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在临床实践中,兰瑞肽与卡麦角林或培维索孟联合用于肢端肥大症患者:ACROCOMB研究。

Use of lanreotide in combination with cabergoline or pegvisomant in patients with acromegaly in the clinical practice: The ACROCOMB study.

作者信息

Puig-Domingo Manuel, Soto Alfonso, Venegas Eva, Vilchez Ricardo, Blanco Concepción, Cordido Fernando, Lucas Tomás, Marazuela Mónica, Casany Rosa, Cuatrecasas Guillem, Fajardo Carmen, Gálvez María Ángeles, Maraver Silvia, Martín Tomás, Romero Enrique, Paja Miguel, Picó Antonio, Bernabeu Ignacio, Resmini Eugenia

机构信息

Hospital Universitario Germans Trias i Pujol, Carretera Canyet, s/n 08916 Badalona, Barcelona, Spain.

Hospital Universitario Virgen del Rocío, Av Manuel Siurot, 0, 41013 Sevilla, Spain.

出版信息

Endocrinol Nutr. 2016 Oct;63(8):397-408. doi: 10.1016/j.endonu.2016.05.010. Epub 2016 Jul 20.

Abstract

PURPOSE

To describe real-world use of lanreotide combination therapy for acromegaly.

PATIENTS AND METHODS

ACROCOMB is a retrospective observational Spanish study of patients with active acromegaly treated with lanreotide combination therapy between 2006 and 2011. 108 patients treated at 44 Spanish Endocrinology Departments were analyzed separately: 61 patients received lanreotide/cabergoline (cabergoline cohort) and 47 lanreotide/pegvisomant (pegvisomant cohort).

RESULTS

Patient median age was 50.8 years in the cabergoline cohort and 42.7 years in the pegvisomant cohort. Prior medical treatments were somatostatin analogue (SSA) monotherapy (40 [66%] patients) or dopamine agonists (7 [11%] patients) in the cabergoline cohort and SSA (29 [62%] patients) or pegvisomant monotherapy (16 [34%] patients) in the pegvisomant cohort. Across both cohorts 12 patients were previously untreated, and prior therapy was unknown/missing in 4 patients. Median duration of combined treatment was 1.6 years (0.1-6) and 2.1 years (0.4-6.3) in the cabergoline and pegvisomant cohorts, respectively. At baseline, median insulin growth factor (IGF)-I values were 149% upper limit of normal (ULN) (15-505%) in the cabergoline cohort and 156% ULN (15-534%) in the pegvisomant cohort, and decreased to 104% ULN (13-557%) p<0.001 and 86% ULN (23-345%) p<0.0001, respectively, at end of study (EOS). Normal age-adjusted values of IGF-I were obtained in 48% of lanreotide/cabergoline-treated patients and 70% of lanreotide/pegvisomant-treated patients at EOS. There were no significant changes in hepatic, cardiac or glycaemic parameters in either cohort.

CONCLUSION

In clinical practice lanreotide treatment combinations are useful options for patients with acromegaly when monotherapy is insufficient; particularly, the combination of lanreotide and pegvisomant in patients not controlled with either SSA or pegvisomant alone has high efficacy and is well-tolerated.

摘要

目的

描述兰瑞肽联合疗法在肢端肥大症实际临床中的应用情况。

患者与方法

ACROCOMB研究是一项回顾性观察性西班牙研究,纳入了2006年至2011年间接受兰瑞肽联合疗法治疗的活动性肢端肥大症患者。对西班牙44个内分泌科治疗的108例患者进行了单独分析:61例患者接受兰瑞肽/卡麦角林治疗(卡麦角林队列),47例患者接受兰瑞肽/培维索孟治疗(培维索孟队列)。

结果

卡麦角林队列患者的中位年龄为50.8岁,培维索孟队列患者的中位年龄为42.7岁。在卡麦角林队列中,既往治疗方式为生长抑素类似物(SSA)单药治疗(40例[66%])或多巴胺激动剂治疗(7例[11%]);在培维索孟队列中,既往治疗方式为SSA治疗(29例[62%])或培维索孟单药治疗(16例[34%])。两个队列共有12例患者既往未接受过治疗,4例患者既往治疗情况未知或缺失。卡麦角林队列和培维索孟队列联合治疗的中位持续时间分别为1.6年(0.1 - 6年)和2.1年(0.4 - 6.3年)。基线时,卡麦角林队列胰岛素生长因子(IGF)-I值的中位数为正常上限(ULN)的149%(15 - 505%),培维索孟队列IGF-I值的中位数为ULN的156%(15 - 534%);研究结束时(EOS),分别降至ULN的104%(13 - 至557%)(p<0.001)和86% ULN(23 - 345%)(p<0.0001)。EOS时,48%接受兰瑞肽/卡麦角林治疗的患者和70%接受兰瑞肽/培维索孟治疗的患者获得了年龄校正后的IGF-I正常数值。两个队列的肝脏、心脏或血糖参数均无显著变化。

结论

在临床实践中,当单药治疗不足时,兰瑞肽联合治疗方案是肢端肥大症患者的有效选择;特别是,对于单独使用SSA或培维索孟均无法控制病情的患者,兰瑞肽与培维索孟联合使用具有高效性且耐受性良好。

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