Farmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos

In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.

Determinação da resistência de Staphylococcus aureus: Um desafio?

The aim of this study was to identify the resistance profile of Staphylococcus aureus strains, in relation to induced clindamycin resistance, and to detect oxacillin resistance by the routine phenotypic methods. The strains were isolated from nasal or lingual swabs taken from healthy adult carriers with no medical history of hospitalization or antibiotic treatment. Eighteen strains were distinguished by the different patterns generated by pulsed field gel electrophoresis (PFGE). Four (22.2%) of these showed sensitivity to clindamycin by the conventional antibacterial susceptibility test, but demonstrated inducible resistance to it by the D-test. One strain (5.6%) was characterized as borderline oxacillin-resistant S. aureus (BORSA), and another (5.6%) as CA MRSA (community-associated methicillin-resistant Staphylococcus aureus). Both of these strains were shown to be cefoxitin susceptible by the disk diffusion test. The polymerase chain reaction (PCR) failed to detect the mecA gene in this last strain and it was thus classified as BORSA. These results show the importance of incorporating the D-test into the routine lab tests for S. aureus inducible clindamycin resistance and also of including the cefoxitin resistance test among the phenotypic methods for MRSA characterization.

Influência da contaminação da dentina por cimentos temporários na resistência da união de sistemas adesivos

Objective: The aim of this study was to assess the bond strength of adhesive systems to dentin contaminated by temporary cements with or without eugenol. Method: Flat dentin surfaces were obtained from twenty-four human third molars. With exception of the control group (n=8), the surfaces were covered with Interim Restorative Material (Caulk Dentsplay, Milford, DE, USA) or Cavit (3M ESPE, St. Paul, MN, USA) and kept in an oven at 37°C for seven days. After removing the cements, the adhesive systems Adper Single Bond (3M ESPE, St. Paul, MN, USA) or Clearfil SE Bond (Kuraray Co. Ltd., Osaka, Japan) were applied in accordance with the manufacturers' recommendations, and then the crowns were constructed in of resin composite. The teeth were sectioned into specimens with a cross-sectional bond area of 0.81mm2, which were submitted to microtensile testing in a mechanical test machine at an actuator speed of 0.5mm/min. The data were analyzed by t- and ANOVA tests, complemented by Tukey tests (α=0.05). Results: For Adper Single Bond (3M ESPE, St. Paul, MN, USA), bond strength did not differ statistically (p>0.05) for all the experimental conditions. For Clearfil SE Bond (Kuraray Co. Ltd., Osaka, Japan), only the Interim Restorative Material (Caulk Dentsplay, Milford, DE, USA) Group showed significantly lower bond strength (30.1 ± 13.8 MPa) in comparison with the other groups; control (38.9 ± 13.5 MPa) and Cavit (3M ESPE, St. Paul, MN, USA) (42.1 ± 11.0 MPa), which showed no significant difference between them. Conclusion: It was concluded that the previous covering of dentin with temporary cement containing eugenol had a deleterious effect on the adhesive performance of the self-etching system only.

Avaliação de Diferentes Compósitos na Resistência à Fratura de Núcleos de Preenchimento

Objective: To evaluate and compare the fracture strength of different composite resins used for core buildup. Method: Thirty-six bovine teeth were decoronated at the cervical third to standardize the length of specimens at 20 mm. Under constant irrigation, the canals were prepared with #5 Largo drills corresponding to the size and diameter of #3 Reforpost fiberglass post. The posts were cemented with Enforce resin sealer, being 16 mm inside the root canal and 4 mm outside the root canal, and the material was light-activated for 30 seconds at each side. The specimens were divided into 3 groups (n=12), in which cores (4 mm diameter and 5 mm high) were prepared from a prefabricated standard with three types of composite resins: Group 1: Z100 (3M), Group 2: Z250 (3M) and Group 3: P60 (3M). The specimens were fixed in a cylindrical device with an adaptor at 45o inclination. This device was adapted to a universal testing machine (EMIC) to simulate the force until fracture of the specimen. Data were subjected to ANOVA (p<0.05). Results: The Z250 resin cores presented the highest mean fracture strength (45.453 kgf), while the mean fracture strengths in Group 1 and Group 3 were 38.014 and 39.506 kgf, respectively. P60 caused the largest number of root fractures. Conclusion: Considering the characteristics and properties of the tested resins, Z250 appears as the most indicated for core buildup.

Influência de diferentes sistemas adesivos na resistência de união de pinos de fibra à dentina intrarradicular

Objective: To evaluate the influence of three adhesive systems on the bond strength of fiber post luted to root dentine. The hypothesis was that the bond strength is influenced by the adhesive system. Method: The canals of thirty single-root bovine roots (16mm in length) were prepared using the preparation drill (FGM) until 12mm. 14 mm of each root was embedded with acrylic resin and the specimens were allocated into three groups (n=10), considering the factor adhesive (3 levels): Gr1- Scotchbond Multipurpose Plus (3M ESPE), Gr2- One Step (Bisco) and Gr3- Excite DSC (Ivoclar Vivadent). The adhesive systems were applied using a microbrush, according to the manufacture's recommendations. The fiber posts (White Post DC, FGM) were luted with dual resin cement (All-Cem,FGM). After, the cores with composite resin (Llis, FGM) were made and each set of root/post/core was submitted to the mechanical cycling (Erios, Brazil) (10 6 cycles, 84N, 4 Hz, inclination of 45 o, 37 oC, water). Each specimen was cut in 4 samples (1.8mm in thickness), which were submitted to the push-out test in a universal testing machine (ServoPulser - Shimadzu) (50Kgf, 1mm/min). The data (MPa) were analyzed using ANOVA (1-way) and Tukey test (5%). Results: The factor adhesive (P=0.00352) influenced the bond strength significantly (ANOVA). Gr1 (6.8±3.8 MPa) a presented higher bond strength values than Gr2 (3.1±1.5 MPa) b and similar to Gr3 (4.4±3.3) a,b. Moreover, Gr3 and Gr2 were similar between them (Tukey). The hypothesis was accepted. Conclusion: Based on the results it was concluded that chemical and dual polymerization adhesive system should be used for the adhesive luting fiber post procedures.

Associação do padrão de ingestão lípidica com a qualidade da dieta, resistência insulínica e homocisteinemia em adultos

Objectives: To evaluate the association between the consumption of different dietary fats with the quality of the diet, insulin resistance, and hyperhomocysteinemia in adults. Methods: Cross-sectional study conducted with 624 overweight subjects (73.7% females). Assessments of food intake (24h food recall and health eating index-HEI), anthropometry, and biochemical assays of fasting glucose, insulin (HOMA-IR and β calculus) and homocysteinemia were performed. Results: The low quality of diet was associated with the vegetable oil at 3rd quintile (≥1.5-2.0 servings) showed risk 2.9 times and cholesterol at quintiles 2nd, 3rd, and 4th was 2.0 times. HOMA-IR was higher at 5th quintile of saturated fat (≥10,7% - total caloric value) with risk of 60% and hyperhomocysteinemia the vegetable oil at 3rd quintile (>1.5-2.0 servings) with risk of 12.0 times and 5th (≥3.5 servings) 7.1 times. However, significance disappeared when adjusted for anthropometric variables. Conclusion: Dietary fats were associated with the harm diet quality, insulin resistance, and hyperhomocysteinemia. However, associations are dependant of demographic variables, dietetic, and nutritional state. © 2011 CELOM.

Perfil de resistência a antimicrobianos de Staphylococcus aureus isolados de granjas e frigoríficos de suínos

Staphylococcus aureus are involved in a wide range of clinical problems to swine industry as son in humans. Epidemiological researchs prove his potential to acquire resistantence to antibiotics. Nowadays, methicillin-resistant S. aureus (MRSA) are responsabilized for nosocomial infections and many studies are done because MRSA are spread to extra hospitalar enrivonment and frequentely isolated from domestic animals including pigs. The aim of this study was to determine the presence o S. aureus at swine farms and identify the mecA, icaA and icaD genes and the resistant proflife to antibiotics. Overal, 458 swabs were taked from five pigeris and two slautherhouses. All the samples were placed on Braid - Parker and blood agar follow by biochemical analyses. The suspect colonies were submitted to PCR to confirm the S. aureus species, by the detection of the coa gene, mecA to avaible meticillin-resistant as son to the virulence gens icaA and icaD that can determine slime production. Antibiogram were done to evaluate the response to 11 antibiotics. All pigeris and slautherhouse were positive and 81 (79%) samples were S. aureus positive including four isolates from pigs employeers. The mecA gene was not detected. The icaD gene was most frequent and 41% were positive to both genes. The antibiogram show a lot of samples penicillin and tetraciclin resistant. Most of the samples were multirestant.

Resistência de genótipos de soja ao nematoide reniforme em ambiente controlado

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)