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"Diabetes mlitus (DM) merupakan penyakit kronis yang terjadi karena gangguan sekresi dan resistensi insulin. Inhibitor dipeptidil peptidase-4 (DPP-4) adalah salah satu golongan obat antidiabetes yang memilki lebih sedikit efek samping dibandingkan golongan lainnya. Kuinazolinon merupakan senyawa yang dipercaya memiliki aktivitas antidiabetes. Pada penelitian sebelumnya 6 turunan dari 2-(Alkil-aminometil)-N- Metilbenzonitril Kuinazolinon telah disintesis. Pada penelitian ini, 6 senyawa tersebut diteliti aktivitas antidiabetesnya dengan menggunakan kit enzim DPP-4. Penyakit diabetes juga berkaitan dengan adanya aktivitas antioksidan, oleh karena itu senyawa yang telah disintesis diuji aktivitas antIoksidannya secara in vitro menggunakan metode radikal bebas DPPH dan FRAP. Untuk menguji aktivitas antiinflamasi yang berkaitan dengan antioksidan maka dilakukan uji aktivitas antiinflamasi menggunakan metode denaturasi protein. Dari keempat uji yang dilakukan didapatkan nilai IC50 dari masing- masing uji. Belum didapatkan hasil yang sebanding dengan standar untuk pengujian antidiabetes dan antioksidan, namun pada pengujian antiinflamasi didapatkan hasil bahwa senyawa 2-({2-[Dimetilaminometil]-4-okso-dihidrokuinazolin-3-il}meti)benzonitril dan 2-({2-[Dietilaminometil]-4-okso-dihidrokuinazolin-3-il}meti)benzonitril menghasilkan nilai IC50 yang sebanding dengan standar yang memungkinkan untuk diteliti lebih lanjut.

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Diabetes mellitus (DM) is a chronic disease that occurs due to impaired insulin secretion and resistance. Dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of antidiabetic drugs that have fewer side effects than other groups. Quinazolinone is a compound that believed to have antidiabetic activity. In previous studies 6 derivatives of 2-(Alkyl-aminomethyl)- N-Methylbenzonitrile Quinazolinone were synthesized. In this study, the 6 compounds were investigated for their antidiabetic activity using the DPP-4 enzyme kit. Diabetes disease is also related to the presence of antioxidant activity, therefore the compounds that have been synthesized were tested for their antioxidant activity using the DPPH and FRAP free radical methods. To test the anti-inflammatory activity associated with antioxidants, the anti-inflammatory activity test was carried out using the protein denaturation method. The value of IC50 is obtained from the each tests. There were no obtained results that comparable to the standards for antidiabetic and antioxidant tests, but in anti- inflammatory tests it was found that the compounds 2-({2-[Dimethylaminomethyl]-4- oxo-dihydroquinazoline-3-yl}methi)benzonitrile and 2-({2 -[Diethylaminomethyl]-4- oxo-dihydroquinazoline-3-yl}methyl)benzonitrile produced an IC50 value comparable to the standard which allows for further investigation."

"Tablet moxifloxacin 400 mg telah dipasarkan di Indonesia untuk beberapa indikasi, yaitu bronkitis kronik eksaserbasi akut, pneumonia didapat di komunitas, dan sinusitis bakterial akut. Untuk menilai keamanan dan tolerabilitas moxifloxacin, dilakukan survei pasca pemasaran pada tahun 2001 yang melibatkan 589 dokter. Selain itu, dinilai pula efikasi kliniknya, baik oleh dokter maupun pasien, dengan menggunakan total skor 6 gejala yang berskala 0-12. Seluruhnya, diperoleh 1715 pasien dengan sinusitis akut, pneumonia didapat di komunitas, bronkitis kronik eksaserbasi akut dan infeksi lainnya yang diobati dengan moxifloxacin oral 400 mg sekali sehari. Sebanyak 151 (8,8%) pasien melaporkan efek samping dan 5 (0.29%) pasien mengalami efek samping serius, yang dianggap berhubungan dengan terapi moxifloxacin. Efek samping tersering adalah mual (4.96%), pusing (1.52%), muntah (0.64%), sakit kepala (0,47%), dan lemah (0,47%). Duapuluh tiga (1,34%) pasien menghentikan terapi akibat efek samping. Toleransi terhadap terapi dinilai sangat baik oleh 647 (37,7%) dan baik oleh 919 (53,6%) pasien. Berdasarkan penilaian klinis oleh dokter, 57,7% pasien dinyatakan sembuh dan 39.9% dinyatakan membaik di akhir terapi. Rerata skor gejala total, sebagaimana dinilai oleh pasien, turun dari 6,43 pada hari pertama menjadi 2,76 pada hari ketiga. Secara umum, 95.3% pasien merasa lebih baik setelah mendapat moxifloxacin dan 97,6% pasien memberikan kesan baik terhadap terapi moxifloxacin. Sebagai kesimpulan, survei pasca pemasaran ini menunjukkan bahwa pengobatan infeksi saluran napas oleh bakteri, terutama bronkitis, pneumonia komunitas dan sinusitis, dengan moxifloxacin 400 mg sekali sehari aman dan dapat ditoleransi dengan baik, dan juga bahwa moxifloxacin sangat efektif untuk pengobatan infeksi ini dengan perbaikan gejala yang cepat. (Med J Indones 2004; 14: 11-19)

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Moxifloxacin 400 mg tablet has been marketed in Indonesia for several indications, i.e. acute exacerbation of chronic bronchitis (AECB), community-acquired pneumonia (CAP), and acute bacterial sinusitis (ABS). To assess the safety and tolerability of moxifloxacin, a post-marketing surveillance study was conducted in the year 2001 involving 589 physicians. Clinical efficacy was also evaluated, both by physicians and patients, using a 6-symptom total score, which was scaled 0-12. A total of 1715 patients with acute sinusitis, CAP, AECB, and other infections were treated with oral moxifloxacin 400 mg once daily. There were 151 (8.8%) patients with adverse events (AEs) and 5 (0.29%) patients with serious adverse events (SAEs) that were considered related to moxifloxacin treatment. The most common adverse reactions were nausea (4.96%), dizziness (1.52 %), vomiting (0.64%), headache (0.47%), and weakness (0.47%). Twenty three (1.34%) patients discontinued treatment due to adverse events. Tolerance to treatment was rated very good and good by 647 (37.7%) and 919 (53.6%) of patients, respectively. Based on physicians? clinical assessment, 57.7% of patients were cured and 39.9% were improved at the end of treatment. Mean total symptom score, as assessed by the patients, decreased from 6.43 on day-1 to 2.76 on day-3. Totally, 95.3% of patients felt better after receiving moxifloxacin and 97.6% of patients had good impression on moxifloxacin treatment. In conclusion, treatment of respiratory tract infections, mainly AECB, CAP and ABS, with moxifloxacin 400 mg once daily in this post-marketing surveillance was shown to be safe and well tolerated. Moxifloxacin was also shown to be highly effective in the treatment of these infections with rapid improvement of symptoms. (Med J Indones 2004; 14: 11-19)"

"Tablet fluvastatin XL 80 mg telah dipasarkan di Indonesia sejak Desember 2002. Survei pasca pemasaran ini dilaksanakan antara Mei 2004 dan April 2005 dengan melibatkan 98 dokter umum untuk melihat keamanan dan tolerabilitas fluvastatin XL 80 mg sekali sehari sebelum tidur selama 8 minggu untuk pengobatan pasien rawat jalan dengan hiperkolesterolemia. Efikasi obat dalam menurunkan kolesterol LDL dan parameter lipid lainnya juga dilihat dalam praktek klinik sehari-hari pada survei ini. Seluruhnya ada 740 pasien yang dapat dievaluasi keamanannya. Sebanyak 32 pasien (4,32%) melaporkan 39 efek samping yang dianggap berhubungan dengan terapi fluvastatin XL. Efek samping yang paling sering adalah pusing kepala (2,03%), nausea (1,22%), dan mialgia (0,68%). Tidak ditemukan efek samping serius pada survei ini dan tidak ada pasien yang menghentikan pengobatan akibat efek samping. Menurut penilaian global dokter, keamanan dan tolerabilitas pengobatan baik pada 91,9% pasien. Evaluasi efikasi hanya dapat dilakukan pada 566 pasien. Pada minggu 8, fluvastatin XL menurunkan kadar kolesterol LDL (LDL-C), kolesterol total (TC) dan trigliserida (TG) berturut-turut sebanyak 28,6%, 30,2%, dan 24,5%, dan meningkatkan kadar kolesterol HDL (HDL-C) sebanyak 14,3%. Pada 74 pasien dengan TG awal > 300 mg/dL, penurunan TG 38,1% dan peningkatan HDL-C 18,1%. Penurunan LDL-C sebanyak > 40% terjadi pada 19,6% pasien. Sebagai kesimpulan, survei pasca pemasaran ini menunjukkan bahwa pengobatan dengan fluvastatin XL 80 mg sekali sehari selama 8 minggu aman dan dapat ditoleransi dengan baik, dan juga efektif dalam menurunkan LDL-C, TC dan TG, dan menaikkan HDL-C dalam praktek klinik sehari-hari.

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AbstractFluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%), nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physician?s global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG > 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of > 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice."

"In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis."