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"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)"

"Pengobatan tuberkulosis biasanya menggunakan obat kombinasi yang disebut fixed dose combination (FDC) yang dapat terdiri dari 2 atau 4 zat aktif yaitu isoniazid (INH), pirazinamid (PZA), rifampisin (RIF), dan etambutol (ETA). Dikarenakan toksiknya obat yang digunakan, maka diperlukan suatu metode analisis untuk mengetahui kadar obat dalam darah. Metode kromatografi cair kinerja tinggi yang sederhana dan reprodusibel telah dikembangkan untuk penentuan kadar INH dan PZA secara simultan di dalam tablet dan plasma manusia secara in vitro. Sistem kromatografi terdiri dari kolom Shimpack® C18 (250 × 4,6 mm, 5 μm) dengan fase gerak kalium dihidrogen fosfat pH 6,2-asetonitril (97:3) untuk analisis di dalam tablet dan fase gerak kalium dihidrogen fosfat pH 6,2-asetonitril (99:1) untuk analisis pada plasma manusia secara in vitro. Larutan dideteksi pada panjang gelombang 242 nm dan laju alir 1,0 mL/menit. Sebagai baku dalam digunakan asam nikotinat. Pada validasi tablet, metode dinyatakan linear dengan nilai koefisien korelasi (r) untuk INH dan PZA berturut-turut 0,9992 dan 0,9992; presisi dengan nilai koefisien variasi (KV) 1,46% dan 0,92%; serta akurat dengan nilai perolehan kembali untuk 3 konsentrasi sebesar 98% - 102%. Proses ekstraksi plasma dilakukan dengan metode pengendapan protein menggunakan asetonitril kemudian dikocok dengan vortex selama 1 menit dan disentrifugasi pada kecepatan 10000 rpm selama 5 menit. Supernatan kemudian diuapkan dan direkonstitusi dengan fase gerak. Pada validasi plasma, nilai perolehan kembali rata-rata untuk INH dan PZA berturut-turut 99.79% dan 99,08% serta nilai LLOQ berturut-turut 4,74 µg/mL dan 16,00 µg/mL. Metode ini juga memenuhi kriteria akurasi dan presisi intra hari dan antar hari selama 5 hari dengan % diff tidak melampaui ± 20% pada LLOQ dan ± 15% pada konsentrasi selain LLOQ. Pada uji stabilitas, INH dan PZA dalam plasma dinyatakan stabil selama 7 hari.

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Treatments for tuberculosis commonly use combination of drugs called fixed dose combination (FDC). It consists of 2 or 4 active ingredient pharmaceutical namely isoniazid (INH), pyrazinamide (PZA), rifampicin (RIF), and ethambutol (ETA). Due to the drug toxicity, analytical method is required to determine the concentration of antituberculosis drug in human plasma. A simple and reproducible high-performance liquid chromatography method was developed for simultaneous determination of INH and PZA in the tablet and human plasma. Chromatography was performed on a Shimpack® C18 column (250 × 4.6 mm, 5 μm) under isocratic elution with potassium dihydrogen phosphate pH 6.2-acetonitrile (97:3) for tablet and potassium dihydrogen phosphate pH 6.2-acetonitrile (99:1) for analytical in human plasma. Detection was made at 242 nm and analysis was run at a flow-rate of 1.0 ml/min. Nicotinic acid was used as internal standard. In tablet validation, the calibration curve was linear by r values 0.9992 and 0.9992, precision by coefficient of variation (CV) were 1.46% and 0.92% also accurate by % recovery for 3 concentrations were 98% - 102% for INH and PZA, respectively.

Plasma extraction was done by deproteination with acetonitrile, mix with vortex for 1 minute, then centrifuge it on 10000 rpm for 5 minutes. The residue was evaporated and reconstituted in eluen. In plasma validation, the recovery was 99.79% and 99.08% for INH and PZA, respectively. The lower limit of quantification (LLOQ) in plasma was 4.74 μg/ml and 16.00 μg/ml for INH and PZA, respectively. The method also fulfill the criteria for accuracy and precision intra and inter day by % diff values not exceed ± 20% for LLOQ and ± 15% for concentrations except LLOQ. On the stability study, INH and PZA in plasma is pronounced to be stable for 7 days."

"Compliance of TB patients with anti TB drugs treatment is a universally recognized problem specially in asian developing countries which results at the consequences of the TB treatment compliances, today there are TB cases defaulters,relapses and MDRTB which is mostly occurring in all over the world due to deferent reasons of the compliances, and Afghanistan is one of the 22nd highest TB burden country in the world. The main problem of TB treatment compliance in Afghanistan can be explain at two aspects: First there would be a high prevalence of TB positivity in country level because of inaccessibility to the health services In the rural areas due to war and low security, second behavioral changes and lack of knowledge of the community about the disease and wrong beliefs and perceptions, socioeconomic factors, socio demographic factors and socio psychological factors, all these factors could be determined and influence the compliance of TB patients among the TB patients in the country.ObjectiveTo determine what factors associated and influenced the compliance of TB patients with anti TB Anti TB drugs treatment in Kandahar Afghanistan.Materials and methodsIt was descriptive study, the study was including 243 TB patients participated 79 TB patients interviewed with well structured questionnaire.ResultsTB patients as much as 58.23 % was not good compliance of their anti TB treatment and 41.77% was good compliance of their anti TB treatment, and the compliance rate was higher among those patients who were not good compaliance, how ever from small sample size statistic could not detect any significant association.ConclussionThe high prevalence of TB cases in the country and high level of compliance of TB patients among the TB confirm patients with the factors influencing the compliance of the treatment is essential to control and take measure immediately, the evidence strengthen the need of collaboration to change the behavior of the community properly for ten agers and activate the education and the result attract to focus more and pay attention on the factors influencing the compliance specially for those who have no any access to the health services to satisfy and encourage them for their regular anti TB treatment therapy."

"MDR-TB menjadi masalah yang penting di Indonesia karena besarnya angka kematian dan morbiditas. Dengan mencari tahu alasan perkembangan tuberculosis menjadi MDR-TB, insidensi dari penyakit mematikan ini dapat dikurangi. Pengumpulan data dilakukan di RS Persahabatan dalam jangka waktu dari Desember 2009 sampai Agustus 2010 dan bertujuan untuk mengukur angka kepatuhan dalam pengobatan tuberculosis primer dan efek dari pembagian OAT secara gratis terhadap kepatuhan pasien. Pasien MDR-TB akan diwawancara secara retrospektif untuk mencari tahu derajat kepatuhan mereka saat pengobatan primer dulu. Hasil wawancara menunjukkan bahwa 46% dari pasien MDR-TB tidak mematuhi regimen pengobatan primer dulu. Angka ini jauh lebih buruk dari data tuberculosis pada umumnya. Hasil juga menyimpulkan bahwa hubungan antara pembagian obat secara gratis dan kepatuhan pasien sebagai non-signifikan.

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The problem of Multi-Drug Resistant Tuberculosis in Indonesia is of high importance due to its high mortality and morbidity rate. Finding clues as to how MDR-TB develops from susceptible strains of TB will help Indonesia in eliminating the menace that is MDR-TB. Data collection is done in RS Persahabatan, Jakarta during the period of December 2009 until August 2010, and aims to measure the rate of compliance in the primary TB treatment of confirmed MDR-TB patients. The study also looks at the effect of free medication on patient compliance. Interview sessions will be set for MDR-TB patients to look in retrospect towards their primary TB treatment. Results show that 46% of patients did not comply in their primary treatment, a lot higher than normal. It also proves of the relationship between compliance and the accessibility of free drugs to be non-significant."

"[ABSTRAK Multi Drug Resitance Tuberculosis (MDR TB) merupakan masalah terbesar dalampencegahan dan pemberantasan TB dunia. Indonesia berada di peringkat 8 dari 27 negaradengan MDR TB terbanyak di dunia. WHO Global Report 2013, memperkirakan pasienMDR TB di Indonesia berjumlah 6.900 pasien. MDR TB adalah penyakit yangdisebabkan oleh Mycobacterium Tuberculosis yang resisten minimal terhadap rifampisindan isoniazid. Penelitian ini berfokus pada bagaimana pengalaman pasien menjalanipengobatan Multi Drugs Resistance Tuberculosis dan seperti apa pasien memaknaipengalamannya tersebut. Desain penelitian kualitatif fenomenologi dipilih untukmendapatkan informasi yang sifatnya individual secara mendalam sesuai pengalaman dankondisi penyakit yang dialami. Partisipan ditentukan dengan tehnik purposive sampling,berjumlah tujuh orang. Tehnik wawancara mendalam dilakukan menggunakan alatperekam dan panduan wawancara semiterstruktur, serta catatan lapangan. Analisa datamenggunakan qualitative content analysis dengan pendekatan Collaizi. Tema yangditemukan sebagai hasil penelitian yaitu : Pemahaman penyakit MDR TB;ketidaknyamanan saat menjalani pengobatan Multi Drugs Resistance Tuberculosis;hambatan penderita untuk sembuh, menerima dukungan, dan harapan pengobatan.Diperlukan studi lebih lanjut untuk mengkaji secara mendalam tema yang telahteridentifikasi pada jumlah partisipan yang lebih banyak dan bervariasi.ABSTRACT Multi Drug Resistant (MDR - TB ) is the biggest problem of TB prevention and

eradication in the world. Indonesia is ranked 8 of 27 countries with MDR-TB in the

world. WHO global reported 2013, estimated MDR-TB patients in Indonesia amounted to

6.900 patient. MDR-TB is caused by Mycobacterium tuberculosis that resistant to at least

rifampicin and isoniazid. This study will focus on how the experience of undergoing

treatment of Multi Drugs Resistance Tuberculosis and patient?s insight of the experience.

Phenomenological qualitative research design was choosen to obtain information that is

significantly individual according to the experience. Participants were determined by

purposive sampling technique to seven people. In-depth interview conducted using a

recorder and semi-structured approach. Themes found as a result of the research : the

understanding of MDR TB; the experience discomfort while undergoing treatment of

Multi Drugs Resistance Tuberculosis; difficulties experienced during treatment; the

support received during treatment; and client expectations. Further study is needed to

profoundly examine the themes that have been identified on more numerous and varied

participants, Multi Drug Resistant (MDR - TB ) is the biggest problem of TB prevention and

eradication in the world. Indonesia is ranked 8 of 27 countries with MDR-TB in the

world. WHO global reported 2013, estimated MDR-TB patients in Indonesia amounted to

6.900 patient. MDR-TB is caused by Mycobacterium tuberculosis that resistant to at least

rifampicin and isoniazid. This study will focus on how the experience of undergoing

treatment of Multi Drugs Resistance Tuberculosis and patient’s insight of the experience.

Phenomenological qualitative research design was choosen to obtain information that is

significantly individual according to the experience. Participants were determined by

purposive sampling technique to seven people. In-depth interview conducted using a

recorder and semi-structured approach. Themes found as a result of the research : the

understanding of MDR TB; the experience discomfort while undergoing treatment of

Multi Drugs Resistance Tuberculosis; difficulties experienced during treatment; the

support received during treatment; and client expectations. Further study is needed to

profoundly examine the themes that have been identified on more numerous and varied

participants]"