Dienogest 2 MG 是什么？

子宮內膜症的處理目前包括荷爾蒙療法和手術治療
根據病人的期望和疾病嚴重的程度，我們可以觀察追蹤、使用荷爾蒙療法、或手術治療或是兩者合併療法。
子宮內膜異位症的治療目的是緩解疼痛，讓異位的子宮內膜組織的增生速度放緩，改善或保護生育能力，並防止舊病復發。一般上可通過腹腔鏡檢查獲得更明確的診斷，倘若發現子宮內膜異位症，也可進行腹腔鏡手術，取出病變組織（如巧克力囊腫）；但是，某些病人可能會在手術後，再次面對病變復發生的問題。
治療子宮內膜異位症最常見的藥物是止痛藥，例如非類固醇抗炎藥物（NSAIDs）、促性腺激素類似劑（GnR Hanalogues）、口服避孕藥及Progestins 、黃體素、Gestrin、Dimetriose、Danazol：等，但以上藥物只能在有限的時間內安全使用或見效，無法滿足所有子宮內膜異位症患者的需求。舉例來說，雖然促性腺激素類似劑注射，是目前最有效的療法，但此療法只能使用6個月，只因會引發骨質疏鬆等副作用。再加上許多女性不喜歡打針，因此她們迫切需要另一種治療選擇。
 

口服新選擇
全新口服藥物Visanne（Dienogest）正式獲准上市，作為減少子宮內膜異位症所帶來的疼痛與病變，讓子宮內膜異位症患者多了一項選擇。Dienogest能緩解因子宮內膜異位症所產生的疼痛，包括經痛、經前疼痛及性交疼痛等等。在一項超過15個月的研究發現，服用Dienogest的子宮內膜異位症患者，疼痛能得到持續改善和緩解。根據臨床研究顯示，與促性腺激素類似劑注射相比，Dienogest引發熱潮紅的案例明顯較低，而骨質密度的改變也明顯較輕微。子宮內膜異位症影響許多正值生育年齡的女性，Dienogest的面市，讓病患多了另一項選擇。

不良反應 不良反應較常出現於開始服用Visanne之後第一個月， 隨著治療時間而消退。Visanne使用者曾通報出現下列 不良反應。 治療期間最常通報(且被視為至少可能與Visanne有關) 的不良反應為頭痛(9.0 %)、乳房不適(5.4 %)、情緒 低落(5.1 %)以及痤瘡(5.1 %)。 此外，大多數接受Visanne治療的病患發生經期出血型 態改變。使用病患日誌評估經期出血型態，然後使用 世界衛生組織(WHO) 90天參考期方法進行分析。在 最初90天的Visanne治療期間，觀察到以下出血型態 (n = 290；100%)：無月經(1.7%)、不常出血 (27.2%)、經常出血(13.4%)、不規則出血(35.2%)、 出血延長(38.3%)、正常出血(亦即不屬於前述任一類 (19.7%))。在第四個參考期間，觀察到以下出血型態 (n = 149；100%)：無月經(28.2%)、不常出血 (24.2%)、經常出血(2.7%)、不規則出血(21.5%)、出 血延長(4.0%)、正常出血(亦即不屬於前述任一類 (22.8%))。

Dienogest (DNG) is a progestin with highly selective progesterone activity and known to be effective in the treatment of endometriosis. This prospective cohort study in patients who had been treated with DNG 2 mg (Visanne®) for endometriosis was conducted to assess the safety and effectiveness of DNG in a large Korean cohort. This study included 3356 patients with endometriosis from 73 centers in Korea. All patients were treated with DNG 2 mg daily and were followed up for at least 6 months after initial visit. Any adverse events were recorded including severity, onset/closing date, outcomes, treatments, and the causality with DNG. Effectiveness of DNG was measured by changes in visual analogue scale (VAS) from baseline at the end of follow-up. The mean age of the subjects was 34.96 years, and the mean duration of treatment was 285.44 days. Incidence of adverse drug reaction (ADR) was 13.27% (413/3113). The most frequently reported ADR were "abnormal uterine bleeding" 4.14% (129/3113), "increased weight" 2.57% (80/3113), and "headache" 1.22% (38/3113). The number of patients (%) with favorable bleeding patterns was observed to increase as the duration of treatment increases. Amenorrhea was observed in 29.63%, 41.25%, 46.26%, and 53.20% of patients at 3 months, 6 months, 12 months, and more than 12 months follow-up period, respectively. The mean (±SD) VAS change from baseline at the last follow-up visit was -28.19 ± 28.39 mm (P value < 0.0001). This large cohort study confirms, in routine clinical practice, that DNG is safe and effective for treatment of endometriosis.

本研究旨在评估地诺孕素治疗子宫内膜异位症的疗效和不良反应。在 6 个月的研究期间，子宫内膜异位症患者连续服用地诺孕素（2 毫克/天）。前瞻性地检查患者在治疗的基线、第三个月和第六个月的疗效和副作用。30 名患者中有 24 名能够完成研究。子宫内膜异位症的平均体积从基线时的 112.63 ± 161.31 cm³ 显着降低至 6 个月随访时的 65.47 ± 95.69 cm³ (-41%) ( p  = .005)。盆腔疼痛的 VAS 评分从 7.50 显着下降到 3.00（p < .001) 在治疗的第六个月。最常见的副作用是月经不调。在研究期间实验室参数没有改变。Dienogest 被认为在使用 6 个月后可有效减小子宫内膜异位症的大小，减少子宫内膜异位症相关的疼痛，并具有良好的安全性和耐受性。

• 影响陈述

• 关于这个主题已经知道了什么？腹腔镜子宫内膜异位症切除术是目前治疗子宫内膜异位症最有效的方法。然而，人们担心手术期间卵巢储备功能受损。

• 这项研究的结果增加了什么？Dienogest 被认为可有效减小子宫内膜异位症的大小，减少子宫内膜异位症相关的疼痛，并具有良好的安全性和耐受性。在尚未生育的年轻子宫内膜异位症患者中长期使用地诺孕素可能会通过减小子宫内膜异位症的大小来降低手术的可能性，并可能保留卵巢储备。

• 这些发现对临床实践和/或进一步研究有何意义？地诺孕素可降低感染性并发症的发生率，如取卵后盆腔脓肿和子宫内膜异位症不孕患者的外科手术。

"点击查看英文标题和摘要"

Abstract

This study aimed to evaluate the efficacy and adverse effects of dienogest for the treatment of endometriomas. Dienogest (2 mg/day) was administered to patients with endometrioma continuously through the 6-month study period. The patients were prospectively examined on the efficacy and side effects at baseline, at third months, and sixth months of the treatment. Twenty-four out of 30 patients were able to complete the study. The mean volume of the endometrioma decreased significantly from 112.63 ± 161.31 cm³ at baseline to 65.47 ± 95.69 cm³ at a 6-month follow-up (−41%) (p = .005). The VAS score for pelvic pain decreased significantly from 7.50 to 3.00 (p < .001) at the sixth months of treatment. The most common side effects were menstrual irregularities. Laboratory parameters did not change during the study. Dienogest considered being effective for 6 months of use in decreasing the size of endometrioma, reducing endometriosis-associated pain with a favourable safety and tolerability profile.

• Impact statement

• What is already known on this subject? Laparoscopic excisional surgery for endometrioma is currently the most valid approach in the treatment of endometriomas. However, there are concerns about ovarian reserve damage during surgery.

• What do the results of this study add? Dienogest considered being effective in decreasing the size of endometrioma, reducing endometriosis-associated pain with a favourable safety and tolerability profile. Long-term use of dienogest in younger patients with endometriomas who are yet to give birth may reduce the possibility of surgery by reducing the size of the endometriomas and may preserve ovarian reserve.

• What are the implications of these findings for clinical practice and/or further research? Dienogest may reduce the incidence of infectious complications such as pelvic abscess after oocyte retrieval and the surgical procedures in infertile patients with endometrioma.