Endometriozisin medikal tedavisinde kronik ağrı semptomları ve rekürrensin değerlendirilmesinde kliniğimizde rutin uygulanmakta olan iki progesteron preparatı noretindron asetat ve dienogestin karşılaştırılması
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Dosyalar
Tarih
2024
Kurum Yazarları
Gürbüz, Tansu Bahar
Süreli Yayın başlığı
Süreli Yayın ISSN
Cilt Başlığı
Yayınevi
Bursa Uludağ Üniversitesi
Özet
Amaç: Bu çalışmada tanısı radyolojik ya da cerrahi olarak konulmuş endometriozisli hastalarda iki progestin türevi NETA (Noretindron asetat) ve dienogestin birincil olarak ağrı semptomları üzerine etkinliğini ve ikincil olarak yan etki profili ve tolerabilitesini karşılaştırdık. Gereç ve Yöntem: Çalışmaya Nisan 2022 – Nisan 2023 yılları arasında Endometriozis polikliniğine başvuran 18-40 yaş arası, gebelik istemi olmayan, medikal tedavi başlanan 70 hasta dahil edilmiştir. Progesteron kullanımının kontraendike olduğu, özgeçmişinde pelvik inflamatuar hastalık olan ve saptanmış uterin anomalili hastalar çalışma dışı bırakılmıştır. Çalışma tek merkezli prospektif, randomize olarak tasarlanmış ve yürütülmüştür. Hastalar protokol numaralarının son rakamına göre tek rakam 'NETA' (Primolut-N, 5 mg,1x1 Bayer, Almanya) çift 'dienogest' (Visanne, 2mg, 1x1 Bayer, Almanya) olacak şekilde iki tedavi protokolünden birine rastgele dağıtılmıştır. Kişisel ve demografik verileri, medikal ve cerrahi tedavi geçmişleri kaydedilmiştir. Hastalar jinekolojik muayene ve yardımcı tanı yöntemleriyle değerlendirilmiştir. Kronik ağrı semptomları tedavi öncesi, 6. ve 12. aylarda vizüel analog ağrı skorlaması ile yapılmıştır. Her değerlendirmede tedavi bırakma oranları, nedenleri ve yan etkiler sorgulanmış, çalışma protokolündeki yardımcı tanı yöntemleri uygulanmıştır. Bulgular: Çalışmamızın birincil sonucu olarak her 2 grupta tüm ağrı skorlarında istatistiksel anlamlı azalma saptanmış ve ağrı skorlarının azalması açısından 2 grup arasında anlamlı fark bulunmamıştır. Dismenore için NETA grubunda başlangıç değeri 7,43 ± 2,9, dienogest grubunda 7,23 ± 2,87, disparoni için NETA grubunda 4,00 ± 4, dienogest grubunda 3,90 ± 3,55, diskezi için NETA grubunda 1,97 ± 3,11, dienogest grubunda 1,85 ± 2,99, kronik pelvik ağrı için NETA grubunda 4,97 ± 3,80, dienogest grubunda 4,18 ± 3,15 bulunmuştur. 6. ay pelvik ağrı skorları NETA grubunda dismenore için 0,00 ± 0,00, dienogest grubunda 0,00±0,00, disparoni için NETA grubunda 0,95±2,52, dienogest grubunda 0,50±1,48, diskezi için NETA grubunda 0,59±2,06, dienogest grubunda 0,00±0,00, kronik pelvik ağrı için NETA grubunda 1,41±2,54 dienogest grubunda 0,81±1,66 olarak bulunmuştur. 12. ay pelvik ağrı skorları dismenore için NETA grubunda 0,00±0,00, dienogest grubunda 0,00±0,00, disparoni için NETA grubunda 0,38±1,50, dienogest grubunda 0,33±1,41, diskezi için NETA grubunda 0,00±0,00, dienogest grubunda 0,00±0,00, kronik pelvik ağrı için NETA grubunda 1,06±2,43, dienogest grubunda 0,00±0,00 bulunmuştur. Endometrioma boyutlarının tedavi sürecinde her iki grupta azaldığı saptanırken NETA grubunda azalma Dienogest grubuna göre istatistiksel olarak daha fazla bulunmuştur (p=0.037). İkincil sonuç olarak değerlendirilen yan etki profili iki grupta da literatürle uyumlu olmakla birlikte, iki grup arasında istatistiksel anlamlı fark bulunmamıştır. Çalışmamızın önemli sonucu olarak ikincil sonuç parametrelerinden tedaviyi bırakma oranı ilk 6 ay içinde dienogest grubunda, ikinci altı ay içinde NETA grubunda daha yüksek bulunmuştur (İlk 6 ay NETA %23,3, dienogest %47,5, ikinci 6 ay NETA %23,3, dienogest %7,5, p=0.026). Sonuç: Endometriozis tedavisinde medikal baskılama olarak kullanılan iki progestinin de literatürden farklı olarak ağrı skorlarını benzer etkinlikte düşürdüğü, bu farklılığın bizim çalışmamızda kullanılan NETA dozunun literatürdeki çalışmalarda kullanılandan yüksek olması ile açıklanabileceği, tedavi etkinlik ve güvenlik profilleri açılarından ise aralarında fark bulunmadığı, tedavi yönetiminde ilacı bırakma oranlarının da bir tercih nedeni olabileceği sonucuna varılmıştır.
Aim: In this study, we compared the efficacy of two progestin derivatives, NETA and dienogest, primarily on pain symptoms in patients diagnosed with endometriosis radiologically or surgically, and secondarily compared their side effect profiles and tolerability. Materials and Methods: The study included 70 patients aged 18-40 years who presented to the Endometriosis Clinic between April 2022 and April 2023, with no desire for pregnancy and undergoing medical treatment. Patients with contraindications to progestin use, a history of pelvic inflammatory disease, and those with detected uterine anomalies were excluded from the study. The study was designed and conducted as a single center prospective, randomized trial. Patients were randomly assigned to one of two treatment protocols, 'NETA' (Primolut-N, 5 mg, 1x1 Bayer, Germany) or 'dienogest' (Visanne, 2mg, 1x1 Bayer, Germany), based on the last digit of their protocol numbers. Personal and demographic data, medical and surgical treatment histories were recorded. Patients were evaluated through gynecological examination and auxiliary diagnostic methods. Chronic pain symptoms were assessed with visual analog pain scoring before treatment, at 6 and 12 months. Treatment discontinuation rates, reasons, and side effects were queried at each assessment, and auxiliary diagnostic methods in the study protocol were applied. Results: As the primary outcome of our study, a statistically significant decrease in all pain scores was found in both groups, with no significant difference between the two groups in terms of the decrease in pain scores. For dysmenorrhea, the starting value was 7.43 ± 2.9 in the NETA group and 7.23 ± 2.87 in the dienogest group. For dyspareunia, values were 4.00 ± 4 in the NETA group and 3.90 ± 3.55 in the dienogest group. For dyschezia, values were 1.97 ± 3.11 in the NETA group and 1.85 ± 2.99 in the dienogest group. For chronic pelvic pain, values were 4.97 ± 3.80 in the NETA group and 4.18 ± 3.15 in the dienogest group. Pelvic pain scores at 6 months were as follows: dysmenorrhea for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; dyspareunia for NETA 0.95 ± 2.52, dienogest 0.50 ± 1.48; dyschezia for NETA 0.59 ± 2.06, dienogest 0.00 ± 0.00; chronic pelvic pain for NETA 1.41 ± 2.54, dienogest 0.81 ± 1.66. Pelvic pain scores at 12 months were as follows: dysmenorrhea for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; dyspareunia for NETA 0.38 ± 1.50, dienogest 0.33 ± 1.41; dyschezia for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; chronic pelvic pain for NETA 1.06 ± 2.43, dienogest 0.00 ± 0.00. While the reduction in endometrioma sizes during the treatment process was observed in both groups, the reduction in the NETA group was statistically significantly greater than in the dienogest group (p=0.037). As a secondary outcome, the side effect profile was consistent with the literature in both groups, with no statistically significant difference between the two groups. As a significant result of our study, the discontinuation rate of treatment within the first 6 months was higher in the dienogest group, while in the second 6 months, it was higher in the NETA group (First 6 months: NETA 23.3%, dienogest 47.5%; Second 6 months: NETA 23.3%, dienogest 7.5%, p: 0.026). Conclusion: Both progestins used in medical suppression for the treatment of endometriosis were found to reduce pain scores similarly, contrary to the literature. This difference could be explained by the higher NETA dose used in our study compared to studies in the literature. There was no difference between the two in terms of treatment efficacy and safety profiles. As a significant result of our study, the treatment discontinuation rate among secondary outcome parameters was higher in the dienogest group in the first 6 months and higher in the NETA group in the second 6 months, which could be a preference in treatment management.
Aim: In this study, we compared the efficacy of two progestin derivatives, NETA and dienogest, primarily on pain symptoms in patients diagnosed with endometriosis radiologically or surgically, and secondarily compared their side effect profiles and tolerability. Materials and Methods: The study included 70 patients aged 18-40 years who presented to the Endometriosis Clinic between April 2022 and April 2023, with no desire for pregnancy and undergoing medical treatment. Patients with contraindications to progestin use, a history of pelvic inflammatory disease, and those with detected uterine anomalies were excluded from the study. The study was designed and conducted as a single center prospective, randomized trial. Patients were randomly assigned to one of two treatment protocols, 'NETA' (Primolut-N, 5 mg, 1x1 Bayer, Germany) or 'dienogest' (Visanne, 2mg, 1x1 Bayer, Germany), based on the last digit of their protocol numbers. Personal and demographic data, medical and surgical treatment histories were recorded. Patients were evaluated through gynecological examination and auxiliary diagnostic methods. Chronic pain symptoms were assessed with visual analog pain scoring before treatment, at 6 and 12 months. Treatment discontinuation rates, reasons, and side effects were queried at each assessment, and auxiliary diagnostic methods in the study protocol were applied. Results: As the primary outcome of our study, a statistically significant decrease in all pain scores was found in both groups, with no significant difference between the two groups in terms of the decrease in pain scores. For dysmenorrhea, the starting value was 7.43 ± 2.9 in the NETA group and 7.23 ± 2.87 in the dienogest group. For dyspareunia, values were 4.00 ± 4 in the NETA group and 3.90 ± 3.55 in the dienogest group. For dyschezia, values were 1.97 ± 3.11 in the NETA group and 1.85 ± 2.99 in the dienogest group. For chronic pelvic pain, values were 4.97 ± 3.80 in the NETA group and 4.18 ± 3.15 in the dienogest group. Pelvic pain scores at 6 months were as follows: dysmenorrhea for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; dyspareunia for NETA 0.95 ± 2.52, dienogest 0.50 ± 1.48; dyschezia for NETA 0.59 ± 2.06, dienogest 0.00 ± 0.00; chronic pelvic pain for NETA 1.41 ± 2.54, dienogest 0.81 ± 1.66. Pelvic pain scores at 12 months were as follows: dysmenorrhea for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; dyspareunia for NETA 0.38 ± 1.50, dienogest 0.33 ± 1.41; dyschezia for NETA 0.00 ± 0.00, dienogest 0.00 ± 0.00; chronic pelvic pain for NETA 1.06 ± 2.43, dienogest 0.00 ± 0.00. While the reduction in endometrioma sizes during the treatment process was observed in both groups, the reduction in the NETA group was statistically significantly greater than in the dienogest group (p=0.037). As a secondary outcome, the side effect profile was consistent with the literature in both groups, with no statistically significant difference between the two groups. As a significant result of our study, the discontinuation rate of treatment within the first 6 months was higher in the dienogest group, while in the second 6 months, it was higher in the NETA group (First 6 months: NETA 23.3%, dienogest 47.5%; Second 6 months: NETA 23.3%, dienogest 7.5%, p: 0.026). Conclusion: Both progestins used in medical suppression for the treatment of endometriosis were found to reduce pain scores similarly, contrary to the literature. This difference could be explained by the higher NETA dose used in our study compared to studies in the literature. There was no difference between the two in terms of treatment efficacy and safety profiles. As a significant result of our study, the treatment discontinuation rate among secondary outcome parameters was higher in the dienogest group in the first 6 months and higher in the NETA group in the second 6 months, which could be a preference in treatment management.
Açıklama
Anahtar kelimeler
Endometriozis, Noretindron asetat, Dienogest, Dismenore, Disparoni, Diskezi, Endometriosis, Norethindrone acetate, Dysmenorrhea, Dyspareunia, Dyschezia
Alıntı
Gürbüz, T. B. (2024). Endometriozisin medikal tedavisinde kronik ağrı semptomları ve rekürrensin değerlendirilmesinde kliniğimizde rutin uygulanmakta olan iki progesteron preparatı noretindron asetat ve dienogestin karşılaştırılması. Yayınlanmamış tıpta uzmanlık tezi. Bursa Uludağ Üniversitesi Tıp Fakültesi.