Caron Philippe, Cogne Muriel, Raingeard Isabelle, Bex-Bachellerie Véronique, Kuhn Jean Marc
Department of Endocrinology, CHU Toulouse, France.
Clin Endocrinol (Oxf). 2006 Feb;64(2):209-14. doi: 10.1111/j.1365-2265.2006.02450.x.
During short-term treatment, monthly subcutaneous injections of lanreotide Autogel are effective in controlling GH/IGF-1 hypersecretion and are well tolerated in patients with acromegaly. This study reports the effectiveness and the tolerability of lanreotide Autogel for at least 3 years in acromegalic patients.
Fourteen patients (nine females, five males) were treated with titrated doses of lanreotide Autogel.
This clinical study was an extension of a previous trial. After three fixed-dose lanreotide Autogel injections, treatment was adjusted according to mean GH and IGF-I levels. After 3 years of treatment, patients were receiving 120 (n=7), 90 (n=2) and 60 mg (n=4) monthly injections of lanreotide Autogel.
Acromegalic symptoms, GH and IGF-1 concentrations were analysed at the end of lanreotide microparticle treatment, and after 4, 8, 12, 24, 30 and 36 months of lanreotide Autogel therapy. Tolerance and side-effects were monitored throughout the 3-year study. RESULTS Hormonal control (GH <or= 2.5 microg/l and age- and sex-normalized IGF-1) was achieved in six (46%) patients. With the exception of an unrelated death due to pulmonary embolism, no patient withdrew from study. The number of patients reporting digestive adverse events was seven (12 episodes) for the fixed-dose period, and four (eight episodes), two (six episodes) and one (three episodes) at the end of the first, second and third year of treatment, respectively. Persistent induration at the injection sites was reported by two patients, and histological findings were consistent with benign injection-site granulomas. New cholelithiasis or sludge occurred in five (35%) patients during the lanreotide Autogel treatment.
This 3-year study shows that lanreotide Autogel is effective in controlling GH/IGF-1 hypersecretion and is well tolerated during long-term treatment of patients with acromegaly.
在短期治疗中，每月皮下注射兰瑞肽缓释凝胶对控制肢端肥大症患者的生长激素（GH）/胰岛素样生长因子-1（IGF-1）分泌过多有效且耐受性良好。本研究报告了兰瑞肽缓释凝胶在肢端肥大症患者中至少3年的有效性和耐受性。
14例患者（9例女性，5例男性）接受了滴定剂量的兰瑞肽缓释凝胶治疗。
本临床研究是先前一项试验的延续。在进行三次固定剂量的兰瑞肽缓释凝胶注射后，根据平均GH和IGF-I水平调整治疗方案。治疗3年后，患者分别接受每月120mg（n = 7）、90mg（n = 2）和60mg（n = 4）的兰瑞肽缓释凝胶注射。
在兰瑞肽微粒治疗结束时以及兰瑞肽缓释凝胶治疗4、8、12、24、30和36个月后，分析肢端肥大症症状、GH和IGF-1浓度。在整个3年的研究中监测耐受性和副作用。结果6例（46%）患者实现了激素控制（GH≤2.5μg/L且IGF-1经年龄和性别校正）。除1例因肺栓塞导致的无关死亡外，无患者退出研究。在固定剂量期，报告有消化不良事件的患者有7例（12次发作），在治疗的第一、第二和第三年末分别为4例（8次发作）、2例（6次发作）和1例（3次发作）。2例患者报告注射部位持续硬结，组织学检查结果与良性注射部位肉芽肿一致。在兰瑞肽缓释凝胶治疗期间，5例（35%）患者出现了新的胆结石或胆泥。
这项为期3年的研究表明，兰瑞肽缓释凝胶在控制肢端肥大症患者的GH/IGF-1分泌过多方面有效，且在长期治疗中耐受性良好。
