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西班牙肢端肥大症患者聚乙二醇化奥曲肽治疗依从性研究(PEGASO 研究)。

Treatment adherence to pegvisomant in patients with acromegaly in Spain: PEGASO study.

机构信息

Hospital Universitario y Politécnico La Fe, Avenida de Fernando Abril Martorell, 106, 46026, Valencia, Spain.

Hospital Universitario Virgen del Rocío, Avenida Manuel Siurot, s/n, 41013, Sevilla, Spain.

出版信息

Pituitary. 2019 Apr;22(2):137-145. doi: 10.1007/s11102-019-00943-1.

DOI:10.1007/s11102-019-00943-1
PMID:30756345
Abstract

PURPOSE

The burden of chronic daily subcutaneous administration of pegvisomant on adherence has not been previously studied. This study was aimed to determine the adherence to pegvisomant treatment in acromegaly patients in the real-world clinical practice setting in Spain.

METHODS

Multicenter, observational, descriptive, cross-sectional study in patients with acromegaly treated with pegvisomant for at least 12 months. Patient adherence was indirectly determined by Batalla and Haynes-Sackett questionnaires and directly by prescription record review. Additionally, treatment satisfaction was assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) and treatment convenience by an ad-hoc Pegvisomant questionnaire. Errors in reconstitution and administration process were determined by direct observation.

RESULTS

108 patients were included in the analysis. Rates of adherence varied from 60.7 to 92.1% and did not correlate with disease control. Older patient age and alternative schedules other than daily pegvisomant dosing were associated with lower adherence. Treatment satisfaction and convenience was high, with a mean (SD) total SATMED-Q score of 74.6 ± 15.4 over 100 and a total ad-hoc Pegvisomant questionnaire score of 71.2 ± 15.2 over 100. 34.3% of patients made mistakes during the reconstitution /administration process.

CONCLUSIONS

Patient adherence to pegvisomant was high (60.7-92.1%), but more than a third of the patients in the study made mistakes during the administration process, with a potential impact on disease control. Besides dosing compliance, correct administration of medication should be carefully assessed in these patients.

摘要

目的

慢性每日皮下给予培维索孟给患者带来的负担对依从性的影响尚未被研究过。本研究旨在确定西班牙真实临床实践环境中接受培维索孟治疗的肢端肥大症患者的依从性。

方法

这是一项多中心、观察性、描述性、横断面研究,纳入至少接受 12 个月培维索孟治疗的肢端肥大症患者。通过 Batalla 和 Haynes-Sackett 问卷以及处方记录审查来间接确定患者的依从性,同时通过治疗满意度用药问卷(SATMED-Q)和培维索孟专用问卷评估治疗便利性。通过直接观察确定在药物复溶和给药过程中的错误。

结果

共纳入 108 例患者进行分析。依从率从 60.7%到 92.1%不等,且与疾病控制无关。患者年龄较大和采用除每日培维索孟剂量以外的其他替代方案与依从性较低相关。治疗满意度和便利性高,SATMED-Q 总评分的平均(标准差)为 74.6±15.4 分(满分 100 分),培维索孟专用问卷总评分的平均(标准差)为 71.2±15.2 分(满分 100 分)。34.3%的患者在复溶/给药过程中出错。

结论

患者对培维索孟的依从性较高(60.7%-92.1%),但研究中有超过三分之一的患者在给药过程中出现错误,这可能对疾病控制产生影响。除了剂量依从性外,还应仔细评估这些患者药物的正确使用情况。

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