Parker S, Armitage M
Diabetes and Endocrine Unit, Royal Bournemouth Hospital, UK.
Clin Endocrinol (Oxf). 1999 Jan;50(1):57-62. doi: 10.1046/j.1365-2265.1999.00596.x.
None of the existing options for long-term testosterone replacement therapy (TRT) for hypogonadal men are ideal. Depot replacement at frequent intervals and implants are effective but invasive and inconvenient for the patient. Oral therapy results in poor hormone levels. Both are associated with undesirable metabolic changes. A transdermal formulation therefore represents a potential therapeutic advance for testosterone replacement.
To carry out a clinical audit of the acceptability and efficacy as a treatment for hypogonadism of the first transdermal testosterone therapy available in the UK (Andropatch, SmithKline Beecham) compared with existing androgen replacement options.
Serum testosterone and questionnaire data on treatment efficacy, side-effects, therapy preference, sexual dysfunction and partner's attitudes to therapy were obtained from 50 hypogonadal men prescribed long-term testosterone replacement.
Eighty per cent of the men returned analysable questionnaires. Eighty-four per cent experienced adverse effects with transdermal therapy, most commonly dermatological problems; 22% of the sample elected to continue with transdermal therapy, 72% returned to depot and 5% returned to oral therapy. The reservoir patches were judged to be too large, uncomfortable, visually obtrusive and noisy. Testosterone levels were comparable to those obtained with depot replacement with the added advantage of a more physiological pharmacokinetic profile. Men taking oral preparations were consistently under-replaced.
Adverse events were substantially higher than reported from clinical trials but in keeping with the spectrum of yellow card reports received by the Committee on Safety of Medicines. The pharmacokinetic advantages are thus largely outweighed by low patient acceptability. In its present form transdermal therapy remains an expensive option for those who cannot tolerate depot testosterone replacement.
对于性腺功能减退男性的长期睾酮替代疗法（TRT），现有的方法都不理想。频繁进行长效制剂替换和植入法虽有效，但具有侵入性，给患者带来不便。口服疗法导致激素水平不佳。这两种方法都伴有不良的代谢变化。因此，透皮制剂代表了睾酮替代疗法的一个潜在治疗进展。
对英国现有的第一种透皮睾酮疗法（安德罗贴片，史克必成公司）作为性腺功能减退治疗方法的可接受性和疗效进行临床审核，并与现有的雄激素替代方法进行比较。
从50名接受长期睾酮替代治疗的性腺功能减退男性中获取血清睾酮以及关于治疗效果、副作用、治疗偏好、性功能障碍和伴侣对治疗态度的问卷调查数据。
80%的男性返回了可分析的问卷。84%的人在透皮治疗中出现不良反应，最常见的是皮肤问题；22%的样本选择继续接受透皮治疗，72%的人恢复使用长效制剂，5%的人恢复口服治疗。储库贴片被认为太大、不舒服、在视觉上引人注目且有噪音。睾酮水平与长效制剂替换相当，且具有更符合生理的药代动力学特征这一额外优势。服用口服制剂的男性始终存在替代不足的情况。
不良事件显著高于临床试验报告，但与药品安全委员会收到的黄卡报告范围相符。因此，药代动力学优势在很大程度上被患者可接受性低所抵消。就目前形式而言，对于无法耐受长效睾酮替代疗法的人来说，透皮疗法仍然是一种昂贵的选择。
