Pengaruh Diabetes Melitus terhadap Gambaran Klinis dan Keberhasilan Pengobatan Tuberkulosis di Tujuh RSU Kelas A dan B di Jawa dan Bali

Diabetes mellitus (DM) may complicate tuberculosis (TB) treatment and control. The National Institute of Health Research and Development in collaboration with seven referral public hospitals in Java and Bali established a disease registry system for tuberculosis (TB) and diabetes mellitus (DM). Medical records containing data of ≥15 years old patients, diagnosed with TB (ICD-10 code A15-A19) in 2014, with or without DM (ICD-10 code E10-E14) were recorded into case report form (CRF). From January 1st 2014 to January 12th 2016, the registry recorded 1975 TB cases, 15% of cases were TB-DM. 73.6% TB-DM were ≥45 years old and 70,8% TB-non DM were <45 years old. Previously treated TB cases were higher than naïve in TB-DM (OR 2.588; 95%CI 2.0-3.4). In TB-DM, predominant symptoms were cough >2 weeks (76.4%), weight loss (72.6%), loss of appetite (65.9%), and night sweats (65.2%). In TB-non DM, predominant symptoms were weight loss (59.4%), loss of appetite (57.8%), cough >2 weeks (57.6%), and fever (56.9%). Higher chest X-rays abnormality in TB-DM (OR 7.249; 95%CI 3.2-16.5) and higher positive AFB smears (OR 2.568; 95%CI 1.8-3.8). TB treatment failure (death, defaulted, failure, or transferred out) were three times higher in TB-DM (aOR 3.042; 95%CI 1.7-5.4). TB-DM Registry showed negative effects of DM on clinical condition and the treatment success of TB. Abstrak Diabetes melitus (DM) menyulitkan pengobatan dan kontrol tuberkulosis (TB). Badan Penelitian dan Pengembangan Kesehatan bersama tujuh rumah sakit (RS) umum kelas A dan B di Pulau Jawa dan Bali mengembangkan Sistem Registri Penyakit TB-DM. Data pasien berusia ≥15 tahun, didiagnosis TB (kode A15-A19 ICD-10) mulai tahun 2014, dengan atau tanpa DM (kode E10-E14 ICD-10) diabstraksi ke dalam case report form (CRF). Mulai 1 Januari 2014 – 2 Januari 2016, terdapat 1975 kasus TB, 15% adalah TB dengan DM. 73,6% pasien TB-DM berusia ≥45 tahun dan 70,8% TB-non DM berusia <45 tahun. Pada kasus TB-DM, kasus TB sebelumnya pernah diobati lebih tinggi dibanding TB naïve (OR 2,588; KI95% 2,0-3,4). Pada TB-DM, gejala terbanyak adalah batuk lebih dari dua minggu, penurunan berat badan, penurunan nafsu makan, dan berkeringat di malam hari, berturut-turut sebanyak 76,4%; 72,6%; 65,9%; dan 65,2%. Pada TB-non DM, gejala dominan adalah penurunan berat badan, penurunan nafsu makan, batuk lebih dari dua minggu, dan demam, berturut-turut sebanyak 59,4%; 57,8%; 57,6%; dan 56,9%. Foto toraks abnormal lebih banyak pada TB-DM (OR 7,249; KI95% 3,2-16,5), demikian juga dengan BTA positif (OR 2,568; KI95% 1,8-3,8). Kegagalan pengobatan TB (meninggal, putus berobat, gagal pengobatan, atau pindah) tiga kali lebih besar pada TD-DM dibanding TB-non DM (aOR 3.042; KI95%1.7-5.4). Registri TB-DM menunjukkan efek negatif DM terhadap gambaran klinis dan keberhasilan pengobatan TB

Proporsi Seksio Sesarea dan Faktor yang Berhubungan dengan Seksio Sesarea di Jakarta

The incidence of caesarean sections (c-section) in Indonesia have been increased in government and private hospitals. To identify c-section proportion and associated factors in the government hospitals and one private hospital in Jakarta during the period January 1st to December 31 , 2011. The study design was cross -sectional. Data retrieved from the medical records of patients who gave birth in a hospital caesarean government and the private hospitals during the period 1 January to 31December 2011. The data were analyzed with chi square test and logistic regression. The proportion of c-section 59.2 %. The proportion of c-section in the RS government 56.5 % and 62.7 % in private hospitals. The related factors c-section were baby indication is fetal distress (ORadj 11.95 ; 95 % CI 1.31 to 108.94 ), maternal indication is prelabor rupture of membranes (ORadj 4.18 ; 95 % CI 1.06 to 16 , 50 ) and hypertension (ORadj 7.13 ; 95 % CI 2.38 to 21.32). The proportion of c-section in a government hospital and a private hospital in Jakarta is quite high 59.2 %. Prelabor rupture of membranes, hypertension and fetal distress were determinant factor c-section in this hospital.Keywords : Caesarean section, baby indication, maternal indicationAbstrakAngka kejadian persalinan seksio sesarea di Indonesia terus meningkat baik di rumah sakit pemerintah maupun swasta. Mendapatkan proporsi seksio sesarea dan berbagai faktor yang berhubungan denganpersalinan SS di satu RS pemerintah dan satu RS swasta di Jakarta selama periode 1 Januari-31 Desember 2011. Disain penelitian ini adalah cross sectional. Data diambil dari catatan medik pasien yang melahirkan sesarea di satu RS pemerintah dan satu RS swasta selama periode 1 Januari-31 Desember 2011. Data dianalisis dengan uji chi square dan regresi logistik. Proporsi persalinan SS sebesar 59,2%. Proporsi SS di RS pemerintah 56,5% dan di RS swasta 62,7%. Faktor yang berhubungan dengan persalinan SS adalah indikasi bayi yaitu gawat janin (ORadj 11,95; 95% CI 1,31-108,94), indikasi ibu yaitu Ketuban pecah dini (ORadj 4,18; 95%CI 1,06-16,50) dan Pre-eklamsi/eklamsi (ORadj 7,13; 95% CI 2,38-21,32). Proporsi persalinan SS di satu RS pemerintah dan satu RSswasta di Jakarta cukup tinggi 59,2%. Ketuban pecah dini, hipertensi dan gawat janin merupakan faktor yang berhubungan untuk terjadinya persalinan sesarea di rumah sakit tersebutKata kunci : Seksio sesarea, indikasi bayi, indikasi ibu

Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

BACKGROUND: Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited. METHODS: In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581. FINDINGS: From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77–1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66–1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14–4·29); for patients who were antibody negative, the OR was 0·51 (0·29–0·90; pinteraction=0·001). INTERPRETATION: When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry. FUNDING: US National Institutes of Health

Validation of a Liquid Chromatography/Tandem Mass Spectrometry Assay for the Quantification of Plasma Dihydroartemisinin

Background: Insufficient plasma level of dihydroartemisinin (DHA) can select resistance and will further hinder malaria elimination program. We investigated clinical applicability of a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay to quantify plasma concentration of DHA in healthy subjects from a single oral administration of fixed dose combination of Dihydroartemisinin-Piperaquine.Materials and Methods: Micro-elution solid-phase extraction in a 96-well plate format was used to prepare the samples. DHA separation happened in Acquity UPLCTM BEH C18 column (50 × 2.1 mm, 1.7 µm). Mobile phase was a mixture of acetonitrile-ammonium acetate 10 mM pH 3.5 (50:50, v/v) at 0.3 mL/minute flow rate. Waters Acquity UPLC™ H-Class system coupled with triple quadruple mass spectrometry in positive electrospray ionization mode was used for detection. The internal standard was a stable isotope labelled DHA.Results: Calibration curve was linear with a correlation coefficient >0.995 over a concentration range of 1–1,000 ng/mL. Bias and variation for accuracy and precision were in the range of 15% (20% at the lower limit of quantification). Using 5 µL sample, lower limit of quantification was 1 ng. Matrix effect was less than 15%. The method was successfully applied to investigate the pharmacokinetics of DHA from five healthy subjects, although carry over and the role of anticoagulants were not tested.Conclusion: The LC-MS/MS assay for the quantification of plasma DHA was validated for selectivity, linearity, lower limit of quantitation, accuracy, precision, matrix effect and stability. Although clinical applicability was demonstrated, this method was to be improved to address the not-tested validation parameters.Keywords: dihydroartemisinin, liquid chromatography/tandem mass spectrometry assay (LC-MS/MS), malaria, Indonesia

Poor Tuberculosis Treatment Outcomes Associated with Older Age, Previous Treatment, HIV and Drug Resistance at Seven Hospitals in Indonesia

Abstract Indonesia is a high burden country for tuberculosis (TB), multidrug-resistant (MDR) TB, and TB-HIV. We aimed to determine factors associated with poor TB treatment outcomes. A hospital-based TB Registry at seven referral hospitals in Java and Bali included data from patients aged ≥15 years who were diagnosed with TB from 1 January 2014 - 31 December 2015. The factors were assessed by logistic regression. From 2,051 TB patients, 1,180 (57.5%) were male and median age was 38 years (IQR 27-50 years), 452 (22%) had previous TB treatment history, 1,447 (70.6%) had pulmonary TB, 216 (10.5%) TB-HIV, 296 (14.4%) TB-DM and 248 (12.1%) were resistant to ≥1 anti-TB drug. Treatment outcome was unknown for 135 (6.6%) subjects and 1,137 (55.4%) who were still on treatment. Among the 779 with available outcome, 358 (46%) were treatment success, 248 (31.8%) transferred out, 112 (14.4%) defaulted, 46 (5.9%) died and 15 (1.9%) failed. After controlling other factors, poor TB treatment was associated with age ≥38 years (p=0.003; aOR 1.58; 95% CI 1.2-2.1), previous history of TB treatment (p<0.001; aOR 2.55; 95% CI 1.5-4.2) and resistance to ≥1 anti-TB drug (p<0.001; aOR 11.66; 95% CI 3.8-36.1). Mortality was associated with previous history of TB treatment (p=0.003; aOR 3.87; 95% CI 1.7-9.6), TB-HIV (p=0.001; aOR 10.43; 95% CI 4.2-26.1), and resistance to ≥1 anti-TB drug (p=0.001; aOR 9.48; 95% CI 2.6-34.0). Treatment in TB patients with older age, history of previous TB treatment, HIV, and drug resistance should be closely monitored. Keywords: Indonesia, tuberculosis, treatment outcome Abstrak Indonesia adalah negara dengan beban tinggi untuk tuberkulosis (TB), TB resisten obat (MDR) dan TB-HIV. Analisis ini bertujuan untuk menentukan faktor yang terkait dengan luaran pengobatan TB yang buruk. Registri TB berbasis rumah sakit di tujuh rumah sakit rujukan di Jawa dan Bali mencakup data dari pasien berusia ≥15 tahun yang didiagnosis TB dari 1 Januari 2014 - 31 Desember 2015. Faktor-faktor tersebut dinilai dengan regresi logistik. Dari 2.051 pasien TB, 1.180 (57,5%) laki-laki dan median usia 38 tahun (IQR 27-50 tahun), 452 (22%) memiliki riwayat pengobatan TB sebelumnya, 1.447 (70,6%) memiliki TB paru, 216 (10,5%) TB-HIV, 296 (14,4%) TB-DM dan 248 (12,1%) resisten terhadap ≥1 obat anti-TB. Luaran pengobatan TB tidak diketahui untuk 135 (6,6%) subjek dan 1.137 (55,4%) yang masih dalam pengobatan. Di antara 779 dengan luaran pengobatan diketahui, 358 (46%) pengobatan berhasil, 248 (31,8%) pindah, 112 (14,4%) putus pengobatan, 46 (5,9%) meninggal dan 15 (1,9%) gagal. Setelah dikontrol terhadap faktor lain, luaran pengobatan TB yang buruk dikaitkan dengan usia ≥38 tahun (p = 0,003; aOR 1,58; 95% CI 1,2-2,1), riwayat pengobatan TB sebelumnya (p <0,001; aOR 2,55; 95% CI 1,5-4,2) dan resistansi terhadap ≥1 obat anti-TB (p <0,001; aOR 11,66; 95% CI 3,8-36,1). Kematian dikaitkan dengan riwayat pengobatan TB sebelumnya (p = 0,003; aOR 3,87; 95% CI 1,7-9,6), TB-HIV (p = 0,001; aOR 10,43; 95% CI 4,2-26,1), dan resistansi terhadap ≥1 anti -TB obat (p = 0,001; aOR 9,48; 95% CI 2,6-34,0). Pengobatan pada pasien TB dengan usia yang lebih tua, riwayat pengobatan TB sebelumnya, HIV dan resistansi obat harus dipantau secara ketat. Kata kunci: Indonesia, tuberkulosis, luaran pengobata

Pengaruh Diabetes Melitus terhadap Gambaran Klinis dan Keberhasilan Pengobatan Tuberkulosis di Tujuh RSU Kelas A dan B di Jawa dan Bali

  Diabetes mellitus (DM) may complicate tuberculosis (TB) treatment and control. The National Institute of Health Research and Development in collaboration with seven referral public hospitals in Java and Bali established a disease registry system for tuberculosis (TB) and diabetes mellitus (DM). Medical records containing data of ≥15 years old patients, diagnosed with TB (ICD-10 code A15-A19) in 2014, with or without DM (ICD-10 code E10-E14) were recorded into case report form (CRF). From January 1st 2014 to January 12th 2016, the registry recorded 1975 TB cases, 15% of cases were TB-DM. 73.6% TB-DM were ≥45 years old and 70,8% TB-non DM were <45 years old. Previously treated TB cases were higher than naïve in TB-DM (OR 2.588; 95%CI 2.0-3.4). In TB-DM, predominant symptoms were cough >2 weeks (76.4%), weight loss (72.6%), loss of appetite (65.9%), and night sweats (65.2%). In TB-non DM, predominant symptoms were weight loss (59.4%), loss of appetite (57.8%), cough >2 weeks (57.6%), and fever (56.9%). Higher chest X-rays abnormality in TB-DM (OR 7.249; 95%CI 3.2-16.5) and higher positive AFB smears (OR 2.568; 95%CI 1.8-3.8). TB treatment failure (death, defaulted, failure, or transferred out) were three times higher in TB-DM (aOR 3.042; 95%CI 1.7-5.4). TB-DM Registry showed negative effects of DM on clinical condition and the treatment success of TB.   Abstrak Diabetes melitus (DM) menyulitkan pengobatan dan kontrol tuberkulosis (TB). Badan Penelitian dan Pengembangan Kesehatan bersama tujuh rumah sakit (RS) umum kelas A dan B di Pulau Jawa dan Bali mengembangkan Sistem Registri Penyakit TB-DM. Data pasien berusia ≥15 tahun, didiagnosis TB (kode A15-A19 ICD-10) mulai tahun 2014, dengan atau tanpa DM (kode E10-E14 ICD-10) diabstraksi ke dalam case report form (CRF). Mulai 1 Januari 2014 – 2 Januari 2016, terdapat 1975 kasus TB, 15% adalah TB dengan DM. 73,6% pasien TB-DM berusia ≥45 tahun dan 70,8% TB-non DM berusia <45 tahun. Pada kasus TB-DM, kasus TB sebelumnya pernah diobati lebih tinggi dibanding TB naïve (OR 2,588; KI95% 2,0-3,4). Pada TB-DM, gejala terbanyak adalah batuk lebih dari dua minggu, penurunan berat badan, penurunan nafsu makan, dan berkeringat di malam hari, berturut-turut sebanyak 76,4%; 72,6%; 65,9%; dan 65,2%. Pada TB-non DM, gejala dominan adalah penurunan berat badan, penurunan nafsu makan, batuk lebih dari dua minggu, dan demam, berturut-turut sebanyak 59,4%; 57,8%; 57,6%; dan 56,9%. Foto toraks abnormal lebih banyak pada TB-DM (OR 7,249; KI95% 3,2-16,5), demikian juga dengan BTA positif (OR 2,568; KI95% 1,8-3,8). Kegagalan pengobatan TB (meninggal, putus berobat, gagal pengobatan, atau pindah) tiga kali lebih besar pada TD-DM dibanding TB-non DM (aOR 3.042; KI95%1.7-5.4). Registri TB-DM menunjukkan efek negatif DM terhadap gambaran klinis dan keberhasilan pengobatan TB.

Proporsi Seksio Sesarea dan Faktor yang Berhubungan dengan Seksio Sesarea di Jakarta

AbstractThe incidence of caesarean sections (c-section) in Indonesia have been increased in government and private hospitals. To identify c-section proportion and associated factors in the government hospitals and one private hospital in Jakarta during the period January 1st to December 31 , 2011. The study design was cross -sectional. Data retrieved from the medical records of patients who gave birth in a hospital caesarean government and the private hospitals during the period 1 January to 31December 2011. The data were analyzed with chi square test and logistic regression. The proportion of c-section 59.2 %. The proportion of c-section in the RS government 56.5 % and 62.7 % in private hospitals. The related factors c-section were baby indication is fetal distress (ORadj 11.95 ; 95 % CI 1.31 to 108.94 ), maternal indication is prelabor rupture of membranes (ORadj 4.18 ; 95 % CI 1.06 to 16 , 50 ) and hypertension (ORadj 7.13 ; 95 % CI 2.38 to 21.32). The proportion of c-section in a government hospital and a private hospital in Jakarta is quite high 59.2 %. Prelabor rupture of membranes, hypertension and fetal distress were determinant factor c-section in this hospital.Keywords : Caesarean section, baby indication, maternal indicationAbstrakAngka kejadian persalinan seksio sesarea di Indonesia terus meningkat baik di rumah sakit pemerintah maupun swasta. Mendapatkan proporsi seksio sesarea dan berbagai faktor yang berhubungan denganpersalinan SS di satu RS pemerintah dan satu RS swasta di Jakarta selama periode 1 Januari-31 Desember 2011. Disain penelitian ini adalah cross sectional. Data diambil dari catatan medik pasien yang melahirkan sesarea di satu RS pemerintah dan satu RS swasta selama periode 1 Januari-31 Desember 2011. Data dianalisis dengan uji chi square dan regresi logistik. Proporsi persalinan SS sebesar 59,2%. Proporsi SS di RS pemerintah 56,5% dan di RS swasta 62,7%. Faktor yang berhubungan dengan persalinan SS adalah indikasi bayi yaitu gawat janin (ORadj 11,95; 95% CI 1,31-108,94), indikasi ibu yaitu Ketuban pecah dini (ORadj 4,18; 95%CI 1,06-16,50) dan Pre-eklamsi/eklamsi (ORadj 7,13; 95% CI 2,38-21,32). Proporsi persalinan SS di satu RS pemerintah dan satu RSswasta di Jakarta cukup tinggi 59,2%. Ketuban pecah dini, hipertensi dan gawat janin merupakan faktor yang berhubungan untuk terjadinya persalinan sesarea di rumah sakit tersebutKata kunci : Seksio sesarea, indikasi bayi, indikasi ibu

The characteristics of bacteremia among patients with acute febrile illness requiring hospitalization in Indonesia

Blood culturing remains the "gold standard"for bloodstream infection (BSI) diagnosis, but the method is inaccessible to many developing countries due to high costs and insufficient resources. To better understand the utility of blood cultures among patients in Indonesia, a country where blood cultures are not routinely performed, we evaluated data from a previous cohort study that included blood cultures for all participants. An acute febrile illness study was conducted from July 2013 to June 2016 at eight major hospitals in seven provincial capitals in Indonesia. All participants presented with a fever, and two-sided aerobic blood cultures were performed within 48 hours of hospital admission. Positive cultures were further assessed for antimicrobial resistance (AMR) patterns. Specimens from participants with negative culture results were screened by advanced molecular and serological methods for evidence of causal pathogens. Blood cultures were performed for 1,459 of 1,464 participants, and the 70.6 (1,030) participants that were negative by dengue NS1 antigen test were included in further analysis. Bacteremia was observed in 8.9 (92) participants, with the most frequent pathogens being Salmonella enterica serovar Typhi (41) and Paratyphi A (10), Escherichia coli (14), and Staphylococcus aureus (10). Two S. Paratyphi A cases had evidence of AMR, and several E. coli cases were multidrug resistant (42.9, 6/14) or monoresistant (14.3, 2/14). Culture contamination was observed in 3.6 (37) cases. Molecular and serological assays identified etiological agents in participants having negative cultures, with 23.1 to 90 of cases being missed by blood cultures. Blood cultures are a valuable diagnostic tool for hospitalized patients presenting with fever. In Indonesia, pre-screening patients for the most common viral infections, such as dengue, influenza, and chikungunya viruses, would maximize the benefit to the patient while also conserving resources. Blood cultures should also be supplemented with advanced laboratory tests when available. © 2022 This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication