Colao Annamaria, Auriemma Renata S, Rebora Alberto, Galdiero Mariano, Resmini Eugenia, Minuto Francesco, Lombardi Gaetano, Pivonello Rosario, Ferone Diego
Department of Molecular and Clinical Endocrinology, University Federico II of Naples, Naples, Italy.
Clin Endocrinol (Oxf). 2009 Aug;71(2):237-45. doi: 10.1111/j.1365-2265.2008.03503.x. Epub 2008 Dec 15.
To evaluate GH and IGF-I control and tumour shrinkage in newly diagnosed patients with acromegaly treated first-line with lanreotide-Autogel (ATG) 120 mg. Design Open, prospective.
Twenty-six patients (17 women, aged 31-70 years): eight enclosed and 12 extrasellar (eight invasive) macroadenomas and six microadenomas (one invasive). ATG 120 mg initially given every 4 weeks for 12 weeks; then intervals between injections increased to every 6 or 8 weeks if GH levels were <or= 2.5 or < 1 microg/l (equal to 6.5 and 2.6 mU/l), respectively.
Final dosage was ATG 120 mg every 4 weeks in nine patients (34.6%), every 6 weeks in eight patients (30.8%) and every 8 weeks in the remaining nine patients (34.6%). After 12 months, both GH and IGF-I were controlled in 14 patients (53.8%). The mean tumour volume decreased from 1405 +/- 1827 mm(3) at study entry to 960 +/- 1381 mm(3) after 6 months, and 799 +/- 1161 mm(3) after 12 months (P < 0.0001). Overall tumour shrinkage was 35.8 +/- 28.1% after 6 months and 48.4 +/- 27.6% after 12 months. After 12 months, 20 patients (76.9%) achieved > 25% tumour shrinkage: 12 of 14 with controlled disease (85.7%) and 8 of 12 with noncontrolled disease (66.7%; P = 0.49). Hyperhydrosis, paresthesiae and arthralgias significantly reduced after treatment. No patient withdrew from the study because of adverse events.
ATG 120 mg in newly diagnosed patients with acromegaly controls GH and IGF-I secretion in 53.8% and induces >or= 25% tumour shrinkage in 76.9% during a 12-month period. The treatment was associated with improvement of clinical symptoms and with a good safety profile.
评估用兰瑞肽缓释凝胶（ATG）120mg一线治疗的新诊断肢端肥大症患者的生长激素（GH）和胰岛素样生长因子-I（IGF-I）控制情况及肿瘤缩小情况。设计：开放、前瞻性研究。
26例患者（17例女性，年龄31 - 70岁）：8例鞍内和12例鞍外（8例侵袭性）大腺瘤以及6例微腺瘤（1例侵袭性）。初始每4周给予ATG 120mg，共12周；如果GH水平分别≤2.5或<1μg/L（相当于6.5和2.6mU/L），则注射间隔增加至每6或8周。
最终剂量为9例患者（34.6%）每4周给予ATG 120mg，8例患者（30.8%）每6周给予，其余9例患者（34.6%）每8周给予。12个月后，14例患者（53.8%）的GH和IGF-I均得到控制。平均肿瘤体积从研究开始时的1405±1827mm³在6个月后降至960±1381mm³，12个月后降至799±1161mm³（P<0.0001）。6个月时总体肿瘤缩小率为35.8±28.1%，12个月时为48.4±27.6%。12个月后，20例患者（76.9%）肿瘤缩小>25%：14例病情得到控制的患者中有12例（85.7%），12例病情未得到控制的患者中有8例（66.7%；P = 0.49）。治疗后多汗、感觉异常和关节痛明显减轻。没有患者因不良事件退出研究。
对于新诊断的肢端肥大症患者，ATG 120mg在12个月期间可使53.8%的患者控制GH和IGF-I分泌，并使76.9%的患者肿瘤缩小≥25%。该治疗与临床症状改善及良好的安全性相关。
