Morange I, De Boisvilliers F, Chanson P, Lucas B, DeWailly D, Catus F, Thomas F, Jaquet P
Department of Endocrinology and CNRS U-9941, Marseilles, France.
J Clin Endocrinol Metab. 1994 Jul;79(1):145-51. doi: 10.1210/jcem.79.1.8027218.
Several clinical studies reported the efficacy of the long-acting SRIH analog, octreotide (Octreotide, Sandoz) in the treatment of acromegaly. Recently, another SRIH analog (BIM 23014, Ipsen Biotech) was shown to decrease plasma GH levels in acromegalic patients. The recent availability of a long-acting formulation of BIM 23014 [slow release (SR) lanreotide] could avoid the inconveniences associated with either repeated sc injections or continuous sc infusions. In this study, we compared the clinical and biochemical efficacies of both drugs in a cohort of 19 acromegalic patients, considered initially as responsive to octreotide and sequentially treated with octreotide (3 sc injections of 100-200 micrograms/day) for 12 months and with SR lanreotide (30 mg, im, every 10 or 14 days) for 6 months. Before octreotide treatment, baseline plasma GH (mean +/- SE of 8 hourly samplings) was 29.0 +/- 10.0 micrograms/L and was lowered to 3.2 +/- .2 micrograms/L during the first 7 h after the first 100-micrograms sc octreotide administration. After 12 months of treatment with octreotide, 14 of 19 patients (74%) were considered normalized, as their mean individual GH profiles and insulin-like growth factor-I (IGF-I) values were within the normal range. After octreotide withdrawal for 1 week, plasma GH and IGF-I levels rose to 18.3 +/- 4.8 and 4.1 +/- 0.4 U/mL, respectively. The first 30-mg SR lanreotide im injection produced an acute suppression of plasma GH levels (mean GH value during the 7 h after the injection, 3.0 +/- 0.4 micrograms/L), not different from results previously observed after the first octreotide injection. After 3 months of treatment with 30 mg SR lanreotide every 14 days, normalization of baseline GH and IGF1 levels was achieved in 6 of 19 patients. Ten patients, who did not achieve normal GH levels, subsequently received a 30-mg SR lanreotide injection every 10 days. Among them, normalization of GH and IGF-I levels occurred in 7 of 10 patients after 3 months of such a regimen. After 6 months of SR lanreotide treatment, 13 of 19 patients (68%) were considered normalized, with mean GH and IGF-I values, respectively, of 3.1 +/- 0.4 micrograms/L and 1.5 +/- 0.1 U/mL. The overall tolerance of both drugs (glucose homeostasis and gallstone formation) was similar.(ABSTRACT TRUNCATED AT 400 WORDS)
多项临床研究报告了长效生长抑素释放抑制激素（SRIH）类似物奥曲肽（善得定，山德士公司生产）治疗肢端肥大症的疗效。最近，另一种SRIH类似物（BIM 23014，益普生生物技术公司生产）被证明可降低肢端肥大症患者的血浆生长激素（GH）水平。BIM 23014长效制剂[缓释（SR）兰瑞肽]的近期问世，可避免重复皮下注射或持续皮下输注带来的不便。在本研究中，我们比较了这两种药物对19例肢端肥大症患者的临床和生化疗效，这些患者最初被认为对奥曲肽有反应，先接受奥曲肽（每日3次皮下注射，每次100 - 200微克）治疗12个月，随后接受SR兰瑞肽（30毫克，肌肉注射，每10或14天1次）治疗6个月。在奥曲肽治疗前，基线血浆GH（8次每小时采样的平均值±标准误）为29.0±10.0微克/升，在首次皮下注射100微克奥曲肽后的最初7小时内降至3.2±0.2微克/升。用奥曲肽治疗12个月后，19例患者中有14例（74%）被认为已正常化，因为他们的个体平均GH谱和胰岛素样生长因子 - I（IGF - I）值在正常范围内。在停用奥曲肽1周后，血浆GH和IGF - I水平分别升至18.3±4.8和4.1±0.4 U/mL。首次肌肉注射30毫克SR兰瑞肽可使血浆GH水平急性降低（注射后7小时内的平均GH值为3.0±0.4微克/升），与首次注射奥曲肽后的结果无差异。每14天用30毫克SR兰瑞肽治疗3个月后，19例患者中有6例实现了基线GH和IGF1水平正常化。10例未达到正常GH水平的患者随后每10天接受一次30毫克SR兰瑞肽注射。在这样的治疗方案3个月后，其中10例患者中有7例实现了GH和IGF - I水平正常化。SR兰瑞肽治疗6个月后，19例患者中有13例（68%）被认为已正常化，平均GH和IGF - I值分别为3.1±0.4微克/升和1.5±0.1 U/mL。两种药物的总体耐受性（葡萄糖稳态和胆结石形成）相似。（摘要截取自400字）
