A 12-month randomized crossover study on the effects of Lanreotide Autogel and Octreotide long-acting repeatable on GH and IGF-I in patients with acromegaly
A 12-month randomized crossover study on the effects of Lanreotide Autogel and Octreotide long-acting repeatable on GH and IGF-I in patients with acromegaly
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DOI：
10.1111/j.1365-2265.2007.03067.x
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发表时间：
2008-03-01
影响因子：
3.2
通讯作者：
Andersen, Marianne
中科院分区：
文献类型：
--
作者：
Andries, Magdalene;Glintborg, Dorte;Andersen, Marianne
背景生长抑素类似物已成功用于肢端肥大症的治疗，但尚无随机研究比较兰瑞肽Autogel（LAN）和醋酸奥曲肽长效可重复（OCT）的疗效目的采用随机对照研究方法，比较局部麻醉（LAN）和光学相干断层扫描（OCT）治疗肢端肥大症的疗效。然后在随机交叉设计中转换为相反的治疗方式6个月，没有洗脱期。GH和IGF-I谱，临床和生化评估进行0，4，6，10和12 months.Results治疗6个月后，5例患者GH水平< 0.38 μ g/L在两种疗法。其余患者在LAN和OCT治疗期间GH水平> 0.38 μ g/l。4例患者在两种治疗方案期间IGF-I水平均正常化。两名接受LAN治疗的患者和一名接受OCT治疗的患者在一次治疗期间IGF-I水平正常化，而在另一次治疗期间则没有。在3名患者中，IGF-I水平在两种治疗期间均升高。4例患者出现可触及结节，2例LAN患者和2例OCT患者。在两种治疗期间，3例患者出现胃肠道投诉，3例仅在LAN期间，1例仅在OCT期间。2例患者因LAN期间的严重不良反应而退出研究。结论LAN和OCT治疗对GH和IGF-I水平的影响相当，但3/10例患者的治疗效果不同，6/10例患者在LAN和OCT治疗期间有不同的副作用。这些结果表明，从LAN到OCT或反之亦然的变化可能是有益的，在一些患者的治疗失败或副作用。
Background Somatostatin analogues have been used successfully for the treatment of acromegaly but no randomized studies have compared the effects of lanreotide Autogel (LAN) and octreotide acetate long-acting repeatable (OCT).Objective To compare the effect of LAN and OCT for the treatment of acromegaly in a randomized study design.Materials and methods Twelve acromegalic patients were included and 10 patients completed treatment with LAN or OCT for 6 months and were then switched to the opposite treatment modality for 6 months without a washout period in a randomized crossover design. GH and IGF-I profiles, clinical and biochemical evaluations were performed at 0, 4, 6, 10 and 12 months.Results After 6 months of treatment, five patients had GH levels < 0.38 mu g/l during both therapies. The remaining patients had GH levels > 0.38 mu g/l during both LAN and OCT treatment. Four patients had normalized IGF-I levels during both treatment regimes. Two patients on LAN and one on OCT had normalized IGF-I levels during one treatment and not during the other. In three patients, IGF-I levels were elevated during both therapies. Four patients developed palpable nodules, two patients on LAN and two patients on OCT. Gastrointestinal complaints were seen in three patients during both therapies, in three patients only during LAN, and in one patient only during OCT. Two patients were withdrawn from the study because of serious adverse effects during LAN. After the study period, four patients preferred LAN and six patients preferred OCT treatment.Conclusion The effects of LAN and OCT therapy on GH and IGF-I levels were comparable, but 3/10 patients had different treatment efficacies and 6/10 had different side-effect profiles during the LAN and OCT treatment. These results indicate that a change from LAN to OCT or vice versa may be beneficial in some patients with treatment failure or side-effects.