Mercado Moises, Borges Fatima, Bouterfa Hakim, Chang Tien-Chun, Chervin Alberto, Farrall Andrew J, Patocs Attila, Petersenn Stephan, Podoba Jan, Safari Mitra, Wardlaw Joanna
Hospital de Especialidades, Centro Medico Nacional Siglo XXI, IMSS, Mexico City, Mexico.
Clin Endocrinol (Oxf). 2007 Jun;66(6):859-68. doi: 10.1111/j.1365-2265.2007.02825.x. Epub 2007 Apr 25.
To evaluate the efficacy, safety and tolerability of octreotide LAR (long-acting repeatable octreotide) in the primary therapy of acromegaly.
Ninety-eight previously untreated acromegalics were recruited into this prospective multicentre study. A total of 68 patients successfully completed 48 weeks of the study period, received 12 doses of octreotide LAR 10-30 mg every 4 weeks, and constituted the population used for this analysis.
A clinically relevant reduction (i.e. to < or = 5 microg/l) in mean GH (mGH) was recorded in 72% of patients after 24 weeks of treatment, and 42% reached a 'safe' GH value (< or = 2.5 microg/l). At week 48, 16 more patients were considered partial GH responders (GH > 2.5 microg/l and < or = 5 microg/l) and 44% had reached a GH level < or = 2.5 microg/l. IGF-1 levels normalized in 38% and 34% of patients after 24 and 48 weeks of treatment, respectively. At study completion, 10 patients (14.7%) who had not normalized their IGF-1 levels had achieved at least a 50% decrement in this marker. In eight microadenoma patients, tumour volume decreased from a mean baseline level of 298 +/- 145 mm3 to 139 +/- 94 mm3 after 24 weeks and to 99 +/- 70 mm3 after 48 weeks of therapy. In 60 patients with macroadenoma, the corresponding values were 3885 +/- 5077 mm3 at baseline and 2723 +/- 3435 and 2406 +/- 3207 mm3 after 24 and 48 weeks, respectively. At weeks 24 and 48, a significant (> 20%) tumour volume reduction was reported in 63% and 75% of patients, respectively. A reduction in the severity of symptoms of acromegaly was observed early in treatment and was maintained throughout the study period.
Octreotide LAR represents a viable alternative to surgery for primary treatment of acromegaly leading to a progressive regression of tumour volume, a sustained control of biochemical abnormalities and an adequate relief of symptoms of the disease.
评估长效可重复注射用奥曲肽（octreotide LAR）在肢端肥大症初始治疗中的疗效、安全性和耐受性。
98例既往未接受过治疗的肢端肥大症患者被纳入这项前瞻性多中心研究。共有68例患者成功完成了48周的研究期，每4周接受12剂10 - 30 mg的长效可重复注射用奥曲肽，这些患者构成了本次分析的研究对象。
治疗24周后，72%的患者平均生长激素（mGH）水平出现具有临床意义的降低（即降至≤5μg/L），42%的患者达到“安全”的生长激素水平（≤2.5μg/L）。在第48周时，又有16例患者被视为部分生长激素反应者（生长激素>2.5μg/L且≤5μg/L），44%的患者生长激素水平降至≤2.5μg/L。治疗24周和48周后，分别有38%和34%的患者胰岛素样生长因子-1（IGF-1）水平恢复正常。研究结束时，10例IGF-1水平未恢复正常的患者该指标至少下降了50%。在8例微腺瘤患者中，治疗24周后肿瘤体积从平均基线水平298±145mm³降至139±94mm³，48周后降至99±70mm³。在60例大腺瘤患者中，基线时相应值为3885±5077mm³,治疗24周和48周后分别为2723±3435mm³和2406±3207mm³。在第24周和48周时，分别有63%和75%的患者报告肿瘤体积显著缩小（>20%）。肢端肥大症症状的严重程度在治疗早期即出现减轻，并在整个研究期间持续存在。
长效可重复注射用奥曲肽是肢端肥大症初始治疗中手术的可行替代方案，可使肿瘤体积逐渐缩小，持续控制生化异常，并充分缓解疾病症状。
