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頁籤選單縮合
題名 | A Randomized Comparative Study of the Effect of Leuprorelin Acetate Depot and Danazol in the Treatment of Endometriosis=以長效性腺激素釋放素和療得高藥劑治療子宮內膜異位症效果之比較 |
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作者姓名(中文) | 張昇平; 吳香達; | 書刊名 | 中華醫學雜誌 |
卷期 | 57:6 1996.06[民85.06] |
頁次 | 頁431-437 |
分類號 | 417.27 |
關鍵詞 | 療得高; 雌二醇; 濾泡刺激素; 黃體生成激素; 長效性腺激素釋放素; Danazol; Estradiol; Follicular stimulating hormone; Leuteinizing hormone; Leuprorelin acetate depot; |
語文 | 英文(English) |
中文摘要 | 背景 本研究之目的是為了比較長效性腺激素釋放素(leuprorelin acetate depot, LA)和療得高(danazol)對治療子宮內膜異位症之功效和安全性。 方法 研究對象為45位以腹腔鏡切片診斷或剖腹探查證實為不同期之子宮內 膜異位症患者。我們以隨機分組方式分別給予LA(每隔28日皮下注射3.75毫克) 或口服療得高(每日800毫克),療程為20週。我們對兩組病人均進行一般生化 檢查及內分泌荷爾蒙檢查,並相互比較。 結果 兩種藥物對病症治療效果以第二次腹腔鏡檢查評估,都有顯著之改善。 以客觀之記分統計兩組病人之最後治療效果,發現沒有統計上之差異。兩組病 人CA-125之值在治療後比治療前顯著的降低(p < 0.01)。在LA治療組之血清生 化檢查顯示全血清蛋白、白蛋白、鹼性磷酸脢、膽紅素、膽固醇、高密度脂蛋 白、低密度脂蛋白、尿酸和鈣等顯著地上升,但沒有病理性之變化。在療得高 治療組之低密度脂蛋白濃度明顯地增加(p < 0.05)。在LA治療組於給藥第四週 後,血清雌二醇降低至相當於去勢後之值(13.87 +/- 1.63 pg/ml),而且於治療期中 持續此濃度。而在療得高治療組,血清雌二醇之濃度反而增加。 結論 LA和療得高對子宮內膜異位症都有治療效果;長效性腺激素釋放素造 成低雌激素之副作用比療得高造成之男性化及合成代謝的副作用較易為病人忍 受;LA之藥價比療得高藥劑高。考慮價格、治療效益、服藥方式及副作用,兩 種藥劑各有其優缺點。 |
英文摘要 | Background. Administration of superactive agonistic analog of gonadotropin-releasing hormone (GnRH) has shown to induce a paradoxic and reversible suppression gonadotropins, so that gonadal steroid concentrations are suppressed and hypoestrogenemia is induced. In order to compare the efficacy and safety of leuprorelin acetate depot (LA) and danazol in the treatment of endometriosis, we conducted this study. Methods. A total of forty-five patients with pelvic endometriosis of different severity at laparoscopy with biopsy of peritoneal implants (n=33) and surgical procedure (enucleation of ovarian chocolate cysts, cystectomy, or fulguration, n=12) were included in the study and followed during the 20 weeks of treatment. LA 3.75mg was injected subcutaneously every 28 days, while the daily oral dose of danazol was 800 mg. Results. Both treatments were associated with a lowering of severity score. There was a consistent decrease in women with stage IV disease in the LA group and an increase in patients with stage I disease in the danazol group, but no difference was found between both treatments. Hot flushing was the most common side effect reported in 97% of LA but occurred only in 13% of danazol-treated patients. In contrast, the androgenic, anabolic side effects of weight gain and myalgia were common in those receiving danazol. The CA-125 levels were significantly lower in both treatment groups compared with their pretreatment levels (p < 0.01). During the five months of the LA treatment, biochemical evaluation revealed no pathologic alternation. Only total protein, albumin, alkaline phosphatase, total bilirubin, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol, uric acid and calcium increased significantly. Danazol was also associated with adverse metabolic effects and significantly increased low- density lipoprotein-cholesterol concentrations (p < 0.05). In the fourth week, serum estradiol (E2) levels decreased to nearly castrated levels (13.87 +/- 1.63 pg/ml) in all patients treated with LA, and remained at this level thereafter. On the contrary, a slight but significant increase of the serum E2 levels was noted during the danazol treatment. After five months of treatment with LA, no significant changes in bone density were observed at the femoral neck or the anteroposterior (AP) view of lumbar spine, but there was a significant loss in bone density at the lateral view of lumbar spine (7.1%, p < 0.05). Conclusions. Both LA and danazol are effective in the treatment of endometriosis. The hypoestrogenic side effects of LA may be better tolerated than the androgenic, anabolic effects of danazol. However, the danazol treatment costs less than LA and has no significant side effect with osteoporosis. |
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