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Abstrak :
ABSTRAK
Latar Belakang: Stres oksidatif merupakan salah satu faktor patogenesis terjadinya retinopati diabetik (RD). Fotokoagulasi laser dan anti-VEGF bermanfaat pada penanganan RD. Keberhasilan terapi dan prognosis dapat dilakukan melalui penilaian klinis dan penanda biologis stres oksidatif. Tujuan: Penelitian ini bertujuan membandingkan pengaruh fotokoagulasi laser dan bevacizumab intravitreal (BIV) terhadap penanda biologis stres oksidatif, antara lain aktivitas ALDH plasma, kadar VEGF, MDA dan aktivitas SOD vitreus pada penyandang RD proliferatif. Metode: Penelitian ini adalah penelitian prospektif dengan desain uji klinis acak tersamar tunggal. Sebanyak 72 mata dari 69 penyandang RD proliferatif di Rumah Sakit Cipto Mangunkusumo (RSCM) antara Februari 2011 ? Juni 2013 dirandomisasi menjadi 4 kelompok terdiri dari kelompok 1) kontrol yaitu kelompok langsung vitrektomi sesuai indikasi (n = 18), 2) kelompok yang mendapat fotokoagulasi laser pre-vitrektomi (n = 18), 3) kelompok yang mendapat BIV pre-vitrektomi(n = 18) dan 4) kelompok yang mendapat kombinasi BIV dan fotokoagulasi laser previtrektomi (n = 18). Hasil: Hasil penelitian ini mendapatkan bahwa pada kelompok 1, 2, 3 dan 4 masingmasing rerata aktivitas ALDH plasma (IU/mg protein) (0,034+0,02; 0,027+0,02; 0,025+0,02; 0,031+0,1; p = 0,66), kadar MDA vitreus (nmol/mL) (1,661+1,21; 1,557+1,32; 1,717+1,54; 1,501+1,09; p = 0,96), dan aktivitas SOD (U/mL) (0,403+0,50; 0,210+0,18; 0,399+0,49; 0,273+0,32 p = 0,38) dan tidak terdapat perbedaan bermakna, sedangkan perbandingan rerata kadar VEGF vitreus (pg/mL) (0,356+0,60; 0,393+0,45; 0,150+0,24; 0,069+0,13; p = 0,05) menunjukkan perbedaan yang bermakna. Kadar VEGF kelompok kombinasi BIV dengan fotokoagulasi laser lima kali lebih rendah dibandingkan dengan kelompok kontrol. Simpulan: Kombinasi BIV dan fotokoagulasi laser tidak berpengaruh terhadap aktivitas ALDH plasma dan SOD vitreus, namun berpengaruh terhadap kadar MDA dan VEGF vitreus penyandang RD proliferatif. Kombinasi BIV dengan fotokoagulasi laser perlu dilakukan pada RD proliferatif. Pengukuran ALDH plasma dapat digunakan sebagai faktor prognostik untuk perubahan CMT dan visus.

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ABSTRACT Background: Diabetic Retinopathy (DR) is retinal vascular complications in patients with diabetes mellitus (DM). Oxidative stress plays a major role in the pathogenesis of this disease. The current management of DR includes laser photocoagulation (LF) and administration of anti-VEGF, such as intravitreal bevacizumab (IVB). Clinical parameters are usually applied in determining the outcomes of these methods of therapies. However, the measurement of biomarkers of oxidative stress can possibly be used to determine the prognosis. Purpose: This study was aimed to compare the effect of LF, IVB and combined treatments on biomarkers of oxidative stress such as plasma ALDH and vitreal SOD activities, and vitreal VEGF and MDA level on proliferative DR patients. Methods: In this single blind randomized clinical trial, 72 eyes from 69 cases of proliferative DR in Cipto Mangunkusumo Hospital (RSCM) between February 2011 - June 2013 were randomized into 4 groups : 1) control group (n = 18), 2) LF previtrectomy group (n = 18), 3) IVB pre-vitrectomy group (n = 18) and 4) combined IVB and LF pre-vitrectomy group (n = 18). In all groups, the biomarkers of oxidative stress were measured as the primary outcome and visual acuity and CMT as secondary outcome. Results: There were no statistically significant differences in the comparison of the average plasma ALDH activity (IU/mg protein) (0.034+0.02; 0.027+0.02; 0.025+0.02; 0.031+0.1; p = 0.66), vitreal MDA level (nmol/mL) (1.661+1.21; 1.557+1.32; 1.717+1.54; 1.501+1.09; p = 0.96) and SOD activity (U/mL) (0.403+0.50; 0.210+0.18; 0.399+0.49; 0.273+0.32 p = 0.38) among these four groups, respectively. However, the average of vitreal VEGF level (pg/mL) among these 4 group showed a statistically significant difference (0.356+0.60; 0.393+0.45; 0.150+0.24; 0.069+0.13; p = 0.05), with the level of vitreal VEGF in the combined group was 5 times lower than control. Conclusion: Combined treatments of DR by IVB and LF does not have any effect on the activities of plasma ALDH and vitreal SOD. However, these combined treatments were correlated with lower vitreal MDA and VEGF level, higher SOD activity and lower VEGF level in proliferative DR. Combined treatments with IVB and LF are recommended for the management of proliferative DR patients. The measurement of plasma ALDH can be used as a prognostic factor for determining the visual acuity and CMT.

Abstrak :
Retinopati diabetik (DR) merupakan komplikasi mikrovaskular diabetes melitus (DM). Fenofibrat oral dapat mencegah progresivitas DR dengan mekanisme pengaturan kadar lipid lipid-related dan mekanisme lain nonlipid-related, antara lain dengan mencegah disfungsi endotel, mengurangi inflamasi, dan angiogenesis. Penelitian ini bertujuan mengetahui efek fenofibrat oral terhadap ketebalan makula sentral (CMT) dan volume makula, serta pengaruhnya pada kadar penanda biologis serum disfungsi endotel eNOS, inflamasi (VCAM-1), dan angiogenesis (VEGF) pada penyandang DR dengan dislipidemia. Penelitian prospektif ini menggunakan disain uji klinis acak tersamar ganda dengan membagi subjek menjadi kelompok intervensi simvastatin dan fenofibrat dan kontrol simvastatin dan plasebo. Penelitian berlangsung sejak Nopember 2016 hingga Oktober 2017, di Klinik Vitreo-retina, Departemen Medik Mata ndash;RSCM Kirana, melibatkan 60 mata dari 30 pasien penyandang DR non-proliferatif NPDR dengan dislipidemia. Penelitian pada tiap subjek dilakukan selama tiga bulan dengan evaluasi klinis, foto fundus, dan spectral domain optical coherence tomography (SD-OCT) makula tiap bulan. Pengukuran kadar eNOS, VCAM-1, dan VEGF, serta HbA1c dan profil lipid dilakukan sebelum dan setelah tiga bulan pengobatan.Sebelum intervensi, pada kedua kelompok tidak didapatkan perbedaan karakteristik demografik, klinik, dan penanda biologis serum. Tidak didapatkan perbedaan bermakna pada CMT kelompok simvastatin fenofibrat 248,0 40,4 m dibandingkan kelompok simvastatin plasebo 265,8 40,8 m, namun CMT lebih rendah secara bermakna pada bulan ke-1 pada kelompok simvastatin fenofibrat. Pada subjek dengan edema makula diabetik DME pemberian simvastatin fenofibrat setelah tiga bulan menunjukkan CMT lebih rendah secara bermakna. Volume makula setelah tiga bulan pemberian obat 10086 886,4 m3 pada kelompok simvastatin fenofibrat dan 10307 1058,6 m3 pada simvastatin plasebo. Perbedaan tersebut tidak bermakna, namun pada subjek dengan regulasi glukosa darah yang baik HbA1c 7 didapatkan volume makula lebih rendah pada bulan ke-2. Kadar penanda biologis serum setelah tiga bulan pemberian obat menunjukkan rerata kadar eNOS dan median VEGF sebesar 3878,8 873,33 pg/mL dan 242,8 86 - 1123,3 pg/mL pada kelompok simvastatin fenofibrat, dibandingkan 4031,2 742,56 pg/mL dan 370 134,8 - 810,6 pg/mL pada kelompok simvastatin plasebo, yang tidak berbeda bermakna, namun penurunan kadar VCAM-1 serum lebih besar secara bermakna pada kelompok simvastatin fenofibrat 50,7 pg/mL, 32,5 - 223,4 pg/mL vs. 40,4 pg/mL, 27,9 - 94,2 pg/mL . Pada subjek dengan kontrol glukosa darah ketat HbA1c 6,5 kadar VEGF 128,7 114,5 - 145,2 pg/mL, lebih rendah secara bermakna dibandingkan 423 86 - 1233,3 pg/mL pada subjek dengan HbA1c > 6,5 .Disimpulkan pemberian simvastatin fenofibrat selama tiga bulan pada subjek DR dengan dislipidemia secara umum tidak menurunkan CMT dan volume makula, namun menurunkan CMT khusus pada subjek DR dengan DME. Pemberian simvastatin fenofibrat pada subjek DR tidak mencegah penurunan kadar eNOS, peningkatan kadar VCAM-1 dan VEGF, namun pengendalian gula darah yang baik dapat mencegah peningkatan kadar VEGF. Simvastatin fenofibrat dapat dipertimbangkan sebagai terapi ajuvan pada penyandang DR dengan DME yang disertai dislipidemia. Pengontrolan glukosa yang baik merupakan manajemen utama pada DR.

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Diabetic retinopathy (DR) is a microvascular complication of diabetes mellitus (DM) due to structural and biochemical changes. Previous studies showed that oral fenofibrate prevents DR progression through lipid-regulating and nonlipid-related mechanisms, including preventing endothelial dysfunction, reducing inflammation and angiogenesis. This study aims to investigate the effects of oral fenofibrate on central macular thickness CMT and macular volume, and on specific biomarkers of endothelial dysfunction eNOS, inflammation VCAM-1 , and angiogenesis VEGF in DR individuals with dyslipidemia. This is a prospective, double-blind randomized clinical trial, with subjects divided into intervention group simvastatin fenofibrate and control group simvastatin placebo. This study was conducted from November 2016 to October 2017 at the Vitreo-retina Clinic, Department of Ophthalmology ndash; RSCM Kirana, involving 60 eyes from 30 non-proliferative DR patients NPDR with dyslipidemia that met inclusion criteria. Each subject was observed for three months, with monthly clinical evaluation, fundus photo, and macular spectral domain optical coherence tomography SD-OCT . Serum eNOS, VCAM-1, and VEGF biomarkers, as well as HbA1c and lipid profile, were examined before and after intervention.Before intervention, there were no differences in demographic and clinical characteristics, and serum biomarker levels between two groups. After three months of treatment, there was no significant difference between CMT in the intervention group and the control group 248 40.4 ? m vs. 265.8 40.8 ? m , but a significantly lower CMT was observed in the intervention group at the first month. There was also a significantly lower CMT compared to the control group 294 39,2 vs 263 24,4, p=0,045 in eyes with diabetic macular edema DME . Macular volume after three-month treatment was 10086 886.4 ? m3 in the intervention group and 10307 1058.6 ? m3 in the control group, this difference was not significant. However, in all subjects with good blood glucose regulation HbA1c 7 , macular volume in the second month was significantly lower compared to subjects with HbA1c > 7 . Serum biologic marker levels after three-month treatment showed no significant difference between control and intervention group, respectively, in mean eNOS 3878.8 873.33 pg/mL vs 4031.2 742.56 pg/mL and median VEGF levels 242.8 86 - 1123.3 pg/mL vs 370 134.8 - 810.6 pg/mL . Nonetheless, the decrease in VCAM-1 level was significantly higher in the intervention group 50.7 pg/mL, 32.5 - 223.4 pg/mL vs. 40.4 pg/mL, 27.9 - 94.2 pg/mL . In subjects with tighter blood glucose control HbA1c 6.5 , serum VEGF level was 128.7 114.5 - 145.2 pg/mL, which was significantly lower compared to 423 86 - 1233.3 pg/mL in subjects with HbA1c > 6.5 .In conclusion, three-month treatment with simvastatin fenofibrate does not reduce CMT and macular volume in overall DR subjects with dyslipidemia, but it reduces CMT in subjects with DME. Simvastatin fenofibrate treatment in DR subjects does not prevent lowering of serum eNOS levels, elevation of VCAM-1 levels, and elevation of VEGF levels, but tight blood sugar control prevents elevation of serum VEGF. Although good glucose control remains the most essential in the management of DR, simvastatin fenofibrate may be considered as adjuvant therapy for DR with dyslipidemia and DME.

Abstrak :
Non-arteritic anterior ischemic optic neuropathy (NAION) adalah penyakit multifaktorial yang mekanismenya belum diketahui secara pasti, namun hiperkoagulasi diduga merupakan faktor yang berperan pada NAION. Karena merupakan penyakit mikrovaskular, maka aktivasi koagulasi pada fase awal dapat menyebabkan koagulasi pada NAION. Penelitian ini bertujuan untuk mengetahui peran hiperkoagulasi pada kejadian NAION dalam upaya memberikan tata laksana yang lebih baik pada pasien NAION. Penelitian dilakukan pada bulan Oktober 2020 hingga April 2022 di Poliklinik Mata Divisi Neuro-oftalmologi FKUI-RSCM Kirana. Subjek adalah pasien NAION yang dibagi menjadi kelompok hiperkoagulasi dan non-hiperkoagulasi. Penelitian potong lintang dilakukan untuk menilai penanda koagulasi dini yaitu E-selectin, P-selectin, microparticle tissue factor (MPTF), prothrombin fragment 1+2 (PF1+2), dan hasil pemeriksaan penunjang berupa optical coherence tomography (OCT), OCT angiography (OCTA), dan Humphrey visual field (HVF). Uji klinis eksperimental dilakukan untuk menilai efektivitas terapi hiperkoagulasi dalam waktu 1 bulan. Terdapat 64,3% subjek NAION dengan hiperkoagulasi dan terjadi aktivasi penanda koagulasi dini pada kedua kelompok. Kesesuaian lokasi OCTA dengan ganglion cell inner plexiform layer (GCIPL) ditemukan pada 33% subjek, retinal nerve fiber layer (RNFL) pada 6,7% subjek, dan HVF pada 40% subjek, namun tidak terdapat korelasi jumlah sektor atau kuadran yang terkena. Nilai GCIPL dan HVF tidak berkorelasi dengan OCTA, di kuadran yang terkena, RNFL berkorelasi dengan OCTA. Kelompok terapi hiperkoagulasi menunjukkan penurunan perfusi lebih sedikit. Tajam penglihatan membaik pada 57,2% subjek di kelompok NAION dengan hiperkoagulasi dan 42,9% di kelompok NAION nonhiperkoagulasi. Berdasarkan fungsi lapang pandang, kedua kelompok menunjukkan perbaikan pada sebagian besar subjek (71,4% pada kelompok NAION dengan hiperkoagulasi dan 85,8% pada kelompok NAION nonhiperkoagulasi). Disimpulkan hiperkoagulasi berperan pada mekanisme NAION, sehingga tata laksana terkait hiperkoagulasi penting pada pasien NAION dalam mencapai luaran klinis yang lebih baik. ......Non-arteritic anterior ischemic optic neuropathy (NAION) is a multifactorial disease with an uncertain mechanism. Hypercoagulability is believed to be one of the factors involved in NAION. Considering that NAION is a microvascular disease, this study assumes that coagulation activation in the early phase is sufficient to cause a coagulation state in NAION. The aim of this research is to evaluate the role of hypercoagulability in the occurrence of NAION in order to provide better management for NAION patients. The subjects were NAION patients divided into hypercoagulability and non-hypercoagulability groups. A cross-sectional study was conducted to assess early coagulation markers, namely E-selectin, P-selectin, microparticle tissue factor (MPTF), and prothrombin fragment 1+2 (PF1+2), as well as ancillary tests such as optical coherence tomography (OCT), OCT angiography (OCTA), and Humphrey visual field (HVF). An experimental clinical trial was conducted to evaluate the effectiveness of hypercoagulation therapy within one month. It was found that 64.3% of NAION subjects had hypercoagulability. Early coagulation marker activation occurred in both groups. There was a concordance between OCTA and ganglion cell inner plexiform layer (GCIPL) location in 33% of subjects, retinal nerve fiber layer (RNFL) in 6.7% of subjects, and HVF in 40% of subjects. However, no correlation was found regarding the number of affected sectors or quadrants. GCIPL and HVF values did not correlate with OCTA, whereas in the affected quadrant, RNFL correlated with OCTA. The hypercoagulation therapy group showed less perfusion reduction. Visual acuity improved in 57.2% of subjects in the hypercoagulability NAION group and 42.9% in the non-hypercoagulability NAION group. Based on visual field function, both groups showed improvement in the majority of subjects (71.4% in the hypercoagulability NAION group and 85.8% in the non- hypercoagulability NAION group). It can be concluded that hypercoagulability plays a role in the mechanism of NAION, thus emphasizing the importance of managing hypercoagulability in NAION patients to achieve better clinical outcomes.