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Background: Peripheral arterial disease is one of the leading complications of type 2 diabetes mellitus. The primary symptom of peripheral arterial disease is claudication pain. Exercise is known to improve the claudication pain, thereby improving the quality of life. Methods: A total of 74 participants were recruited in each group and a detailed demographic assessment was done for all the participants. The study group received a comprehensive structured exercise program and standard care whereas the control group received only the standard care. Progression of the exercise was made at the 6th week of the protocol. All the outcome measures were reassessed after the 12th weeks for both study and control group. Results: The mean age of participants was 60.78 ± 11.29 (years) and 59.98 ± 11.42 (years) for the study and control group, respectively. There was a statistically significant difference in toe brachial index (p < 0.001), ankle brachial index (p < 0.001), 6-minute walk distance (p < 0.001), WHO-BREF quality of life questionnaire (p < 0.001), and walking ability ((p < 0.001) in the study group in comparison to the control group. Conclusion: In the present study we found that comprehensive structured exercise program improves the arterial indices, quality of life, walking ability and reduces claudication pain in type 2 diabetes mellitus with peripheral arterial disease. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01426-2.
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PURPOSE: We report the rare occurrence of unilateral acute hypertensive uveitis in the acute phase of systemic leptospirosis. METHODS: Observational case report and review of literature. RESULTS: A young male mason from coastal Karnataka in south India, presenting with acute febrile illness, was diagnosed to have systemic leptospirosis. He also had features of sudden raised intraocular pressure with anterior uveitis in one eye, which subsided with medical management. CONCLUSION: Leptospirosis should be considered as a differential in the diagnosis of acute hypertensive uveitis.
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Process changes are inevitable in the life cycle of recombinant monoclonal antibody therapeutics. Products made using pre- and post-change processes are required to be comparable as demonstrated by comparability studies to qualify for continuous development and commercial supply. Establishment of comparability is a systematic process of gathering and evaluating data based on scientific understanding and clinical experience of the relationship between product quality attributes and their impact on safety and efficacy. This review summarizes the current understanding of various modifications of recombinant monoclonal antibodies. It further outlines the critical steps in designing and executing successful comparability studies to support process changes at different stages of a product's lifecycle.
Assuntos
Anticorpos Monoclonais/química , Química Farmacêutica/métodos , Química Farmacêutica/normas , Garantia da Qualidade dos Cuidados de Saúde/métodos , Proteínas Recombinantes/química , Descoberta de Drogas , Humanos , Processamento de Proteína Pós-TraducionalRESUMO
Meropenam, a beta-lactam antibiotic has been used for severe infections of skin, tissue, intra- abdominal and urogenital infections in hospitalized patients. The common adverse effects reported are diarrhoea, vomiting, rashes and hypersensitivity reactions. Here we report two cases of meropenam induced hypokalemia, wherein, meropenam was prescribed for cellulitis and urinary tract infection in the first and second case respectively. Hypokalemia can manifest as muscular weakness, fatigue, muscle cramps, constipation, ileus, flaccid paralysis, hyporeflexia, hypercapnia, tetany, rhabdomyolysis or respiratory failure. Hence, it is necessary to make physicians aware of such an adverse effect which can develop with meropenam.
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Forced degradation studies have become integral to the development of recombinant monoclonal antibody therapeutics by serving a variety of objectives from early stage manufacturability evaluation to supporting comparability assessments both pre- and post- marketing approval. This review summarizes the regulatory guidance scattered throughout different documents to highlight the expectations from various agencies such as the Food and Drug Administration and European Medicines Agency. The various purposes for forced degradation studies, commonly used conditions and the major degradation pathways under each condition are also discussed.
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Anticorpos Monoclonais/metabolismo , Química Farmacêutica/métodos , Proteínas Recombinantes/metabolismo , Tecnologia Farmacêutica/métodos , Anticorpos Monoclonais/genética , Guias como Assunto , Humanos , Concentração de Íons de Hidrogênio , Estabilidade Proteica , Proteólise , TemperaturaRESUMO
We present this rare occurrence of a 17 yr old boy, a known case of congenital hypoparathyroidism, who presented with fever and jaundice for 8 days and 2 episodes of generalised tonic-clonic seizures. Premorbidly patient was on regular oral calcium supplementations with normal serum calcium levels. Investigations revealed severe hypocalcaemia (3.2 mg/dL), low 25 hydroxyvitamin D levels and hypomagnesaemia. The marked elevation of serum bilirubin was accompanied by derangement of liver enzymes. Microbiological investigations were confirmatory for both hepatitis A and typhoid fever. In spite of the aggressive management with intravenous calcium gluconate infusion, refractory hypocalcaemia persisted with recovery only after gradual decline in the bilirubin levels. We inferred that the cholestatic process produced by both acute viral hepatitis A and typhoid fever precipitated this state of refractory hypocalcaemia in the previously well preserved patient.