Clinical experience with Andriol® Testocaps® -: The first Austrian surveillance study on the treatment of late-onset hypogonadism
Clinical experience with Andriol® Testocaps® -: The first Austrian surveillance study on the treatment of late-onset hypogonadism
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DOI：
10.1080/13685530701495088
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发表时间：
2007-12-01
期刊：
影响因子：
2.6
通讯作者：
Geurts, Paul
中科院分区：
文献类型：
--
作者：
Jungwirth, Andreas;Plas, Eugen;Geurts, Paul
客观的。本研究的目的是在临床实践中记录新制剂 Andriol(R) Testocaps(R) 在治疗迟发性性腺功能减退症中的功效和耐受性。方法。主要纳入标准是有症状的睾酮缺乏，经两次实验室检测（早晨总睾酮<12 mnol/L）证实。该研究在奥地利 43 个中心进行，口服十一酸睾酮剂量为 2 x 80 毫克/天，为期三个月。 ADAM 问卷、AMS 量表和 SF-36 问卷由患者进行，并向处方者提出具体问题。结果。共完成189份患者报告表和185份医生报告表。参与者的平均年龄为 54.7 +/- 12.3 岁，平均治疗持续时间为 13.9 +/- 2.2 周。血清睾酮水平增加超过 50%，从 8.7 +/- 4.3 nmol/L 增加到 13.2 +/- 6.7 nmol/L (p < 0.001)。治疗改善了 ADAM 和 AMS 量表的症状，但 SF-36 未观察到任何变化。对血清PSA水平没有显着影响。结论。在临床实践中，口服十一酸睾酮短期治疗可改善睾酮水平低下的老年男性的迟发性性腺功能减退症症状。
Objective. The objective of this study was to document the efficacy and tolerability of the new formulation of Andriol(R) Testocaps(R) in the treatment of late-onset hypogonadism in a clinical practice setting.Methods. The primary inclusion criterion was symptomatic testosterone deficiency, as confirmed by laboratory testing (morning total testosterone < 12 mnol/L) on two separate occasions. The study was performed in 43 centres in Austria and a dosage of oral testosterone undecanoate of 2 x 80 mg/day was used for three months. The ADAM questionnaire, the AMS scale and the SF-36 questionnaire were administered by the patients and specific questions were asked to the prescribers.Results. A total of 189 patient report forms and 185 doctor report forms were completed. The average age of the participants was 54.7 +/- 12.3 years and average treatment duration was 13.9 +/- 2.2 weeks. Serum testosterone level increased by more than 50% from 8.7 +/- 4.3 nmol/L to 13.2 +/- 6.7 nmol/L (p < 0.001). Treatment improved symptoms on the ADAM and AMS scales, whereas no changes were observed on the SF-36. There were no significant effects on serum PSA levels.Conclusion. Short-term treatment with oral testosterone undecanoate in a clinical practice setting improved late-onset hypogonadism symptoms in aging men with low testosterone levels.