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使用兰瑞肽Autogel/长效注射剂治疗类癌综合征的患者报告结局:一项国际观察性研究。

Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study.

作者信息

Ruszniewski Philippe, Valle Juan W, Lombard-Bohas Catherine, Cuthbertson Daniel J, Perros Petros, Holubec Luboš, Delle Fave Gianfranco, Smith Denis, Niccoli Patricia, Maisonobe Pascal, Atlan Philippe, Caplin Martyn E

机构信息

Beaujon Hospital and Paris Diderot University, Clichy, France.

Institute of Cancer Studies, University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.

出版信息

Dig Liver Dis. 2016 May;48(5):552-558. doi: 10.1016/j.dld.2015.12.013. Epub 2016 Jan 15.

DOI:10.1016/j.dld.2015.12.013
PMID:26917486
Abstract

BACKGROUND

Lanreotide Autogel/Depot effectively controls symptoms in patients with carcinoid syndrome associated with neuroendocrine tumours. Data on patient-reported outcomes are sparse.

AIM

To evaluate the effect of lanreotide on patient-reported outcomes (PROs) with carcinoid syndrome.

METHODS

This was an international, open-label, observational study of adults with neuroendocrine tumours and history of diarrhoea, receiving lanreotide for >3 months for relief of carcinoid syndrome symptoms. The primary PRO measure was satisfaction with diarrhoea control. Secondary PRO measures included severity, change in symptoms and impact on daily life of diarrhoea; and patient satisfaction with flushing control.

RESULTS

Of 273 patients enrolled, 76% were 'completely' or 'rather' satisfied with diarrhoea control; 79% reported improvement in diarrhoea with lanreotide. The proportion of patients with 'mild', 'minimal', or 'no diarrhoea' increased from 33% before treatment to 75% during treatment; 75% were unconcerned about the impact of diarrhoea on daily life. Satisfaction with flushing control amongst patients with significant flushing at treatment initiation was 73%.

CONCLUSIONS

Lanreotide treatment was associated with improvements in symptoms as well as a range of PROs in patients with neuroendocrine tumours and carcinoid syndrome (ClinicalTrials.gov: NCT01234168).

摘要

背景

兰瑞肽长效注射剂/长效混悬剂可有效控制与神经内分泌肿瘤相关的类癌综合征患者的症状。关于患者报告结局的数据较少。

目的

评估兰瑞肽对类癌综合征患者报告结局(PROs)的影响。

方法

这是一项针对患有神经内分泌肿瘤且有腹泻病史的成年人的国际开放性观察性研究,这些患者接受兰瑞肽治疗超过3个月以缓解类癌综合征症状。主要的PRO指标是对腹泻控制的满意度。次要的PRO指标包括腹泻的严重程度、症状变化以及对日常生活的影响;以及患者对潮红控制的满意度。

结果

在纳入的273例患者中,76%对腹泻控制“完全”或“相当”满意;79%的患者报告使用兰瑞肽后腹泻有所改善。“轻度”、“轻微”或“无腹泻”的患者比例从治疗前的33%增至治疗期间的75%;75%的患者对腹泻对日常生活的影响不担心。治疗开始时存在明显潮红的患者对潮红控制的满意度为73%。

结论

兰瑞肽治疗与神经内分泌肿瘤和类癌综合征患者的症状改善以及一系列PROs改善相关(ClinicalTrials.gov:NCT01234168)。

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