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接受过睾酮治疗的男性对十一酸睾酮口服制剂的满意度:一项开放标签、单中心临床试验

Patient Satisfaction with Oral Testosterone Undecanoate in Men Who Received Prior Testosterone Therapy: An Open-Label, Single-Center Clinical Trial.

作者信息

Rivero Marco-Jose, Reddy Rohit, Muthigi Akhil, Reddy Raghuram, Han Sunwoo, Reis Isildinha M, Patel Mehul, Ramasamy Ranjith

机构信息

Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL, USA.

Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA.

出版信息

World J Mens Health. 2024 Oct;42(4):762-771. doi: 10.5534/wjmh.230164. Epub 2024 Jan 2.

Abstract

PURPOSE

To evaluate patient satisfaction and symptom control in hypogonadal men transitioning from other testosterone therapies to oral testosterone undecanoate (TU).

MATERIALS AND METHODS

In this open-label clinical trial, men aged 18 to 75 years with hypogonadism were switched to oral TU after a sufficient washout of previous testosterone therapies. Treatment satisfaction and symptom control were primarily measured using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) and quantitative androgen deficiency in aging males (qADAM) questionnaires, respectively. Secondary outcomes included changes in serum testosterone (T), estradiol (E2), hematocrit (HCT), and prostate-specific antigen (PSA) levels.

RESULTS

Forty-one men participated, with significant improvements in all TSQM-9 scores observed over 6 months. Symptom control as measured by qADAM remained consistent. There was a significant increase in serum T and E2 levels, but HCT and PSA levels remained stable.

CONCLUSIONS

Switching to oral TU from other testosterone therapies is associated with increased patient satisfaction and stable hypogonadal symptom control.

摘要

目的

评估性腺功能减退男性从其他睾酮疗法转换为口服十一酸睾酮(TU)后的患者满意度和症状控制情况。

材料与方法

在这项开放标签临床试验中,年龄在18至75岁的性腺功能减退男性在充分洗脱先前的睾酮疗法后改用口服TU。治疗满意度和症状控制主要分别使用9项药物治疗满意度问卷(TSQM - 9)和老年男性定量雄激素缺乏(qADAM)问卷进行测量。次要结局包括血清睾酮(T)、雌二醇(E2)、血细胞比容(HCT)和前列腺特异性抗原(PSA)水平的变化。

结果

41名男性参与,在6个月内观察到所有TSQM - 9评分均有显著改善。通过qADAM测量的症状控制保持一致。血清T和E2水平显著升高,但HCT和PSA水平保持稳定。

结论

从其他睾酮疗法转换为口服TU与患者满意度提高和性腺功能减退症状控制稳定相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aba2/11439809/c303aa10191c/wjmh-42-762-g001.jpg

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