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一项为期 6 个月、前瞻性、观察性研究,旨在评估拉丁美洲勃起功能障碍男性使用 PDE5 抑制剂的治疗持久性和依从性。

A 6 month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Latin American men with erectile dysfunction.

机构信息

Asociación Mexicana para la Salud Sexual, AC (AMSSAC), Mexico City, Mexico.

出版信息

Curr Med Res Opin. 2013 Jun;29(6):695-706. doi: 10.1185/03007995.2013.791262. Epub 2013 Apr 16.

DOI:10.1185/03007995.2013.791262
PMID:23540375
Abstract

OBJECTIVES

To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence.

METHODS

Men from Brazil, Mexico, and Venezuela with ED who were naïve to PDE5Is were prescribed sildenafil, tadalafil, vardenafil, or lodenafil on-demand dosing and asked to provide information about PDE5I use at baseline and at 1, 3, and 6 months. Patients were persistent if they used ≥1 dose during the 4 week period prior to each evaluation. Patients were adherent if they complied with dosing instructions during most recent dose. Main outcome measures included Persistence and Adherence Questionnaire (PAQ), Partner Relationship Questionnaire (PRQ), Self-Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence and adherence.

RESULTS

A total of 511 men were enrolled; most had mild to moderate ED (77.1%); 317 patients (62.0%) were prescribed tadalafil, 116 (22.7%) sildenafil, 75 (14.7%) vardenafil, and 3 (0.6%) lodenafil (not further analyzed). A total of 340 patients (66.5%) were 'persistent' at 6 months; 345 (67.5%) were 'adherent'. Persistence and adherence were associated with age, education level, and ED duration. Reasons for non-persistence included medication cost and lack of efficacy. Study limitations included its design, brief observation period, its bias observed toward tadalafil selection; its dependence on patient self-reporting, limited number of factors that were analyzed for persistence/adherence association, its small number of participating patients and Latin American countries, and inherent differences in PDE5I preference and medical practices.

CONCLUSION

Approximately two-thirds of PDE5I-naïve, Latin American men with ED were persistent and adherent after 6 months of therapy. Factors like education level, ED severity, and ED duration were associated with persistence and adherence; additional study is warranted to investigate the predictive value of these factors.

摘要

目的

评估磷酸二酯酶 5 抑制剂(PDE5I)按需剂量在拉丁美洲勃起功能障碍(ED)男性中的持续/依从率,并探讨可能预测 PDE5I 持续和依从性的患者特征和治疗因素。

方法

来自巴西、墨西哥和委内瑞拉的 PDE5I 初治 ED 男性接受按需给予西地那非、他达拉非、伐地那非或洛地那非治疗,并在基线和 1、3 和 6 个月时提供 PDE5I 使用信息。如果患者在每次评估前的 4 周内使用≥1 剂,则认为其具有持续性。如果患者在最近一次剂量时遵守了剂量说明,则认为其具有依从性。主要结局指标包括:持续/依从性问卷(PAQ)、伴侣关系问卷(PRQ)、自尊和关系问卷(SEAR)和国际勃起功能指数(IIEF)。采用多变量逻辑回归来确定与持续和依从性相关的因素。

结果

共纳入 511 名男性;大多数患者 ED 为轻度至中度(77.1%);317 名患者(62.0%)被处方他达拉非,116 名(22.7%)西地那非,75 名(14.7%)伐地那非,3 名(0.6%)洛地那非(未进一步分析)。共有 340 名患者(66.5%)在 6 个月时为“持续”;345 名患者(67.5%)为“依从”。持续和依从性与年龄、教育水平和 ED 持续时间相关。非持续的原因包括药物费用和缺乏疗效。研究局限性包括其设计、观察期短、对他达拉非选择的观察偏倚、对患者自我报告的依赖、对持续/依从性关联进行分析的因素有限、参与患者和拉丁美洲国家数量较少,以及 PDE5I 偏好和医疗实践的固有差异。

结论

大约三分之二的 PDE5I 初治、拉丁美洲 ED 男性在治疗 6 个月后具有持续性和依从性。教育水平、ED 严重程度和 ED 持续时间等因素与持续和依从性相关;需要进一步研究以探讨这些因素的预测价值。

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