MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.
METHODS: A cross-sectional descriptive study with convenient sampling was carried out Hospital Tuanku Ja'afar, Hospital Port Dickson and Hospital Tuanku Ampuan Najihah in Negeri Sembilan, Malaysia. The participants answered a questionnaire regarding the source of their information about organ donation, their knowledge about brain death and willingness to donate. The association between variables was tested using chi-squared test or Fischer's exact test as appropriate.
RESULTS: A total of 385 individuals completed the survey of whom 134 (35%) were willing to donate their organs upon death and 25(19%) were registered donors. Higher educational level (41%), age 30 and below (42%) and people who attended organ donation awareness campaigns (60%) were more willing to donate their organs. Correct understanding of brain death was associated with willingness to be an organ donor. The commonest reason cited for unwillingness to donate was opposition from family members.
CONCLUSION: Marital status, religion, source of knowledge and occupation are significant factors in willingness to donate organs among Malaysians. Lower age and higher educational level were positive factors towards organ donation. Direct personal contact through awareness campaigns, family and friends has a potential for greater positive impact on organ donation.
METHODS: This is a clinical audit involving all patients admitted to our institution from January 2008 to June 2018 of those who had undergone revascularization surgery for lower limb trauma.
RESULTS: Fifty-nine patients were in this study with a mean age of 28.1 years. Most of the patients were motorcyclist involved in road traffic accidents with cars (n=30, 50.8%). The popliteal artery was most commonly seen injury (n=41, 69.5%). The mean duration of ischaemia was 14.1 hours. The limb salvage rate was 89.8%.
CONCLUSION: Lower extremity vascular injury caused by RTA treated in our institution predominantly involved young patients aged between 18-30 years associated with long bone fractures causing contusion and thrombosis of the popliteal artery.
METHODS: The patients were evaluated clinically and FNP was graded using the House Brackmann (HB) scale. High resolution computerized tomography (HRCT) of the temporal bone was used to evaluate temporal bone fractures. Transmastoid facial nerve decompression was performed and the facial nerve function was re-evaluated in subsequent follow ups.
RESULTS: There were five cases with immediate onset and four with delayed onset of FNP. Only three cases had pure temporal bone fractures, the others were associated with other life threatening injuries. The sensitivity and specificity of HRCT temporal bone to detect the obvious facial canal fracture line were 50% and 40% respectively. 75% of patients with immediate onset of HB grade VI FN palsy who were operated within a month recovered completely. Surgeries for the delayed onset FNP were performed at a mean of 70 days (range 51-94). All recovered to HB grade II-III from severe FNP.
CONCLUSIONS: Our study demonstrated that transmastoid FN decompression surgery was beneficial to traumatic nerve injury. Early intervention resulted in better outcomes. However, FN function could still be salvaged even in delayed FN decompression.
METHODS: Girls received 2 (months 0 and 6 [0, 6]: n = 301; months 0 and 12 [0, 12]: n = 151) or 3 doses (months 0,2, and 6 [0, 2, 6]: n = 301); boys received 2 doses ([0, 6]: n = 301; [0, 12]: n = 150); and young women received 3 doses ([0, 2, 6]: n = 314) of 9vHPV vaccine. Anti-HPV geometric mean titers (GMTs) were assessed by competitive Luminex immunoassay (cLIA) and immunoglobulin G-Luminex immunoassay (IgG-LIA) through month 36.
RESULTS: Anti-HPV GMTs were highest 1 month after the last 9vHPV vaccine regimen dose, decreased sharply during the subsequent 12 months, and then decreased more slowly. GMTs 2 to 2.5 years after the last regimen dose in girls and boys given 2 doses were generally similar to or greater than GMTs in young women given 3 doses. Across HPV types, most boys and girls who received 2 doses (cLIA: 81%-100%; IgG-LIA: 91%-100%) and young women who received 3 doses (cLIA: 78%-98%; IgG-LIA: 91%-100%) remained seropositive 2 to 2.5 years after the last regimen dose.
CONCLUSIONS: Antibody responses persisted through 2 to 2.5 years after the last dose of a 2-dose 9vHPV vaccine regimen in girls and boys. In girls and boys, antibody responses generated by 2 doses administered 6 to 12 months apart may be sufficient to induce high-level protective efficacy through at least 2 years after the second dose.
METHODS: A total of 232 women who had experienced ≥2 unexplained RPL and 141 available male partners were recruited, with 360 healthy Malay and 166 parous female controls. Prevalence of M2 carriage and RPL odds ratios were calculated in (a) control and patient groups; (b) clinically defined subgroups in categories of pregnancy loss, primary, secondary, and tertiary; and (c) timing of pregnancy loss in early, ≤15th gestation week and "late" fetal losses, and >15th gestation week subgroups.
RESULTS: Both male and female subjects had similar M2/ANXA5 allele frequencies. The carrier rate of M2/ANXA5 for the general Malay population was 42.2 and 34.9% for parous controls. These carrier rates compared to Malay RPL subjects (52% M2 carriers) resulted in elevated odds ratios (95% confidence interval) of 1.53 (1.1 to 2.1) and 1.97 (1.3 to 3.1) accordingly for early fetal losses. Moreover, exceeding copy numbers of M2/ANXA5 alleles seemed to afflict a greater chance of RPL in couples, especially when both partners were M2 carriers.
CONCLUSION: This study confirmed the proposed role of M2/ANXA5 as embryonic, genetically associated thrombophilia predisposition factor for early RPL among ethnic Malay of Malaysia.
METHODS: A multiplex analytic microarray system was used to analyze the occurrence of antibodies to 10 different citrullinated peptides (filaggrin [fil307-324], vimentin [Vim2-17, Vim60-75], fibrinogen [Fibα563-583, Fibα580-600, Fibβ36-52, Fibβ62-81a, Fibβ62-81b], enolase [Eno5-21], and type II collagen [CitCII355-378]) in serum samples from 4,089 RA patients (1,231 Malaysian and 2,858 Swedish) and 827 healthy control subjects (249 Malaysian and 578 Swedish). The positive reaction threshold for each peptide was set separately for each population based on a specificity of 98%.
RESULTS: Distinct differences in the frequencies of 5 ACPA fine specificities (Vim60-75, Vim2-17, Fibβ62-81b, Eno5-21, and CitCII355-378) were found between the Malaysian and Swedish RA populations, despite a nearly identical percentage of patients in each population who were positive for anti-cyclic citrullinated peptide 2 antibodies. In Malaysian RA patients compared with Swedish RA patients, the frequencies of antibodies to Vim60-75 (54% versus 44%, corrected P [Pcorr ] = 1.06 × 10-8 ) and CitCII355-378 (17% versus 13%, Pcorr = 0.02) were significantly higher, while the frequencies of antibodies to Vim2-17 (25% versus 32%, Pcorr = 1.91 × 10-4 ), Fibβ62-81b (15% versus 30%, Pcorr = 2.47 × 10-22 ), and Eno5-21 (23% versus 50%, Pcorr = 3.64 × 10-57 ) were significantly lower.
CONCLUSION: Serum ACPA fine specificities differ between RA patients in different populations, although the total proportions of individuals positive for ACPAs are similar. Differing patterns of ACPA fine specificity could be attributed to variations in genetic and/or environmental factors.
Methods: This is a prospective, non-interventional, comparative study of 59 male (27 smokers and 32 non-smokers) undergraduates of a public university. Tear film stability was evaluated using non-invasive tear break-up time and fluorescein tear break-up time. Corneal staining was determined using Efron grading scale. MDEQ and OSDI Questionnaires were used to assess dry eye symptoms. Data were obtained from the right eye only and analyzed using descriptive and correlation analysis.
Results: The age range of the participants was between 19 and 25 years. The mean age for smokers and non-smokers was 22.19 ± 2.20 and 21.22 ± 1.83 years, respectively (P = 0.07). The smoker group had statistically significant lower tear film stability than the non-smoker group (P < 0.0001). Corneal staining was statistically significant higher at the nasal and temporal parts of the cornea in smokers (P < 0.05). There was a moderate correlation between tear film stability and scores of MDEQ and OSDI.
Conclusions: Tobacco smoke has a significant effect on the tear film stability, seen in reduced tear stability values among smokers. Corneal staining was found to be more extensive in the smokers. These findings would be useful to eye-care providers in the management of their dry eye patients related to smoking.