Effectiveness, Safety and Obedience of Dienogest and Leuprolide Acetate in Postlaparoscopic Endometriosis Patients

Abstract

Effectiveness, Safety and Obedience of Dienogest and Leuprolide Acetate in Postlaparoscopic Endometriosis Patients Efektivitas, Keamanan dan Kepatuhan terhadap Dienoges dan Leuprolide Asetat pada Pasien Endometriosis Pascalaparoskopi Abstract Joko P. Purwanto, Yusuf Effendi, Heriyadi Manan, Theodorus Department of Obstetrics and Gynecology Faculty of Medicine Universitas Sriwijaya Dr. Mohammad Hoesin General Hospital Objective: Comparing therapeutic effectiveness, safety profile, and adherence between Dienogest and postoperative Leuprolide Acetate in women with endometriosis who underwent laparoscopy. Methods: This study was a randomized clinical trial comparing the open-label study to compare the effectiveness of therapy, safety profile, and obedience between postoperative dienogest and leuprolide acetate in women with endometriosis who underwent laparoscopy. Results: From the statistical test it was found that there was the effectiveness of dienogest after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.004). In the leuprolide acetate group, it was also found that there was the effectiveness of administration after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.003). There was no difference in systolic blood pressure (p = 0.481), diastolic blood pressure (p = 1.000) and pulse frequency (p = 0.125) breath frequency (p = 1.000) and temperature (p = 0.236) between patients who received dienogest and leuprolide acetate. From the statistical analysis, it was found that there were no differences in side effects in patients who received dienogest and leuprolide acetate (p = 0.238). Conclusions: There was no difference in therapeutic effectiveness, and the safety profile assessed by side effects as well as the obedience of postoperative Dienogest and Leuprolide Acetate in endometriosis women undergoing Laparoscopy because in both groups there was a decrease in VAS scores from week to week. Keywords: endometriosis, dienogest, leuprolide acetate, postlaparoscopy, therapy Palembang Abstrak Tujuan: Membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara dienogest dengan leuprolid asetat pascaoperatif pada perempuan endometriosis yang menjalani lapararoskopi. Metode: Penelitian ini merupakan uji klinik acak berpembanding dengan studi label terbuka untuk membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara dienoges dan leuprolid asetat pascaoperatif pada perempuan endometriosis yang menjalani lapararoskopi. Hasil: Dari uji statistik didapatkan hasil terdapat efektivitas pemberian dienoges setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004), dan setelah 12 minggu terapi (p = 0,004). Pada kelompok leuprolid asetat juga didapatkan hasil terdapat efektivitas pemberian setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004) dan setelah 12 minggu terapi (p = 0,003). Tidak terdapat perbedaan tekanan darah sistolik (p = 0,481), tekanan darahdiastolik (p = 1,000) dan frekuensi nadi (p = 0,125) frekuensi napas (p = 1,000) dan suhu (p = 0,236) antara pasien yang mendapatkan dienoges dan leuprolid asetat. Dari analisis statistik didapatkan hasil tidak terdapat perbedaan efek samping pada pasien yang mendapatkan dienoges dan leuprolid asetat (p = 0,238). Kesimpulan: Tidak terdapat perbedaan efektivitas terapi, dan profil keamanan yang dinilai dari efek samping serta kepatuhan dienoges dan leuprolid asetat pascaoperatif pada perempuan endometriosis yang menjalani Lapararoskopi karena pada kedua kelompok terdapat penurunan VAS skor dari minggu ke minggu. Kata kunci: endometriosis, dienoges, leuprolide acetate, postlaparoscopy, terapi