Manual do extensionista.

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Análise de colecistectomias videolaparoscópicas no Hospital de Clínicas de Porto Alegre

OBJECTIVE: Laparoscopic cholecystectomy (LC) is the treatment of choice for cholelithiasis. Our objective was to assess the results of LC in comparison with previous data published in 1994.PATIENTS AND METHODS: From 1992 to 1999, 2,300 patients were submitted to surgery at the Hospital de Clínicas de Porto Alegre. The medical records of 1,540 of these patients were assessed retrospectively. The variables evaluated were preoperative diagnosis, duration of hospital stay and of surgery, intra- and postoperative complications, conversion rate to open surgery, and anatomicopathological examination of the gallbladder.RESULTS: The most common preoperative diagnosis was of symptomatic gallstones (92%); the average hospital stay was of 3.6 ± 6 days (median of 2 days); the average duration of surgery was of 89.5 ± 38 minutes; the most frequent intraoperative complications were gallbladder rupture (7.3%), calculi in peritoneum (0.8%), and iatrogenic bile duct injury (0.2%); and the postoperative complications reported were wound infection (1.3%), retained stones (0.6%), and biliary peritonitis (0.5%). The conversion rate to open procedure was of 2.5%, and reoperation was necessary in 1.8% of cases. There was only one death (0.06%).CONCLUSION: In comparison to data from a previous experience, there has been an improvement in LC results, but additional technical improvements can still be made. OBJETIVO: A colecistectomia videolaparoscópica (CVL) é o tratamento preferencial da colelitíase. O objetivo deste trabalho é avaliar os resultados da CVL comparando com a experiência inicial relatada em 1994.PACIENTES E MÉTODOS: De 1992 a 1999 foram operados 2.300 pacientes no Hospital de Clínicas de Porto Alegre. Deste total foram revisados retrospectivamente 1.540 prontuários. As variáveis analisadas foram a indicação cirúrgica, o tempo de internação hospitalar e cirúrgico, as complicações trans e pós-operatórias, a taxa de conversão para cirurgia aberta e o exame anatomopatológico da vesícula biliar.RESULTADOS: A principal indicação de cirurgia foi a colelitíase sintomática (92%). O tempo de internação hospitalar foi 3,6 ± 6 dias e a mediana de 2 dias e o tempo cirúrgico médio de 89,5 ± 38 minutos. As principais complicações intra-operatórias foram a perfuração da vesícula biliar (7,3%), a queda de cálculos na cavidade (0,8%) e lesão iatrogênica de via biliar (0,2%). No pós-operatório, as complicações mais freqüentes foram a infecção de ferida operatória (1,3%), a coledocolitíase residual (0,6%) e o coleperitônio (0,5%). A taxa de conversão foi de 2,5% e de reoperação de 1,8%. Houve apenas um óbito (0,06%).CONCLUSÕES: Em relação à experiência inicial, a CVL evoluiu muito, mas ainda pode ser aprimorada tecnicamente. &nbsp

The Portuguese Society of Rheumatology position paper on the use of biosimilars

Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.info:eu-repo/semantics/publishedVersio