0.05). Kesimpulan, Terdapat perubahan yang bermakna secara statistik tetapi tidak bertnakna secara klinis perubahan kadar estradiol, kholesterol dan trigliserida sebelum dan sesudah pemakaian kedau kontrasepsi. Tidak terdapat perbedaan yang bermakna secara Minis dan statistik kadar HDL,LDL, SGOT, SGPT dan MDA setelah pemakaian kedua kontrasepsi. Backgroud: Injectable contraceptive is a reliable contraceptive methode based on if effectiveness, side effect, and acceptability. Planibu® is a new contraceptive drug produced by Fahrenhet that have the same component with Depoprogestin by Harsen. Hopefully this two drugs have the same pharmacokinetics and pharmacodynamics. Objective: To compare estradiol, lipide profile, random blood sugar (RBS), SGOT, SGPT, and malondialdehyde level in injection contraceptive Planibu'~' with Depoprogestin®. Design: Double-blind randomized clinical trial. Place: Purworejo and Manado District. Material and Methode: Seventy eligible acceptor divide into two groups. Thirtyfive acceptor in first group receive Planibu® injection and 35 acceptor in second group recieve Depoprogestin® injection. Labolatorium test (estradiol, RBS, cholesterol, triglyseride, LDL, HDL, SGOT, SGPT, and MDA) was take one month before and after injection. Result: Estradiol level changes in Planibu® was 59.69f60.62 to 117.17f80 (p=0.00) and in Depoprogestiri 67.99t58.53 to 110±43.85 (p=0.00). Tryglyseride level changes in Planibu® was 130.13±59.22 to 100.7D: 40.41 (p=0.00). Cholesterol level changes in Planibu® was 168.27 to 157.83±39.38 (p=0.09) and in Depo~rogestiri was 171.71f28.88 to 147.27±28.68 (p=0.00). RBS changes in Planibu was 92.82±17.90 to 93.49f28.62 (p=0.90) and in Depoprogestin was 90.63±19 to 88.80f26.96 (p=0.71) and in Depoprogestin,® was 108.37±47.73 to 77.95±32.47 (p=0.19). HDL level changes in Planibu® was 56.44f9.94 to 58.87f47.73 (p=0.15) and in Depoprogestin® was 55.47±11.17 to 57.44f12.72 (p=0.33). LDL level changes in Planibu* was 109.57±110.34 to 110.34±16.54 (p=0.84) and in Depoprogestin® was 105.77f12.14 to 108.85±12.54 (p=0.19). ASL level changes in Planibu® was 26.15±7.71 to 23.30±3.23 (p= 0.16), and in Depoprogestiri was 26.21±7.08 to 24.86±2.94 (p= 0.38). ALT level changes in Planibu® was 20.74f0.62 to 21.46f1.89 (p= 0.43) and in Depoprogestin was 21.23f1.58 to 21.5910.17 to 0.57f0.12 (p= 0.12). Conelution: There was statistic significantly different on estradiol level before and after injection between Planibu (p = 0.00) and Depoprogestin® (p = 0.00), but there was no clinical significantly different because etradiol increase was still in folliculare phase. There was statistic significantly different on tryglyseride level after injection between Planibu (p = 0.01) and Depoprogestin® (p = 0.00) but there was no clinical significantly different because still in normal limit. There was statistic significantly different on cholesterol level after injection Depoprogestin® (p = 0.00) but no clinical significantly. There was no statistic and clinical significantly different on HDL, LDL, SGOT, SGPT, and MDA level after and before injection of Planibu and Depoprogestiri ."> 0.05). Kesimpulan, Terdapat perubahan yang bermakna secara statistik tetapi tidak bertnakna secara klinis perubahan kadar estradiol, kholesterol dan trigliserida sebelum dan sesudah pemakaian kedau kontrasepsi. Tidak terdapat perbedaan yang bermakna secara Minis dan statistik kadar HDL,LDL, SGOT, SGPT dan MDA setelah pemakaian kedua kontrasepsi. Backgroud: Injectable contraceptive is a reliable contraceptive methode based on if effectiveness, side effect, and acceptability. Planibu® is a new contraceptive drug produced by Fahrenhet that have the same component with Depoprogestin by Harsen. Hopefully this two drugs have the same pharmacokinetics and pharmacodynamics. Objective: To compare estradiol, lipide profile, random blood sugar (RBS), SGOT, SGPT, and malondialdehyde level in injection contraceptive Planibu'~' with Depoprogestin®. Design: Double-blind randomized clinical trial. Place: Purworejo and Manado District. Material and Methode: Seventy eligible acceptor divide into two groups. Thirtyfive acceptor in first group receive Planibu® injection and 35 acceptor in second group recieve Depoprogestin® injection. Labolatorium test (estradiol, RBS, cholesterol, triglyseride, LDL, HDL, SGOT, SGPT, and MDA) was take one month before and after injection. Result: Estradiol level changes in Planibu® was 59.69f60.62 to 117.17f80 (p=0.00) and in Depoprogestiri 67.99t58.53 to 110±43.85 (p=0.00). Tryglyseride level changes in Planibu® was 130.13±59.22 to 100.7D: 40.41 (p=0.00). Cholesterol level changes in Planibu® was 168.27 to 157.83±39.38 (p=0.09) and in Depo~rogestiri was 171.71f28.88 to 147.27±28.68 (p=0.00). RBS changes in Planibu was 92.82±17.90 to 93.49f28.62 (p=0.90) and in Depoprogestin was 90.63±19 to 88.80f26.96 (p=0.71) and in Depoprogestin,® was 108.37±47.73 to 77.95±32.47 (p=0.19). HDL level changes in Planibu® was 56.44f9.94 to 58.87f47.73 (p=0.15) and in Depoprogestin® was 55.47±11.17 to 57.44f12.72 (p=0.33). LDL level changes in Planibu* was 109.57±110.34 to 110.34±16.54 (p=0.84) and in Depoprogestin® was 105.77f12.14 to 108.85±12.54 (p=0.19). ASL level changes in Planibu® was 26.15±7.71 to 23.30±3.23 (p= 0.16), and in Depoprogestiri was 26.21±7.08 to 24.86±2.94 (p= 0.38). ALT level changes in Planibu® was 20.74f0.62 to 21.46f1.89 (p= 0.43) and in Depoprogestin was 21.23f1.58 to 21.5910.17 to 0.57f0.12 (p= 0.12). Conelution: There was statistic significantly different on estradiol level before and after injection between Planibu (p = 0.00) and Depoprogestin® (p = 0.00), but there was no clinical significantly different because etradiol increase was still in folliculare phase. There was statistic significantly different on tryglyseride level after injection between Planibu (p = 0.01) and Depoprogestin® (p = 0.00) but there was no clinical significantly different because still in normal limit. There was statistic significantly different on cholesterol level after injection Depoprogestin® (p = 0.00) but no clinical significantly. There was no statistic and clinical significantly different on HDL, LDL, SGOT, SGPT, and MDA level after and before injection of Planibu and Depoprogestiri .">
Laporkan Masalah

Perbandingan kadar estradiol, profil lipid, gula darah sewaktu, SGOT, SGPT dan Lipid Peroksida pada penggunaan kontrasepsi Planibu dan Depoprogestin :: Kajian penggunaan 1 bulan

SOFFANTO, Arief, Prof.Dr. H.M. Sulchan Sofoewan, Ph.D.,SpOG(K)

2006 | Tesis | PPDS I Obstetri dan Ginekologi

Latar belakang : Kontrasepsi suntikan merupakan metode kontrasepsi yang dapat dipercaya berdasarkan efektivitas, efek samping, dan akseptabilitasnya.. Planibu adalah obat kontrasepsi baru Produksi Fahrenhet yang mengandung bahan baku yang sama dengan Depoprogestin produksi Harsen. Dengan bahan obat yang sama diharapkan farmakodinamika dan farmakokinetika kedua obat tersebut sama. Tujuan : Membandingkan perubahan kadar estradiol, profil lipide, gula darah sewaktu, SGOT, SGPT dan malondialdehyde pada penggunaan kontrasepsi suntikan PlanibuS dengan kontrasepsi suntikan Depoprogestin"' . Rancangan penelitian : Double-blind randomized clinical trial. Tempat : Kabupaten Purworejo dan di Kotamadya Manado Bahan dan cara : Tujuh puluh akseptor yang memenuhi kriteria inkiusi dan eksklusi terbagi dalam dua kelompok. Kelompok pertama 35 akseptor mendapatkan suntikan Planibu ® dan kelompok kedua 35 orang mendapatkan suntikan Depoprogestin®. Sebelum dan sesudah 1 bulan suntikan dilakukan pemeriksaan laboratorium yang meliputi estradiol, GDS, kholesterol, trigliserida, LDL, HDL, SGOT, SGPT dan MDA. Hasil : Terjadi peningkatan yang bermakna secara statistik kadar estradiol dan penurunan yang bermakna secara statistik kadar trigliserida dan kholesterol. Perubahan estradiol pada Planibu® 59.65f60.62 menjadi 117.17f80 (p = 0.00) dan pada Depoprogestin® 67.99±58.53 menjadi 110f43.85 (p = 0.00). Perubahan trigliserida pada Planibu® dari 130.13f59.22 menjadi 100.71±40.41 (p = 0.01) dan pada Depbprogestin® 108.37147.73 menjadi 77.95±32.47 (p = 0.00). Perubahan kolesterol Tada Planibu 168.27 menjadi 157.83f39.38 (p = 0.09) dan pada Depoprogestin dari 171.71f28.55 menjadi 147.27f28.68 (p = 0.00). Sedangkan kadar GDS, HDL, LDL, SGOT, SGPT dan MDA tidak mengalami perubahan yang bermakna secara statistik ( p >0.05). Kesimpulan, Terdapat perubahan yang bermakna secara statistik tetapi tidak bertnakna secara klinis perubahan kadar estradiol, kholesterol dan trigliserida sebelum dan sesudah pemakaian kedau kontrasepsi. Tidak terdapat perbedaan yang bermakna secara Minis dan statistik kadar HDL,LDL, SGOT, SGPT dan MDA setelah pemakaian kedua kontrasepsi.

Backgroud: Injectable contraceptive is a reliable contraceptive methode based on if effectiveness, side effect, and acceptability. Planibu® is a new contraceptive drug produced by Fahrenhet that have the same component with Depoprogestin by Harsen. Hopefully this two drugs have the same pharmacokinetics and pharmacodynamics. Objective: To compare estradiol, lipide profile, random blood sugar (RBS), SGOT, SGPT, and malondialdehyde level in injection contraceptive Planibu'~' with Depoprogestin®. Design: Double-blind randomized clinical trial. Place: Purworejo and Manado District. Material and Methode: Seventy eligible acceptor divide into two groups. Thirtyfive acceptor in first group receive Planibu® injection and 35 acceptor in second group recieve Depoprogestin® injection. Labolatorium test (estradiol, RBS, cholesterol, triglyseride, LDL, HDL, SGOT, SGPT, and MDA) was take one month before and after injection. Result: Estradiol level changes in Planibu® was 59.69f60.62 to 117.17f80 (p=0.00) and in Depoprogestiri 67.99t58.53 to 110±43.85 (p=0.00). Tryglyseride level changes in Planibu® was 130.13±59.22 to 100.7D: 40.41 (p=0.00). Cholesterol level changes in Planibu® was 168.27 to 157.83±39.38 (p=0.09) and in Depo~rogestiri was 171.71f28.88 to 147.27±28.68 (p=0.00). RBS changes in Planibu was 92.82±17.90 to 93.49f28.62 (p=0.90) and in Depoprogestin was 90.63±19 to 88.80f26.96 (p=0.71) and in Depoprogestin,® was 108.37±47.73 to 77.95±32.47 (p=0.19). HDL level changes in Planibu® was 56.44f9.94 to 58.87f47.73 (p=0.15) and in Depoprogestin® was 55.47±11.17 to 57.44f12.72 (p=0.33). LDL level changes in Planibu* was 109.57±110.34 to 110.34±16.54 (p=0.84) and in Depoprogestin® was 105.77f12.14 to 108.85±12.54 (p=0.19). ASL level changes in Planibu® was 26.15±7.71 to 23.30±3.23 (p= 0.16), and in Depoprogestiri was 26.21±7.08 to 24.86±2.94 (p= 0.38). ALT level changes in Planibu® was 20.74f0.62 to 21.46f1.89 (p= 0.43) and in Depoprogestin was 21.23f1.58 to 21.5910.17 to 0.57f0.12 (p= 0.12). Conelution: There was statistic significantly different on estradiol level before and after injection between Planibu (p = 0.00) and Depoprogestin® (p = 0.00), but there was no clinical significantly different because etradiol increase was still in folliculare phase. There was statistic significantly different on tryglyseride level after injection between Planibu (p = 0.01) and Depoprogestin® (p = 0.00) but there was no clinical significantly different because still in normal limit. There was statistic significantly different on cholesterol level after injection Depoprogestin® (p = 0.00) but no clinical significantly. There was no statistic and clinical significantly different on HDL, LDL, SGOT, SGPT, and MDA level after and before injection of Planibu and Depoprogestiri .

Kata Kunci : Kontrasepsi Suntikan,Planibu ,Farmakokinetika dan Farmakodinamika, Planibu, Depoprogestin®, estradiol, profile lipide, random blood sugar, SGOT, SGPT, malondialdehyde


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