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Abstrak :
6-Merkaptopurin merupakan obat antineoplastik golongan antimetabolit yang digunakan dalam terapi pengobatan leukemia limfositik akut. 6-Merkaptopurin memiliki indeks terapi sempit sehingga diperlukan pemantauan terapi obat. Pemantauan terapi obat tersebut memerlukan metode analisis yang sensitif, selektif, dan valid untuk menganisis kadar analit dan metabolit dalam plasma manusia. Penelitian ini dilakukan untuk mengoptimasi kondisi analisis dan melakukan validasi metode analisis 6-merkaptopurin dan 6-metilmerkaptopurin dalam plasma. Kondisi optimum kromatografi adalah menggunakan kolom C18 SunfireTM (5μm, 250 x 4,6 mm); suhu 30°C; fase gerak air-metanol-asetonitril pada kondisi elusi gradien; laju alir 1,00 mL/menit; dan dideteksi dengan detektor photodiode array pada panjang gelombang 303 nm. Sebagai baku dalam digunakan 5-fluorourasil. Ekstraksi plasma dilakukan dengan metode ekstraksi cair-cair menggunakan diklormetan sebagai pengekstrak. Hasil validasi metode analisis yang diperoleh valid dan linear pada rentang konsentrasi merkaptopurin 2,0 - 200,0 ng/mL dengan nilai r > 0,9991 dan rentang konsentrasi 6-metilmerkaptopurin 20 - 2000 ng/mL dengan nilai r > 0,9993. Akurasi dan presisi intra-hari dan antar-hari memenuhi persyaratan yaitu nilai koefisien variasi ≤ 20% (LLOQ) dan ≤ 15% (sampel QC). Pada uji stabilitas, 6-merkaptopurin dan 6-metilmerkaptopurin stabil dalam plasma suhu -20°C selama 21 hari. Metode analisis yang diperoleh memenuhi persyaratan EMEA bioanalytical guideline. ......6-Mercaptopurin is antineoplastics drug that included in antimetabolite group used in acute lymphocytics leukemia medication. 6-Merkaptopurin has narrow therapeutic index, so it requires therapeutic drug monitoring. Therapeutic drug monitoring requires sensitive, selective, and valid method to anlyze the level of anlyte and it's metabolite in human plasma. This study aimed to optimize the analytical conditions and do validation for analysis of 6-mercaptopurine and it's one of metabolites (6-methylmercaptopurine) in plasma. Optimal chromatographic condition for analysis was performed using C18 SunfireTM column (5μm, 250 x 4.6 mm); temperature 30°C; the mobile phase contains water-methanol-acetonitril bellow gradient elusion condition; and detected at PDA wavelength of 303 nm. 5-Fluorouracil was used as internal standard. Plasma extraction was done by liquid-liquid extraction method using dichlormethane. The method was valid and linear at concentration range of 2.0 - 200.0 ng/mL with r > 0.9991 for 6-mercaptopurine and 20 - 2000 ng/mL with r > 0.9993 for 6-methylmercaptopurine. Accuracy and precision within-run and between-run fulfill the acceptance criteria, coefficient of variation ≤ 20% (LLOQ) and ≤ 15% (QC samples). 6-Mercaptopurine and 6-methylmercaptopurine was stable in plasma at least for 21 days when stored at -20ºC. This method fulfill the acceptance criteria based on EMEA bioanalytical guideline.

Abstrak :
[ABSTRAK
Latar belakang dan tujuan: Keloid merupakan pertumbuhan berlebih dari kolagen dermis yang dapat menimbulkan masalah fisis dan psikis bagi penderitanya. Berbagai pilihan terapi telah digunakan untuk pengobatan keloid. Penelitian ini membandingkan efikasi dan efek samping antara kombinasi triamsinolon asetonid (TA) dan 5-fluorouracil (5-FU) dengan TA intralesi pada terapi keloid. Metode: Studi eksperimen dengan desain single blind randomized controlled trial (RCT) terhadap pasien keloid. Penelitian ini melibatkan 2 kelompok, yaitu: kelompok intervensi yang mendapat kombinasi 5-fluorourasil dan triamsinolon asetonid intralesi, dan kelompok kontrol yang mendapat terapi tunggal triamsinolon asetonid intralesi. Kedua kelompok diberi pengobatan 1 kali perminggu selama 8 minggu dan lesi keloid diukur tinggi dan volume. Hasil: Penurunan tinggi dan volume terjadi pada kedua kelompok. Pada penurunan tinggi, respons baik terjadi pada 75% kelompok intervensi dan 63,6% kelompok kontrol (p = 0,403). Sedangkan pada penurunan volume, respons baik terjadi pada 58,3% kelompok intervensi dan 63,6% kelompok kontrol (p = 0,713). Sebanyak 5 dari 24 SP pada kelompok intervensi mengalami efek samping berupa gatal, nyeri ringan, ulkus dangkal, dan telangiektasi. Sedangkan pada kelompok kontrol terdapat 7 dari 22 SP yang mengeluh gatal, nyeri ringan, dan telangiektasi. Kesimpulan: Secara umum, efikasi dan efek samping kombinasi TA dan 5-FU intralesi sebanding dengan TA saja.

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ABSTRACT
Background and objectives: Keloid are benign growths of dermal collagen that can cause physical and psychological problems for patients. A variety of treatment regimens have been used for treatment of keloids. This study was conducted to compare efficacy and side effects intralesional combination triamcinolone acetonide (TA) with 5-fluorouracil (5-FU) and TA alone for the treatment of keloid. Methods: Experimental study, single blind randomized controlled trial (RCT) for keloid patients. This study involved two groups: intervention group who received intralesional combination TA with 5-FU, and the control group who received intralesional TA alone. Both groups received treatment once a week for 8 weeks and lesions were assessed for height and volume. Results: Both groups showed improvement in height and volume. In height flattening, 75% patients in intervention group had good response, comparing to 63,6% control group (p = 0,403). While in volume reduction, 58,3% patients in intervention group had good response, comparing to 63,6% in control group (p = 0,713). Five out of 24 patients in intervention group had some side effects like itch, mild pain, superficial ulcer, and telangiectasis. While in control group, 7 out of 22 patients had itch, mild pain, and telangiectasis. Conclusions: The overall efficacy and side effects of combination triamcinolon acetonide with 5-fluorouracil was comparable with triamcinolone acetonide alone;Background and objectives: Keloid are benign growths of dermal collagen that can cause physical and psychological problems for patients. A variety of treatment regimens have been used for treatment of keloids. This study was conducted to compare efficacy and side effects intralesional combination triamcinolone acetonide (TA) with 5-fluorouracil (5-FU) and TA alone for the treatment of keloid. Methods: Experimental study, single blind randomized controlled trial (RCT) for keloid patients. This study involved two groups: intervention group who received intralesional combination TA with 5-FU, and the control group who received intralesional TA alone. Both groups received treatment once a week for 8 weeks and lesions were assessed for height and volume. Results: Both groups showed improvement in height and volume. In height flattening, 75% patients in intervention group had good response, comparing to 63,6% control group (p = 0,403). While in volume reduction, 58,3% patients in intervention group had good response, comparing to 63,6% in control group (p = 0,713). Five out of 24 patients in intervention group had some side effects like itch, mild pain, superficial ulcer, and telangiectasis. While in control group, 7 out of 22 patients had itch, mild pain, and telangiectasis. Conclusions: The overall efficacy and side effects of combination triamcinolon acetonide with 5-fluorouracil was comparable with triamcinolone acetonide alone;Background and objectives: Keloid are benign growths of dermal collagen that can cause physical and psychological problems for patients. A variety of treatment regimens have been used for treatment of keloids. This study was conducted to compare efficacy and side effects intralesional combination triamcinolone acetonide (TA) with 5-fluorouracil (5-FU) and TA alone for the treatment of keloid. Methods: Experimental study, single blind randomized controlled trial (RCT) for keloid patients. This study involved two groups: intervention group who received intralesional combination TA with 5-FU, and the control group who received intralesional TA alone. Both groups received treatment once a week for 8 weeks and lesions were assessed for height and volume. Results: Both groups showed improvement in height and volume. In height flattening, 75% patients in intervention group had good response, comparing to 63,6% control group (p = 0,403). While in volume reduction, 58,3% patients in intervention group had good response, comparing to 63,6% in control group (p = 0,713). Five out of 24 patients in intervention group had some side effects like itch, mild pain, superficial ulcer, and telangiectasis. While in control group, 7 out of 22 patients had itch, mild pain, and telangiectasis. Conclusions: The overall efficacy and side effects of combination triamcinolon acetonide with 5-fluorouracil was comparable with triamcinolone acetonide alone, Background and objectives: Keloid are benign growths of dermal collagen that can cause physical and psychological problems for patients. A variety of treatment regimens have been used for treatment of keloids. This study was conducted to compare efficacy and side effects intralesional combination triamcinolone acetonide (TA) with 5-fluorouracil (5-FU) and TA alone for the treatment of keloid. Methods: Experimental study, single blind randomized controlled trial (RCT) for keloid patients. This study involved two groups: intervention group who received intralesional combination TA with 5-FU, and the control group who received intralesional TA alone. Both groups received treatment once a week for 8 weeks and lesions were assessed for height and volume. Results: Both groups showed improvement in height and volume. In height flattening, 75% patients in intervention group had good response, comparing to 63,6% control group (p = 0,403). While in volume reduction, 58,3% patients in intervention group had good response, comparing to 63,6% in control group (p = 0,713). Five out of 24 patients in intervention group had some side effects like itch, mild pain, superficial ulcer, and telangiectasis. While in control group, 7 out of 22 patients had itch, mild pain, and telangiectasis. Conclusions: The overall efficacy and side effects of combination triamcinolon acetonide with 5-fluorouracil was comparable with triamcinolone acetonide alone]

Abstrak :
Latar belakang : Insidens kutil anogenital KA terus mengalami peningkatan. Hingga saat ini belum ada terapi yang efektif untuk semua jenis KA. Terdapat berbagai macam pilihan terapi KA, antara lain terapi yang dapat diaplikasikan sendiri, contohnya krim 5-fluorourasil 5-FU 1 dan 5-FU 5 dan terapi yang diaplikasikan oleh dokter, contohnya larutan asam trikloroasetat TCA 90 . Larutan TCA 90 merupakan terapi standar KA, memerlukan kurang lebih 4-6 kali kunjungan tiap minggu untuk mencapai kesembuhan. Hingga saat ini terapi KA yang dapat diaplikasikan sendiri oleh pasien sendiri, belum tersedia di Indonesia. Tujuan : Mengetahui efektivitas dan keamanan krim 5-FU 1 dan krim 5-FU 5 dibandingkan dengan larutan TCA 90 untuk terapi KA pada genitalia eksterna dan atau perianus. Metode : Uji klinis acak terkontrol dilakukan terhadap pasien KA pada bulan Januari hingga Mei 2018. Pasien yang memenuhi kriteria penerimaan dan bersedia mengikuti penelitian akan mendapat terapi 5-FU 1 , 5-FU 5 , atau larutan TCA 90 sesuai dengan randomisasi blok. Pasien dicatat identitas, jumlah, dan ukuran lesi KA kemudian diamati respons terapi dan efek samping subyektif dan obyektif setiap minggu, hingga minggu ketujuh. Dilakukan analisis intention to treat. Hasil : Didapatkan total 72 subjek. Terdapat 5 SP drop out, dua dari kelompok 5-FU 1 dan tiga dari kelompok TCA 90 . Tidak terdapat perbedaan efektivitas antara kelompok 5-FU 1 dengan TCA 90 p=0,763 . Respons sempurna pada 5-FU 1 adalah 671 , sedangkan TCA 90 adalah 63 . Begitupula dengan perbandingan efektivitas antara kelompok 5-FU 5 dengan TCA 90 . Pada awalnya saat minggu kedua TCA 90 tampak lebih cepat memberikan kesembuhan daripada 5-FU 5 p=0,036 , namun setelah enam minggu terapi ternyata tidak ada perbedaan efektivitas antara keduanya p=0,274 . Didapatkan bahwa respons sempurna pada 5-FU 5 adalah 46 dan 63 pada TCA 90 . Terdapat perbedaan efek samping subyektif yang lebih ringan secara bermakna pada kelompok 5-FU 1 dibandingkan dengan kelompok TCA 90 p=0,004 . Terdapat pula perbedaan efek samping subyektif yang lebih ringan secara bermakna pada kelompok 5-FU 5 dibandingkan dengan kelompok TCA 90 p=0,001 . Efek samping gatal ketika evaluasi minggu keempat pada kelompok 5-FU 1 adalah 21 dan 33 pada kelompok 5-FU 5 . Efek samping tersering pada kelompok TCA 90 adalah nyeri 96 ketika aplikasi TCA 90 pertama kali. Terdapat perbedaan efek samping obyektif yang lebih ringan secara bermakna ketika evaluasi minggu kedua, keenam, dan ketujuh pada kelompok 5-FU 1 dibandingkan dengan TCA 90 p ......Background: Anogenital wart incidence is increasing lately. Up till now there is no effective therapy for every type of anogenital wart. There are various kind of anogenital wart therapy, such as self applied therapy e.g. 5-fluorouracil 1 cream and 5-fluorouracil 5 cream and physician-applied therapy e.g. trichloroacetic acid 90 solution . Trichloroacetic acid is the standard therapy for anogenital wart, need around 4-6 times until totally improved. Currently, there is no self applied anogenital wart therapy available in Indonesia. Objective: To know the effectivity and safety of 5-fluorouracil 1 cream and 5-fluorouracil 5 cream compared to trichloroacetic acid 90 solution in the treatment of anogenital wart. Methods: A randomized control study of adult patients with anogenital wart during the period of January-Mei 2018. Patients who fulfiled inclusion criteria and willing to follow this research, allocated to receive 5-fluorouracil 1 cream, 5-fluorouracil 5 cream, or trichloroacetic acid 90 solution in accordance with block randomization. The identity, number and size of the anogenital wart were recorded, then the response of therapy and side effect subjective and objective were observed each weeks, up to seventh week. The data was analyzed with intention to treat analysis. Result: A total of 72 subjects were enrolled, two subjects from 5-FU 1 and three subjects from TCA 90 dropped out. There was no diference in the effectivity between 5-FU 1 group compared to TCA 90 p=0,763 . Total response in 5-FU 1 was 67 and 63 in TCA 90 . Likewise the comparison of effectivity between 5-FU 1 group and TCA 90 group. On the second week TCA 90 gave faster improvement than 5-FU 5 p=0,036 , but after 6 weeks treatment there was no difference between both groups p=0,274 . Total response in 5-FU 5 was 46 and 63 in TCA 90 . There was significant milder subjective side effect on 5-FU 1 compared to TCA 90 group p=0,004 , as well as significant milder subjective side effect on 5-FU 5 compared to TCA 90 p=0,001 . On the fourth week there was 21 in the 5-FU 1 group felt itchy and 33 in TCA 90 group. The most common side effect in TCA 90 group was painful, 96 of the subjects experienced it while their first TCA application. We also found significant milder objective side effect in 5-FU 1 group on the second week, sixth week, and seventh week evaluation compared to TCA 90 group p