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"ABSTRAKTuberkulosis merupakan suatu penyakit infeksi menular yang mendapat perhatian khusus di dunia.Pengawas Minum Obat merupakan bagian dari Directly Observed Treatment Shourtcourse.Penelitian ini dilakukan untuk meningkatkan keberhasilan pengobatan TB Indonesia.Desain penelitian menggunakan potong lintang 205 subyek,dari data rekam medis dan TB-01 tahun 2012-2014 dan eksperimental 23 subyek kelompok kontrol,23 subyek kelompok terintervensi .Penelitian menunjukkan indikasi pemberian KDT 96,6 tepat dan 3,4 tidak tepat,lama pemberian 74,2 tepat dan 25,8 tidak tepat,pemberian dosis 85,9 tepat dan 14,1 tidak tepat. Hubungan efek samping KDT dengan keberhasilan pengobatan TB tidak bermakna secara statistik p=0,173;0,757,IK95 :0,077-1,612 .Kelompok terintervensi terjadi peningkatan PMO pengetahuan cukup 8,6 ,kelompok kontrol meningkat 13 .Pengetahuan kurang kelompok terintervensi menurun 8,6 ,kelompok kontrol menurun 13 .Tidak ada hubungan bermakna secara statistik antara hubungan pengetahuan PMO setelah 2 bulan p=0,575;IK95 : 0,978-1,151 dan 6 bulan pengobatan konversi dahak setelah 6 bulan 100 .Kepatuhan berobat pasien selama 6 bulan 100 .Efek samping minor tidak memengaruhi keberhasilan pengobatan TB,sehingga pengobatan tetap dilanjutkan meskipun muncul efek samping.Tidak ada hubungan tingkat pengetahuan PMO dengan kepatuhan berobat,tingkat pengetahuan PMO dengan konversi dahak,serta kepatuhan berobat dengan konversi dahak.

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ABSTRACTTuberculosis is an infectious disease which is under special attention by the world.Direct Observed Treatment DOT is part of the Directly Observed Treatment Shourtcourse.This research is conducted to improve TB treatment success rate in Indonesia.Design of research used cross sectional study 205 subjects which data was obtained from medical record and TB 01 card between 2012 2014 and experimental study 23 subjects as controlled group,23 subjects as experimental group. FDC treatment indication was 96.6 correct and 3,4 incorrect, FDC treatment duration was 74.2 correct and 25.8 incorrect, FDC dosage treatment was 85.9 correct and 14.1 incorrect.There was 8.6 increase in DOT rsquo s level of understanding in the experimental group while there was 13 increase in the control group.There was no statistical significant relationship between DOT rsquo s level of understanding with 2nd month p 0.575 95 CI 0,978 1,151 and 6th month treatment sputum conversion after 6 months was 100 .Medical treatment adherence within 6 month period was 100 .Side effect does not impact TB treatment success rate,therefore patients were still continued the treatment.There is no correlation between DOT rsquo s level of understanding with medical treatment adherence, DOT rsquo s level of understanding with sputum conversion as well as between medical treatment adherence with sputum conversion."

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Pasien pediatri merupakan golongan yang rentan terkena tuberkulosis. Kompleksnya regimen terapi serta masih minimnya sediaan yang ramah pasien pediatri menjadi suatu tantangan dalam pengobatan tuberkulosis. Hal tersebut memberikan potensi pengembangan suatu sediaan yang dapat menyederhanakan regimen terapi serta ramah bagi pasien pediatri. Film berlapis cepat hancur kombinasi dosis tetap menjadi solusi dari tantangan-tantangan yang dihadapi dalam proses pengobatan tuberkulosis pada pasien pediatri. Penelitian bertujuan untuk memperoleh film cepat hancur berlapis kombinasi dosis tetap yang mengandung rifampisin dan isoniazid dengan metode solvent casting. Terdapat tujuh formula film lapis rifampisin dan tujuh formula film lapis isoniazid dengan masing-masing formula memiliki variasi konsentrasi HPMC dan PVA yakni R1 (100:0); R2 (75:25); R3 (60:40); R4 (50:50); R5 (40:60); R6 (25:75); R7 (0:100). Ketujuh formula dari masing-masing film lapis dikarakterisasi dengan tujuan menentukan formula film terbaik yang nantinya akan dikombinasikan menjadi sediaan utuh. Karakterisasi tersebut mencakup evaluasi organoleptis, kekuatan peregangan, waktu disintegrasi dan persentase kelembapan. Setelah ditentukan formula terbaik dari masing-masing film, kedua film dikombinasikan dan diuji kembali. Uji yang dilakukan diantaranya uji yang telah dilakukan pada proses karakterisasi ditambah dengan uji penetapan kadar serta uji disolusi. Hasil karakterisasi menunjukkan formula R6 dari masing-masing formula film lapis memiliki karakteristik terbaik dari segi organoleptis dan waktu disintegrasi dengan waktu disintegrasi sebesar 49,94 ± 3,38 detik untuk film lapis rifampisin dan 38,84 ± 4,27 detik untuk film lapis isoniazid. Film lapis rifampisin R6 memiliki nilai tensile strength sebesar 0,7478 ± 0,0233 N/mm² dan persentase kelembapan 15,29 ± 1,36%. Sedangkan film lapis isoniazid R6 memiliki nilai tensile strength sebesar 0,8136 ± 0,0612 N/mm² dan persentase kelembapan 15,60 ± 1,23%. Film cepat hancur kombinasi dosis tetap yang diperoleh memiliki organoleptis yang baik, waktu disintegrasi yang cepat yakni 52,82 ± 2,76 detik namun tidak memenuhi kriteria uji penetapan kadar dan uji disolusi yang diinginkan.

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Pediatric patients are vulnerable group susceptible to tuberculosis. The complexity of the treatment regimen and the limited availability of pediatric-friendly formulations pose challenges in tuberculosis treatment. This presents an opportunity for the development of a formulation that can simplify the treatment regimen and be patient-friendly for pediatric patients. Fast-disintegrating multilayer films with fixed-dose combinations offer a solution to the challenges faced in the tuberculosis treatment process in pediatric patients. The research aimed to obtain fast-disintegrating multilayer films with fixed-dose combinations containing rifampicin and isoniazid using the solvent casting method. There were seven formulations of rifampicin films and seven formulations of isoniazid films, each with variations in HPMC and PVA concentrations, namely R1 (100:0); R2 (75:25); R3 (60:40); R4 (50:50); R5 (40:60); R6 (25:75); R7 (0:100). The seven formulations of each film were characterized to determine the best film formulation that would later be combined into a complete formulation. The characterization included organoleptic evaluation, tensile strength, disintegration time, and moisture content. After determining the best formulation for each film, the two films were combined and retested. The tests conducted included the previously performed characterization tests, as well as assay and dissolution testing. The characterization results showed that formulation R6 of each film had the best characteristics in terms of organoleptic properties and disintegration time, with a disintegration time of 49.94 ± 3.38 seconds for rifampicin film and 38.84 ± 4.27 seconds for isoniazid film. Rifampicin film R6 had a tensile strength of 0.7478 ± 0.0233 N/mm² and a moisture content of 15.29 ± 1.36%. Meanwhile, isoniazid film R6 had a tensile strength of 0.8136 ± 0.0612 N/mm² and a moisture content of 15.60 ± 1.23%. The obtained fast-disintegrating multilayer films with fixed-dose combinations had good organoleptic properties and fast disintegration time of 52.82 ± 2.76 seconds but did not meet the criteria for assay and desired dissolution testing.

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