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一线长效奥曲肽治疗可使肢端肥大症患者肿瘤缩小并控制激素过量:一项开放、前瞻性、多中心试验的结果

First-line octreotide-LAR therapy induces tumour shrinkage and controls hormone excess in patients with acromegaly: results from an open, prospective, multicentre trial.

作者信息

Colao Annamaria, Pivonello Rosario, Rosato Francesca, Tita Patrizia, De Menis Ernesto, Barreca Antonina, Ferrara Roberto, Mainini Franco, Arosio Maura, Lombardi Gaetano

机构信息

Department of Molecular and Clinical Endocrinology and Oncology, Federico II, University of Naples, Italy.

出版信息

Clin Endocrinol (Oxf). 2006 Mar;64(3):342-51. doi: 10.1111/j.1365-2265.2006.02467.x.

DOI:10.1111/j.1365-2265.2006.02467.x
PMID:16487447
Abstract

BACKGROUND

The majority of patients with acromegaly have large tumours and the outcome of conventional management remains poor.

OBJECTIVE

To investigate the clinical application of octreotide-LAR as primary treatment in newly diagnosed patients with GH-secreting pituitary tumours.

DESIGN

Open, prospective, multicentre, 24-week follow-up study.

PATIENTS

Thirty-four patients were enrolled (20 men, 14 women; mean age, 50 years); 13 had microadenoma [median tumour volume 327 mm(3) (range 31-629 mm(3))], 21 had macroadenoma [median tumour volume 1,325 mm(3) (range 503-11,583 mm(3))]. Interventions Octreotide-LAR at the dosage of 20 mg every 28 days for the first 12 weeks increased to 30 mg every 28 days to control GH and/or IGF-I excess in 20 patients (64.7%).

MAIN OUTCOME MEASURES

Primary endpoints were control of GH (fasting < 2.5 microg/l) and IGF-I secretion (gender- and age-normalized) and presence and entity of tumour mass shrinkage. Secondary endpoint was improvement of symptoms score.

RESULTS

In patients with micro- and macroadenomas GH levels decreased to < 2.5 microg/l in 84.6% and 45%, serum IGF-I levels normalized for age and gender in 61.5% and 35% of cases. Failure in achieving either GH < 2.5 microg/l or normal IGF-I levels was found in none of the patients with micro- and in 45% of patients with macroadenoma. Median tumour volume was reduced by 54% (range: -90% to +350%) in micro- and by 49% (range -94% to -14%) in macroadenomas. Headache, perspiration and osteo-arthralgias disappeared in 21%, paresthesias in 38%, fatigue in 26% and carpal tunnel syndrome in 15%. The treatment was well tolerated: more frequent adverse events were gastrointestinal (in 44%).

CONCLUSIONS

In both patients with micro- or macroadenoma, primary octreotide-LAR treatment controls hormone excess, induces tumour shrinkage and improves symptoms of acromegaly with limited side effects and can be therefore successfully employed in patients with contraindications for surgery or in those who refuse surgery.

摘要

背景

大多数肢端肥大症患者患有大肿瘤,传统治疗的效果仍然不佳。

目的

探讨长效奥曲肽作为新诊断的生长激素分泌型垂体瘤患者的一线治疗的临床应用。

设计

开放、前瞻性、多中心、24周随访研究。

患者

共纳入34例患者(20例男性,14例女性;平均年龄50岁);13例为微腺瘤[肿瘤体积中位数327 mm³(范围31 - 629 mm³)],21例为大腺瘤[肿瘤体积中位数1325 mm³(范围503 - 11583 mm³)]。干预措施:前12周每28天给予20 mg长效奥曲肽,之后增加至每28天30 mg,以控制20例患者(64.7%)的生长激素和/或胰岛素样生长因子-I过量。

主要观察指标

主要终点为生长激素(空腹<2.5 μg/L)和胰岛素样生长因子-I分泌(按性别和年龄标准化)的控制情况以及肿瘤体积缩小的存在和程度。次要终点为症状评分的改善情况。

结果

微腺瘤和大腺瘤患者中,生长激素水平降至<2.5 μg/L的比例分别为84.6%和45%,血清胰岛素样生长因子-I水平按年龄和性别标准化的比例分别为61.

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