Objectives: An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer. Methods: Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis. Results: Enrollment was slow, accrual was closed when 7+ years had passed. With a medianfollow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19–0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCAon-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11–1.18; p=0.091). Conclusions Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.

Introduction: This study was designed to determine the influence of bariatric surgery on changes in the body mass index (BMI), and the control of diabetes, hypertension and dyslipidaemia among obese patients in Malaysia. Materials And Methods: This was a retrospective cohort study undertaken at a public tertiary care centre in the state of Perak, Malaysia. Information of obese patients who underwent bariatric surgery was obtained from their medical records. The changes in the BMI, HbA1C, systolic and diastolic blood pressure (SBP and DBP), and lipid levels between three months before and after the surgery were assessed. Results: The patients (n=106) were mostly Malay (66.0%), had at least one comorbidity (61.3%), and had a mean age of 40.38±11.75 years. Following surgery, the BMI of the patients was found to reduce by 9.78±5.82kg/m2. For the patients who had diabetes (n=24) and hypertension (n=47), their mean HbA1C, SBP and DBP were also shown to reduce significantly by 2.02±2.13%, 17.19±16.97mmHg, and 11.45±12.63mmHg, respectively. Meanwhile, the mean total cholesterol, triglyceride and low-density lipoprotein levels of those who had dyslipidaemia (n=21) were, respectively, lowered by 0.91±1.18mmol/L, 0.69±1.11mmol/L and 0.47±0.52mmol/L. Conclusion: The findings suggest that in addition to weight reduction, bariatric surgery is helpful in improving the diabetes, hypertension and dyslipidaemia control among obese patients. However, a large-scale trial with a control group is required to verify our findings

Objective:Escalator signage could be playing a vital role to alert users for safe use of escalators.This study aimed to evaluate the availability,standardization,and content of safety information on escalator signage in the shopping malls.Methods:An observational study was conducted from November 2017 to February 2018 to assess the availability,standardization of safety information among the signage inside the shopping mall,and the content of safety information for public safety in Malaysia.A checklist was developed by adapting escalator safety guidelines from seven countries and regions including Malaysia.Data collectors identified from the selected states were required to capture three photographs at different angles of the escalator signage for each ascending and descending directions at each entrance of the mall.Descriptive analysis was performed;each criterion was presented in frequency and percentage.Results:A total of 268 escalators from 84 shopping malls in 9 states of Malaysia were assessed.Two operating escalators were not equipped with signage.More than one-fifth (23.0％) of the signage was not standardized within the mall.The majority of safety information was displayed in the form of a pictogram,a minority of signage displayed information in both pictogram and text format:"children must hold hand" (12.7％) and "be careful of long clothing" (10.8％),respectively.Nevertheless,"toddlers should be carried" (8.6％) and "take extra care with rubber shoes/tied shoes/laces" (30.2％) were found absent in most of the signage.Conclusion:Escalator signage was present in almost all of the escalators observed.However,non-standardization of the signage of escalators should warrant the attention of relevant authorities to revise the safety guidelines and improve the quality of escalator.

Arm ; Asian Continental Ancestry Group ; Bias (Epidemiology) ; Carboplatin ; Disease-Free Survival ; Doxorubicin ; Drug Therapy ; Follow-Up Studies ; Humans ; Maintenance Chemotherapy ; Ovarian Neoplasms ; Prognosis ; Quality of Life ; Recombination, Genetic ; Sample Size

Background: Unsafe blood products may cause transfusion-transmissible infections. This study aimed to evaluate the knowledge and perceptions of blood donors regarding blood safety. Methods: This was a cross-sectional study conducted in the Kelantan state of Malaysia. The questionnaire comprised 39 questions that covered areas such as donors’ social demographic information, knowledge of transfusion-transmitted diseases, blood screening and donor eligibility and perceptions towards blood safety. The knowledge score was categorised as good or poor. Results: Of the 450 distributed questionnaires, 389 were suitable for analysis. Only 18.5% of the donors had good knowledge, with 81.5% having poor knowledge. Less than 30% were aware that people with multiple sexual partners, bisexual people and male homosexual people are permanently deferred from blood donation. Only 29.4% agreed that donors are responsible if their blood causes infection. Furthermore, 39.3% assumed that they could check their HIV status through blood donation, and 10.3% and 5.4% of the respondents believed that donors are free from infection if they wear a condom during sex or only have oral sex when involved in prostitution, respectively. Conclusion: Poor knowledge and notable misperceptions concerning safe blood donation were found among blood donors. The Ministry of Health should incorporate safe blood education in future public awareness programmes.

Introduction: Previous studies reported that a two-week double-dose clopidogrel treatment following percutaneous coronary intervention has no difference in safety compared to standard therapy. This study aimed to determine the all-cause readmission rate and survival after a year of percutaneous coronary intervention (PCI) in patients who were treated with two-week double-dose clopidogrel regimen. Methods: This was a retrospective study on patients who underwent PCI in a state general hospital in Malaysia in 2014. Patients’ one month and one-year survival status were retrieved using the hospital electronic patient management system. Patients who received a two-week course of 150mg clopidogrel and subsequently a one-year course of standard double antiplatelet therapy were included. Results: A total of 381 out of 563 patients who underwent PCI were included in the analysis, while those who were switched to ticagrelor and transferred to other hospitals post-PCI excluded. Patients had a mean age of 56.9 (SD 10.7), with majority male (331, 86.9%) and Malay (144, 37.8%). The PCI was mainly indicated for ST-elevated myocardial infarction (188, 49.3%), non-STEMI (114, 29.9%) and unstable angina (36, 9.4%). A total of 107 (28.1%) patients were readmitted within the one year post-PCI period. Readmissions were mainly due to ACS (55.5%) and bleeding events (2.4%). The 30-day and 1-year all-cause mortality was 33 cases and 43 cases, respectively. Conclusion: The low readmission and bleeding related readmission suggested that the two-week double-dose clopidogrel regimen was safe for the post PCI patients. Future randomised trial to establish the efficacy of this dosing regimen is therefore warranted.

Aim: This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet). 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.

Novel biologics that redirect cytotoxic T lymphocytes (CTLs) to kill tumor cells bearing a tumor associated antigen hold great promise in the clinic. However, the ability to safely and potently target CD3 on CTL toward tumor associated antigens (TAA) expressed on tumor cells remains a challenge of both technology and biology. Herein we describe the use of a Half DVD-Ig format that can redirect CTL to kill tumor cells. Notably, Half DVD-Ig molecules that are monovalent for each specificity demonstrated reduced non-specific CTL activation and conditional CTL activation upon binding to TAA compared to intact tetravalent DVD-Ig molecules that are bivalent for each specificity, while maintaining good drug like properties and appropriate PK properties.
Animals ; Antibodies, Bispecific ; immunology ; Antibodies, Monoclonal ; immunology ; pharmacokinetics ; CD3 Complex ; metabolism ; Cell Line, Tumor ; Cytotoxicity, Immunologic ; ErbB Receptors ; metabolism ; Female ; Humans ; Lymphocyte Activation ; immunology ; Mice, SCID ; Neoplasms ; immunology ; pathology ; Rats, Sprague-Dawley ; T-Lymphocytes, Cytotoxic ; immunology