Gresser Ursula, Gleiter C H
Praxisklinik Sauerlach, Internal Medicine, Tegernseer Landstr. 8, D-82054 Sauerlach, Germany.
Eur J Med Res. 2002 Oct 29;7(10):435-46.
Since introduction of the PDE-5 inhibitor sildenafil 4 years ago, there has been a fundamental change in the treatment of erectile dysfunction (ED). Intracavernosal or intraurethral injections of vasoactive substances or penile implants as mechanical aids now play hardly any part in it. - The development of the PDE-5 inhibitors vardenafil and tadalafil prompts the question of whether and how these three substances differ in terms of their efficacy and adverse effects. - Sildenafil has proven to be a very effective medicinal product. Studies with a follow-up period of up to 6 years have been conducted. The success rate of sildenafil varies in the group of ED patients with an organic underlying disease from 43% in patients who have undergone radical prostatectomy to 85% in patients with a neurological underlying disease, and amounts to an average 82% (range 43-85%, 100mg). - In an evaluation of spontaneous reports of deaths associated with sildenafil, the FDA concluded that there was no deducible evidence of an increase in the mortality rate among sildenafil users compared to the general population. In fact, fewer deaths associated in time with the ingestion of sildenafil were reported than might have been expected purely statistically on the basis of the normal mortality rate for men in this age group. - According to the initial studies conducted, vardenafil and tadalafil demonstrate efficacy data approximately comparable to those of sildenafil. As yet, insufficient data are available to evaluate the adverse effects of vardenafil and tadalafil, particularly their long-term use and use in high-risk groups. - Sildenafil has already been used by over 20 million men in over 110 countries and is one of the best-studied pharmacological substances available. This adventage in terms of knowledge and safety data makes sildenafil a safe and reliable treatment for patients with erectile dysfunction.
自从4年前磷酸二酯酶-5（PDE-5）抑制剂西地那非问世以来，勃起功能障碍（ED）的治疗发生了根本性变化。如今，海绵体内或尿道内注射血管活性物质或阴茎植入作为机械辅助手段在治疗中几乎不再使用。- PDE-5抑制剂伐地那非和他达拉非的出现引发了这样一个问题，即这三种物质在疗效和不良反应方面是否存在差异以及如何存在差异。- 西地那非已被证明是一种非常有效的药物。已经进行了长达6年随访期的研究。西地那非在患有器质性基础疾病的ED患者组中的成功率有所不同，从接受根治性前列腺切除术的患者中的43%到患有神经学基础疾病的患者中的85%，平均为82%（范围43%-85%，100毫克）。- 在对与西地那非相关的死亡自发报告进行评估时，美国食品药品监督管理局（FDA）得出结论，与普通人群相比，没有可推断的证据表明西地那非使用者的死亡率增加。事实上，与摄入西地那非在时间上相关的死亡报告比仅根据该年龄组男性的正常死亡率在统计学上预期的要少。- 根据最初进行的研究，伐地那非和他达拉非显示出与西地那非大致相当的疗效数据。目前，尚无足够数据来评估伐地那非和他达拉非的不良反应，特别是它们的长期使用以及在高危人群中的使用情况。- 西地那非已在110多个国家被2000多万男性使用，是现有研究最为充分的药理物质之一。在知识和安全性数据方面的这一优势使西地那非成为勃起功能障碍患者安全可靠的治疗方法。
