In the last decades, the air traffic system has been changing to adapt itself to new social demands, mainly the safe growth of worldwide traffic capacity. Those changes are ruled by the Communication, Navigation, Surveillance/Air Traffic Management (CNS/ATM) paradigm, based on digital communication technologies (mainly satellites) as a way of improving communication, surveillance, navigation and air traffic management services. However, CNS/ATM poses new challenges and needs, mainly related to the safety assessment process. In face of these new challenges, and considering the main characteristics of the CNS/ATM, a methodology is proposed at this work by combining ""absolute"" and ""relative"" safety assessment methods adopted by the International Civil Aviation Organization (ICAO) in ICAO Doc.9689 [14], using Fluid Stochastic Petri Nets (FSPN) as the modeling formalism, and compares the safety metrics estimated from the simulation of both the proposed (in analysis) and the legacy system models. To demonstrate its usefulness, the proposed methodology was applied to the ""Automatic Dependent Surveillance-Broadcasting"" (ADS-B) based air traffic control system. As conclusions, the proposed methodology assured to assess CNS/ATM system safety properties, in which FSPN formalism provides important modeling capabilities, and discrete event simulation allowing the estimation of the desired safety metric. (C) 2011 Elsevier Ltd. All rights reserved.

Safety of a railway wheelset - derailment simulation with increasing lateral force

The motivation for this research is to make a comparison between dynamic results of a free railway wheelset derailment and safety limits. For this purpose, a numerical simulation of a wheelset derailment submitted to increasing lateral force is used to compare with the safety limit, using different criteria. A simplified wheelset model is used to simulate derailments with different adhesion conditions. The contact force components, including the longitudinal and spin effects, are identified in a steady-state condition on the verge of a derailment. The contact force ratios are used in a three-dimensional (3D) analytical formula to calculate the safety limits. Simulation results obtained with two contact methods were compared with the published results and the safety limit was identified with the two criteria. Results confirm Nadal`s conservative aspect and show that safety 3D analytical formula presents slightly higher safety limits for lower friction coefficients and smaller limits for high friction, in comparison with the simulation results with Fastsim.

Vehicle Dynamic Safety in Measured Rough Pavement

Dynamic vehicle behavior is used to identify safe traffic speed limits. The proposed methodology is based on the vehicle vertical wheel contact force response excited by measured pavement irregularities on the frequency domain. A quarter-car model is used to identify vehicle dynamic behavior. The vertical elevation of an unpaved road surface has been measured. The roughness spectral density is quantified as ISO Level C. Calculations for the vehicle inertance function were derived by using the vertical contact force transfer function weighed by the pavement spectral density roughness function in the frequency domain. The statistical contact load variation is obtained from the vehicle inertance density function integration. The vehicle safety behavior concept is based on its handling ability properties. The ability to generate tangential forces on the wheel/road contact interface is the key to vehicle handling. This ability is related to tire/pavement contact forces. A contribution to establish a traffic safety speed limit is obtained from the likelihood of the loss of driveability. The results show that at speeds faster than 25 km/h the likelihood of tire contact loss is possible when traveling on the measured road type. DOI: 10.1061/(ASCE)TE.19435436.0000216. (C) 2011 American Society of Civil Engineers.

Development of Control Systems for Safety Instrumented Systems

Safety Instrumented Systems (SIS) are designed to prevent and / or mitigate accidents, avoiding undesirable high potential risk scenarios, assuring protection of people`s health, protecting the environment and saving costs of industrial equipment. The design of these systems require formal methods for ensuring the safety requirements, but according material published in this area, has not identified a consolidated procedure to match the task. This sense, this article introduces a formal method for diagnosis and treatment of critical faults based on Bayesian network (BN) and Petri net (PN). This approach considers diagnosis and treatment for each safety instrumented function (SIF) including hazard and operability (HAZOP) study in the equipment or system under control. It also uses BN and Behavioral Petri net (BPN) for diagnoses and decision-making and the PN for the synthesis, modeling and control to be implemented by Safety Programmable Logic Controller (PLC). An application example considering the diagnosis and treatment of critical faults is presented and illustrates the methodology proposed.

Saxitoxins accumulation by freshwater tilapia (Oreochromis niloticus) for human consumption

The accumulation of saxitoxins (STXs) in fish from freshwater aquaculture was investigated for the first time in the present study. Cyanotoxins have been monitored in liver and muscle samples of Oreochromis miloticus by chromatographic methods, both before and after the deputation process. The results show that tilapia can accumulate STXs. Our findings suggest that deputation with clean water is an alternative process to eliminate STXs from fish and, therefore, improve the safety of tilapia for consumers. (C) 2009 Elsevier Ltd. All rights reserved.

Consumer purchase habits and views on food safety: A Brazilian study

This study aimed to evaluate the attitudes towards food safety among consumers in the city of So Paulo, the major consumer market in Brazil. Focus group sessions were conducted with 30 adults responsible for food choices and purchases. Results indicated a preference for supermarkets over street markets, for the variety of foods, convenience and confidence in the safety assurance. On the other hand, the ""naturalness"" of the products in the street markets was the main reason for purchases in those places. Participants showed concerns with respect to food additives, hormones and pesticides - technological rather than ""natural"" hazards. Minimally processed and ready-to-eat foods were considered convenient products meeting the need for time/labor-savings in the kitchen, although suspicion about wholesomeness and safety came up among consumers. Lack of awareness regarding potentially risky behaviors was observed, including handling and storage of foods in the domestic environment. In conclusion, this study suggests that Brazilian regulators should create more effective risk communication combining technical information with actual consumer perceptions of food risks. (C) 2010 Elsevier Ltd. All rights reserved.

Statin regulation of CYP3A4 and CYP3A5 expression

CYP3A4 and CYP3A5 are cytochrome P450 enzymes that are highly expressed in the liver and gut and metabolize endogenous compounds and xenobiotics. Statins are cholesterol-lowering drugs that are extensively metabolized by CYP3A4 and CYP3A5. The bioavailability of statins is affected by CYP3A4 and CYP3A5 and glucuronidases metabolism as well as uptake and efflux transporters that affect drug disposition. CYP3A4 and CYP3A5 variants have been demonstrated to influence the pharmacokinetics, efficacy and safety of statins. Inducers and inhibitors of CYP3A4 and CYP3A5 play an important role in reducing statin efficacy and increase the risk of adverse effects, respectively. Statins have been demonstrated to increase CYP3A expression in vitro, most likely because they are ligands to nuclear receptors (pregnane X receptor and constitutive androsterone receptor) that form heterodimers with retinoid X receptors and bind to responsive elements in the CYP3A4 and CYP3A5 promoter regions. This special report outlines the earlier studies on variability of response to statins owing to CYP3A variants and highlights findings on the induction of CYP3A4 and CYP3A5 expression by statins.

Evaluation of gastroprotective activity of Plinia edulis (Vell.) Sobral (Myrtaceae) leaves in rats

Plinia edulis, an arboreous species popularly known as ""cambuca"", is native to the Brazilian Atlantic Rain Forest. Despite its traditional uses, no reports are available on the safety of this utilization or on the relationship between the antiulcer activity of its extract and its phytochemical compounds. This paper reports on the investigation of the acute toxicity and gastroprotective effect of the aqueous ethanol extract of leaves of Plinia edulis on HCl/ethanol-induced ulcers. In order to correlate the secondary metabolites and the efficacy of the crude drug in traditional medicine, the extract was submitted to chromatographic fractionation after solvent partition. The extract did not show acute toxicity in mice treated with 5 g/kg p.o.. but exhibited significant antiulcer activity in rats at doses of 100, 200, and 400 mg/kg p.o., more active than the reference drug lansoprazole. The ethyl acetate fraction yielded P-amyrin, oleanolic acid, ursolic acid, and maslinic acid, which were identified based on spectrometric analyses. Since antiulcerogenic activity is not restricted to one class of compounds in plants, the triterpenoids isolated in the extract can be associated with the observed effect. (C) 2008 Elsevier Ireland Ltd. All rights reserved.

Physical, physicochemical and chemical characterization of turf, sulphur mud and fango for cosmetic application

Focusing on the therapeutic and cosmetic potentials of the thermal water, several processes were developed to achieve a raw material known as fango which presents in its constitution water, clay and organic soil. This research work aimed at characterizing turf, sulphur mud and fango from Araxa, MG, Brazil, through physical, physicochemical, inorganic and organic assessments for cosmetic and topical product proposes. The characterization permitted the determination of relevant parameters to suggest the efficacy (presence, of ions) and safety (absence of toxic metals) of those raw materials for cosmetic and pharmaceutical utilization.

Process Capability Indexes Determination on Tabletting Performance during the Process Validation for Metamizol Tablets

The aim of the present study was to provide a numerical measure, through the process capability indexes (PCIs), C(p) and C(pk), on whether or not the manufacturing process can be considered capable of producing metamizol (500 mg) tablets. They were also used as statistical tool in order to prove the consistency of the tabletting process, making sure that the tablet weight and the content uniformity of metamizol are able to comply with the preset requirements. Besides that, the ANOVA, the t-test and the test for equal variances were applied to this study, allowing additional knowledge of the tabletting phase. Therefore, the proposed statistical approach intended to assure more safety, precision and accuracy on the process validation analysis.