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Indonesia DIA-RAMADAN Study: A Real-life, Prospective and Observational of Gliclazide MR in Type-2 Diabetes Patients During Ramadan Fasting

Sat, 01 Jan 2022 00:00:00 GMT

Title: Indonesia DIA-RAMADAN Study: A Real-life, Prospective and Observational of Gliclazide MR in Type-2 Diabetes Patients During Ramadan Fasting Authors: Adi Soelistijo, Soebagijo; Makbul Aman, Andi; Zufry, Hendra Abstract: Background: Sulfonylureas (SUs) have been widely used in many countries for T2DM treatment. Gliclazide is one of the SUs with the lowest risk of hypoglycemia; however, the safety and effectiveness of gliclazide MR during Ramadan has not yet been reported in Indonesia. This study aimed to assess safety, efficacy, and tolerability of gliclazide modified release (MR) during Ramadan fasting. Methods: The study was a part of DIA-RAMADAN study, a prospective observational study with subjects of T2DM patients aged >18 years, who had either controlled or sub-optimally controlled blood glucose level, performed Ramadan fasting. Subjects had been treated with gliclazide MR for at least 90 days prior the study, and were examined for their body mass index (BMI), fasting plasma glucose (FPG) and HbA1c levels 6 to 8 weeks before Ramadan (V0) and 4 to 6 weeks after the end of Ramadan (V1). Results: Out of 198 subjects participating in the study, there were only two subjects (1.0%) who reported symptomatic HEs (either confirmed or not confirmed) and no severe HEs had been reported. There were no significant changes in HbA1c and FPG levels (p>0.05). Interestingly, there was a reduction of bodyweight (-0.4kg) from pre- to post-Ramadan (p < 0.001). Almost no subjects reported discontinuation of gliclazide MR throughout the entire study; however, there was one subject who reported a change of diabetic treatment into diet only. Conclusion: gliclazide MR is safe, well tolerated and can maintain glycemic control effectively for Indonesian patients with T2DM who perform Ramadan fasting. Keywords: type 2 DM, gliclazide MR, Ramadan, Indonesia.

The Validity and Reliability of the Indonesian Version of the Chronic Liver Disease Questionnaire (CLDQ) in Measuring Quality of Life in Patients with Liver Cirrhosis

Sat, 01 Jan 2022 00:00:00 GMT

Title: The Validity and Reliability of the Indonesian Version of the Chronic Liver Disease Questionnaire (CLDQ) in Measuring Quality of Life in Patients with Liver Cirrhosis Authors: Hasan, Irsan; Pratomo Putra, Robby; Yunihastuti, Evy; Kurniawan, Juferdy Abstract: Background: Liver cirrhosis remains the major cause of liver-related morbidity and mortality around the world. Cirrhosis also negatively affects health-related quality of life. Quality of life evaluation in cirrhosis treatment is often overlooked, despite its importance compared to traditional outcome. One of the specific tools to measure quality of life in cirrhosis patient is the Chronic Liver Disease Questionnaire (CLDQ). Although this tool has been widely used in many countries, no studies have been conducted on its validity and reliability in the Indonesian language. This study aimed to assess the validity and reliability of the Indonesian version of CLDQ using appropriate methods. Methods: This is a cross-sectional study conducted at Hepatobiliary outpatient clinic in Dr. Cipto Mangunkusumo National General Hospital (RSCM), from April-May 2021. The CLDQ was first translated into the Indonesian language and subsequent pretest was performed on 10 people, resulting in the final Indonesian version of the CLDQ. The final version was later tested in the main study with larger number of subjects (52 people). Validity was assessed using construct and external validity tests, while reliability was tested using internal consistency and test-retest methods. Results: The Indonesian version of CLDQ had a good construct validity (r 0.613-0.917), moderate external validity (54.1%), strong correlations between CLDQ and SF-36, good internal consistency (Cronbach-Alpha ≥ 0.7), and good test-retest reliability (ICC > 0.7). Conclusion: The Indonesian version of CLDQ is valid and reliable in measuring the quality of life of liver cirrhosis patients in Indonesia. Keywords: chronic liver disease questionnaire, liver cirrhosis, quality of life, validity, reliability

Correlation of Moxifloxacin Concentration, C-Reactive Protein, and Inflammatory Cytokines on QTc Interval in Rifampicin-Resistant Tuberculosis Patients Treated with Shorter Regimens

Sat, 01 Jan 2022 00:00:00 GMT

Title: Correlation of Moxifloxacin Concentration, C-Reactive Protein, and Inflammatory Cytokines on QTc Interval in Rifampicin-Resistant Tuberculosis Patients Treated with Shorter Regimens Authors: Kusmiati, Tutik; Mertaniasih, Ni Made; Nugroho Eko Putranto, Johanes Abstract: Background: Drug-resistant tuberculosis (DR-TB) is a global health concern. QTc prolongation is a serious adverse effect in DR-TB patients receiving a shorter regimen. This study aimed to evaluate the correlation of moxifloxacin concentration, CRP, and inflammatory cytokines with QTc interval in DR-TB patients treated with a shorter regimen. Methods: This study was performed in 2 groups of rifampicin-resistant (RR-TB) patients receiving shorter regimens. Correlation for all variables was analyzed. Results: CRP, IL-1β, and QTc baseline showed significant differences between 45 RR-TB patients on intensive phase and continuation phase with p-value of <0.001, 0.040, and <0.001, respectively. TNF-α and IL-6 between RR-TB patients on intensive phase and continuation phase showed no significant difference with p=0.530 and 0.477, respectively. CRP, TNF-α, IL-1 β, and IL-6 did not correlate with QTc interval in intensive phase (p=0.226, 0.281, 0.509, and 0.886, respectively), and also in continuation phase (0.805, 0.865, 0.406, 0.586, respectively). At 2 hours after taking the 48th-dose, moxifloxacin concentration did not correlate with QTc interval, both in intensive phase (p=0.576) and in continuation phase (p=0.691). At 1 hour before taking the 72nd-hour dose, moxifloxacin concentration also did not correlate with QTc interval in intensive phase (p=0.531) and continuation phase (p=0.209). Conclusion: Moxifloxacin concentration, CRP, and inflammatory cytokines did not correlate with QTc interval in RR-TB patients treated with shorter regimens. The use of moxifloxacin is safe but should be routinely monitored and considered the presence of other risk factors for QTc prolongation in RR-TB patients who received shorter regimens. Keywords: Drug-resistant Tuberculosis, shorter treatment regimen, QTc interval

Palliative Screening Tools to Identify Palliative Care Consultation at Tertiary Hospital

Sat, 01 Jan 2022 00:00:00 GMT

Title: Palliative Screening Tools to Identify Palliative Care Consultation at Tertiary Hospital Authors: Putranto, Rudi; Arianita Agung, Ratih; Irawan, Cosphiadi; Heriawan Soejono, Czeresna; Shatri, Hamzah Abstract: Background: The need of palliative care is increasing, but it is not all achievable. It is necessary to identify palliative patients in order to provide the proper care according to the needs of the patients. Cipto Mangunkusumo Hospital has been making the identification using a palliative-patient screening questionnaire, but no performance assessment has been carried out on the screening tool. This study aimed to evaluate the performance of the screening-tool questionnaire used on palliative-care patients at Cipto Mangunkusumo Hospital in order to assess the need of palliative-care consultation and to find out the optimal cut-off point of palliative care screening tools. Methods: The design of this study is cross-sectional and was conducted at Cipto Mangunkusumo National Central Public Hospital in July – October 2019. The sampling was collected by consecutive sampling. The reliability test was performed by the intraclass correlation coefficient (ICC). The internal consistency was measured by the Cronbach’s-Alpha coefficient. The criterion-validity test was run by an evaluation using the Pearson test. Results: There were 64 subjects collected, the largest age group was 51-70 years (50%). Cancer was the main disease found in most of the subjects (56 people / 87.5%). The most common comorbidity was kidney disease (11 people). The most common palliative score distribution was 6 (15 people). The average score was 7.51. The mortality rate at the hospital was 51.6%, 33 patients from a total of 64 patients. From the palliative score distribution curve, the AUC value was 0.687 with a 95% CI (0.557-0.818). The optimal cut-off point was 8. All patients were palliative according to expert opinion based on WHO criteria. Conclusion: The performance of this tool is sufficient to screen palliative patients in a terminal and complex condition, but requires improvements to screen for patients who need early palliative care. The optimal cut-off point to determine the limit of consultation on palliative patients is found at score 8. Keywords: palliative care, performance, screening questionnaire, optimal cut-off point.