Bolanowski Marek, Zgliczyński Wojciech, Sowiński Jerzy, Bałdys-Waligórska Agata, Bednarek-Tupikowska Grażyna, Witek Przemysław, Zieliński Grzegorz, Liebert Włodzimierz, Siemińska Lucyna, Andrysiak-Mamos Elżbieta, Marek Bogdan, Kajdaniuk Dariusz, Malicka Joanna, Rosiek Violetta, Jawiarczyk-Przybyłowska Aleksandra, Investigators Csms Bpl
Department of Endocrinology, Diabetes, and Isotope Therapy, Wrocław Medical University, Wroclaw, Poland.
Department of Endocrinology, Medical Centre Postgraduate Education, Warszawa, Poland.
Endokrynol Pol. 2020;71(4):285-291. doi: 10.5603/EP.a2020.0050.
The aim of this study was to assess the therapeutic effect and the safety of pre-surgical treatment with long-acting octreotide in patients with acromegaly.
This project was conducted in 25 centres across Poland as a non-interventional, multicentre, observational study in patients with acromegaly, in which long-acting octreotide Sandostatin® LAR®) was administered before surgery. They were 148 patients included into the study: 88 females and 60 males aged 18-86 years (51.3 ± 13.4).
Eighty patients completed the study (underwent tumour surgery). The CRF included: baseline visit, four follow-up visits every three months before surgery, and two follow-up visits every three months after surgery. Sandostatin® LAR® was administered every four weeks. The efficacy measures were as follows: change of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels, number of patients fulfilling criteria of cure, and change of adenoma (micro- and macroadenomas) size during the treatment. Normalisation of GH and IGF-1 concentrations were obtained in 42.4 and 49.1% of patients at the end of medical therapy, respectively. Normalisation of GH and IGF-1 concentrations were obtained in 77.9 and 83.8% of patients after surgery, respectively. Reduction of microadenoma size was documented in 58.8% of patients, and in 70% of patients with macroadenomas at the end of medical therapy. In 74.0% of patients no pituitary tumour was shown on MRI after surgery.
We have shown good surgical outcome in patients with acromegaly after pre-treatment with somatostatin analogue, and good tolerance and safety of the therapy, supporting the national recommendation for pre-surgical treatment with long-acting somatostatin analogues in acromegaly patients.
本研究旨在评估长效奥曲肽术前治疗肢端肥大症患者的疗效及安全性。
该项目在波兰的25个中心开展，是一项针对肢端肥大症患者的非干预性、多中心观察性研究，术前给予患者长效奥曲肽（善龙®）治疗。纳入研究的患者共148例，其中女性88例，男性60例，年龄18 - 86岁（51.3±13.4）。
80例患者完成研究（接受肿瘤手术）。病例报告表包括：基线访视、术前每三个月进行的4次随访以及术后每三个月进行的2次随访。每四周给予一次善龙®。疗效指标如下：生长激素（GH）和胰岛素样生长因子1（IGF - 1）水平的变化、达到治愈标准的患者数量以及治疗期间腺瘤（微腺瘤和大腺瘤）大小的变化。药物治疗结束时，分别有42.4%和49.1%的患者GH和IGF - 1浓度恢复正常。术后分别有77.9%和83.8%的患者GH和IGF - 1浓度恢复正常。药物治疗结束时，58.8%的微腺瘤患者和70%的大腺瘤患者腺瘤大小缩小。术后74.0%的患者MRI检查未显示垂体肿瘤。
我们已证明肢端肥大症患者经生长抑素类似物预处理后手术效果良好，且该治疗耐受性和安全性良好，支持在肢端肥大症患者中使用长效生长抑素类似物进行术前治疗的国家推荐。
