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"Latar Belakang: Tuberkulosis resistan obat (TB-RO) masih menjadi masalah kesehatan global, penyakit utama penyebab kematian kasus infeksi tunggal terbanyak setelah Corona virus disease 2019 (COVID-19). Tahun 2021 secara global terdapat 167.000 orang dengan TB Multi Drug Resistant/Rifampicin Resistant (MDR/RR) terkonfirmasi, 162.000 memulai terapi. Angka keberhasilan global pengobatan TB RR/MDR sebesar 60%, sedangkan di Indonesia sebesar 47%. WHO merekomendasikan paduan bebas injeksi untuk TB-RO tahun 2019 meningkatkan angka keberhasilan 60% menjadi 73% dan menurunkan angka putus berobat 17,3% menjadi 9,9%. Pengobatan OAT all-oral direkomendasikan di Indonesia sejak 2020 termasuk paduan individual. Penelitian ini bertujuan untuk mengetahui luaran pengobatan TB-RO dengan paduan individual all-oral serta faktor apa saja yang memengaruhi keberhasilan pengobatan TB-RO di RSUP Persahabatan.Metode: Desain penelitian ini adalah kohort retrospektif menggunakan data rekam medis fisik dan elektronik, dilakukan di Poli TB-RO RSUP Persahabatan Oktober 2022, dengan teknik total sampling. Subjek penelitian adalah pasien TB-RO yang mendapatkan paduan individual all-oral dan memulai terapi Januari2020-Desember 2021 di poli TB-RO RSUP Persahabatan yang memenuhi kriteria penelitian.Hasil: Didapatkan 162 subjek penelitian dengan karakteristik median usia 44 (18−74) tahun, 61,7% laki-laki dan 52,5% subjek dengan IMT<18,5 kg/m2. Komorbid terbanyak adalah DM tipe 2 dengan proporsi 37%. Jenis resistansi terbanyak TB-MDR 45,1% dengan proporsi bacterial load terbanyak BTA negatif (25,9%). Proporsi konversi biakan sputum ≤ 2 bulan 56,2%. Terdapat 86,4% subjek mengalami intoleransi obat dengan proporsi terbanyak gastrointestinal 66,2%. Luaran berhasil sebesar 43,2%, meninggal 40,1%, putus berobat 13,6% dan gagal 3,1%. Analisis multivariat mendapatkan bacterial load dan kecepatan konversi merupakan faktor-faktor yang memengaruhi keberhasilan pengobatan TB-RO.Kesimpulan: Luaran berhasil pasien TB-RO yang menggunakan paduan individual all-oral 43,2%, meninggal 40,12%, gagal 3,09% dan putus berobat 13,6%. Bacterial load,BTA ≤1+ dan kecepatan konversi ≤ 2 bulan merupakan faktor yang memengaruhi keberhasilan pengobatan TB-RO dengan paduan individual all-oral. Nilai odds masing-masing faktor berturut-turut aOR:2,35 (95%IK: 1,12-4,90) dan aOR: 2,2 (95%IK: 1,05-4,61).

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Background: Drug-resistant tuberculosis (DR-TB) is still the global health problem, the leading cause of death in the single infectious case after Corona virus disease 2019 (COVID-19). Globally, there were 167.000 confirmed cases of Multi Drug Resistant/Rifampicin Resistant tuberculosis (MDR/RR-TB) in 2021 and 162.000 started treatment. Global success rate for MDR/RR-TB treatment reach 60% while in Indonesia 47%. In 2019 WHO recommended injection-free regimen that increase treatment success rate of DR-TB treatment from 60% to 73% and lower lost to follow up (LTFU) cases 17,3% to 9,9%. Indonesia started all-oral regimen in 2020 consist of shorter and longer regimen. Aim of this study is to observe outcomes of drug-resistant tuberculosis (DR-TB) treated with long term all-oral regimen and factors that influence the success rate of DR-TB treatment at Persahabatan Hospital Jakarta.

Metods: Design of the study was retrospective cohort using secondary data, physical and electronic medical records. It carried out in October 2022 at DR-TB clinic Persahabatan Hospital with total sampling technique. Subject of this study were medical records of DR-TB patients enrolled with long-term all-oral regimen treatment by January 2020-December 2021 which met the inclusion criteria.

Results: There were 162 subjects with median of age 44 (18-74) years old, 61,7% were male, and 52,5% subject were malnutrition. Proportion of DM type 2 comorbid was 37%. MDR-TB were found in 45,1% of subject with the high proportion of negative smear bacterial load (25,9%) as baseline. Amount of sputum Mtb culture conversion within 2 months reached 56,2%. There were 86,4% subjects experiencing drug intolerance with the highest proportion being gastrointestinal 66,2%. Outcomes of the long-term DR-TB treatment were successful 43,2%, died 40,1%, dropped-out 13,6% and failed 3,1%. Multivariate analysis found that bacterial load and time of sputum conversion were factors that associated with DR-TB success rate treatment.

Conclusion: Outcomes of drug-resistant tuberculosis (DR-TB) treated with long term all-oral regimen 43,2% cured, 40,12% died, dropped-out from treatment 13,6% and failed 3,1%. Bacterial load ≤1+ and time of sputum conversion ≤2 months were factors that associated with DR-TB success rate treatment with adjusted aOR:2,35 (CI95% :1,12-4,90) and aOR:2,2 (CI95% : 1,05-4,61) respectively."

"Latar belakang: Tuberkulosis (TB) hingga saat ini masih menjadi masalah kesehatan utama di dunia dan merupakan salah satu dari 10 penyebab kematian di dunia. Sesuai dengan rekomendasi WHO tahun 2020, pengobatan TB RO di Indonesia saat ini menggunakan paduan tanpa obat injeksi yang terbagi menjadi dua, yaitu paduan pengobatan jangka pendek (9-11 bulan) dan jangka panjang (18-20 bulan). Penelitian ini dilakukan untuk mengindentifikasi luaran penggunaan regimen pengobatan jangka pendek pada TB RO di RSUP Persahabatan dan faktor-faktor yang mempengaruhi luaran. Metode : Penelitian ini merupakan studi kohort prospektif yang dilakukan sejak Agustus 2019 – Januari 2021 dengan consecutive sampling pada pasien TB RO yang berobat ke Poli TB RO RSUP Persahabatan. Pasien yang telah memenuhi kriteria pengobatan jangka pendek akan diberikan pengobatan standar dan akan dievaluasi mengenai faktor-faktor yang mempengaruhi. Faktor-faktor yang dinilai pada penelitian ini antara lain usia, jenis kelamin, indeks massa tubuh, faktor komorbid, BTA awal pengobatan, luas lesi foto toraks, merokok, riwayat pengobatan TB, desentralisasi, lama konversi, dan pola resistan. Hasil akhir pengobatan yang dievaluasi pada penelitian ini adalah sembuh, gagal pengobatan, meninggal, putus berobat, dan pindah.Hasil : Subjek penelitian yang memenuhi kriteria inklusi penelitian sebanyak 68 orang dengan karakteristik rerata usia 42,03 (13,22) tahun. Pada kelompok jenis kelamin laki- laki (66,7%), gizi obese (71,4%), riwayat merokok indeks berat (81,8%), riwayat gagal kategori 2 sebelumnya (100%), gambaran foto toraks lesi luas (66,7%), tidak desentralisasi (59%), konversi BTA > 3 bulan, BTA awal pengobatan 3+ (66,7%), dan poliresistan (80%) akan mengalami luaran tidak berhasil lebih cepat dibandingkan kelompok lainnya. Hasil akhir pengobatan pada penelitian ini didapatkan angka kesembuhan sebesar 42,6%, gagal pengobatan sebesar 17,6%, meninggal sebesar 8,8%, putus berobat sebesar 27,9% dan transfer out sebesar 2,9%.Kesimpulan : Pada penelitian ini tidak didapatkan perbedaan bermakna antara faktor- faktor yang mempengaruhi luaran pengobatan TB RO dengan regimen jangka pendek (STR).

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Background: Tuberculosis (TB) remains a major health problem and one of the top ten causes of death in the world. According to WHO recommendations in 2020, drug- resistant TB (DR-TB) treatment in Indonesia currently uses an injection-free drug combination which was divided into short-term (nine to eleven months) and long term (eighteen to twenty months) treatments. The aim of this study is to identify the outcome of using a short-term treatment regimen (STR) for DR-TB in patients treated at Persahabatan Hospital, Jakarta, Indonesia and factors that influence their clinical outcomes.

Methods: This study was a prospective cohort study conducted from August 2019 until January 2021 in Persahabatan Hospital, Jakarta, Indonesia. All DR-TB patients were evaluated whether they met criteria for the STR treatment. Outcomes evaluated in this study were cured, treatment failure, death, loss to follow up, and transferred out. Factors assessed in this study included age, sex, body mass index, comorbid factors, bacterial load, chest x-ray lesions, smoking, TB treatment history, decentralization, time-to- conversion, and resistance pattern.

Results: Sixty eight subjects were included in this study. Mean age was 42.03 (+ 13.22) years. Males, obese, heavy smoking index, history of second category treatment failure, extensive lesion in chest x ray, decentralisation, acid fast baccili (AFB) conversion by >3 months, AFB stain at pre-treatment of +3, and poly-drug-resistance were more likely to have an unfavourable outcome. However, the results were not statistically significant (p>0.05). The treatment result of this study showed a cure rate of 42.6%, with treatment failure was 17.6%, death was 8.8%, loss to follow up was 27.9%, and transferred out was 2.9%.

Conclusion: In this study, there were no significant differences between the factors that influenced the outcome of DR-TB receiving STR."

"Latar belakang: Kompleksitas pengobatan TB RO berupa durasi pengobatan yang panjang, penggunaan beberapa obat lini kedua, toksisitas obat, dan interaksi obat akibat multidrug use dapat menyebabkan efek samping pengobatan pada pasien. Hal ini dapat mengurangi efektivitas pengobatan dan memengaruhi luaran pengobatan TB RO. Tujuan: Untuk melihat efek samping obat/kejadian tidak diinginkan terhadap luaran pengobatan TB RO.Metode: Penelitian observasional dengan desain kohort retrospektif ini dilakukan di RSUP Persahabatan, Jakarta. Sumber data adalah data sekunder dari sistem informasi tuberkulosis (SITB) yang melibatkan pasien TB RO yang menjalani pengobatan di tahun 2021 – 2023. Metode sampling berupa total sampling. Analisis data bivariat antara KTD dengan luaran pengobatan TB RO berupa Cox regresi dan uji Log-Rank, yang kemudian dilanjutkan dengan analisis multivariat menggunakan Extended Cox Regresi.Hasil: Dari 583 subjek yang diikutsertakan dalam penelitian ini, insidens luaran pengobatan tidak berhasil sebanyak 40,65%. Sebanyak 12,69% pasien mengalami efek samping berat. Sebagian besar efek samping terjadi pada fase intensif pengobatan TB RO (43,57%). Jenis efek samping yang paling sering dialami pada pasien adalah gangguan gastrointestinal (79,25%), gangguan muskuloskeletal (58,32%), dan gangguan saraf (49,40%). Efek samping berupa KTD berat/serius tidak memiliki asosiasi yang signifikan terhadap terjadinya pengobatan tidak berhasil berdasarkan hasil analisis Cox regresi bivariat (HR=0,823; 95% CI: 0,558-1,216; p=0,329) dan analisis multivariat Extended Cox regresi (setelah dikontrol oleh variabel kovariat). Probabilitas survival antara kelompok dengan KTD berat dan kelompok non-KTD berat tidak berbeda bermakna. Kesimpulan: pemantauan efek samping selama pengobatan TB RO berlangsung merupakan hal yang penting untuk menunjang keberhasilan pengobatan.

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Background: The complexity of treating drug-resistant tuberculosis (DR TB) involves prolonged treatment duration, the use of several second-line drugs, drug toxicity, and drug interactions due to multidrug use, which can lead to adverse drug reactions in patients. These issues can reduce treatment effectiveness and affect treatment outcomes for DR TB.

Objective: To investigate the impact of adverse drug reactions/adverse events on DR TB treatment outcomes.

Methods: This observational study utilized a retrospective cohort design conducted at RSUP Persahabatan, Jakarta. The data source was secondary data from the tuberculosis information system (SITB) involving DR TB patients who underwent treatment between 2021 and 2023. The sampling method was total sampling. Bivariate data analysis between adverse events and TB RO treatment outcomes involved Cox regression and Log Rank tests, followed by multivariate analysis using Extended Cox Regression.

Results: Among the 583 subjects included in this study, the incidence of unsuccessful treatment outcomes was 40.65%. Severe adverse drug reactions were experienced by 12.69% of patients. Most adverse reactions occurred during the intensive phase of TB RO treatment (43.57%). The most common types of adverse reactions experienced by patients were gastrointestinal disorders (79.25%), musculoskeletal disorders (58.32%), and neurological disorders (49.40%). Severe/serious adverse reactions did not have a significant association with unsuccessful treatment outcomes based on the results of the bivariate Cox regression analysis (HR=0.823; 95% CI: 0.558-1.216; p=0.329) and the multivariate Extended Cox regression analysis (after adjusting for covariate variables). The survival probability between the group with severe adverse reactions and the non- severe adverse reactions group did not differ significantly.

Conclusion: Monitoring adverse drug reactions during DR TB treatment is crucial to support the success of the treatment."