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他达拉非和伐地那非“无反应者”的治疗策略:一项真实世界研究。

Treatment strategy for "non-responders" to tadalafil and vardenafil: a real-life study.

作者信息

Hatzimouratidis Konstantinos, Moysidis Kyriakos, Bekos Athanasios, Tsimtsiou Zoi, Ioannidis Evangelos, Hatzichristou Dimitrios

机构信息

The 2nd Department of Urology, Papageorgiou General Hospital, and the Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Greece.

出版信息

Eur Urol. 2006 Jul;50(1):126-32; discussion 132-3. doi: 10.1016/j.eururo.2006.02.060. Epub 2006 Mar 10.

Abstract

OBJECTIVES

To develop and test step-wise treatment strategy for erectile dysfunction "non-responders" to tadalafil and vardenafil.

MATERIAL AND METHODS

Two groups [tadalafil-treated (TG); vardenafil-treated (VG)] of 100 consecutive patients complaining of non-response to treatments were enrolled in three-phase study. Phase 1: inadequate use was identified and patients were rechallenged, after receiving detailed usage information. Phase 2: true non-responders were given new instructions based on drugs' pharmacologic profiles: TGs were dosed at least 2 h before intercourse; VGs were dosed only in fasted state. Remaining non-responders entered phase 3: continuous administration of 20 mg tadalafil every other day, or 20 mg vardenafil every day for 2 weeks. Efficacy was based on positive (yes) response to two questions: "Were your erections rigid, and did they last long enough to have successful intercourse?" and "Do you want to repeat your prescription?"

RESULTS

Tadalafil group: Inappropriate use was recognized in 32 patients; 14 (43.75%) responded after adequate instruction. Phase 2: 32 of 86 (37.2%) had intercourse at least 2 h after dose intake. Phase 3: 6 of 86 (11.1%) responded to continuous administration. Overall salvage rate was 52 of 100 (52%). Vardenafil group: Inappropriate use was recognized in 38 patients; 12 (31.58%) responded after adequate instruction. Phase 2, 22 of 88 (25%) responded to dosing in a fasted state. Phase 3: 12 of 66 (18.2%) responded to daily dosing. Overall salvage rate was 46 of 100 (46%).

CONCLUSIONS

Following proposed treatment strategy may maximize response rate to phosphodiesterase 5 inhibitors; appropriate usage instructions may play significant role in response rate.

摘要

目的

为对他达拉非和伐地那非无反应的勃起功能障碍患者制定并测试逐步治疗策略。

材料与方法

两组(他达拉非治疗组(TG);伐地那非治疗组(VG))各100例连续抱怨治疗无反应的患者被纳入一项三期研究。第1阶段:识别使用不当情况,并在给予详细使用信息后让患者重新接受治疗。第2阶段:根据药物的药理学特性对真正的无反应者给予新的指导:TG组在性交前至少2小时给药;VG组仅在禁食状态下给药。其余无反应者进入第3阶段:每隔一天持续服用20毫克他达拉非,或每天服用20毫克伐地那非,持续2周。疗效基于对两个问题的肯定(是)回答:“你的勃起坚硬吗,并且持续时间足够长以进行成功的性交吗?”以及“你想重复你的处方吗?”

结果

他达拉非组:32例患者被识别出使用不当;14例(43.75%)在得到充分指导后有反应。第2阶段:86例中的32例(37.2%)在服药后至少2小时进行了性交。第3阶段:86例中的6例(11.1%)对持续给药有反应。总体挽救率为100例中的52例(52%)。伐地那非组:38例患者被识别出使用不当;12例(31.58%)在得到充分指导后有反应。第2阶段,88例中的22例(25%)在禁食状态下给药有反应。第3阶段:66例中的12例(18.2%)对每日给药有反应。总体挽救率为100例中的46例(46%)。

结论

遵循所提出的治疗策略可能会使对磷酸二酯酶5抑制剂的反应率最大化;适当的使用指导可能在反应率方面发挥重要作用。

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