Pascal-Vigneron V, Weryha G, Bosc M, Leclere J
Clinique Médicale et Endocrinologique, CHU de Nancy.
Presse Med. 1995 Apr 29;24(16):753-7.
Cabergoline is a new, long-acting D2 agonist, highly effective in suppressing prolactin and restoring gonadal function in hyperprolactinaemic amenorrhoea. This study compares its efficacity and safety with that of the reference compound, bromocriptine.
A prospective study involved 21 French Centres and 120 women, with hyperprolactinaemic amenorrhoea, randomized to either cabergoline (CAB 0.5-1 mg twice weekly) or bromocriptine (BRC 2.5-5 mg twice daily). Treatment is given under double-blind conditions for the first 8 weeks, and subsequently in open conditions in further 16 weeks with dose adjustments according to response. Patients were assessed for biochemical and clinical efficacy and drug safety (adverse symptoms and biology).
Normoprolactinaemia was achieved in 56/60 (93.3%) taking CAB and 27/58 (48.2%) taking BRC (p < 0.0001). Ovulatory cycles or pregnancy were recorded in 71.6% and 48.2% of patients (p = 0.001). Prolactin suppression to below 50% of the baseline value was observed in 1.6% and 15.5% (p = 0.007). Adverse symptoms were recorded in 31/60 (51.6%) and 40/58 (69.2%) patients respectively in the double-blind period, and 53.3% versus 65.5% for the full course of the study. There were significantly fewer gastro-intestinal symptoms in the CAB group, 36.6% versus 84.5% (p < 0.0001).
Cabergoline is a new prolactin-lowering drug, more effective and better tolerated with fewer gastrointestinal symptoms than the reference compound, bromocriptine.
卡麦角林是一种新型长效D2激动剂，在抑制高泌乳素血症性闭经患者的泌乳素水平及恢复性腺功能方面疗效显著。本研究将其疗效和安全性与对照药物溴隐亭进行比较。
一项前瞻性研究，涉及21个法国研究中心的120例高泌乳素血症性闭经女性，随机分为卡麦角林组（CAB 0.5 - 1 mg，每周两次）和溴隐亭组（BRC 2.5 - 5 mg，每日两次）。前8周采用双盲治疗，随后16周采用开放治疗，并根据反应调整剂量。评估患者的生化和临床疗效以及药物安全性（不良症状和生物学指标）。
服用CAB的60例患者中有56例（93.3%）实现了正常泌乳素血症，服用BRC的58例患者中有27例（48.2%）实现了正常泌乳素血症（p < 0.0001）。排卵周期或妊娠分别记录于71.6%和48.2%的患者中（p = 0.001）。泌乳素水平抑制至基线值的50%以下分别见于1.6%和15.5%的患者（p = 0.007）。双盲期分别有31/60（51.6%）和40/58（69.2%）的患者记录到不良症状，研究全程分别为53.3%和65.5%。CAB组胃肠道症状明显较少，分别为36.6%和84.5%（p < 0.0001）。
卡麦角林是一种新型降低泌乳素的药物，比对照药物溴隐亭更有效，耐受性更好，胃肠道症状更少。
