Suppr超能文献

奥曲肽长效释放制剂与兰瑞肽缓释剂在肢端肥大症长期治疗中的比较。

A comparison between octreotide-LAR and lanreotide-SR in the chronic treatment of acromegaly.

作者信息

Cozzi R, Dallabonzana D, Attanasio R, Barausse M, Oppizzi G

机构信息

Division of Endocrinology, Niguarda Hospital, Milan, Italy.

出版信息

Eur J Endocrinol. 1999 Sep;141(3):267-71. doi: 10.1530/eje.0.1410267.

Abstract

BACKGROUND

At present long-acting somatostatin analogs represent the first-line medical treatment of acromegaly. These drugs produce stable suppression of GH in most sensitive patients and IGF-I normalization in many; they also increase the compliance of acromegalic patients. The recent availability of octreotide (OC)-LAR, a somatostatin analog to be administered at 28-day intervals, has prompted us to compare, in the same group of patients, its effects and those of another somatostatin analog already available, lanreotide-SR (LSR, to be administered at 14-day intervals).

PATIENTS

Twelve somatostatin analog-sensitive acromegalic patients with active disease were enrolled in a prospective open sequential study after giving their informed consent. After chronic treatment with LSR (6-24 months), the patients were changed to treatment with OC-LAR, without wash-out. LSR had been administered at individually tailored dosages (30 mg i.m. at 7-21-day intervals, median 10 days - every 7 days in seven patients, 10 days in two patients, 14 days in two patients and 21 days in one patient) according to GH and IGF-I responses. Disease stability was obtained, as shown by maximal GH/IGF-I suppression without any significant hormonal change between the last two control measurements. OC-LAR was administered i.m. at 28-day intervals six times at the dosage of 20 mg for the first three times and 10 or 30 mg for the last three times (according to individual GH/IGF-I responses). GH (mean of three, hourly samples) and IGF-I concentrations were evaluated on the same day as each administration of the drug, before its injection.

RESULTS

GH and IGF-I values were significantly decreased by LSR treatment. GH decreased from 41.6 +/- 14.6 microg/l (mean +/- s.e.) to 7.2 +/- 1.5 microg/l (P < 0.02), whereas IGF-I values declined from 959 +/- 95 microg/l to 460 +/- 61 microg/l (P < 0.00001), expressed as absolute values, and from 287 +/- 30% to 137 +/- 19% expressed as percentage of the upper limit of normal range (% ULNR). At the end of the last cycle, OC-LAR treatment achieved a significant further suppression both in GH (to 5.1 +/- 1.1 microg/l, P < 0.05 compared with LSR) and in IGF-I concentrations (to 374 +/- 60 microg/l, P<0.05 compared with LSR, and to 112 +/- 19% as % ULNR). LSR decreased GH concentrations to less than 2.5 microg/l in one patient and normalized IGF-I concentrations in four patients. OC-LAR decreased GH concentrations to less than 2.5 microg/l in four patients and normalized or near-normalized IGF-I concentrations (i.e. to < 110% ULNR) in eight patients.

CONCLUSIONS

These preliminary results show that the once-monthly OC-LAR administration schedule proved more efficacious than LSR given every 7-21 days, in a greater number of acromegalic patients.

摘要

背景

目前,长效生长抑素类似物是肢端肥大症的一线药物治疗方法。这些药物在大多数敏感患者中能稳定抑制生长激素(GH),并使许多患者的胰岛素样生长因子 -I(IGF-I)恢复正常;它们还提高了肢端肥大症患者的依从性。最近可获得的奥曲肽(OC)-LAR是一种每28天给药一次的生长抑素类似物,这促使我们在同一组患者中比较它与另一种已有的生长抑素类似物兰瑞肽缓释剂(LSR,每14天给药一次)的效果。

患者

12名对生长抑素类似物敏感且患有活动性疾病的肢端肥大症患者在签署知情同意书后参加了一项前瞻性开放序贯研究。在接受LSR慢性治疗(6 - 24个月)后,患者改为接受OC-LAR治疗,期间未进行洗脱期。根据GH和IGF-I的反应,LSR以个体化调整的剂量给药(30mg肌肉注射,间隔7 - 21天,中位数为10天 - 7名患者每7天一次,2名患者每10天一次,2名患者每14天一次,1名患者每21天一次)。达到了疾病稳定状态,表现为在最后两次对照测量之间GH/IGF-I达到最大抑制且激素无任何显著变化。OC-LAR每28天肌肉注射一次,共6次,前三次剂量为20mg,后三次剂量为10mg或30mg(根据个体GH/IGF-I反应)。在每次给药当天注射药物前评估GH(每小时3次采样的平均值)和IGF-I浓度。

结果

LSR治疗使GH和IGF-I值显著降低。GH从41.6 +/- 14.6μg/l(平均值 +/- 标准误)降至7.2 +/- 1.5μg/l(P < 0.02),而IGF-I值从959 +/- 95μg/l降至460 +/- 61μg/l(P < 0.00001),以绝对值表示,从正常范围上限的287 +/- 30%降至137 +/- 19%(以正常范围上限的百分比表示,% ULNR)。在最后一个周期结束时,OC-LAR治疗在GH(降至5.1 +/- 1.1μg/l,与LSR相比P < 0.05)和IGF-I浓度(降至374 +/- 60μg/l,与LSR相比P < 0.05,以% ULNR表示为112 +/- 19%)方面均实现了进一步的显著抑制。LSR使1名患者的GH浓度降至低于2.5μg/l,4名患者的IGF-I浓度恢复正常。OC-LAR使4名患者的GH浓度降至低于2.5μg/l,8名患者的IGF-I浓度恢复正常或接近正常(即< 110% ULNR)。

结论

这些初步结果表明,对于更多的肢端肥大症患者,每月一次的OC-LAR给药方案比每7 - 21天给药一次的LSR更有效。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验