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Abstrak :
Background: treatment of erythropoietin (EPO) is essential in chronic kidney disease (CKD) patients to maintain optimal hemoglobin (Hb) level. Renogen is a biosimilar epoetin-α, and Eprex is the originator epoetin-α. This study aimed to compare the efficacy and tolerance of Renogen with Eprex in CKD anemia. Methods: Renogen and Eprex were compared in a randomized (2:1), open-label study for 8 weeks, proceeded by 4 weeks adjustment (maintenance) phase, in anemic CKD patients undergoing HD in Cipto Mangunkusumo General Hospital, Jakarta, from June 2017 to October 2018. Results: a total of 45 patients (31 received biosimilar EPO and 14 received originator EPO) were included in the study. At baseline, mean (SD) Hb levels were 10,9 (0,74) g/dL and 10,9 (0,61) g/dL in biosimilar and originator EPO groups, respectively. At end of study (8 weeks), mean (SD) Hb levels were 10,5 (1,28) g/dL and 11,0 (1,13) g/dL in biosimilar EPO and originator EPO groups, respectively. The proportion of patients with Hb levels maintained within the target range (>10 g/dL) during 8 weeks randomization phase were 58,1% and 71,4% in biosimilar EPO and originator EPO, respectively (p=0,60; NS). There were no significant difference in epoetin dose between the 2 groups, and there was no drug-related adverse event in either group. Conclusion: Hb level at >10 g/dL could be maintained for 8 weeks of treatment with both originator and biosimilar EPO (more consistent with originator EPO and more fluctuations with biosimilar EPO), with similar epoetin dose and no drug-related adverse event.

Abstrak :
ABSTRAK
Glimepirid adalah suatu antihiperglikemia golongan sulfonilurea untuk terapi oral diabetes melitus tipe 2. Studi ini dilakukan untuk menilai glimepirid monoterapi dalam mengendalikan gula darah (HbA1c) pada pasien DM tipe 2, dosis yang digunakan, dan profil keamanannya. Metode: Studi observasional prospektif ini dilakukan di 4 klinik pribadi di Semarang, Jambi, Mojokerto dan Medan antara Oktober 2006 sampai September 2007 pada pasien rawat jalan, pria dan wanita, umur >20 tahun, dengan DM tipe 2, HbA1c >7%, dan tidak mendapat antidiabetik oral paling sedikit 3 bulan sebelumnya. Tablet glimepirid diberikan sekali sehari selama 3 bulan. Hasil: Dari 74 pasien yang memenuhi syarat, 18 pasien tidak kembali untuk evaluasi dan 56 pasien menyelesaikan studi 3 bulan ini, terdiri dari 26 pasien baru (belum pernah mendapat obat antidiabetes) dan 30 pasien yang sebelumnya pernah diobati (dengan obat antidiabetes). Dosis glimepirid awal dan akhir tidak berbeda untuk pasien baru maupun pasien yang sebelumnya pernah diobati (awal 2,0 mg, akhir 2,3 mg). Penurunan rata-rata kadar HbA1c 1,8% untuk semua pasien, lebih besar pada pasien baru (2,3%) dibandingkan dengan pasien yang sebelumnya pernah diobati (1,3%). Berdasarkan berat massa tubuh, penurunan rata-rata kadar HbA1c pada 20 pasien dengan BB normal 1,3%, dan lebih besar pada 20 pasien obese (2,4%). Penurunan rata-rata kadar gula darah puasa pada semua pasien 54 mg/dL, lebih besar pada pasien baru (83 mg/dL) dibandingkan pasien yang pernah diobati (30 mg/dL), tetapi tidak dipengaruhi oleh berat badan. Berat badan meningkat selama studi dengan rerata 0.9 kg. Tidak ada efek samping yang dialami oleh pasien selama 3 bulan monoterapi dengan glimepirid pada studi ini. Kesimpulan: Glimepirid monoterapi pada studi observasional dalam praktek sehari-hari selama 3 bulan ini efektif dalam menurunkan kadar HbA1c dan gula darah puasa, terutama pada pasien baru. Glimepirid pada studi ini disertai dengan peningkatkan berat badan meskipun tidak bermakna secara statistik. Tidak dilaporkan adanya efek samping dalam studi ini.

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Abstract
Background: Glimepiride is a sulphonylurea antihyperglycemic agent for oral therapy of type-2 diabetes mellitus. This study was carried out to evaluate glimepiride monotherapy in controlling blood glucose (HbA1c) in type-2 DM patients, its dosage, and safety profile. Methods: This was a prospective observational study carried out at 4 private clinics in Semarang, Jambi, Mojokerto and Medan between October 2006 and September 2007 in outpatients of both gender, aged > 20 years, with type-2 DM, HbA1c > 7%, and received no oral antidiabetic treatment for at least 3 months. Glimepiride tablet was given once daily for 3 months. Results: From 74 eligible patients, 18 patients were lost to follow-up and 56 patients completed this 3 months study, consisting of 26 treatment-naive patients and 30 previously treated patients. The initial and final doses of glimepiride were similar in both treatment-naive patients and previously treated patients (initial 2.0 mg, final 2.3 mg). The mean reduction of HbA1c levels was 1.8% (absolute) for all patients, higher in naive patients (2.3%) compared to previously treated patients (1.3%). Based on BMI, the mean reduction of HBA1c in 20 normal weight patients was 1.3%, and more marked in 20 obese patients (2.4%). The mean reduction of FBG levels in all patients was 54 mg/dL, more pronounced in naive patients ( 83 mg/dL) compared to previously treated patients (30 mg/dL), but not affected by body weight. Bodyweight was increased during the study by a mean of 0.9 kg. No adverse event was encountered in any patient during 3 months monotherapy with glimepiride in the present study. Conclusion: Glimepiride monotherapy in the present observational study in daily practice for 3 months was shown to be effective in reducing HbA1c and FBG levels, especially in treatment naive patients. Glimepiride in the present study was associated with weight gain, although not statistically significant. No adverse event was reported in the present study.

Abstrak :
Background: the use of statin to lower blood cholesterol is often associated with bothersome adverse effects such as myopathy and liver dysfunction. NC120 is herbal lipid lowering drug containing red yeast rice (RYR) extract, guggulipid, and chromium picolinate, and expected to have better safety profile. The aim of this study was to evaluate the efficacy and safety profiles of NC120 in lowering blood lipid. Methods: this was a double blind randomized clinical trial comparing NC120 with placebo in subjects with hypercholesterolemia. Two capsules of NC120 or placebo were administered twice a day for 28 days. Blood total-cholesterol, LDL-cholesterol, and triglyceride were measured on day-0, day-7, and day-28. Unpaired t-test was used to compare study parameter between groups, and one-way ANOVA was used to compare within group. Results: 25 subjects received NC120 and 24 subjects received placebo. Significant decrease of total cholesterol and LDL-cholesterol were observed since day-7 in NC120 group, while the changes in placebo group were not significant at all time of observation. No significant decrease of triglyceride was observed in NC120 group and in placebo group. Side effects were minor and comparable between the two groups. Conclusion: NC120 is effective in reducing total cholesterol and LDL-cholesterol, but not triglyceride. This drug shows a good safety profile, and thus can be considered for patients who can not tolerate statin drugs.

Abstrak :
Tujuan : untuk mengetahui kejadian VTE pada pasien Indonesia yang menjalani bedah ortopedi mayor dan tidak menerima tromboprofi laksis. Metode Uji klinik terbuka pada pasien Indonesia yang menjalani bedah ortopedi mayor, dilakukan di 3 senter di Jakarta. Venografi bilateral dilakukan antara 5 dan 8 hari pasca bedah untuk menemukan VTE yang asimptomatik dan memastikan VTE yang simptomatik. Pasien dievaluasi hingga 1 bulan pasca bedah. Hasil Telah diteliti 17 pasien dengan median usia 69 tahun dan 76,5% di antaranya perempuan. Enam belas dari 17 pasien (94,1%) menjalani bedah fraktur panggul. Median waktu antara fraktur dengan tindakan adalah 23 hari (antara 2 sampai 197 hari), median lamanya tindakan bedah 90 menit (antara 60 sampai 255 menit), dan median lamanya imobilisasi 3 hari (antara 1 sampai 44 hari). Tiga belas dari 17 pasien menjalani venografi kontras untuk mendeteksi VTE yang asimtomatik. VTE ditemukan pada 9 dari 13 pasien (69,2%) saat akan keluar dari rumah sakit (RS). VTE yang simtomatik ditemukan pada 3 pasien (23,1%), semuanya dengan tanda-tanda klinis DVT dan tidak seorangpun dengan tanda klinis embolisme paru (PE). Pasien tersebut diobati dengan heparin berat molekul rendah, dilanjutkan dengan antikoagulan oral warfarin. Tidak ada kematian mendadak sampai pasien keluar dari RS. Tidak ada kasus VTE simtomatik baru sejak keluar dari RS sampai 1 bulan kemudian. Tidak ditemukan kematian mendadak, komplikasi pendarahan, ataupun perawatan ulang di RS dalam studi ini. Kesimpulan Insidens VTE asimtomatik sebesar 69,2% dan simtomatik 23,1% setelah bedah ortopedi mayor tanpa tromboprofi laksis. Studi yang lebih besar dibutuhkan untuk memastikan insidens yang benar, dan yang lebih penting, untuk menggunakan tromboprofi laksis pada pasien-pasien ini.

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Aim To estimate the incidence of VTE in Indonesian patients undergoing major orthopedic surgery and not receiving thromboprophylaxis. Methods This was an open clinical study of consecutive Indonesian patients undergoing major orthopedic surgery, conducted in 3 centers in Jakarta. Bilateral venography was performed between days 5 and 8 after surgery to detect the asymptomatic and to confi rm the symptomatic VTE. These patients were followed up to one month after surgery. Results A total of 17 eligible patients were studied, which a median age of 69 years and 76.5% were females. Sixteen out of the 17 patients (94.1%) underwent hip fracture surgery (HFS). The median time from injury to surgery was 23 days (range 2 to 197 days), the median duration of surgery was 90 minutes (range 60 to 255 minutes), and the median duration of immobilization was 3 days (range 1 to 44 days). Thirteen out of the 17 patients were willing to undergo contrast venography. A symptomatic VTE was found in 9 patients (69.2%) at hospital discharge. Symptomatic VTE was found in 3 patients (23.1%), all corresponding to clinical signs of DVT and none with clinical sign of PE. These patients were treated initially with a low molecular weight heparin, followed by warfarin. Sudden death did not occur up to hospital discharge. From hospital discharge until 1-month follow-up, there were no additional cases of symptomatic VTE. No sudden death, bleeding complication, nor re-hospitalization was found in the present study. Conclusion The incidence of asymptomatic (69.2%) and symptomatic (23.1%) VTE after major orthopedic surgery without thromboprophylaxis in Indonesian patients (SMART and AIDA), and still higher than the results of the Western studies. A larger study is required to establish the true incidence, and more importantly, that the use of thromboprophylaxis in these patients is warranted.