卡麦角林与溴隐亭治疗高泌乳素血症性闭经的比较。卡麦角林比较研究组。

A comparison of cabergoline and bromocriptine in the treatment of hyperprolactinemic amenorrhea. Cabergoline Comparative Study Group.

作者信息

Webster J, Piscitelli G, Polli A, Ferrari C I, Ismail I, Scanlon M F

机构信息

Section of Endocrinology, Metabolism, and Diabetes, University of Wales College of Medicine, Cardiff, United Kingdom.

出版信息

N Engl J Med. 1994 Oct 6;331(14):904-9. doi: 10.1056/NEJM199410063311403.

DOI:10.1056/NEJM199410063311403

PMID:7915824

Abstract

BACKGROUND

Cabergoline is a long-acting dopamine-agonist drug that suppresses prolactin secretion and restores gonadal function in women with hyperprolactinemic amenorrhea. We designed a study to compare its safety and efficacy with those of bromocriptine, which has been the standard therapy.

METHODS

A total of 459 women with hyperprolactinemic amenorrhea were treated with either cabergoline (0.5 to 1.0 mg twice weekly) or bromocriptine (2.5 to 5.0 mg twice daily), administered in a double-blind fashion for 8 weeks and subsequently in an open fashion for 16 weeks, during which adjustments in the dose were made according to the response. Of the 459 women, 279 had microprolactinomas, 3 had macroprolactinomas, 1 had a craniopharyngioma, 167 had idiopathic hyperprolactinemia, and the remainder had an empty sella. Clinical and biochemical status was assessed at 2-week intervals for 8 weeks and monthly thereafter for a total of 6 months, with an additional assessment at 14 weeks.

RESULTS

Stable normoprolactinemia was achieved in 186 of the 223 women treated with cabergoline (83 percent) and 138 of the 236 women treated with bromocriptine (59 percent, P < 0.001). Seventy-two percent of the women treated with cabergoline and 52 percent of those treated with bromocriptine had ovulatory cycles or became pregnant during treatment (P < 0.001). Amenorrhea persisted in 7 percent of the cabergoline-treated women and 16 percent of the bromocriptine-treated women. Adverse effects were recorded in 68 percent of the women taking cabergoline and 78 percent of those taking bromocriptine (P = 0.03); 3 percent discontinued taking cabergoline, and 12 percent stopped taking bromocriptine (P < 0.001) because of drug intolerance. Gastrointestinal symptoms were significantly less frequent, less severe, and shorter-lived in the women treated with cabergoline.

CONCLUSIONS

Cabergoline is more effective and better tolerated than bromocriptine in women with hyperprolactinemic amenorrhea.

摘要

背景

卡麦角林是一种长效多巴胺激动剂药物，可抑制高泌乳素血症闭经女性的泌乳素分泌并恢复性腺功能。我们设计了一项研究，以比较其与已作为标准疗法的溴隐亭的安全性和疗效。

方法

共有459例高泌乳素血症闭经女性接受卡麦角林（每周两次，每次0.5至1.0毫克）或溴隐亭（每日两次，每次2.5至5.0毫克）治疗，以双盲方式给药8周，随后以开放方式给药16周，在此期间根据反应调整剂量。在这459例女性中，279例患有微泌乳素瘤，3例患有大泌乳素瘤，1例患有颅咽管瘤，167例患有特发性高泌乳素血症，其余患有空蝶鞍。在8周内每2周评估一次临床和生化状况，此后每月评估一次，共6个月，并在第14周进行额外评估。

结果

在接受卡麦角林治疗的223例女性中，186例（83%）实现了稳定的正常泌乳素血症，在接受溴隐亭治疗的236例女性中，138例（59%）实现了稳定的正常泌乳素血症（P<0.001）。接受卡麦角林治疗的女性中有72%、接受溴隐亭治疗的女性中有52%在治疗期间有排卵周期或怀孕（P<0.001）。接受卡麦角林治疗的女性中有7%、接受溴隐亭治疗的女性中有16%持续闭经。服用卡麦角林的女性中有68%、服用溴隐亭的女性中有78%记录到不良反应（P=0.03）；3%的女性因药物不耐受而停止服用卡麦角林，12%的女性停止服用溴隐亭（P<0.001）。接受卡麦角林治疗的女性胃肠道症状的发生频率明显较低、严重程度较轻且持续时间较短。