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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)"

"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."

"Latar belakang: Kandidiasis vaginal (KV) adalah salah satu penyakit jamur yang paling sering dijumpai. Candida albicans adalah jamur penyebab yang paling sering dan telah diisolasi dari lebih 80% spesimen yang diperoleh dari wanita dengan KV. Ketokonazol adalah obat jamur oral yang pertama, dosisnya untuk KV 200 mg 2x sehari selama 5 hari. Flukonazol,obat jamur oral yang lebih baru, diberikan untuk KV sebagai dosis tunggal 150 mg. Karena fl ukonazol 150 mg cukup mahal, dosis tunggal 100 mg ketokonazol dan 40 mg fl ukonazol dalam kombinasi telah diuji untuk pengobatan KV. Hasil uji pendahuluan pada 11 wanita dengan diagnosis pasti KV, setelah 1-2 minggu pemberian obat, kultur mikologis negatif pada 8 wanita, positif pada 1 wanita, dan 2 wanita tidak kembali. Hasil yang baik ini menyebabkan penelitian ini dilakukan dengan tujuan untuk mengkonfi rmasi observasi tersebut dalam uji klinik yang formal. Metode: Sejumlah 165 pasien wanita 18 tahun ke atas, dengan diagnosis KV yang ditegakkan berdasarkan gejala klinik (rasa gatal atau rasa terbakar atau pengeluaran cairan dari vagina yang berlebihan) dan pulasan mikroskopik positif (pseudohifa dan/atau sel ragi) dirandom untuk mendapat dosis tunggal kombinasi keto-fl uko (n = 85) atau fl ukonazol (n = 80), dan kembali pada hari ke-8. Hasil: Tigapuluh sembilan pasien tidak mempunyai Candida pada kultur awal, sehingga tinggal 126 pasien yang dapat dievaluasi untuk efi kasi. Eradikasi mikologis dalam kelompok keto-fl uko 74,5% (41 pasien dari total 55 pasien yang mempunyai kultur mikologis), sedangkan dalam kelompok fl ukonazol 70,2% (40 pasien dari 57 pasien yang mempunyai kultur mikologis), dan perbedaan ini tidak bermakna. Respons klinik (kesembuhan dan perbaikan klinik) dalam kelompok keto-fl uko (n = 60) 98,3%, sedangkan dalam kelompok fl ukonazol (n = 66) 100%. Kejadian tidak diinginkan ditemukan pada 5 pasien, 3 pasien pada kelompok keto-fl uko (3/85 = 3,5%) dan 2 pasien pada kelompok fl ukonazol (2/80 = 2,5%). Kesimpulan: Uji klinik ini menunjukkan bahwa efi kasi dan keamanan kombinasi ketokonazol 100 mg dengan fl ukonazol 40 mg tidak inferior dibandingkan dengan fl ukonazol 150 mg dalam dosis tunggal untuk pengobatan kandidiasis vaginal.

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AbstractBackground: Vaginal candidiasis (VC) is one of the most common fungal diseases. Candida albicans is the most common causative fungus and has been isolated from more than 80% of specimens obtained from women with VC. Ketoconazole is the fi rst orally active antifungal, the dosage for VC is 200 mg twice daily for 5 days. Fluconazole is the newer oral antifungal, its dosage for VC is a single oral dose of 150 mg. Since fl uconazole 150 mg is considerably expensive, a single dose of 100 mg ketoconazole and 40 mg fl uconazole in combination has been tested for the treatment of VC. The results showed that from 11 women with confi rmed VC, 1-2 weeks after drug administration, the mycological culture was negative in 8 women, positive in 1 woman, and 2 woman lost to follow-up. This promising result led to the present study with the objective to confi rm the effi cacy and safety of the above combination in a formal clinical trial. Methods: A total of 165 female patients, aged 18 years or older, with the diagnosis of VC from clinical symptoms (pruritus or burning or excessive discharge) and positive microscopic smear (pseudohyphae and/or yeast cells) were randomized to receive a single dose of either keto-fl uco combination (n = 85) or fl uconazole (n = 80), and returned for follow-up visit on day 8. Results: Among these patients, 39 patients had negative baseline culture, leaving 126 patients eligible for effi cacy evaluation. The mycological eradication in the keto-fl uco group was 74.5% (41 patients from a total of 55 patients with available mycological culture), while that in the fl uconazole group was 70.2% (40 patients from 57 patients with available culture) and this difference was not signifi cant. The clinical favorable response (clinical cure and clinical improvement) in the keto-fl uco arm (n = 60) was 98.3%, while that in the fl uconazole group (n = 66) was 100%. Adverse events were found in 5 patients, 3 patients in the keto-fl uco group (3/85 = 3.5%) and 2 patients in the fl uconazole group (2/80 = 2.5%). Conclusion: The present study showed that the effi cacy and safety of ketoconazole 100 mg and fl uconazole 40 mg combination was not inferior compared to fl uconazole 150 mg in single doses for the treatment of vaginal candidiasis."

"Meningkatnya MDR-TB menambah beban pada kontrol TB. Beberapa faktor resiko dihubungkan dengan insiden MDR-TB pada pasien yang pernah menjalani pengobatan TB, termasuk pemilihan kombinasi obat yang salah oleh dokter. Penilitian ini ditujukan untuk mengetahui pemilihan obat yang diberikan kepada MDR-TB pasien sewaktu pengobatan TB yang pertama kali. Di samping itu, hubungan dengan tempat pengobatan juga diteliti. Penilitian ini menggunakan metode cross sectional dengan interview pada pasien MDR-TB di RS Persahabatan, Jakarta (n=50) pada periode Desember 2009 sampai Agustus 2010. Hasil menunjukkan mayoritas pasien diberi OAT-KDT/Kombipak (68%) dan regimen kategori 1 (78%). Pengobatan di institusi pemerintah atau swasta membuat perbedaan bermakna pada pemberian OAT-KDT/Kombipak.

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The increase of MDR-TB has saddled the TB control. Various risk factors are identified to contribute the development of MDR-TB from previous TB treatment, including mistake in giving drug combination in initial phase (i.e. error in prescription by physician). This study aims to measure the frequency of drug combination given to the MDR-TB patients during their primary TB treatment. In addition, its association with primary treatment place is investigated.

This is a cross-sectional study by interview to MDR-TB patients in Persahabatan Hospital, Jakarta (n=50) from December 2009 to August 2010. Results show that majority of the patients are given FDC/Combipack (68%) and Category 1 (78%) drug. This study suggests that going to public or private treatment place make differences on whether FDC/Combipack is prescribed."

"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."

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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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"Pendahuluan: Tuberkulosis (TB) adalah penyebab utama kematian akibat infeksi di dunia. Sejak tahun 2008 - 2017 terdapat penurunan angka keberhasilan pengobatan TB di Indonesia (< 90%). Rekomendasi pengobatan TB di Indonesia adalah paduan obat antituberkulosis (OAT) dosis berselang sebagian (2RHZE/4R3H3) atau harian (2RHZE/4RH). Menurut WHO, paduan OAT RHZE/R3H3 mempunyai angka kegagalan dan kekambuhan yang lebih tinggi. Namun, penelitian meta-analisis RCT menyatakan bahwa kedua paduan OAT mempunyai angka kegagalan dan kekambuhan yang sama. Oleh karena itu, dilakukan penelitian untuk membandingkan hasil pengobatan dan efek samping antara paduan OAT 2RHZE/2RH dengan 2RHZE/4R3H3.Metode: Penelitian ini merupakan studi analitik observasional dengan desain cross sectional yang membandingkan hasil pengobatan dan efek samping antara paduan OAT 2RHZE/4RH dengan 2RHZE/4R3H3 pada pasien TB paru kategori I di RSUP Persahabatan periode Januari 2015 sampai Juni 2018. Data sekunder diambil dari rekam medik. Hasil pengobatan dinilai sesuai definisi dalam pedoman nasional penanggulangan TB di Indonesia dan WHO. Efek samping dinilai dari seluruh efek samping terkait OAT yang tercatat dalam rekam medik.Hasil: Terdapat 175 pasien pada masing-masing kelompok. Pada kelompok paduan OAT 2RHZE/4RH terdapat 89.1% pasien berhasil, 13.1% sembuh,76.0% pengobatan lengkap, 10.6% putus berobat, 0.6% gagal, dan tidak ada yang meninggal. Pada kelompok paduan OAT 2RHZE/4R3H3 terdapat 91.4% pasien berhasil, 39.4% sembuh, 52.0% lengkap, 8% putus berobat, tidak ada yang gagal, dan 0.6% meninggal. Tidak ada perbedaan bermakna untuk keberhasilan pengobatan (p=0.470, OR=1.299, IK95%;0.637-2.648), putus berobat (p=0.659 ,OR=0.758, IK95%;0.365-1.577), gagal (p=1.000), dan meninggal (p=1.000) di antara kedua kelompok. Namun, terdapat perbedaan bermakna untuk kesembuhan (p=0.003, OR=2.358, IK95%;1.375-5.206) dan pengobatan lengkap (p=<0.001, OR=0.342, IK95%;0.217-0.540). Sebagian besar pasien mengalami efek samping pengobatan (51.1%) terutama di tahap intensif (73.2%). Pada tahap lanjutan tidak ada perbedaan bermakna kejadian efek samping antara kedua kelompok (p= 0.324, OR=1.386, IK95%; 0.723-2.657).Kesimpulan: Kesembuhan kelompok paduan OAT 2RHZE/4R3H3 lebih baik daripada 2RHZE/4RH, sedangkan pengobatan lengkap sebaliknya. Tidak ada perbedaan bermakna untuk keberhasilan pengobatan, putus berobat, kegagalan, meninggal, dan kejadian efek samping pada tahap lanjutan di antara kedua kelompok.

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Introduction: Tuberculosis (TB) is the main cause of death for infectious disease in the world. Since 2008 - 2017, there was a decline of TB success rate (< 90%) in Indonesia. Treatment of TB in Indonesia are using antituberculosis drugs with part daily dose combination (2RHZE/4R3H3) or daily dose combination (2RHZE/4RH). WHO concluded that 2RHZE/4R3H3 combination had higher failure and recurrence rate. However, a meta-analysis study showed that both combinations had same failure and recurrence rate. Therefore, this study is conducted to compare treatment outcomes and adverse effects between 2RHZE/4RH combination and 2RHZE/4R3H3 combination.

Method: This was an observational analytic study with cross sectional design which compared treatment outcomes and adverse effects between 2RHZE/4RH combination and 2RHZE/4R3H3 combination in pulmonary tuberculosis patient at RSUP Persahabatan period January 2015 until June 2018. Secondary data was taken from medical record. Treatment outcomes were assessed using definition in Indonesia National Guideline of TB and WHO. Adverse effects were assessed from all adverse effects that written in medical record.

Result: There are 175 patients in each group. In 2RHZE/4RH combination group, there were 89.1% patients succeed, 13.1% cured, 76.0% completed treatment, 10.6% lost to follow up, 0.6% failed and no one died. In 2RHZE/4R3H3 combination group, there were 91.4% patients succeed, 39.4% cured, 52.0% completed treatment, 8% lost to follow up, no one failed, and 0.6% died. There was no significant difference for success (p=0.470, OR=1.299, IK95%;0.637-2.648), loss to follow up (p=0.659, OR=0.758, IK95%;0.365-1.577), failure (p=1.000), and death rate (p=1.000) between two groups. However, there was a significant difference for cure (p=0.003, OR=2.358, IK95%;1.375-5.206) and complete treatment rate (p=<0.001, OR=0.342, IK95%;0.217-0.540) between two groups. Most patients had adverse effects (51,5%), especially in intensive phase (73,2%). In continuation phase, there was no significant difference of adverse effects event between two groups (p = 0.324, OR= 1.386, IK95%; 0.723-2.657).

Conclusion: Cure rate was better in 2RHZE/4R3H3 group than 2RHZE/4RH group, for completed treatment on the contrary. There was no significant difference for success rate, loss to follow up rate, failure rate, death rate, and adverse effects event in continuation phase between two groups."

"Tuberkulosis (TB) hingga saat ini menjadi salah satu masalah kesehatan masyarakat dunia. Di Indonesia, prevalensi infeksi TB mencapai 8,5% dan merupakan angka prevalensi TB terbesar kedua di dunia pada tahun 2019. Dalam rangka mendukung keberhasilan program penanggulangan TB nasional, dilaksanakan upaya pemantauan dan evaluasi keberhasilan program penanggulangan TB di Indonesia. Sejak bulan Maret 2022 – Mei 2023, puskesmas kecamatan cengkareng telah melayani 166 pasien dewasa TB Sensitif Obat (TB-SO) dosis intermiten. Dalam rangka menilai keberhasilan program tersebut, dilakukan evaluasi hasil pengobatan periode Maret 2022 – April 2023 serta dilakukan penyusun leaflet sebagai sarana edukasi pengobatan TB-SO dosis intermiten. Evaluasi pengobatan dilaksanakan melalui pengelolahan data retrospektif menggunakan perangkat lunak Microsoft excel dari data sekunder hasil rekapitulasi pengobatan OAT 2HRZE/4H3R3 sejak bulan Maret 2022 – Mei 2023. Sedangkan, pembuatan leaflet dilakukan berdasarkan studi literatur dari pustaka tahun 2009 – 2021 dan ditulis secara ringkas dan menarik. Berdasarkan hasil evaluasi, dari 166 pasien dewasa TB-SO dosis intermiten; 48,80% pasien sembuh; 13,25% pasien dirujuk ke fasilitas kesehatan lain; 9,64% pasien Loss to Follow Up; 0,6% pasien meninggal; 21,08% pasien menjalankan terapi fase awal; dan 6,63% pasien menjalankan terapi fase lanjutan. Selain itu, telah dibuat leaflet pengobatan TB dosis 4HRZE/2H3R3 sebagai media edukasi bagi pasien TB.

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Tuberculosis (TB) has become one of the world's public health problems. In Indonesia, the prevalence of TB infection reached 8.5% and was the second highest TB prevalence in the world in 2019. To support the success of the national TB program, evaluation, and monitoring of TB programs in Indonesia were carried out. From March 2022 – May 2023, Puskesmas kecamatan cengkareng has treated 166 adult patients with drug-sensitive TB (SO-TB). To assess the success of the program, an evaluation of the treatment was carried out and the leaflet was compiled as an educational media. The evaluation was carried out retrospectively using secondary data from the recapitulation of OAT 2HRZE/4H3R3 treatment from March 2022 – May 2023, all the data were processed using Microsoft Excel software. Meanwhile, the leaflet was created based on literature studies from the 2009 – 2021 literature. Based on the evaluation results, from 166 adult patients with intermittent dose TB-SO; 48.80% of the patients recovered; 13.25% of patients were referred to other health facilities; 9.64% of patients were Loss to Follow Up; 0.6% of patients died; 21.08% of patients underwent intensive phase therapy; and 6.63% of patients underwent continuous phase therapy. In addition, the leaflet for drug-sensitive TB has been made as educational media for TB patients."

"ABSTRACTKebijakan pemberantasan Soil Transmitted Helminths saat ini adalah menggunakan albendazol oral dosis tunggal namun, metode tersebut hanya efektif terhadap Ascaris lumbricoides dan tidak untuk Trichuris trichiura. Albendazol triple dose lebih efektif dari dosis tunggal namun sulit diimplementasikan sehingga diperlukan antelmintik yang memiliki efektifitas serupa dengan frekuensi pemberian lebih mudah. Penelitian ini bertujuan untuk mengetahui efektivitas mebendazol 500mg double dose dan albendazol 400mg triple dose dalam pengobatan trikuriasis. Randomized controlled trial dilakukan pada anak-anak berusia 1-15 tahun di desa Pero, Sumba Barat Daya pada bulan Juli 2016. Sebanyak 303 anak diminta mengumpulkan tinja kemudian diperiksa dengan metode Kato-Katz untuk mengetahui prevalensi trikuriasis dan anak yang positif dibagi dua kelompok secara acak. Kelompok pertama diberi albendazol triple dose dan kelompok kedua diberikan mebendazol double dose. Dua minggu setelah pengobatan dilakukan pemeriksaan tinja untuk mengetahui angka kesembuhan pengobatan. Dari 303 anak yang diperiksa didapatkan 190 subjek positif T.trichiura prevalensi 62,7, kemudian diambil 47 subjek berdasarkan rumus besar sampel untuk masing-masing kelompok. Proporsi trikuriasis setelah pengobatan albendazol triple dose adalah 38,3 sedangkan mebendazol double dose 36,2. Pada uji McNemar tidak didapatkan perbedaan bermakna pada kedua jenis pengobatan p> 0,05. Angka kesembuhan albendazol triple dose 61,7 dan mebendazol double dose 63,8. Tidak didapatkan perbedaan bermakna pada angka kesembuhan tersebut uji chi square p>0,05. Disimpulkan mebendazol double dose sama efektifnya dengan albendazol triple dose. Diperlukan penelitian lebih lanjut untuk mengetahui efektivitas mebendazol double dose dengan triple dose dalam pengobatan trikuriasis.

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ABSTRACTThe current STH eradication policy is to use single dose oral albendazole, however this treatment is only effective against Ascaris lumbricoides and not for Trichuris trichiura. Albendazole triple dose is more effective than single dose but is difficult to implement so an antelmintic that has similar effectiveness but less delivery frequency is required. This study was aimed to determine the effectiveness of mebendazole 500mg double dose and albendazole 400mg in the treatment of trichuriasis. A randomized controlled trial was conducted on children aged 1 15 years old in Pero village, Southwest Sumba in July 2016. A total of 303 children were asked to collect feces and then examined by Kato Katz method to determine the prevalence of positive trichuriasis, afterwards the children were divided into groups by random. The first group was given triple dose and the second group was given double dose mebendazole. Two weeks after the treatment, the stools were reexamined to determine the rate of cure of treatment. Of 303 children examined, 190 subjects were T.trichiura positive prevalence 62,7 , then 47 subjects based on the sample formula were selected for each group. The proportion of trichuriasis after treatment of albendazoe triple dose was 38.3 while mebendazole double dose was 36.3. In McNemar test, there was no significant difference between the two treatments p 0.05. Cure rate of albendazole double dose was 61.7 and mebendazole double dose was 63.8. There was no significant difference in the cure rate chi square test p 0.05. In conclusion, mebendazole double dose is as effective as albendazole triple dose. Further research is needed to determine the effectiveness of mebendazole double dose and triple dose in the treatment of trichuriasis. "