Gestión de riesgos aplicado al diseño de un nuevo proceso productivo de un inmunoterapéutico del Centro de Ingeniería Genética y Biotecnología / Risk management applied to the design of a new production process for an immunotherapeutic from the Center for Genetic Engineering and Biotechnology

El estudio expone las acciones dirigidas a la reducción de los riesgos en el diseño de un nuevo proceso de producción del ingrediente farmacéutico activo de un inmunoterapéutico producido en el Centro de Ingeniería Genética y Biotecnología. El análisis modal de fallas y efectos fue conducido por un equipo multidisciplinario del referido centro. La administración de riesgos a la calidad se aplicó a la tecnología de obtención de una proteína recombinante con uso diagnóstico que se proponía transferir a la Dirección de Desarrollo Tecnológico. El riesgo en el diseño de un nuevo proceso de producción evaluó las fallas de mayor influencia en el bajo recobrado y el incumplimiento de las especificaciones de calidad del inmunoterapéutico. Las causas potenciales de estos fallas fueron: la insuficiente cantidad de viales de los bancos de células, el medio de cultivo complejo con componentes de origen bovino, la incorrecta manipulación de las muestras por los operarios, el uso de equipamiento no adecuado, los parámetros de operación (agitación, pH y conductividad) fuera de límites de especificación con efecto sobre la pureza por el alto porcentaje de contaminantes del hospedero; así como, un medio filtrante inadecuado unido a una incorrecta preparación del sistema de filtración redundantes en un producto no estéril. Las acciones llevaron a modificaciones en la tecnología propuesta por la Dirección de Investigaciones Biomédicas que permitió el diseño de un nuevo proceso productivo para un biofarmacéutico destinado al tratamiento de enfermedades virales crónicas(AU)

The study aimed at reducing risks in the design of a new production process for the active pharmaceutical ingredient of an immunotherapeutic produced at the Center for Genetic Engineering and Biotechnology. The failure mode and effects analysis were conducted by a multidisciplinary team from the center. Quality risk management was applied to the technology for obtaining a recombinant protein for diagnostic use that was proposed to be transferred to Technological Development Division. The risk analyses evaluated the greatest influence on low recovery and non-compliance with the immunotherapeutic quality specifications. The potential causes of the failures were: the insufficient number of vials in cell banks, the complex culture medium with components of bovine origin, the samples handling errors by the operators, the use of inappropriate equipment, the parameters of operation (agitation, pH and conductivity) outside specification limits affecting purity due to the high percentage of contaminants from the host; as well as, the inadequate filtering medium together with an incorrect preparation of the redundant filtration system in a non-sterile product. The actions could modify the technology proposed by Biomedical Research Division that allowed the design of a new production process of a biopharmaceutical product for the treatment of chronic viral diseases(AU)

In-solution buffer-free digestion for the analysis of SARS-CoV-2 RBD proteins allows a full sequence coverage and detection of post-translational modifications in a single ESI-MS spectrum

Subunit vaccines based on the receptor-binding domain (RBD) of the spike protein of SARS-CoV-2, are among the most promising strategies to fight the COVID-19 pandemic. The detailed characterization of the protein primary structure by mass spectrometry (MS) is mandatory, as described in ICHQ6B guidelines. In this work, several recombinant RBD proteins produced in five expression systems were characterized using a non-conventional protocol known as in-solution buffer-free digestion (BFD). In a single ESI-MS spectrum, BFD allowed very high sequence coverage ([≥] 99 %) and the detection of highly hydrophilic regions, including very short and hydrophilic peptides (2-8 amino acids), the His6-tagged C-terminal peptide carrying several post-translational modifications at Cys538 such as cysteinylation, glutathionylation, cyanilation, among others. The analysis using the conventional digestion protocol allowed lower sequence coverage (80-90 %) and did not detect peptides carrying some of the above-mentioned post-translational modifications. The two C-terminal peptides of a dimer [RBD(319-541)-(His)6]2 linked by an intermolecular disulfide bond (Cys538-Cys538) with twelve histidine residues were only detected by BFD. This protocol allows the detection of the four disulfide bonds present in the native RBD and the low-abundance scrambling variants, free cysteine residues, O-glycoforms and incomplete processing of the N-terminal end, if present. Artifacts that might be generated by the in-solution BFD protocol were also characterized. BFD can be easily implemented and we foresee that it can be also helpful to the characterization of mutated RBD.

Phosphodiesterase-5 inhibition improves bone regeneration at the early stages of ischemic osteonecrosis of the femoral head in rats.

Posttraumatic osteonecrosis of the femoral head (ONFH) affects patients at different ages and may lead to functional limitation and joint replacement, with total hip arthroplasty, which is a costly procedure. Proposed methods to optimize ischemic tissue regeneration have been reported. Phosphodiesterase-5 inhibitors act by inhibiting the degradation of guanosine 3',5'-cyclic monophosphate in the nitric oxide pathway, increasing its bioavailability and promoting vascular endothelial growth factor (VEGF)-mediated neovascular recruitment and the induction of tissue regeneration in the traumatized bone. Thirty male Sprague-Dawley rats (6 months old) were subjected to an experimental model of traumatic ONFH divided into two groups, according to the administration of 5 mg/kg sildenafil or water (control group). Rats were then killed at 7, 14, and 21 days. Histological (Goldner's trichrome), histochemical (periodic acid-Schiff [PAS]), and immunohistochemical (VEGF and osteopontin [OPN]) techniques were used to quantify bone and vascular responses. Higher levels of VEGF (p < 0.01) and OPN (p < 0.01) immunostaining in the epiphysis, the greater formation of osteoid tissue (p < 0.01 on Day 7; p < 0.05 on Day 14), and higher levels of PAS staining (p < 0.01 on Day 7) were observed in the sildenafil-treated group. The present study demonstrated that sildenafil optimized bone tissue regeneration by increasing VEGF signaling and OPN expression, with increased bone formation (osteoid and carbohydrate macromolecule deposition) in the early stages following traumatic ischemic insult. Thus, sildenafil treatment may improve the prognosis of patients with osteonecrosis.

Antiplasmodial and Cytotoxic Activities of Extracts of Selected Medicinal Plants Used to Treat Malaria in Embu County, Kenya.

Malaria is a deadly disease caused by a protozoan parasite whose mode of transmission is through a female Anopheles mosquito. It affects persons of all ages; however, pregnant mothers, young children, and the elderly suffer the most due to their dwindled immune state. The currently prescribed antimalarial drugs have been associated with adverse side effects ranging from intolerance to toxicity. Furthermore, the costs associated with conventional approach of managing malaria are arguably high especially for persons living in low-income countries, hence the need for alternative and complementary approaches. Medicinal plants offer a viable alternative because of their few associated side effects, are arguably cheaper, and are easily accessible. Based on the fact that studies involving antimalarial medicinal plants as potential sources of efficacious and cost-effective pharmacotherapies are far between, this research was designed to investigate antiplasmodial and cytotoxic activities of organic and aqueous extracts of selected plants used by Embu traditional medicine practitioners to treat malaria. The studied plants included Erythrina abyssinica (stem bark), Schkuhria pinnata (whole plant), Sterculia africana (stem bark), Terminalia brownii (leaves), Zanthoxylum chalybeum (leaves), Leonotis mollissima (leaves), Carissa edulis (leaves), Tithonia diversifolia (leaves and flowers), and Senna didymobotrya (leaves and pods). In vitro antiplasmodial activity studies of organic and water extracts were carried out against chloroquine-sensitive (D6) and chloroquine-resistance (W2) strains of Plasmodium falciparum. In vivo antiplasmodial studies were done by Peter's four-day suppression test to test for their in vivo antimalarial activity against P. berghei. Finally, cytotoxic effects and safety of the studied plant extracts were evaluated using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) rapid calorimetric assay technique. The water and methanolic extracts of T. brownii and S. africana and dichloromethane extracts of E. abyssinica, S. pinnata, and T. diversifolia leaves revealed high in vitro antiplasmodial activities (IC50 ≤ 10 µg/ml). Further, moderate in vivo antimalarial activities were observed for water and methanolic extracts of L. mollissima and S. africana and for dichloromethane extracts of E. abyssinica and T. diversifolia leaves. In this study, aqueous extracts of T. brownii and S. africana demonstrated high antiplasmodial activity and high selectivity indices values (SI ≥ 10) and were found to be safe. It was concluded that T. brownii and S. africana aqueous extracts were potent antiplasmodial agents. Further focused studies geared towards isolation of active constituents and determination of in vivo toxicities to ascertain their safety are warranted.

Intrapelvic Migration of the Cephalic Screw of a Proximal Femoral Long Intramedullary Nail: Case Report.

The use of cephalomedullary devices has gained popularity in the treatment of proximal femoral fractures. Despite their biomechanical advantages, several complications are well described in the literature. One of these complications, which is rarely reported, is the medial migration of the cephalic screw. The authors present this unusual complication in a case of a long-nail implant, which was treated with removal of the implants as a first step, and posterior osteosynthesis with a locked proximal femur plate as a second step, as well the outcome until fracture consolidation and resolution of the case.

Intrapelvic Migration of the Cephalic Screw of a Proximal Femoral Long Intramedullary Nail: Case Report* / Migração intrapélvica do parafuso cefálico da haste intramedular longa para fêmur proximal: Relato de caso

Abstract The use of cephalomedullary devices has gained popularity in the treatment of proximal femoral fractures. Despite their biomechanical advantages, several complications are well described in the literature. One of these complications, which is rarely reported, is the medial migration of the cephalic screw. The authors present this unusual complication in a case of a long-nail implant, which was treated with removal of the implants as a first step, and posterior osteosynthesis with a locked proximal femur plate as a second step, as well the outcome until fracture consolidation and resolution of the case.

Resumo O uso dos dispositivos cefalomedulares tem ganhado popularidade no tratamento das fraturas do fêmur proximal. Apesar das vantagens biomecânicas, várias complicações são descritas, entre as quais a migração medial do parafuso cefálico é pouco conhecida. Os autores apresentam um caso dessa complicação incomum em um implante de haste longa tratada em dois tempos cirúrgicos para a retirada dos implantes e posterior osteossíntese com placa bloqueada para fêmur proximal, assim como o desfecho até a consolidação da fratura e resolução do caso.

Barriers to Clinical Research in Latin America.

Enhancing health research capacity in developing countries is a global health priority. Understanding the orthopedic burden of disease in Latin America will require close partnership between more-developed and less-developed countries. To this end, the Osteosynthesis and Trauma Care Foundation assembled a research consortium of Latin-American orthopedic leaders. Prior to the meeting, we surveyed attendees on perceived barriers to conducting research at their institutions. During the event, working groups discussed these barriers, developed strategies for addressing them, and planned future steps for collaboration. The participants established the need for global relationships that allow colleagues from Latin America to access to training and established investigational infrastructure of North American centers to address research questions relevant to their communities. As a result of the discussion, the International Orthopaedic Multicenter Study (INORMUS) in Fracture Care was initiated. Since then, an expanded international working group, Associación de Cirujanos Traumatológicos en las Americas (ACTUAR), has been created with the purpose of promoting increased global partnership for research capacity development.

Analysis of risk factors for success of lumbar spinal stenosis surgery

ABSTRACT Objective: To identify the patient profile that obtains better clinical and quality of life improvement after lumbar spinal stenosis surgery, comparing the results in the pre and postoperative periods. Methods: Thirty-seven patients with lumbar spine stenosis submitted to surgery were prospectively evaluated. Through the 36-Item Short Form General Health Survey (SF-36) questionnaire we performed a preoperative analysis to identify morbidities and social security benefit earning. The SF-36 is a subjective postoperative questionnaire to assess surgical success six months after the surgery. Results: There were unfavorable outcomes in patients who received social security benefits and in those who had morbidities. According to the SF-36 score, the surgical result is better when the patient is non-smoker (p=0.05), non-hypertense (p=0.040), non-diabetic (p =0.010) or non sedentary (p=0.019), respectively on mental health, pain, social aspects and general health domains. Conclusion: The patient profiles that best benefit from the surgery are those who do not have morbidities and had no social security benefit. Evidence Level II, Prospective Study.

ANALYSIS OF RISK FACTORS FOR SUCCESS OF LUMBAR SPINAL STENOSIS SURGERY.

OBJECTIVE: To identify the patient profile that obtains better clinical and quality of life improvement after lumbar spinal stenosis surgery, comparing the results in the pre and postoperative periods. METHODS: Thirty-seven patients with lumbar spine stenosis submitted to surgery were prospectively evaluated. Through the 36-Item Short Form General Health Survey (SF-36) questionnaire we performed a preoperative analysis to identify morbidities and social security benefit earning. The SF-36 is a subjective postoperative questionnaire to assess surgical success six months after the surgery. RESULTS: There were unfavorable outcomes in patients who received social security benefits and in those who had morbidities. According to the SF-36 score, the surgical result is better when the patient is non-smoker (p=0.05), non-hypertense (p=0.040), non-diabetic (p =0.010) or non sedentary (p=0.019), respectively on mental health, pain, social aspects and general health domains. CONCLUSION: The patient profiles that best benefit from the surgery are those who do not have morbidities and had no social security benefit. Evidence Level II, Prospective Study.

Myocardial fibrosis and ventricular remodeling in severe chronic aortic regurgitation.

BACKGROUND: Significant symptomatic chronic aortic regurgitation (AR) leads to considerable left ventricular remodeling at the expense of myocyte hypertrophy and extracellular matrix remodeling. The relevance of interstitial fibrosis concentration in these patients is unknown. We analyzed the degree of fibrosis in the left ventricle (LV) in symptomatic patients with AR submitted to surgical treatment, and its relationship with functional and anatomical characteristics. OBJECTIVE: To evaluate myocardial fibrosis in chronic severe aortic regurgitation. METHODS: Twenty-eight patients with chronic symptomatic AR (16 with normal LV function and 12 with LV dysfunction) were selected and assessed pre- and postoperatively by echocardiography. Functional capacity was measured using maximal oxygen consumption (VO2max) through the cardiopulmonary test. Myocardial fibrosis volume fraction (MFV) was quantified through endomyocardial biopsy performed in all patients during surgery. We compared the histopathologic results with a nine-patient control group. RESULTS: The mean age was 39 +/- 12 years, 75% of the patients were male, and the rheumatic etiology accounted for 84% of the cases. Twenty-five patients remained in FC l and ll at the end of the study, and there was a significant reduction of the LV diameters between the preoperative and late postoperative timepoints. Three deaths occurred but they were not related to postoperative ventricular dysfunction. The parameters of the cardiopulmonary test were similar between pre- and postoperative timepoints. MFV in patients with AR was significantly higher than in the control group (3.47 +/- 1.9% vs 0.82 +/- 0.96%, respectively, p=0.001). There was no statistical correlation among LV fibrosis and LV diameters, LVEF and MVO2. CONCLUSION: In patients with significant symptomatic AR, the presence of limited myocardial fibrosis was not associated with clinical, echocardiographic or functional complications.

Fibrose miocárdica e remodelamento ventricular na insuficiência aórtica crônica importante / Fibrosis miocárdica y remodelación ventricular en la insuficiencia aórtica crónica severa / Myocardial fibrosis and ventricular remodeling in severe chronic aortic regurgitation

FUNDAMENTO: A insuficiência aórtica crônica importante sintomática (IAo) leva a grande remodelamento ventricular esquerdo, à custa de hipertrofia de mióciotos e remodelamento da matriz extracelular. A relevância da concentração de fibrose intersticial nos pacientes acometidos é desconhecida. Analisamos o grau de fibrose no ventrículo esquerdo (VE) em pacientes sintomáticos com IAo submetidos a tratamento cirúrgico e sua relação com características funcionais e anatômicas. OBJETIVO: Avaliar a fibrose miocárdica na insuficiência aórtica crônica importante. MÉTODOS: Selecionaram-se 28 pacientes com IAo (16 com função VE normal e 12 com disfunção do VE), os quais foram analisados no pré e pós-operatório por ecodopplercardiografia. A capacidade funcional foi medida pelo teste de esforço cardiopulmonar. Para comparação dos resultados histopatológicos, um grupo-controle de 9 pacientes foi constituído. RESULTADOS: A média etária foi de 39 ± 12 anos, 75 por cento do sexo masculino com 84 por cento de etiologia reumática. Vinte e cinco pacientes permaneceram em classes funcionais I e II ao fim do estudo e apresentaram redução significativa dos diâmetros do VE entre os momentos pré e pós-operatórios. Houve três óbitos não relacionados à disfunção VE. Os parâmetros do teste cardiopulmonar não se modificaram entre o pré e o pós-operatório. O volume de fibrose intersticial em pacientes com IAo foi significativamente quando maior comparado ao grupo controle (3,47 ± 1,9 por cento vs 0,82 ± 0,96 por cento, respectivamente, p = 0,001). Não houve correlação entre o grau de fibrose do VE, parâmetros ecocardiográficos e funcionais. CONCLUSÃO: Em pacientes com IAo, a presença de fibrose miocárdica não se associou às alterações clínicas, ecocardiográficas ou funcionais.

BACKGROUND: Significant symptomatic chronic aortic regurgitation (AR) leads to considerable left ventricular remodeling at the expense of myocyte hypertrophy and extracellular matrix remodeling. The relevance of interstitial fibrosis concentration in these patients is unknown. We analyzed the degree of fibrosis in the left ventricle (LV) in symptomatic patients with AR submitted to surgical treatment, and its relationship with functional and anatomical characteristics. OBJECTIVE: To evaluate myocardical fibrosis in chronic severe aortic regurgitation. METHODS: Twenty-eight patients with chronic symptomatic AR (16 with normal LV function and 12 with LV dysfunction) were selected and assessed pre- and postoperatively by echocardiography. Functional capacity was measured using maximal oxygen consumption (VO2max) through the cardiopulmonary test. Myocardial fibrosis volume fraction (MFV) was quantified through endomyocardial biopsy performed in all patients during surgery. We compared the histopathologic results with a nine-patient control group. RESULTS: The mean age was 39 ± 12 years, 75 percent of the patients were male, and the rheumatic etiology accounted for 84 percent of the cases. Twenty-five patients remained in FC l and ll at the end of the study, and there was a significant reduction of the LV diameters between the preoperative and late postoperative timepoints. Three deaths occurred but they were not related to postoperative ventricular dysfunction. The parameters of the cardiopulmonary test were similar between pre- and postoperative timepoints. MFV in patients with AR was significantly higher than in the control group (3.47 ± 1.9 percent vs 0.82 ± 0.96 percent, respectively, p=0.001). There was no statistical correlation among LV fibrosis and LV diameters, LVEF and MVO2. CONCLUSION: In patients with significant symptomatic AR, the presence of limited myocardial fibrosis was not associated with clinical, echocardiographic or...

FUNDAMENTO: La insuficiencia aórtica crónica severa sintomática (IAo crónica severa) ocasiona una gran remodelación ventricular izquierda, por cuenta de hipertrofia de miociotos y remodelación de la matriz extracelular. Se desconoce la relevancia de la concentración de fibrosis intersticial en los pacientes acometidos. Analizamos el grado de fibrosis en el ventrículo izquierdo (VI) en pacientes sintomáticos con IAo crónica severa sometidos a tratamiento quirúrgico y su relación con características funcionales y anatómicas. OBJETIVO: Evaluar la fibrosis miocárdica en la insuficiencia aórtica crónica severa. MÉTODOS: Se seleccionaron a 28 pacientes con IAo crónica severa (16 con función VI normal y 12 con disfunción del VI), los que se analizaron en el pre y el postoperatorio por ecocardiografía Doppler. Se midió la capacidad funcional por la prueba de esfuerzo cardiopulmonar. Para comparación de los resultados histopatológicos, se constituyó a un Grupo Control de 9 pacientes. RESULTADOS: El promedio de edad fue de 39±12 años, el 75 por ciento del sexo masculino con el 84 por ciento de etiología reumática. El total de 25 pacientes permanecieron en clases funcionales I e II al fin del estudio y presentaron reducción significativa de los diámetros del VI entre los momentos pre y postoperatorios. Hubo tres óbitos no relacionados a la disfunción VI. Los parámetros de la prueba cardiopulmonar no se modificaron entre el pre y el postoperatorio. El volumen de fibrosis intersticial en pacientes con IAo crónica severa fue significativo cuando mayor, comparado al Grupo control (3,47 ± 1,9 por ciento vs. 0,82 ±0,96 por ciento, respectivamente, p = 0,001). No hubo correlación entre el grado de fibrosis del VI, parámetros ecocardiográficos y funcionales. CONCLUSIÓN: En pacientes con IAo crónica severa, la presencia de fibrosis miocárdica no se asoció a las alteraciones clínicas, ecocardiográficas o funcionales.

O uso da membrana amniótica como substituto do tendão calcaneano: estudo experimental / Using amniotic membrane to replace calcaneus tendon. An experimental study

Objetivo: Avaliar o comportamento biológico da membrana amniótica, através de análise histológica, após implantação como enxerto do tendão calcaneano de coelhos. Métodos: Foi produzida uma lesão cirúrgica completa, com ressecção de 2cm do tendão calcaneano, na pata traseira direita de 60 coelhos machos jovens. A lesão foi tratada com enxerto de membrana amniótica humana em 30 animais (grupo A) e nos 30 restantes (grupo B) serviu como controle. A resolução da lesão foi acompanhada por seis, oito e 12 semanas, após o que os animais foram sacrificados e as peças submetidas a análise macroscópica e microscópica (técnicas histológicas, histoquímicas e imunomarcação). Na análise microscópica foi observado que, com o tempo de resolução, o colágeno, de início desorganizado, se reorganizou, a reação inflamatória desapareceu, embora em um animal do subgrupo de 12 semanas notou-se o aparecimento de células gigantes de corpo estranho e, em alguns animais com oito semanas, ocorreu uma reação alérgica representada pelo grande número de mastócitos na área tendão-membrana. Não houve a participação de miofibroblastos no processo de remodelação, demonstrando que a vasculogênese foi adequada; com aumento temporário de proteoglicanas ácidas durante a etapa de fibrilogênese em áreas do tendão e pouca participação de fibras elásticas e glicoproteínas neutras durante o processo. Resultado: A membrana amniótica comportou-se como biocompatível diferenciando-se em tecido semelhante ao preexistente (tendinoso). Conclusão: A membrana amniótica humana, quando usada em experimento, em animais, mostrou-se eficiente como elemento reparador de lesões tendinosas...

Fratura de estresse da tíbia: relato de caso / Stress fracture of the proximal third of the tibia: a case report

The authors report a tibial stress fracture in a 32 year-old man. His main complain was pain in the anteromedial portion of the knee. The clinical examination simulated a medial collateral ligament injury. The radiographic examination was normal. The MRI revealed a fracture of the anteromedial portion of the tibia. The need for MRI in selected cases is emphasized.

Mini-sternotomy for the treatment of aortic valve lesions

OBJECTIVE: To compare inverted-L mini-sternotomy performed above the sternal furcula with conventional sternotomy in patients with aortic valve diseases who undergo surgical treatment. METHODS: We operated upon 30 patients who had aortic valve lesions that had clinical and hemodynamic findings. All patients underwent inverted-L sternotomy, which extended from above the manubrium of the sternum to the 3rd right intercostal space, without opening the pleural cavity. Their ages ranged from 32 to 76 years, and 18 were males and 12 were females. We used negative pressure in a venous »-inch cannula, and the patients were maintained in Trendelemburg's position. Twenty-seven patients received bioprostheses with diameters ranging from 23 to 29mm. Three patients underwent only removal of the calcifications of the aortic valve leaflets and aortic commissurotomy. RESULTS: The mean duration of anoxic cardiac arrest was 63.11min. Access was considered good in all patients. One death was due to pulmonary and renal problems not related to the incision. All patients had a better recovery in the intensive care unit, got out of bed sooner, coughed more easily, and performed prophylactic physiotherapeutic maneuvers for respiratory problems more easily and with less pain in the incision. Early ambulation was more easily carried out by all patients. CONCLUSION: Mini-sternotomy proved to be better than the conventional sternotomy because it provided morecomfort for the patients in the early postoperative period, with less pain and greater desire for early ambulation and all its inherent advantages

Consolidaçäo da fratura após o uso prolongado de corticóide: estudo experimental em ratos / Fracture healing after prolonged use of steroids: experimental study in rats

O presente estudo tem por objetivo avaliar o efeito do uso prolongado de corticóide na consolidaçäo da fratura de tíbia em ratos. No experimento foram utilizados 50 ratos jovens; em 25 animais administrou-se hidrocortisona 0,4mg/100g/dia por via subcutânea (grupo A) e nos outros 25, usados como grupo controle, empregou-se soro fisiológico (grupo B). Após 30 dias da administraçäo de corticóide e soro fisiológico, todos os animais foram submetidos a fratura da tíbia direita. Os animais foram sacrificados com três, sete, 14, 21 e 35 dias pós-fratura. As tíbias fraturadas foram submetidas à análise histológica e radiológica para avaliaçäo das alterações induzidas pela droga. O grupo submetido à corticoterapia desenvolveu hematoma fraturário reduzido, assim como menor formaçäo de tecido cartilaginoso e, posteriormente, atraso na sua substituiçäo por tecido ósseo, mantendo o calo ósseo desorganizado e com pouca formaçäo de osso imaturo, quando comparado com o grupo controle. Verificou-se que o corticóide altera o processo de formaçäo do calo ósseo, retardando a consolidaçäo da fratura, fato detectado durante o período de avaliaçäo limitado pela pesquisa

Tratamento da pseudartrose do escafóide carpal pela técnica de Matti-Russe utilizando enxerto retirado do olecrânio / The Matti-Russe procedure with bone graft from the olecranon for nonunion of carpal scaphoid

No período compreendido entre maio de 1996 e abril de 1999, 10 pacientes com pseudartrose do escafóide foram tratados pela técnica cirúrgica de Matti-Russe modificada, que consiste na utilização de um enxerto córtico-esponjoso, retirado do olecrânio ipsilateral e implantado na cavidade pré-formada entre os dois fragmentos do escafóide. O tratamento visou a consolidação do escafóide e uma melhora significante da dor, restabelecendo a estabilidade do carpo. Todos os pacientes foram avaliados clínica e radiologicamente. A consolidação da pseudartrose foi observada em 90 por cento dos casos e a maioria dos pacientes ficou satisfeita com o resultado.

Avaliação histológica das alterações da placa epifisária distal do fêmur após uso crônico de corticóide: estudo experimental / Histologic evaluation of alterations in the epiphyseal plates of the distal femur after chronic use of corticoid: experimental study

Foram utilizados no experimento 50 ratos jovens. Em 25 animais administrou-se corticóide e nos outros 25, usados como grupo-controle, empregou-se soro fisiológico na mesma forma e via de administração. Os animais foram sacrificados com 4, 5, 6, 7 e 9 semanas de uso das substâncias e, as placas epifisárias distais do fêmur, submetidas a exame histológico para avaliação das alterações locais provocadas pela droga. Verificou-se que o corticóide promoveu alterações na estrutura e espessura da placa epifisária.

Epifisiólise proximal do fêmur: análise da fixação profilática do quadril contralateral / Slipped capital femoral epiphysis: prophylactic pinning of the contralateral hip analysis

Vinte e um pacientes foram submetidos à fixação profilática do quadril contralateral na epifisiólise proximal do fêmur, utilizando um único parafuso AO 6,5mm no mesmo ato cirúrgico da fixação do quadril acometido. Obteve-se o fechamento da placa fisária em todos os casos, não tendo ocorrido nenhuma complicação. Em razão dos elevados índices de bilateralidade, na maioria das vezes assintomática, e das possíveis seqüelas, os autores recomendam a fixação profilática como rotina.

Influência da enoxaparina na consolidaçäo das fraturas: estudo experimental em ratos / Influence of enoxaparin on bone repair: experimental study in rats

Foi realizado estudo experimental em 16 ratos da raça Wistar, com o objetivo de avaliar a influência da enoxaparina, uma heparina de baixo peso molecular, no processo de consolidaçäo e fraturas. Os animais foram divididos em dois grupos iguais, tendo suas tíbias direitas fraturadas manualmente. Os do grupo A receberam, por via subcutânea, 0,3mg de enoxaparina por dia e os do grupo B, também por via subcutânea, 0,3ml de soluçäo fisiológica diariamente, por um período de seis semanas. Os ratos foram sacrificados com uma, duas, quatro e seis semanas após a produçäo das fraturas. Suas tíbias direitas foram dissecadas e avaliadas radiográfica e histologicamente, após preparo adequado. Os resultados mostraram que a enoxaparina estimulou a formaçäo do calo ósseo em relaçäo ao grupo-controle.

Epifisiólise proximal do fêmur: estudo da fixaçäo "in situ" com um parafuso esponjosa AO 6.5mm / Slipped capital femoral epiphysis: a study of fixation with a single AO 6.5 mm screw

Foram estudados 46 quadris com diagnóstico de epifisiólise proximal do fêmur submetidos à fixaçao in situ através da colocaçao de um único parafuso tipo esponjosa AO de 6,5mm de diâmetro. Através do estudo radiográfico, avaliaram-se o posicionamento dos parafusos e o fechamento da placa fisária, assim como foi pesquisada a presença de escorregamento adicional. Os resultados funcionais foram avaliados pelos critérios de Heyman & Herndon, tendo sido encontrados 90 por cento de bons resultados no grupo de quadris com escorregamento do tipo I, II e III (pré-escorregamento, leve e moderado). Conseguiu-se o fechamento da placa fisária, evitando-se escorregamento adicional em todos os pacientes analisados, tendo sido relatados como complicaçoes do atos cirúrgicos o hematoma na ferida operatória, a penetraçao nao-diagnosticada do parafuso na articulaçao, a quebra da broca durante o ato cirúrgico, a condrólise e a necrose avascular da cabeça femoral. Em razao dos resultados apresentados, é recomendada a fixaçao in situ com um único parafuso esponjosa AO de 6,5 mm de diâmetro nos casos leves, moderados e nos pré-escorregamentos. Nos escorregamentos graves (tipo IV), outros procedimentos devem ser considerados.