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Abstrak :
Menurut WHO (World Health Organization) sepertiga penduduk dunia telah terinfeksi dengan tuberkulosis (TB). Sekitar 2 juta orang meninggal akibat penyakit ini setiap tahunnya dan akan muncul lebih dari 8 juta penderita TB baru setiap tahunnya. Selain itu, kembali menurut WHO (2000), jumlah kematian akibat tuberkulosis akan menjadi 35 juta orang pada tahun 2000-2020. Sebagian besar pasien tuberkulosis di dunia masih tetap diobati dengan beberapa obat-obat tunggal, atau mungkin dengan obat TB kombinasi dosis tetap (KDT) yang berisi 2 obat. Untuk meningkatkan mutu hasil pengobatan maka WHO merekomendasikan penggunaan obat TB dalam bentuk TB kombinasi dosis tetap (KDT) yang berisi 2 dan 3 obat dalam strategi DOTS. Sejak 1999, KDT yang berisi 4 obat telah dimasukkan pula dalam “WHO Model List of Essential Drugs”. Dewasa ini KDT merupakan alat penting untuk makin meningkatkan mutu pelayanan pada pasien TB, dalam akselerasi program DOTS untuk segera mencapai target global. Obat TB dalam bentuk kombinasi dosis tetap (KDT) dapat menyederhanakan cara pengobatan dan juga manajemen pengelolaan / distribusi obat TB serta mampu mencegah timbulnya resistensi. KDT menyederhanakan cara pengobatan karena jumlah tablet yang harus ditelan pasien akan berkurang, ddari 15 – 16 buah menjadi 3 – 4 buah saja, dan juga menurunkan kesalahan penulisan resep. Juga jauh lebih mudah untuk menerangkan kepada pasien bahwa ia harus makan 4 tablet yang sejenis, daripada harus makan berbagai tablet dalam berbagai bentuk dan warna yang berbeda. Kemungkinan tidak memakan semua obat yang diharuskan juga dapat dicegah karena satu obat KDT sudah merupakan campuran dari beberapa obat sekalligus. KDT juga akan memudahkan para dokter dan petugas kesehatan karena hanya harus mengingat satu macam obat, lebih sederhana dan tidak membingungkan. Akhirnya, seluruh aspek distribusi obat (pembelian, pengapalan, penggudangan) juga jauh lebih sederhana dalam bentuk KDT ini.Efek samping obat tidaklah akan bertambah bila kita menggunakan KDT. Bila terjadi juga efek samping maka mungkin diperlukan obat dalam bentuk tunggal. Kualitas, keamanan dan efektivitas KDT ditentukan oleh proses pembuatannya, artinya seberapa jauh produsen mematuhi kaidah “good manufacturing practices (GMP)” dan spesifikasi farmakopea. Pengelola program TB nasional harus membuat sistem jaga mutu (“QA system”). Dalam hal ini WHO telah membangun jaringan laboratorium untuk menilai KDT yang ada sesuai dengan permintaan pihak industri farmasi. (Med J Indones 2003; 12: 114-9)

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According to the World Health Organization, a third of the world’s population is infected with tuberculosis. The disease is responsible for nearly 2 million deaths each year and over 8 million were developing active diseases. Moreover, according to WHO (2000), tuberculosis deaths are estimated to increase to 35 million between 2000-2020. The majority of tuberculosis patients worldwide are still treated with single drugs, or with 2-drug fixed-dose combinations (FDCs). To improve tuberculosis treatment, 2- and 3-drug FDCs were recommended by the World Health Organization (WHO) as part of the DOTS strategy. Since 1999 a 4-drug FDC was included on the WHO Model List of Essential Drugs. Today, FDCs are important tools to further improve the quality of care for people with TB, and accelerate DOTS expansion to reach the global TB control targets. Fixed dose combination TB drugs could simplifies both treatment and management of drug supply, and may prevent the emergence of drug resistance .Prevention of drug resistance is just one of the potential benefits of the use of FDCs. FDCs simplify administration of drugs by reducing the number of pills a patient takes each day and decreasing the risk of incorrect prescriptions. Most tuberculosis patients need only take 3–4 FDCs tablets per day during the intensive phase of treatment, instead of the 15–16 tablets per day that is common with single-drug formulations It is much simpler to explain to patients that they need to take four tablets of the same type and colour, rather than a mixture of tablets of different shapes, colours and sizes. Also, the chance of taking an incomplete combination of drugs is eliminated, since the four essential drugs are combined into one tablet. FDCs are also simpler for care-givers as they minimize the risk of confusion. Finally, drug procurement, in all its components (stock management, shipping, distribution), is simplified by FDCs. Adverse reactions to drugs are not more common if FDCs are used. Nevertheless, whenever side-effects to one or more components in a FDC are suspected, there will be a need to switch to single-drug formulations. Quality, safety and efficacy of FDC drugs are determined by the manufacturing process i.e. by compliance of the manufacturer with the requirements of good manufacturing practices (GMP) and pharmacopoeial specifications. National TB programmes must establish a QA system WHO established a laboratory network that tests the quality of FDCs in the marketplace and registers products upon request from the pharmaceutical industry. (Med J Indones 2003; 12: 114-9)

Abstrak :
Background: a patient with a history of tuberculosis (TB) has a risk up to 27% to develop recurrence within 2 years after being cured. Indonesia itself has more than 7,500 recurrent cases annually, regardless of reinfection or relapse. This is an important problem, as recurrent TB is associated with lower cure rates with the anti-TB therapy and higher risk of developing drug resistance. Some risk factors for this recurrence are smoking, poor treatment adherence, low economic status, and weak immune status. This study is aimed to identify whether the use of fixed-dose combination (FDC) anti-tuberculosis therapy increases the risk for tuberculosis recurrence compared with using separate drug formulation. Methods: the search was conducted on MEDLINE, ProQuest, EBSCO, ScienceDirect, and Cochrane according to clinical question. The studies were selected based on inclusion and exclusion criteria and led to five useful articles. The selected studies were critically appraised for their validity, importance, and applicability. Results: five cohort studies were found with comparable validity. Only 1 study has accurate relative risk (RR) with 3.97 (1.14-13.80) and number needed to harm of 18. Other four studies fulfilled the applicability criteria for our case. Conclusion: the use of FDC anti-tuberculosis therapy increases the risk for tuberculosis recurrence compared with using separate drug formulation.

Abstrak :
Pendahuluan : Walaupun pemerintah Indonesia sudah menetapkan programDirect Observed Treatment Short course DOTS dengan ObatAntituberkulosis OAT kombinasi dosis tetap KDT , masih ditemukan kasustuberkulosis TB baru di Indonesia. Informasi tentang perbedaan efektivitasdan efek samping OAT KDT dan OAT dosis lepasan pada fase intensif danfase lanjutan masih merupakan suatu perdebatan. Penelitian ini bertujuan untukmembandingkan efektivitas dan efek samping OAT KDT dengan OAT dosislepasan pada pasien TB paru kasus baru konfirmasi bakteriologis danmengevaluasi penggunaan fase sisipan pada kedua kelompok OAT. Metode : Penelitian retrospektif observasional ini menggunakan datasekunder dari rekam medis pasien TB paru kasus baru konfirmasibakteriologis yang mendapat pengobatan OAT kategori 1 KDT atau OAT dosislepasan dalam periode 1 Januari 2014 sampai dengan 31 Januari 2017.Efektivitas dinilai dari konversi basil tahan asam BTA pada akhir bulan ke 2dan akhir bulan ke 6, serta evaluasi penggunaan fase sisipan pada akhir bulanke 3. Efek samping dinilai dari efek samping obat ESO mayor dan minoryang timbul selama pemakaian OAT KDT atau dosis lepasan. Perbedaanefektivitas dinilai dengan Chi square. Hasil : Data pasien yang mendapat OAT KDT 33 orang dan OAT dosislepasan 30 orang selama periode 1 Januari 2014 ndash; 31 Januari 2017 di RS drEsnawan Antariksa Halim Perdanakusuma Jakarta di evaluasi. Pada akhir faseintensif, proporsi pasien pada kelompok OAT KDT dan lepasan yangmengalami konversi BTA tidak berbeda bermakna 78,8 vs 83,3 , p=0,693 .Pada akhir fase sisipan, 100 pasien kelompok OAT lepasan mengalamikonversi, satu pasien 14,3 pada kelompok KDT gagal konversi dandikeluarkan dari penelitian ini. Semua pasien yang menyelesaikan fase lanjutanpada kedua kelompok mengalami konversi BTA. ESO mayor berupa hepatitisdan reaksi sensitivitas ditemukan lebih banyak pada kelompok KDTdibandingkan lepasan 6.1 vs 0 . ESO minor juga lebih banyakditemukan pada kelompok KDT dibandingkan lepasan 30.3 vs 23.3 . Efeksamping minor yang paling banyak dialami adalah nyeri perut dan mual.Proporsi subjek yang mengalami ESO lebih banyak pada kelompok KDTdibandingkan kelompok lepasan 33,3 vs 23,3. Kesimpulan : Tidak terdapat perbedaan efektivitas dan efek samping OATkategori 1 KDT dibanding dosis lepasan pada fase intensif dan lanjutan. Terdapat keberhasilan konversi pada akhir fase sisipan pada kedua kelompokOAT.

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Introduction : Eventhough Indonesian Government has established DirectObserved Treatment Short Course DOTS program with fixed dosecombination FDC Antituberculosis, new tuberculosis cases continue to occur.Information on differences in effectiveness and adverse drug reactions ADRs of FDC and separate formulations persists. This study aimed to evaluate theeffectiveness and adverse drug reactions of FDC versus separateantituberculosis formulations in new onset bacteriological confirmedpulmonary TB patients and to evaluate the effect of one month extension ofintensive phase in both groups. Methods : A retrospective observational study was conducted using patientdata records. All new onset pulmonary TB patients with recordedbacteriological confirmation and received first category FDC or separate antituberculosis formulations during January 1st 2014 until January 31st 2017 period were included. Efectiveness outcome were determined by Acid fastbacilli sputum smear conversion at the end of intensive phase month 2 andmonth 6 of therapy, and evaluation of extended phase at the end of month 3.Major and minor ADRs occured during antituberculosis treatment wereconsidered as ADRs outcome. The difference on acid bacilli sputum conversions between two groups were analyzed using Chi Square test. Results : Patients treated with FDC n 33 and with separate formulations n 30 during January 1st 2014 to Januari 31st 2017 at dr. Esnawan AntariksaHospital, Halim perdanakusuma Jakarta were evaluated. The rate of sputumsmear conversions at the end of intensive phase was not significantly higher inseparate formulations group as compared with FDC group 83,3 vs 78,7 ,p 0,693 . The intensive phase was extended one more month for patients withconversion failure at month 2, at the end of extended intensive phase, 100 of separate formulation were convertion. One patient 14,3 in FDC group didnot gain sputum conversion during the extended phase and was considered asmedication failure and being excluded from the study. At the end ofcontinuation phase, sputum smear conversions were achieved by all patients inboth groups. Major ADRs hepatitis and hypersensitivity reactions were foundhigher in FDC group as compared with separate formulations group 6.1 vs0 . Minor ADRs also were found higher in FDC group 30.3 vs 23.3 .The most frequently occurred ADRs were abdominal discomfort and nausea. The proportion of subjects with ADRs were higher in FDC than separateformulation group 33,3 vs 23,3. Conclusion : There were no differences in the effectiveness and safety profile of the first category FDC and separate antituberculosis formulations.Successfulconversions occured at the end of the extended intensive phase in both groups.

Abstrak :
Masih banyak ditemukan resep obat antituberkulosis anak dengan kombinasi beberapa obat dalam racikan puyer yang tidak sesuai standar program pemberantasan tuberkulosis (TB) paru Kementerian Kesehatan Republik Indonesia. Studi ini bertujuan untuk mengetahui situasi dan permasalahan berhubungan praktik peresepan puyer sebagai obat anti tuberkulosis (OAT). Pada periode Mei hingga Desember tahun 2009, penelitian diawali dengan pengukuran persentase peracikan OAT dalam bentuk puyer, dilanjutkan dengan penelitian kualitatif eksploratif. Data dikumpulkan dari rumah sakit, puskesmas, apotek dan dinas kesehatan di Jakarta, Bandung, Medan, dan Makassar. Pada tiap fasilitas kesehatan, 30 sampel resep pengobatan diambil untuk pasien tuberkulosis anak usia 1 _ 12 tahun. Kemudian dilakukan wawancara mendalam terhadap dokter anak, apoteker, keluarga pasien, dan pegawai dinas kesehatan yang terkait. Penelitian menemukan persentase peracikan OAT adalah 25% untuk campuran rifampicin dan isoniazid, dan 18% untuk campuran rifampicin, isoniazid, dan pyrazinamid. Semua informan menyadari bahwa praktik peracikan puyer tergolong pengobatan yang irasional, tetapi situasi yang mereka hadapi membuat mereka terus meresepkan dan membuat peracikan puyer. Ketersediaan fixed dose combination (FDC) yang rendah untuk OAT serta harga yang mahal menjadi alasan utama. Pemerintah dan organisasi profesi perlu meningkatkan pembinaan secara terus menerus kepada tenaga kesehatan berhubungan serta meningkatkan akses masyarakat terhadap FDC untuk tuberkulosis anak.

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There are still many practices of treating sick children with a mixture of several medicines for children suffering from tuberculosis, called it "puyer". It is not following the standard from Ministry of Health. This study explored the complex situation dealing with the practice of compounded medicines. It was innitially by assessment the percentage of "puyer" prescription, and followed by the qualitative study, from May to December 2009. Data were collected from hospitals, primary health cares and pharmacies in Jakarta, Bandung, Medan, and Makassar. From every health cares facilities, 30 prescriptions were collected for children age 1 to 12 years old. Then, we conducted in-depth interviews with pediatricians, pharmacist, patients? families and health officers about ?puyer? prescription for children. The prevalence of prescription consists of ?puyer? for children were 25% for isoniazid and rifampicin and 18% for isoniazid, pyrazinamid, and rifampicin. All informants knew ?puyer? prescription is irrational, because the complex situation they faced they continued to give ?puyer? to patients. Low availability and high price of fixed doses combination (FDC) are main reasons. The government and association of doctors/pharmacist should enforce discipline to their member to obey therapy standard. The government should improve access to FDC medicines for children suffering tuberculosis.