van der Heijden P F, de Wit W, Brownell J, Schoemaker J, Rolland R
Department & Obstetrics & Gynaecology, Sint Radboud University Hospital Nijmegen, The Netherlands.
Eur J Obstet Gynecol Reprod Biol. 1991 Jul 1;40(2):111-8. doi: 10.1016/0028-2243(91)90101-p.
Forty-seven hyperprolactinaemic patients with serum prolactin (PRL) concentrations persistently above 1500 mU/l were treated with the new dopamine agonist CV 205-502 or bromocriptine in a prospective, randomized and double-blind fashion during a 24-week period. Two women had to be excluded because of poor compliance in the first month. Therefore 45 patients remained for evaluation. 81% of the patients in the CV 205-502 group and 70% of the patients in the bromocriptine group normalized their prolactin levels within the study period with a treatment dose as permitted in this protocol. In general serum prolactin normalized within 8 to 12 weeks of treatment. There were no differences between the two tested drugs regarding restoration of the menstrual cycle or disappearance of galactorrhoea. Both drugs gave rise to adverse reactions, especially during the initiation of therapy. However, the adverse reactions reported during CV 205-502 treatment were less severe and persistent than those attributed to bromocriptine. Patient acceptance of the new drug with regard to tolerability was judged by 90% of the women in that treatment group as very good or good, while 75% of those treated with bromocriptine evaluated its tolerability as very good or good. We conclude that CV 205-502 is highly effective in the treatment of hyperprolactinaemia with concomitant restoration of gonadal function and prevention of galactorrhoea. The tolerability of the drug seems better than of bromocriptine and therefore this drug is of value in the treatment of hyperprolactinaemic patients.
47名血清催乳素(PRL)浓度持续高于1500 mU/l的高催乳素血症患者,在24周期间接受了新型多巴胺激动剂CV 205-502或溴隐亭的前瞻性、随机双盲治疗。由于第一个月依从性差,两名女性不得不被排除。因此,剩余45名患者接受评估。CV 205-502组81%的患者和溴隐亭组70%的患者在本方案允许的治疗剂量下,在研究期间催乳素水平恢复正常。一般来说,血清催乳素在治疗8至12周内恢复正常。在恢复月经周期或溢乳消失方面,两种受试药物之间没有差异。两种药物都会引起不良反应,尤其是在治疗开始时。然而,CV 205-502治疗期间报告的不良反应比溴隐亭引起的不良反应较轻且持续时间较短。该治疗组90%的女性认为新药在耐受性方面患者接受度非常好或良好,而接受溴隐亭治疗的患者中有75%将其耐受性评价为非常好或良好。我们得出结论,CV 205-502在治疗高催乳素血症方面非常有效,同时可恢复性腺功能并预防溢乳。该药物的耐受性似乎优于溴隐亭,因此在治疗高催乳素血症患者方面具有价值。