■GAIL研究的第一阶段(“用芳香化酶抑制剂和亮丙瑞林治疗的女孩,\“ISRCTN11469487)表明,阿那曲唑和亮丙瑞林联合使用24个月可以安全有效地改善青春期早期和生长预测受损的女孩的预测成年身高(PAH),与仅抑制青春期相比,其得分为1.21标准差(SDS;7.51cm),+0.31SDS(+1.92cm)。
■在GAIL研究的第二阶段,我们在第一阶段结束时评估成人身高(AH)/近成人身高(NAH),此外,此后阿那曲唑单药治疗在进一步改善NAH方面的疗效。
■我们测量了AH(年龄16.5岁)/NAH[骨龄(BA),包括40个女孩中的15年],分为两组:A组(阿那曲唑亮丙瑞林治疗20名女孩)和B组(单用亮丙瑞林治疗20名女孩)。A组进一步随机分为两个亚组:A1和A2。A1组(n=10),完成联合治疗后,接受阿那曲唑1mg/天作为单一疗法,直到BA14年,6个月的随访。A2组(n=10)和B组(n=20),只接受联合治疗和亮丙瑞林,分别,被召回评估AH/NAH。
■AH或NAH在所有组的GAIL研究的2年初始阶段完成时超过PAH,但结果仅在A1组中有统计学意义:NAH-PAH组A1,+3.85cm(+0.62SDS,p=0.01);A2组,+1.6cm(+0.26SDS,p=0.26);B组,+1.7cm(+0.3SDS,p=0.08)。A1组的增益显着大于A2组(p=0.04)和B组(p=0.03)。在A1组中,即使作为单一疗法,阿那曲唑也被确定为是安全的。
■在生长潜力受损的早熟女孩中,联合使用亮丙瑞林和阿那曲唑治疗2年或直到11岁,当继续阿那曲唑单药治疗直到达到NAH时,导致身高总增加9.7厘米,如果不继续使用阿那曲唑单药治疗,则为7.4cm,而单独使用亮丙瑞林治疗则为3.6cm。因此,如果持续阿那曲唑单药治疗至BA14年,则联合干预在距目标身高最短距离处结束.
UNASSIGNED: The first phase of the GAIL
study (\"Girls treated with an Aromatase Inhibitor and Leuprorelin,\" ISRCTN11469487) has shown that the combination of anastrozole and leuprorelin for 24 months is safe and effective in improving the predicted adult height (PAH) in girls with early puberty and compromised growth prediction by +1.21 standard deviation score (SDS; +7.51 cm) compared to inhibition of puberty alone, +0.31 SDS (+1.92 cm).
UNASSIGNED: In the second phase of the GAIL
study, we assessed the adult height (AH)/near-adult height (NAH) at the end of the first phase and, in addition, the efficacy of anastrozole monotherapy thereafter in further improving NAH.
UNASSIGNED: We measured the AH (age 16.5 years)/NAH [bone age (BA), 15 years] of the 40 girls included, divided into two matched groups: group A (20 girls on anastrozole + leuprorelin) and group B (20 girls on leuprorelin alone). Group A was further randomized into two subgroups: A1 and A2. Group A1 (n = 10), after completion of the combined therapy, received anastrozole 1 mg/day as monotherapy until BA 14 years, with a 6-month follow-up. Group A2 (n = 10) and group B (n = 20), who received only the combined treatment and leuprorelin alone, respectively, were recalled for evaluation of AH/NAH.
UNASSIGNED: AH or NAH exceeded the PAH at the completion of the 2-year initial phase of the GAIL
study in all groups, but the results were statistically significant only in group A1: NAH-PAH group A1, +3.85 cm (+0.62 SDS, p = 0.01); group A2, +1.6 cm (+0.26 SDS, p = 0.26); and group B, +1.7 cm (+0.3 SDS, p = 0.08). The gain in group A1 was significantly greater than that in group A2 (p = 0.04) and in group B (p = 0.03). Anastrozole was determined to be safe even as monotherapy in Group A1.
UNASSIGNED: In early-maturing girls with compromised growth potential, the combined treatment with leuprorelin and anastrozole for 2 years or until the age of 11 years resulted in a total gain in height of +9.7 cm when continuing anastrozole monotherapy until the attainment of NAH, as opposed to +7.4 cm if they do not continue with the anastrozole monotherapy and +3.6 cm when treated with leuprorelin alone. Thus, the combined intervention ends at the shortest distance from the target height if continued with anastrozole monotherapy until BA 14 years.