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Abstract Exopolysaccharides (EPS) produced by Klebsiella oxytoca are of environmental, pharmaceutical, and medicinal interest. However, studies about the anti-inflammatory activity of EPS produced by this microorganism still remain limited. The aim of this study was to produce, characterize, and evaluate the anti-inflammatory activity of EPS from K. oxytoca in a pleurisy model. Colorimetric analysis revealed that precipitated crude exopolysaccharides (KEPSC) and deproteinated exopolysaccharides (KEPS) present high levels of total carbohydrates (65.57% and 62.82%, respectively). Analyses of uronic acid (7.90% in KEPSC and 6.21% in KEPS) and pyruvic acid (3.01% in KEPSC and 1.68% in KEPS) confirm that the EPS are acidic. Gas chromatography-mass spectrometry analyses demonstrated that the EPS consisted of rhamnose (29.83%), glucose (11.21%), galactose (52.45%), and mannose (6.50%). The treatment of an experimental pleurisy model in rats through subcutaneous administration of 50, 100, 200, and 400 mg/kg of KEPS decreased both the volume of inflammatory exudate and the number of leukocytes recruited to the pleural cavity. The present data showed that EPS production by K. oxytoca using the method described is easy to perform and results in a good yield. In addition, we show that KEPS exhibit anti-inflammatory activity when administered subcutaneously in rats.

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PURPOSE: To evaluate the efficacy of the cellulosic exopolysaccharide membrane (CEM) as a urethral reinforcement for urethrovesical anastomosis. METHODS: Twenty eight rabbits were submitted to urethrovesical anastomosis with or without CEM reinforcement. The animals were divided into 4 groups: C7, CEM7, C14 and CEM14: (C= only anastomosis or CEM = anastomosis + CEM), evaluated after 7 weeks, and 14 weeks. The biointegration and biocompatibility of CEM were evaluated according to stenosis, fistula, urethral wall thickness, urethral epithelium, rate of inflammation and vascularization. RESULTS: Between the two experimental groups, the difference in the number of stenosis or urinary fistula was not statistically significant. The morphometric analysis revealed preservation of urethral lumen, well adhered CEM without extrusion, a controlled inflammatory process and implant vascularization. The urothelium height remained constant over time after CEM reinforcement and the membrane wall was thicker, statistically, after 14 weeks. CONCLUSION: The absence of extrusion, stenosis or urinary fistula after 14 weeks of urethrovesical anastomosis demonstrates cellulosic exopolysaccharide membrane biocompatibility and biointegration with tendency to a thicker wall.

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Abstract Purpose: To evaluate the efficacy of the cellulosic exopolysaccharide membrane (CEM) as a urethral reinforcement for urethrovesical anastomosis. Methods: Twenty eight rabbits were submitted to urethrovesical anastomosis with or without CEM reinforcement. The animals were divided into 4 groups: C7, CEM7, C14 and CEM14: (C= only anastomosis or CEM = anastomosis + CEM), evaluated after 7 weeks, and 14 weeks. The biointegration and biocompatibility of CEM were evaluated according to stenosis, fistula, urethral wall thickness, urethral epithelium, rate of inflammation and vascularization. Results: Between the two experimental groups, the difference in the number of stenosis or urinary fistula was not statistically significant. The morphometric analysis revealed preservation of urethral lumen, well adhered CEM without extrusion, a controlled inflammatory process and implant vascularization. The urothelium height remained constant over time after CEM reinforcement and the membrane wall was thicker, statistically, after 14 weeks. Conclusion: The absence of extrusion, stenosis or urinary fistula after 14 weeks of urethrovesical anastomosis demonstrates cellulosic exopolysaccharide membrane biocompatibility and biointegration with tendency to a thicker wall.

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INTRODUCTION: Burn injuries represent a high risk of morbidity and mortality. The wound healing process is complex and requires the participation of different types of cells. Therefore, new biomaterials, which innovate the wound healing process, are being investigated. OBJECTIVE: The aim of this study was to investigate the use of bacterial cellulose both in its pure state and enriched with lidocaine in full-thickness burns in rats. METHODS: Thirty rats (Wistar) (260 ± 20 gramas) divided into control group (CG), bacterial cellulose membrane group (MG) and bacterial cellulose membrane enriched with lidocaine group (MLG) were used. The burns were induced using a 150°C heated soldering iron, held on the animal neck for 10 seconds. The biomaterial was applied immediately after injury and skin samples were collected on the tenth day of the treatment. The level of significance of p⩽0.05 was used for the conclusion of the statistical analysis. RESULTS: The groups treated with the biomaterials, a histological pattern compatible with a more advanced repair stage showing skin appendages, mild inflammatory infiltrate, better collagen fiber organization and mild immunostaining COX-2 and MMP-9 was observed, when compared to the control group that did not receive any type of treatment. CONCLUSION: Thus, was concluded that the bacterial cellulose-based biomaterial both in its pure state and enriched with lidocaine optimizing the full-thickness burn wound healing in rats.

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BACKGROUND: Dry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention. METHODS: A phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains. RESULTS: The primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions. CONCLUSIONS: Xanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.

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Bacterial cellulose (BC) produced by some bacteria, among them Gluconacetobacter xylinum, which secrets an abundant 3D networks fibrils, represents an interesting emerging biocompatible nanomaterial. Since its discovery BC has shown tremendous potential in a wide range of biomedical applications, such as artificial skin, artificial blood vessels and microvessels, wound dressing, among others. BC can be easily manipulated to improve its properties and/or functionalities resulting in several BC based nanocomposites. As example BC/collagen, BC/gelatin, BC/Fibroin, BC/Chitosan, etc. Thus, the aim of this review is to discuss about the applicability in biomedicine by demonstrating a variety of forms of this biopolymer highlighting in detail some qualities of bacterial cellulose. Therefore, various biomedical applications ranging from implants and scaffolds, carriers for drug delivery, wound-dressing materials, etc. that were reported until date will be presented.

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In randomized, controlled field trials in Area Norte and Area Occidente of Santiago, Chile, 2 (Norte) or 3 (Occidente) doses of live oral typhoid vaccine Ty21a in enteric-coated capsules conferred protection against confirmed Salmonella enterica serovar Typhi disease (53% efficacy in Norte; 67% efficacy in Occidente) during 3 years of follow-up. There was also a trend in each trial showing protection against S. enterica serovar Paratyphi B disease (56% efficacy in Norte; 42% efficacy in Occidente). To enhance statistical power, an analysis was performed using pooled data from the 2 trials; this pooling of data was justified by the following facts: epidemiologic surveillance and microbiological methods were identical, the trials overlapped during 22 of the 36 months of follow-up in each trial, the estimates of efficacy against paratyphoid B fever in the 2 trials were roughly similar, and the ratio of follow-up of vaccine recipients to control subjects in both trials was ~1 : 1. In the pooled analysis, Ty21a conferred significant protection against paratyphoid B fever (efficacy, 49%; 95% confidence interval, 8%-73%; P=.019).

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OBJECTIVE: To identify evidence of the impact of Haemophilus influenzae type b (Hib) conjugate vaccine on the epidemiology of invasive Hib disease. SOURCES OF DATA: This review was based on a search of MEDLINE, LILACS, technical reports, national and international guidelines (publications from 1991 to 2005). The keywords Haemophilus influenzae type b, immunization, impact, and effectiveness, alone or in combination, were used to retrieve the articles. Studies published before 1991 and cited in the references of the studies reviewed were analyzed for useful information. SUMMARY OF THE FINDINGS: Introduction of the Hib conjugate vaccine produced great decline in the incidence of invasive Hib disease in childhood in countries where this vaccine was introduced into the routine immunization schedule. Nevertheless, the resurgence of invasive Hib disease in some regions has challenged several researchers to identify the reasons for this epidemiological pattern, as well as the measures to be implemented in order to avoid such a phenomenon. CONCLUSIONS: The use of Hib conjugate vaccine on a population scale has been greatly effective; nonetheless, changes in the vaccination scheme seem to be necessary to keep invasive Hib disease under control.

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OBJETIVO: Identificar as evidências sobre o impacto da vacina conjugada para Haemophilus influenzae tipo b (Hib) na epidemiologia da doença invasiva por Hib. FONTE DOS DADOS: Pesquisa nas bases de dados do MEDLINE, LILACS, publicações técnicas de organizações internacionais, diretrizes nacionais e internacionais, nos últimos 15 anos (1991-2005), utilizando os seguintes unitermos: Haemophilus influenzae type b, immunization, impact, effectiveness. Foram incluídas as publicações que apresentaram informação para atender o objetivo deste artigo. Artigos publicados em período anterior ao da pesquisa e citados em referências dos artigos incluídos foram analisados quanto à apresentação de informação de interesse. SíNTESE DOS DADOS: A introdução da vacina conjugada para Hib produziu grande declínio na incidência de casos de doença invasiva por Hib nos diversos países em que seu uso foi incorporado à rotina de vacinação das crianças. No entanto, o ressurgimento de casos com doença invasiva por Hib tem mobilizado vários investigadores na busca das possíveis explicações para esses eventos, bem como a identificação das medidas a serem implementadas para evitar o reaparecimento da doença. CONCLUSÕES: O uso da vacina conjugada para Hib em escala populacional tem sido extremamente efetivo. No entanto, mudanças no esquema vacinal poderão ser necessárias para a manutenção do controle da doença invasiva por Hib, frente ao atual cenário epidemiológico das infecções pelo Hib.

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Acute bacterial meningitis is an important cause of morbidity and mortality among children less than five years old, Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidis being the most important agents of bacterial meningitis in developing countries. The development of the conjugate vaccines in the beginning of the 90's, especially type b H. influenzae (Hib), and more recently the heptavalent pneumococcal and the serogroup C meningococcal vaccines, have contributed directly to changes in the epidemiological profile of these invasive diseases (direct effect) and of their carriage status (indirect effect). We review the impact of the Hib conjugate vaccine in Latin American countries, where this vaccine has been implemented, and the potential of pneumococcal and meningococcal conjugate vaccines for the reduction of meningitis worldwide. We also address constraints for the development and delivery of these vaccines and review new candidate state-of-the-art vaccines. The greatest challenge, undoubtedly, is to implement these vaccines worldwide, especially in the developing regions.

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Day care centers are a relatively new phenomenon in Brazil that bring together large numbers of young children susceptible to contagious diseases. Haemophilus influenzae (Hi) is an important infection in the age range of those attending day care centers. In the present study, the carriage rate of Haemophilus influenzae was identified in 38 day care attendees age 6 to 37 months, and 23 staff members, at a day care center in Ribeirão Preto-São Paulo, in 1997. To identify the carriers, two nasopharyngeal swabs were collected; one in July and one in December. The rate of H. influenzae carriers among the children was 77%. Only 2 of 23 staff members (9%) had Hi. Among the children, there were 58 isolates in the two sampling periods; 6 of the Hi were serotype b, 1 was serotype e, and 48 isolates were non-typeable. Two were identified as H. parainfluenzae. One adult had a non-typeable Hi and 1 had H. paraphrohaemolyticus. Three of the 6 children with type B had received a conjugate vaccine against H. influenzae type b, but they still carried this bacterium in the nasopharynx (50%). Forty ribotype patterns were found among the isolates, showing a high exchange rate of nontypeable H. influenzae carriers. The results indicate that, because of the high and changing biotype of Hi carriage, day care centers should be carefully monitored as potential point source of HI disease in the community.

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OBJECTIVE: To determine total and functional serogroup C antibody response after vaccination with a quadrivalent meningococcal polysaccharide vaccine. DESIGN: Prospective, before and after intervention study. SUBJECTS: Study subjects were between the ages of 0.5 and 19.9 years, and were eligible for a community-wide public health immunization campaign against Neisseria meningitidis serogroup C. METHODS: Total and functional antibody response was measured by enzyme-linked immunosorbent assay and bactericidal assay, respectively. RESULTS: One month after vaccination, total capsular polysaccharide antibody significantly increased in all age groups; a significant rise in bactericidal antibody, that correlated with total capsular polysaccharide antibody, was seen in children 18 months of age and older. At 1 year bactericidal antibody titers were maintained but capsular polysaccharide antibody declined substantially in children younger than 5 years. CONCLUSION: Total capsular polysaccharide antibody concentration appears to be a useful surrogate measure of bactericidal antibody in children 18 months and older. Children who originally received the vaccine at less than 18 months of age should be considered for revaccination if there is a new or continuing risk of disease. Because of the differences in the total and bactericidal antibodies formed, vaccine efficacy trials are required to define which serologic measures are associated with protection.

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In this study we compared natural vs. induced Haemophilus influenzae type b (Hib) anti-capsular polyribosylribitol phosphate (PRP) antibody response in a low socioeconomic population. One hundred twenty five 2-month-old children received the complete HbOC vaccine immunization scheme and a booster dose at 15 months of age. One hundred twenty five non-immunized children served as the control group. Serum Hib anti-PRP antibody titers were determined by ELISA in all children. We found at the end of the primary immunization scheme an antibody concentration of 27.28 micrograms/ml in the immunized group vs. 7.48 micrograms/ml in the control group. The antibody response was mainly of the IgG1 class in both groups. After the booster dose the antibody concentration was 30.14 g/ml in the vaccinated group vs. 6.06 micrograms/ml in the control group (p < 0.01). Ninety nine percent of immunized and non-immunized infants had titers greater than 1 microgram/ml. These results confirm that immunization with the HbOC vaccine induces an important increase in anti-PRP specific antibody titer, but they also demonstrate that natural exposure induces responses higher than those referred as protective (1 microgram/ml).

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The incidence of invasive Haemophilus influenzae type b (Hib) infection was decreased significantly among Navajo children since the licensure of Hib conjugate vaccines, even though two lots of Hib (polyribosylribitol phosphate)-meningococcal B outer-membrane protein conjugate vaccine (PRP-OMP) widely used among the Navajo were later found to be of low immunogenicity. We measured the effectiveness of all Hib conjugate vaccines combined, PRP-OMP alone, and the PRP-OMP lots with lower-than-expected immunogenicity among Navajo infants and children. This was a matched case-control study using active, laboratory-based surveillance for the ascertainment of Navajo children 2 1/2 to 59 months of age with invasive Hib infection; 45 patients with infection and 180 control subjects were enrolled. The effectiveness of one, two, and three doses, respectively, of all Hib conjugate vaccines combined was 96% (95% confidence interval (CI) 65%, 99%), 99% (95% CI, 69%, 100%), and 99% (95% CI - 57%, 100%). The effectiveness of one or more doses of PRP-OMP was 95% (95% CI, 66%, 99%). The effectiveness of a single dose of the lots of lower-than-expected immunogenicity was 89% (95% CI, -8%, 99%). The Hib conjugate vaccine coverage increased from 49% during 1991 to 94% during 1992; no control subjects younger than 18 months of age were enrolled during 1993. The occurrence of invasive Hib infections in this population after licensure of Hib conjugate vaccines was the result of gradual vaccine uptake, not poor vaccine effectiveness. The use of PRP-OMP has been highly effective despite concerns about the immunogenicity of several lots.

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Asplenic persons are at increased risk of overwhelming sepsis caused by Streptococcus pneumoniae. Vaccination with polyvalent pneumococcal polysaccharide has been shown to stimulate a nearly normal antibody response in these individuals, indicating that active vaccination might prevent pneumococcal disease in this population. To obtain information on the duration of protective levels of pneumococcal antibody, 33 asplenic children were vaccinated and antibody levels were measured at intervals for up to 4 1/2 years after vaccination. Significant antibody decline was observed in children who had undergone splenectomy because of trauma, but antibody decline was not observed in children whose spleens had been removed because of hereditary spherocytosis. There was a highly significant difference in rates of antibody decline among the 12 antibody serotypes measured: types 1, 4, 6A, 7F, 8, 19F, and 23F showed the greatest decline. Based on measured rates of antibody decline, subprotective antibody levels (antibody nitrogen less than 300 ng/ml) for types 7F, 8, and 19F would be reached 1 to 2 years after vaccination; type 6A never reached the protective level; and antibodies against the remaining eight types either were within the protective range initially or did not show significant decline. Asplenic children may benefit from revaccination with certain antigen types (7F, 8, and 19F) 1 to 2 years after initial vaccination.

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Three hundred C3H mice were used to ascertain the validity of treatment of brain cancer with arsenicals and bacterial polysaccharide. It was found that this method of therapy was efficacious. Also, that a prophylactic effect was demonstrated. 2. In 14 patients with advanced intracranial neoplasm it was found: a) that no curative effect could be brought about once the cancer had spread beyond a certain point. This "point of no return" depends on tumor type, location and degree of brain destruction and general state of debility. b) That subjective and even some temporary objective improvement was possible even in advanced cancer. Necrosis of cancer tissue, that could be attributed to the therapy, was found in a number of cases. c) That some cases of brain cancer showed remarkable response to this form of therapy; more so if radiation therapy was given at the time of administration of the arsenical and bacterial polysaccharide. d) That some cases of brain metastasis showed "complete" destruction of the neoplasms in the brain although the patient subsequently died of the primary neoplasm and multiple metastasis. e) That the principle of enhancing the deposition of the curative material in the neoplasm by the use of bacterial polysaccharide is valid. f) That if this method of treatment (i.e. arsenical, bacterial polysaccharide and radiation) is instituted in the "early" cancer cases we may find it to be an efficacious mode of attack. g) That aresnical by mouth and bacterial polysaccharide by I.M. injection may be useful as a prophylactic to the formation of cancer. This may be contemplated for use in families that seem to show a predisposition to cancer formation. A mode of administration would probably be somewhat similary to the maintencance therapy described in the body of this paper. h) That bacterial polysaccharides have been shown to have the ability to destroy cancers.3,9 This method of enhancing the patients antigen-antibody reaction may eventually be used as a means of gaining an efficient vaccine in cancer therapy. i) Wherever possible definitive surgery should be carried out before the arsenical-bacterial polysaccharide-radiation method is instituted. j) In brain cancer, after craniotomy with removal of all or part of the neoplasm where feasible, the patient should be left with a subtemporal decompression. This will allow for the oedema of the brain that occurs with cerebral radiation therapy. k) That the principle of destruction of the cancer by certain special substances is valid. That the increase of affinity between cancer and destructive (curative) material can be brought about by administering a bacterial polysaccharide at the same time and that radiation therapy may enhance the beneficial effects of this method. 1) That the principle of brining the greatest toxicity to the cancer cells and the least toxic effect to the organism has been applied in the use of this method of treatment. m) That in some cases the cancer may not be destroyed by this therapy but may be made to retrogress or be held in check.

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