Long-term safety and efficacy of depot long-acting somatostatin analogs for the treatment of acromegaly
Long-term safety and efficacy of depot long-acting somatostatin analogs for the treatment of acromegaly
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DOI：
10.1210/jc.2001-011913
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发表时间：
2002-09-01
影响因子：
5.8
通讯作者：
Sheppard, MC
中科院分区：
文献类型：
--
作者：
Ayuk, J;Stewart, SE;Sheppard, MC
Depot生长抑素类似物现在越来越多地被用作治疗肢端肥大症的辅助和主要治疗方法。以前的研究表明，它们既有效又安全，在50-65%的病例中将生长激素水平抑制在2微克/升以下，在65%的病例中使血清IGF-I水平正常化。然而，关于它们的长期有效性和安全性的公开数据很少。我们分析了22名患者(16名女性和6名男性)使用善得定LAR或兰瑞肽治疗的数据，平均治疗时间为41个月(范围12-)。3名患者之前接受了手术治疗，2名患者接受了放射治疗，7名患者同时接受了手术和放射治疗。10名患者接受了初级药物治疗。治疗前平均生长激素水平为13.1+/-3.4mug/L，胰岛素样生长因子-I水平为592.9+/-53.9mug/L。结果治疗12个月后，胰岛素样生长因子-I(321.9+/-33.9mug/L；P<；0.001)和生长激素(3.22+/-0.7umg/L；P<；0.0001)浓度明显下降，并持续到最近一次随访。使用生长激素标准(血清生长激素2杯/升)，46%的受试者在12个月后治愈，36%的受试者实现长期治愈。52%的人在12个月时达到正常的IGF-I值，67%的人长期达到正常水平。最近一次随访和12个月时的平均空腹和2小时血糖浓度与基线值相似。3名患者在治疗后12个月内出现糖耐量受损，1名患者发展为糖尿病。然而，有5名患者的葡萄糖耐量有所改善。5名患者在治疗过程中出现胆结石。综上所述，这项研究报告了仓库生长抑素类似物作为辅助或主要治疗的长期疗效。虽然总体糖耐量没有改变，但在生长激素水平没有改变的情况下，3名患者出现糖耐量受损，这突出了监测这些制剂的长期安全性的持续需要。
Depot somatostatin analogs are now increasingly being prescribed as adjuvant and primary therapy for the treatment of acromegaly. Previous studies have shown them to be both effective and safe, suppressing GH levels to less than 2 mug/liter in 50-65% of cases and normalizing serum IGF-I levels in 65%. However, published data on their long-term efficacy and safety is scanty. We analyzed data from 22 patients (16 female and 6 male) treated with Sandostatin LAR or Lanreotide for an average of 41 months (range 12-89). Three patients had previously been treated with surgery, two with radiotherapy, and seven with both. Ten patients had received primary medical therapy. Mean pretreatment GH levels were 13.1 +/- 3.4 mug/liter, and IGF-I levels were 592.9 +/- 53.9 mug/liter. Results after 12 months of therapy indicated reduction in GH (3.2 +/- 0.7 mug/liter; P < 0.0001) and IGF-I (321.9 +/- 33.9 mug/liter; P < 0.001) concentrations, and this was sustained at latest follow-up. Using GH criteria (serum GH < 2 mug/liter), 46% of subjects achieved a cure at 12 months, and 36% achieved a cure long-term. Fifty-two percent achieved normal IGF-I values at 12 months, and 67% long-term. Mean fasting and 2-h plasma glucose concentrations were similar at latest follow-up and at 12 months to baseline values. Three patients developed impaired glucose tolerance within 12 months of treatment, one going on to develop frank diabetes mellitus. However, glucose tolerance improved in five patients. Five patients developed gallstones while on treatment. In summary, this study reports the long-term efficacy of the depot somatostatin analogs as either adjuvant or primary therapy. Although overall glucose tolerance did not change, the development of impaired glucose tolerance in three patients at a time when GH levels were not changing highlights the ongoing need to monitor the long-term safety of these preparations.