AIM: This study investigated ADR signalling techniques to detect serious ADRs in Malaysian children aged from birth to 12 years old using an electronic ADRs' database.
METHODS: Four techniques (Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS)) were tested on ADR reports submitted to the National Pharmaceutical Regulatory Agency between 2016 and 2020. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the techniques were compared.
RESULTS: A total of 31 medicine-Important Medical Event pairs were found and examined among the 3152 paediatric ADR reports. Three techniques (PRR, ROR, MGPS) signalled oculogyric crisis and dystonia for metoclopramide. BCPNN and MGPS signalled angioedema for paracetamol, amoxicillin and ibuprofen. Similar performances were found for PRR, ROR and BCPNN (sensitivity of 12%, specificity of 100%, PPV of 100% and NPV of 21%). MGPS revealed the highest sensitivity (20%) and NPV (23%), as well as similar specificity and PPV (100%).
CONCLUSIONS: This study suggests that medication safety signalling techniques could be applied on electronic health records to monitor medication safety issues in children. Clinicians and medication safety specialist could prioritise the signals for further clinical consideration and prompt response.
OBJECTIVE: To determine the impact of a multidisciplinary team HF (MDT-HF) clinic on the use of guideline-directed medical therapy and patients' clinical outcomes at 1 year.
METHODS: This retrospective study was conducted in a single cardiac centre in Malaysia. Patients with HFrEF who were enrolled in the MDT-HF clinic between November 2017 and June 2020 were compared with a matched control group who received the standard of care. Data were retrieved from the hospital electronic system and were analyzed using statistical software.
RESULTS: A total of 54 patients were included in each group. Patients enrolled in the MDT-HF clinic had higher usage of renin-angiotensin system blockers (54 [100%] vs 47 [87%], p < 0.001) and higher attainment of the target dose for these agents (35 [65%] vs 5 [9%], p < 0.001). At 1 year, the mean left ventricular ejection fraction (LVEF) was significantly greater in the MDT-HF group (35.7% [standard deviation 12.3%] vs 26.2% [standard deviation 8.7%], p < 0.001), and care in the MDT-HF clinic was significantly associated with better functional class, with a lower proportion of patients categorized as having New York Heart Association class III HF at 1 year (1 [2%] vs 14 [26%], p = 0.001). Patients in the MDT-HF group also had a significantly lower rate of readmission for HF (4 [7%] vs 32 [59%], p < 0.001).
CONCLUSIONS: Patients who received care in the MDT-HF clinic had better use of guideline-directed medical therapy, greater improvement in LVEF, and a lower rate of readmission for HF at 1 year relative to patients who received the standard of care.
METHODS: A micelle was prepared using the film hydration method, and the micellar solution was lyophilized. The cake formed was analyzed. The factors investigated include the concentrations of the surfactants, ratio of vitamin E TPGS/Poloxamer 407, temperature of the hydrating solution, duration of hydration, and freezing temperature before lyophilization. The effects of these factors on the encapsulation efficiency and particle size of the micelle were also studied. The encapsulation efficiency was measured using a UV-Vis spectrophotometer, while particle size was measured using dynamic light scattering.
RESULTS: The optimized micelle was found to have 90% encapsulation efficiency with a particle size of less than 40 nm, which was achieved using a 10% concentration of surfactants at a vitamin E TPGS/Poloxamer 407 ratio of 3:1. The optimized temperature for hydrating the micellar film was 40 °C, the optimized mixing time was 1 h, and the optimized freezing temperature was -80 °C. The solubility of the luteolin-loaded micelles increased 459-fold compared to pure Lut in water. The critical micelle concentration of the vitamin E TPGS/Poloxamer 407 micelle was 0.001 mg/mL, and the release study showed that luteolin-loaded micelles exhibited sustained release behavior. The release of luteolin from a micelle was found to be higher in pH 6.8 compared to pH 7.4, which signified that luteolin could be accumulated more in a tumor microenvironment compared to blood.
CONCLUSION: This study demonstrated that several factors need to be considered when developing such nanoparticles in order to obtain a well-optimized micelle.