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ABSTRACT Objective: To determine whether enteral melatonin decreases the incidence of delirium in critically ill adults. Methods: In this randomized controlled trial, adults were admitted to the intensive care unit and received either usual standard care alone (Control Group) or in combination with 3mg of enteral melatonin once a day at 9 PM (Melatonin Group). Concealment of allocation was done by serially numbered opaque sealed envelopes. The intensivist assessing delirium and the investigator performing the data analysis were blinded to the group allocation. The primary outcome was the incidence of delirium within 24 hours of the intensive care unit stay. The secondary outcomes were the incidence of delirium on Days 3 and 7, intensive care unit mortality, length of intensive care unit stay, duration of mechanical ventilation and Glasgow outcome score (at discharge). Results: We included 108 patients in the final analysis, with 54 patients in each group. At 24 hours of intensive care unit stay, there was no difference in the incidence of delirium between Melatonin and Control Groups (29.6 versus 46.2%; RR = 0.6; 95%CI 0.38 - 1.05; p = 0.11). No secondary outcome showed a statistically significant difference. Conclusion: Enteral melatonin 3mg is not more effective at decreasing the incidence of delirium than standard care is in critically ill adults.
RESUMO Objetivo: Determinar se a melatonina enteral diminui a incidência de delirium em adultos em estado grave. Métodos: Neste estudo controlado e randomizado, os adultos foram admitidos à unidade de terapia intensiva e/ou receberam apenas o padrão de cuidado habitual (Grupo Controle) ou o tratamento combinado com 3mg de melatonina enteral uma vez ao dia às 21h (Grupo Melatonina). A ocultação da alocação foi feita por meio de envelopes selados opacos e numerados sequencialmente. O intensivista que avaliou o delirium e o pesquisador que realizou a análise dos dados foram cegados quanto à alocação do grupo. O desfecho primário foi a incidência de delirium dentro de 24 horas de internação na unidade de terapia intensiva. Os desfechos secundários foram a incidência de delirium nos dias 3 e 7, a mortalidade na unidade de terapia intensiva, a duração da internação na unidade de terapia intensiva, a duração da ventilação mecânica e o escore da escala de desfecho de Glasgow (na alta). Resultados: Foram incluídos 108 pacientes na análise final, com 54 sujeitos em cada grupo. Em 24 horas de internação na unidade de terapia intensiva, a incidência de delirium não foi diferente entre os Grupos Melatonina e Controle (29,6% versus 46,2%; RR = 0,6; IC95% 0,38 - 1,05; p = 0,11). Nenhum desfecho secundário apresentou diferenças estatisticamente significativas. Conclusão: Em adultos em estado grave, 3mg de melatonina enteral não foi mais eficaz que os cuidados padrão na redução da incidência de delirium.
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Background: Gutka chewing is the most and popular form of smokeless tobacco use in India. Epidemiological studies showed a strong association between smokeless tobacco use and oral precancerous lesions, carcinoma and other oral mucosal lesions. Aim and objectives: To know the patterns of clinical and pathological manifestations of oral mucosal lesions in Gutka chewers (patients) attending out-patient department of oral Medicine and Radiology at Govt. Dental college/ Hospital, Hyderabad, To assess the efficacy of the oral brush cytology in the detection of precancer and cancerous conditions of the buccal mucosa. Materials and methods: Oral mucosal lesions diagnosed in patients of both sexes with Gutka chewing habit were taken at Dept. of Oral Medicine and Radiology, Govt. Dental College, Hyderabad. Total 800 cases were studied from 2006 to 2017 (10 years study), Oral Brush cytology Procedure with papanicolaou staining procedure was used. Brush cytology results were divided into 3 groups: Negative brush cytology (normal or inflammatory smear), Positive brush cytology (Dysplasia positive smear), Atypical brush biopsy (Suspicious smear). Results: Out of 800 patients, males (80%) outnumbered females. Total no of controls 2246 with 51% were males. 75% were below 30 years of age. Higher percentage of cases (60%) belonged to the P. Ram Mohan, Lakshmi Narayana, G. Sai Sowmya, Tamilarasi. Clinical, Cytological and Histopathological Correlation of Oral Mucosal Changes in Gutka Chewers - A Prospective Study. IAIM, 2018; 5(11): 70-76. Page 71 lower socio economic groups. Clinical diagnosis of sub mucosal fibrosis and carcinoma corresponding to histopathological confirmation is almost 100%. Conclusion: Oral brush cytology is useful in early detection of precancerous and cancerous conditions of the oral cavity lesions in Gutka chewers
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Aims: The aim of the present work was to design and evaluate the Imatinib mesylate microspheres using natural and semi synthetic polymers for stomach specific drug delivery. Study Design: Design and Evaluation of Imatinib Mesylate loaded microspheres Place and Duration of the Study: The study was carried out in Department of Pharmaceutics, JKKMMRF’s Annai JKK Sampoorani Ammal College of Pharmacy, between November 2012 and July 2013. Methodology: The microspheres were prepared using Sodium alginate as a polymer by Emulsification Ionic Gelation Technique. Copolymers of natural origin namely Guar gum, Karaya gum, Chitosan and semi synthetic origin namely Hydroxy propoylmethyl cellulose K4M, K15M, K100M are used as mucoadhesive polymers. The prepared microspheres were evaluated for their percentage yield, entrapment efficiency, degree of swelling, particle size, surface morphology and in-vitro mucoadhesion, drug release studies. Drug release kinetics was determined from drug release data. Selected formulations are subjected to stability studies under varying conditions of temperature and humidity. Results: The production yields of microspheres were found to be between 76.74 to 88.18%. Percentage drug entrapment efficiency of Imatinib mesylate microspheres was ranged from 65.51 to 88.78%. Particle size of the prepared microspheres was in the size range of 440-810μm. SEM analysis revealed that all the prepared microspheres were discrete, spherical in shape. The in-vitro mucoadhesive study demonstrated that Hydroxy propoylmethyl cellulose adhered to the mucus to a greater extent than other polymers. The in-vitro release study shows that, retarded release with increase in percentage of polymers. The release of drug from the microspheres followed Krosmeyer Peppas kinetics. After the stability studies, the formulations remained stable at the end of storage period. Conclusion: Based on the results, it was concluded that, the formulations with natural polymers were found to be best than semi synthetic polymers for the oral delivery of Imatinib mesylate.
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The present study involves in the formulation and evaluation of sustained release tablets of Voriconazole (250mg). The objective of the present study was to formulate Voriconazole sustained release tablets by wet granulation method by using natural (Xanthan gum, Karaya gum) and semi synthetic polymers (HPMC K100M). Lactose was used as diluting agent, Magnesium stearate was used as a lubricant and Talc was used as a glident. These sustained release tablets can release the drug up to 12 hours in predetermined rate. The formulated powder blend was evaluated for bulk density, tapped density, compressibility index and angle of repose. The formulated tablets were evaluated for physical characteristics of sustained release tablets such as thickness, hardness, friability, weight variation and drug content. The results of the formulations found to be within the limits specified in official books. The tablets were evaluated for In-vitro drug release studies by using USP type I dissolution test apparatus. The dissolution test was performed in 0.1 N HCL for 2 hr and phosphate buffer pH 6.8 for 10hrs. The in-vitro cumulative drug release profile of all formula-tions F1-F10 at 12 hours showed 84.25% to 99.82% drug release, respectively. From the data it was clear that by increasing the amount of polymer in the formulation the amount of drug release was decreased. Hence, Formulation F9 was the most promising formulation as it gives satisfactory release (99.82%) for 12 hours and F9 found to be the best formulation.
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The present study involves in the formulation and evaluation of sustained release tablets of Voriconazole (250mg). The objective of the present study was to formulate Voriconazole sustained release tablets by wet granulation method by using natural (Xanthan gum, Karaya gum) and semi synthetic polymers (HPMC K100M). Lactose was used as diluting agent, Magnesium stearate was used as a lubricant and Talc was used as a glident. These sustained release tablets can release the drug up to 12 hours in predetermined rate. The formulated powder blend was evaluated for bulk density, tapped density, compressibility index and angle of repose. The formulated tablets were evaluated for physical characteristics of sustained release tablets such as thickness, hardness, friability, weight variation and drug content. The results of the formulations found to be within the limits specified in official books. The tablets were evaluated for In-vitro drug release studies by using USP type I dissolution test apparatus. The dissolution test was performed in 0.1 N HCL for 2 hr and phosphate buffer pH 6.8 for 10hrs. The in-vitro cumulative drug release profile of all formula-tions F1-F10 at 12 hours showed 84.25% to 99.82% drug release, respectively. From the data it was clear that by increasing the amount of polymer in the formulation the amount of drug release was decreased. Hence, Formulation F9 was the most promising formulation as it gives satisfactory release (99.82%) for 12 hours and F9 found to be the best formulation.
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Prediction of outcome after cardiac surgery is difficult despite a number of models using pre-, intra- and post-operative factors. Ideally, risk factors operating in all three phases of the patients' stay in the hospital should be incorporated into any outcome prediction model. The aim of the present study was to identify the perioperative risk factors associated with morbidity, mortality and length of stay in the recovery room [LOSR] and length of stay in the hospital [LOSH]. Eighty-eight adults of either sex, patients undergoing elective open cardiac surgery were studied prospectively. The ability of a number of pre-, intra- and post-operative factors to predict outcome in the form of mortality, immediate morbidity [LOSR] and intermediate morbidity [LOSH] was assessed. Factors associated with higher mortality were preoperative prothrombin index [PTI], American Society of Anesthesiology-Physical Status [ASA-PS] grade, Cardiac Anaesthesia Risk Evaluation [CARE] score and New York Heart Association [NYHA] class, intraoperative duration of cardiopulmonary bypass [DCPB], number of inotropes used while coming off cardiopulmonary bypass and postoperatively, Acute Physiology and Chronic Health Evaluation [APACHE] II excluding the Glassgow Comma Scale [GCS] component and the number of inotropes used. Immediate morbidity was associated with preoperative PTI, inotrope usage intra- and post-operatively and the APACHE score. Intermediate morbidity was associated with DCPB and intra- and post-operative inotrope usage. Individual surgeon influenced the LOSR and the LOSH. APACHE score, a general purpose severity of illness score, was relatively ineffective in the postoperative period because of sedation, neuromuscular blockade and elective ventilation used in a number of these patients. The preoperative and intraoperative factors like CARE, ASA-PS grade, NYHA, DCPB and number of inotropes used influencing morbidity and mortality are consistent with the literature, despite the small size of our sample