Neuroendocrine Unit, Division of Endocrinology, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Neuroendocrinology. 2010;92(2):120-7. doi: 10.1159/000317314. Epub 2010 Aug 25.
Nearly 40% of acromegalic patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients not controlled by octreotide alone in short-term studies. This study was designed to evaluate short- and long-term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.
Open-label, single arm, prospective trial. Nineteen patients (14 females, 29-78 years of age) with high IGF-I on octreotide-LAR (30 mg/month IM) for > or =6 months were enrolled. Study I: Cabergoline (PO) was started at 1.0, increased to 2.0 and 3.5 mg/week, and withdrawn at 6-week intervals. IGF-I, GH, and PRL were measured at baseline and at 6-week intervals. Study II: Responder patients (IGF-I < or =1 ULN) resumed cabergoline at individual lowest effective doses and were evaluated at 6-month intervals for > or =12 months. Study III: Responders were withdrawn from octreotide and hormonally evaluated at 3-month intervals.
Serum IGF-I (IRMA), GH (ICMA) and PRL (ICMA) levels were determined by commercially available kits.
Addition of cabergoline to octreotide-LAR normalized IGF-I levels in 7 of 19 patients (37%) during both short- and long-term follow-up (12-27 months, mean: 18 months). Octreotide withdrawal increased IGF-I levels in only 2 of 6 responder patients. Normalization of IGF-I levels by cabergoline was strongly associated with IGF-I < or =2.2 ULNR and/or GH < or =4.0 ng/ml under octreotide treatment.
Addition of cabergoline to octreotide was effective in both short- and long-term control of IGF-I in acromegaly, especially in patients with mild/moderately elevated GH/IGF-I levels during octreotide.
近 40%的肢端肥大症患者使用生长抑素类似物（SAs）无法控制 GH/IGF-I 水平。多巴胺激动剂（DAs）的效果更差，但在短期研究中，SAs 和 DAs 的联合治疗可使单独使用奥曲肽治疗未控制的患者中 33-56%的 IGF-I 水平正常化。本研究旨在评估卡麦角林在控制接受奥曲肽治疗的肢端肥大症患者 IGF-I 水平方面的短期和长期疗效。
开放性、单臂、前瞻性试验。19 例患者（14 名女性，年龄 29-78 岁）接受奥曲肽 LAR（30mg/月肌内注射）治疗>或=6 个月，且 IGF-I 较高。研究 I：卡麦角林（PO）起始剂量为 1.0mg，每周增加至 2.0 和 3.5mg，并在 6 周间隔时停药。在基线和 6 周间隔时测量 IGF-I、GH 和 PRL。研究 II：应答患者（IGF-I<或=1ULN）以最低有效剂量恢复卡麦角林，并在>或=12 个月时每 6 个月评估一次。研究 III：应答者停止奥曲肽治疗，并在 3 个月间隔时进行激素评估。
血清 IGF-I（IRMA）、GH（ICMA）和 PRL（ICMA）水平由商业试剂盒测定。
在短期和长期随访（12-27 个月，平均 18 个月）期间，卡麦角林联合奥曲肽-LAR 使 19 例患者中的 7 例（37%）IGF-I 水平正常化。在 6 例应答者中，只有 2 例在奥曲肽撤药后 IGF-I 水平升高。卡麦角林使 IGF-I 水平正常化与奥曲肽治疗时 IGF-I<或=2.2ULNR 和/或 GH<或=4.0ng/ml 密切相关。
卡麦角林联合奥曲肽在肢端肥大症患者的 IGF-I 短期和长期控制中均有效，特别是在奥曲肽治疗时 GH/IGF-I 水平轻度/中度升高的患者中。
