Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University, No 58, Zhongshan Er Road, Guangzhou 510080, People's Republic of China.
Eur J Endocrinol. 2010 Apr;162(4):661-6. doi: 10.1530/EJE-09-0908. Epub 2010 Jan 8.
To investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas.
A prospective, randomised study.
After a baseline evaluation, patients were randomly assigned to 4-month preoperative treatment with lanreotide (starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8 if mean GH >2.5 microg/l on GH day curves; pretreatment group, Group 1) or to transsphenoidal surgery (direct surgery group, Group 2). Cure was evaluated 4 months postoperatively primarily by fasting IGF1 less than or equal to age-adjusted upper limit of normal.
A pool of 108 patients was randomly divided into two groups. Five patients in each group were lost to follow-up during the study period, so 49 patients in each group were analysed. At baseline, no difference was observed between the two groups. Cure was established in 24 of 49 (49.0%, 95% confidence interval (CI), 35.0-63.0%) pretreated patients (Group 1) versus 9 of 49 (18.4%, 95% CI, 7.6-29.2%) direct surgery patients (Group 2; P=0.001). Surgical morbidity was recorded in 12 patients (12.2%) and was similar in Group 1 and 2 patients (14.3 and 10.2% respectively; P=0.538). The postoperative hospital stay was similar between groups: being 4.5+/-1.6 days in Group 1 vs 4.8+/-1.9 days in Group 2 (P=0.328).
Pretreatment with lanreotide before transsphenoidal surgery improves surgical cure rates in patients with GH-secreting pituitary macroadenomas. Pretreatment does not affect surgical complications or duration of hospital stay (ClinicalTrials.gov number, NCT00993356).
研究术前 4 个月给予兰瑞肽治疗是否能提高新诊断的生长激素腺瘤型肢端肥大症患者的手术治愈率。
前瞻性、随机研究。
基线评估后，患者被随机分为 4 个月术前兰瑞肽治疗组（起始剂量为 30mg/2 周肌内注射，第 8 周时，如果 GH 日曲线 GH>2.5μg/l，则增至 30mg/周肌内注射；预处理组，1 组）或经蝶窦手术（直接手术组，2 组）。术后 4 个月主要通过空腹 IGF1 低于或等于年龄调整的正常值上限来评估治愈情况。
108 例患者被分为两组。研究期间每组各有 5 例患者失访，因此每组各有 49 例患者被分析。基线时，两组间无差异。49 例预处理患者中有 24 例（49.0%，95%可信区间[CI]，35.0-63.0%）治愈（1 组），而 49 例直接手术患者中仅有 9 例（18.4%，95%CI，7.6-29.2%）治愈（2 组；P=0.001）。两组均有 12 例（12.2%）患者发生手术并发症，两组间无差异（1 组和 2 组分别为 14.3%和 10.2%；P=0.538）。两组术后住院时间相似：1 组为 4.5+/-1.6 天，2 组为 4.8+/-1.9 天（P=0.328）。
在经蝶窦手术前给予兰瑞肽治疗可提高生长激素分泌型垂体大腺瘤患者的手术治愈率。治疗不影响手术并发症或住院时间（ClinicalTrials.gov 编号，NCT00993356）。
