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  1. Ab Rahman N, Lim MT, Lee FY, Lee SC, Ramli A, Saharudin SN, et al.
    Vaccine, 2022 Jul 30;40(32):4394-4402.
    PMID: 35667917 DOI: 10.1016/j.vaccine.2022.05.075
    BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia.

    METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period.

    RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21).

    CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

  2. Ab Rahman N, Lim MT, Lee FY, Anak Jam EB, Peariasamy KM, Sivasampu S, et al.
    Vaccine X, 2023 Aug;14:100303.
    PMID: 37091730 DOI: 10.1016/j.jvacx.2023.100303
    This study evaluates 21-day risk of myocarditis/pericarditis following COVID-19 vaccination among those aged 12 years and older in Malaysia. We used data from nationwide COVID-19 vaccine registry linked to hospital episode database to identify individuals vaccinated with BNT162b2, CoronaVac, or ChAdOx1 and hospitalised for myocarditis/pericarditis between 1 February 2021 and 28 February 2022. There were 87 myocarditis/pericarditis cases identified within 1-21 days after vaccination. Most cases were reported following BNT16262 vaccination (77.0%) with absolute risk of 0.33 cases/100,000 vaccinated persons or 1.73 per million doses administered. Highest risk was observed following second dose and in younger, male individuals. The risk of myocarditis/pericarditis following CoronaVac and ChAdOx1 were much lower compared to BNT162b2. The findings on higher risk observed among younger following mRNA vaccine were consistent with literature and important for targeted surveillance.
  3. Ab Rahman N, Lim MT, Lee FY, Wo WK, Yeoh HS, Peariasamy KM, et al.
    Sci Rep, 2023 Nov 22;13(1):20471.
    PMID: 37993548 DOI: 10.1038/s41598-023-47486-x
    This study assessed the association between COVID-19 vaccines, SARS-CoV-2 infection and the risk of thrombocytopenia and venous thromboembolism (VTE). This self-controlled case series study used hospital records between 1st February 2021 and 28th February 2022 linked to the national immunisation registry and COVID-19 surveillance data in Malaysia. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) of events in the risk period (day 1-21 post-exposure) relative to control period with the corresponding 95% confidence interval (CI) adjusted for calendar period. We found no significant increased risk of thrombocytopenia in 1-21 days following BNT162b2, CoronaVac and ChAdOx1 vaccines while the risk was increased following SARS-CoV-2 infection (IRR 15.52, 95% CI 13.38-18.00). Similarly, vaccination with BNT162b2, CoronaVac, or ChAdOx1 was not associated with an increased risk of VTE during the 1-21 days risk period. SARS-CoV-2 infection was associated with increased risk of VTE (IRR 39.84, 95% CI 27.45-32.44). Our findings showed low event rates of thrombocytopenia and VTE following booster vaccination with comparable safety profiles between those who received homologous and heterologous booster combinations. Our findings showed the risk of thrombocytopenia and VTE was not increased after COVID-19 vaccination while the risks were substantially higher after SARS-CoV-2 infection.
  4. Choong CL, Wong HS, Lee FY, Lee CK, Kho JV, Lai YX, et al.
    Transplant Proc, 2018 Oct;50(8):2515-2520.
    PMID: 30316389 DOI: 10.1016/j.transproceed.2018.04.024
    BACKGROUND: Inhibition of calcineurin inhibitor (CNI) metabolism with diltiazem reduces the dose of tacrolimus required to achieve its therapeutic blood concentration in kidney transplant recipients (KTRs). This cost-savings maneuver is practiced in several countries, including Malaysia, but the actual impacts of diltiazem on tacrolimus blood concentration, dose-response relationship, cost-savings, and safety aspects are unknown.

    METHODS: This retrospective study was performed on all KTRs ≥18 years of age at our center from January 1, 2006 to December 31, 2015, who were prescribed diltiazem as tacrolimus-sparing agent. Blood tacrolimus trough level (TacC0) and other relevant clinical data for 70 eligible KTRs were reviewed.

    RESULTS: The dose of 1 mg tacrolimus resulted in a median TacC0 of 0.83 ± 0.52 ng/mL. With the introduction of a 90-mg/d dose diltiazem, there was a significant TacC0 increase to 1.39 ± 1.31 ng/mL/mg tacrolimus (P < .01). A further 90-mg increase in diltiazem to 180 mg/d resulted in a further increase of TacC0 to 1.66 ± 2.58 ng/mL/mg tacrolimus (P = .01). After this, despite a progressive increment of every 90-mg/d dose diltiazem to 270 mg/d and 360 mg/d, there was no further increment in TacC0 (1.44 ± 1.15 ng/mL/mg tacrolimus and 1.24 ± 0.94 ng/mL/mg tacrolimus, respectively [P < .01]). Addition of 180 mg/d diltiazem reduced the required tacrolimus dose to 4 mg/d, resulting in a cost-savings of USD 2045.92 per year (per patient) at our center. Adverse effects reported within 3 months of diltiazem introduction were bradycardia (1.4%) and postural hypotension (1.4%), which resolved after diltiazem dose reduction.

    CONCLUSION: Coadministration of tacrolimus and diltiazem in KTRs appeared to be safe and resulted in a TacC0 increment until reaching a 180-mg/d total diltiazem dose, at which point it began to decrease. This approach will result in a marked savings in immunosuppression costs among KTRs in Malaysia.

  5. Gurung R, Ali AA, Lee FY, Mra A, Hayati F
    Urol Case Rep, 2021 Sep;38:101687.
    PMID: 33996498 DOI: 10.1016/j.eucr.2021.101687
    Spigelian hernia (SH) occurs due to the protrusion through a congenital or acquired defect or weakness in the Spigelian aponeurosis. SH accounts for only 0.1-0.4% of occurrence and a 17-24% risk of strangulation. We hereby report a case of a 34-year-old gentleman presented with concomitant incarceration of the omentum with small intestine and testis in Spigelian hernia sac. We have successfully operated on this patient via a transperitoneal approach with a small incision over the hernia site. This incision could be an alternative to midline laparotomy as a safe and effective method in managing incarcerated SH in an emergency setting.
  6. Islahudin F, Lee FY, Tengku Abd Kadir TNI, Abdullah MZ, Makmor-Bakry M
    Res Social Adm Pharm, 2021 10;17(10):1831-1840.
    PMID: 33589374 DOI: 10.1016/j.sapharm.2021.02.002
    BACKGROUND: An adherence model is required to optimise medication management among chronic kidney disease (CKD) patients, as current assessment methods overestimate the true adherence of CKD patients with complex regimens. An approach to assess adherence to individual medications is required to assist pharmacists in addressing non-adherence.

    OBJECTIVE: To develop an adherence prediction model for CKD patients.

    METHODS: This multi-centre, cross-sectional study was conducted in 10 tertiary hospitals in Malaysia using simple random sampling of CKD patients with ≥1 medication (sample size = 1012). A questionnaire-based collection of patient characteristics, adherence (defined as ≥80% consumption of each medication for the past one month), and knowledge of each medication (dose, frequency, indication, and administration) was performed. Continuous data were converted to categorical data, based on the median values, and then stratified and analysed. An adherence prediction model was developed through multiple logistic regression in the development group (n = 677) and validated on the remaining one-third of the sample (n = 335). Beta-coefficient values were then used to determine adherence scores (ranging from 0 to 7) based on the predictors identified, with lower scores indicating poorer medication adherence.

    RESULTS: Most of the 1012 patients had poor medication adherence (n = 715, 70.6%) and half had good medication knowledge (n = 506, 50%). Multiple logistic regression analysis determined 4 significant predictors of adherence: ≤7 medications (constructed score = 2, p 

  7. Jagwani AV, Mugialan P, Lee C, Fairuz M, Lee FY, Yusof MR, et al.
    Ann R Coll Surg Engl, 2022 Jun;104(6):e164-e167.
    PMID: 34846183 DOI: 10.1308/rcsann.2021.0241
    An elderly man was treated for severe acute scrotum pain with centesis. We report the diagnosis, underlying causes and management, and discuss the procedure. Centesis is performed rarely, but could be undertaken more often given the added benefits.
  8. Lee FY, Lim L, Gee T
    Med J Malaysia, 2016 Aug;71(4):215-216.
    PMID: 27770126 MyJurnal
    Epithelioid sarcoma (ES) of the small bowel is a rare gastrointestinal tumour. We report a case of gastrointestinal bleeding secondary to small bowel ES in a 55-year-old gentleman. After gastroscopy and colonoscopy failed to identify the source of bleeding, we proceeded with computed tomography angiogram of the mesentery, which revealed intraluminal blood clot in the distal jejunum with features of obstruction. This is a rare cause of obscure gastrointestinal bleeding and emphasises the need for additional evaluation in the presence of negative endoscopic findings.
  9. Lee FY, Islahudin F, Makmor-Bakry M, Wong HS, Bavanandan S
    Int J Clin Pharm, 2021 Oct;43(5):1311-1321.
    PMID: 33677789 DOI: 10.1007/s11096-021-01252-z
    Background Optimum antihypertensive drug effect in chronic kidney disease is important to mitigate disease progression. As frequent adjustments to antihypertensive drugs might lead to problems that may affect their effectiveness, the modifiable factors leading to frequent adjustments of antihypertensive drugs should be identified and addressed. Objective This study aims to identify the factors associated with frequent adjustments to antihypertensive drugs among chronic kidney disease patients receiving routine nephrology care. Setting Nephrology clinics at two Malaysian tertiary hospitals. Method This multi-centre, retrospective cohort study included adult patients under chronic kidney disease clinic follow-up. Demographic data, clinical information, laboratory data and medication characteristics from 2018 to 2020 were collected. Multiple logistic regression was used to identify the factors associated with frequent adjustments to antihypertensive drugs (≥ 1 per year). Main outcome measure Frequent adjustments to antihypertensive drugs. Results From 671 patients included in the study, 219 (32.6%) had frequent adjustments to antihypertensive drugs. Frequent adjustment to antihypertensive drugs was more likely to occur with follow-ups in multiple institutions (adjusted Odds Ratio [aOR] 1.244, 95% confidence interval [CI] 1.012, 1.530), use of traditional/complementary medicine (aOR 2.058, 95% CI 1.058, 4.001), poor medication adherence (aOR 1.563, 95% CI 1.037, 2.357), change in estimated glomerular filtration rate (aOR 0.970, 95% CI 0.951, 0.990), and albuminuria categories A2 (aOR 2.173, 95% CI 1.311, 3.603) and A3 (aOR 2.117, 95% CI 1.349, 3.322), after controlling for confounding factors. Conclusion This work highlights the importance of close monitoring of patients requiring initial adjustments to antihypertensive drugs. Antihypertensive drug adjustments may indicate events that could contribute to poorer outcomes in the future.
  10. Lee FY, Wong HS, Chan HK, Mohamed Ali N, Abu Hassan MR, Omar H, et al.
    Pharmacoepidemiol Drug Saf, 2020 12;29(12):1669-1679.
    PMID: 33064335 DOI: 10.1002/pds.5153
    PURPOSE: To determine the incidence, demographic profile, background of reporters, causative agents, severity and clinical outcomes of hepatic adverse drug reaction (ADR) reports in Malaysia using the national ADR reporting database.

    METHODS: The ADR reports recorded between 2000 and 2017 were retrospectively analysed to identify hepatic ADR reports. The trend and characteristics of hepatic ADR cases were described. Multivariate disproportionality analysis of the causative agents was performed to generate signals of hepatic ADRs.

    RESULTS: A total of 2090 hepatic ADRs (1.77% of all ADRs) were reported with mortality rate of 12.7% among cases with known clinical outcomes. The incidence of hepatic ADR reporting in Malaysia increased significantly over 18 years from 0.26 to 9.45 per million population (P 

  11. Leow YC, Roslani AC, Xavier RG, Lee FY
    Indian J Surg, 2021 May 27.
    PMID: 34075282 DOI: 10.1007/s12262-021-02945-5
    Neoadjuvant therapy is the gold standard treatment of locally advanced rectal cancer. It may induce complete sterilization of tumor cell and decreases its local recurrence rate. While 15-20% of patients were found to have pathological complete response (pCR) with combined multimodal therapy, Asian data were generally scarce. pCR rate can indicate the suitability of applying the "watch-and-wait" strategy, which advocates deferment of surgery that can alleviate surgery-associated morbidity.To determine the percentage of pCR of rectal cancer after neoadjuvant therapy. Patients diagnosed with rectal cancer underwent treatment from 2013 to 2017 were retrieved retrospectively. Demographic data, tumor localization, pre- and post-operative pathological reports, neoadjuvant therapy, and pCR status were collected from patients' records. A total of 242 out of 259 patients were treated with definitive rectal surgery. Mean age was 67.1 years old. Chinese ethnicity and male gender were predominant (n = 131, 54.1% and n = 146, 64.3% respectively). More than half (n = 124, 51.2%) had tumor located at mid or low rectum. Histologically, moderate differentiated adenocarcinoma was predominant (n = 227, 93.8%). Merely half (n = 123, 50.8%) of the patients received neoadjuvant chemoradiation therapy, but only 12 (9.8%) had a pCR. From follow-up on these 12 pCR patients, most had 2-year disease-free survival but 1 (8.3%) of the pCR had distant metastasis within 1-year post-surgery. The pathological complete response rate in our center was lower than reported. Stringent patient selection with close follow-up for patients should be carried out if the "watch-and-wait" strategy is implemented in our population.
  12. Yusof MR, Mohd Sharin MF, Aizat Sabri I, Jagwani AV, Lee FY, Ahmad Zaidi AI, et al.
    Urologiia, 2023 May.
    PMID: 37401715
    Urethral catheterization is a common procedure, but it is associated with a number of complications. Iatrogenic hypospadias can rarely occur. There is a limited literature dedicated to this condition. We report a young patient with COVID-19 with iatrogenic hypospadias of grade 3. He was undergone to a two-stage procedure with acceptable outcome. Surgical repair should be offered and performed for young patients to ensure good function with acceptable penile appearance. A surgical treatment will improve psychological, sexual and social outcomes.
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