146 research outputs found

    Quality and stability studies of metformin hydrochloride tablets marketed in Sri Lanka

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    Objective: An attempt was made to assess the quality and stability of generic and branded products of metformin hydrochloride tablets B.P.500mg marketed in Sri Lanka. Method: two generic and three branded products including the brand leader were used in this study. Three batches were selected randomly from each of the five products. Three samples of tablets from each batch were collected from different market places in this study. Each sample was tested according to British Pharmacopoeial specifications. The real time stability test was carried out for a period of six months. Results: Our results showed that all the batches of five products passed the disintegration, identification and dissolution. However one batch of brand leader did not comply with the uniformity of weight test and one batch of another branded product was found to be substandard due to failure in assay test. Hence this study showed that out of fifteen batches tested only thirteen batches are of acceptable quality at present. All the batches except the one which failed to meet the pharmacopoeial specifications for assay have passed the assay and stability test. However, considering the rate of loss of potency during stability test period it can be concluded that two of the five products will not retain the stability throughout the shelf life of the product. Conclusion: All three branded products of metformin hydrochloride tablets manufactured by foreign manufactures were found to be substandard. Hence through this study it is possible to contribute towards the concept of rational use of generic medicines in Sri Lanka.

    Early Identification of Trauma-induced Coagulopathy: Development and Validation of a Multivariable Risk Prediction Model.

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    OBJECTIVE: The aim of this study was to develop and validate a risk prediction tool for trauma-induced coagulopathy (TIC), to support early therapeutic decision-making. BACKGROUND: TIC exacerbates hemorrhage and is associated with higher morbidity and mortality. Early and aggressive treatment of TIC improves outcome. However, injured patients that develop TIC can be difficult to identify, which may compromise effective treatment. METHODS: A Bayesian Network (BN) prediction model was developed using domain knowledge of the causal mechanisms of TIC, and trained using data from 600 patients recruited into the Activation of Coagulation and Inflammation in Trauma (ACIT) study. Performance (discrimination, calibration, and accuracy) was tested using 10-fold cross-validation and externally validated on data from new patients recruited at 3 trauma centers. RESULTS: Rates of TIC in the derivation and validation cohorts were 11.8% and 11.0%, respectively. Patients who developed TIC were significantly more likely to die (54.0% vs 5.5%, P < 0.0001), require a massive blood transfusion (43.5% vs 1.1%, P < 0.0001), or require damage control surgery (55.8% vs 3.4%, P < 0.0001), than those with normal coagulation. In the development dataset, the 14-predictor BN accurately predicted this high-risk patient group: area under the receiver operating characteristic curve (AUROC) 0.93, calibration slope (CS) 0.96, brier score (BS) 0.06, and brier skill score (BSS) 0.40. The model maintained excellent performance in the validation population: AUROC 0.95, CS 1.22, BS 0.05, and BSS 0.46. CONCLUSIONS: A BN (http://www.traumamodels.com) can accurately predict the risk of TIC in an individual patient from standard admission clinical variables. This information may support early, accurate, and efficient activation of hemostatic resuscitation protocols

    The Use of the S-Quattro Dynamic External Fixator for the Treatment of Intra-Articular Phalangeal Fractures: A Review of the Literature

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    Intra-articular phalangeal fractures are a common injury. If left untreated, these injuries can lead to poor functional outcome with severe dehabilitating consequences, especially in younger patients

    Outcomes following trauma laparotomy for hypotensive trauma patients: A UK military and civilian perspective.

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    BACKGROUND: The management of trauma patients has changed radically in the last decade, and studies have shown overall improvements in survival. However, reduction in mortality for the many may obscure a lack of progress in some high-risk patients. We sought to examine the outcomes for hypotensive patients requiring laparotomy in UK military and civilian cohorts. METHODS: We undertook a review of two prospectively maintained trauma databases: the UK Joint Theatre Trauma Registry for the military cohort (February 4, 2003, to September 21, 2014) and the trauma registry of the Royal London Hospital major trauma center (January 1, 2012, to January 1, 2017) for civilian patients. Adults undergoing trauma laparotomy within 90 minutes of arrival at the emergency department (ED) were included. RESULTS: Hypotension was present on arrival at the ED in 155 (20.4%) of 761 military patients. Mortality was higher in hypotensive casualties (25.8% vs. 9.7% in normotensive casualties; p < 0.001). Hypotension was present on arrival at the ED in 63 (35.7%) of 176 civilian patients. Mortality was higher in hypotensive patients (47.6% vs. 12.4% in normotensive patients; p < 0.001). In both cohorts of hypotensive patients, neither the average injury severity, the prehospital time, the ED arrival systolic blood pressure, nor mortality rate changed significantly during the study period. CONCLUSIONS: Despite improvements in survival after trauma for patients overall, the mortality for patients undergoing laparotomy who arrive at the ED with hypotension has not changed and appears stubbornly resistant to all efforts. Specific enquiry and research should continue to be directed at this high-risk group of patients. LEVEL OF EVIDENCE: Prognostic/Epidemiologic, level IV

    ‘There is a Time to be Born and a Time to Die’ (Ecclesiastes 3:2a): Jewish Perspectives on Euthanasia

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    Reviewing the publications of prominent American rabbis who have (extensively) published on Jewish biomedical ethics, this article highlights Orthodox, Conservative and Reform opinions on a most pressing contemporary bioethical issue: euthanasia. Reviewing their opinions against the background of the halachic character of Jewish (biomedical) ethics, this article shows how from one traditional Jewish textual source diverse, even contradictory, opinions emerge through different interpretations. In this way, in the Jewish debate on euthanasia the specific methodology of Jewish (bio)ethical reasoning comes forward as well as a diversity of opinion within Judaism and its branches

    Participation in environmental enhancement and conservation activities for health and well-being in adults: a review of quantitative and qualitative evidence

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    Electives in undergraduate medical education: AMEE Guide No. 88

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    This Guide outlines the scope and potential roles an elective can contribute to undergraduate medical training and identifies ways to maximize learning opportunities, including within global health. The types of educational activity available for electives range from meeting individual educational need through to exploration of potential career pathways, with many factors influencing choice. Key areas of organization underpinning a successful elective before, during and after the placement include developing clarity of the intended educational outcomes as well as addressing practicalities such as travel and accommodation. Risk management including the implications for the participating schools as well as the student and their elective supervisors is crucial. This Guide would not be complete without some discussion around ethics and professional conduct during an elective, with consideration of the impact of elective placements, particularly in low-middle income countries
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