Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease.
Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease.
复制标题
DOI：
10.1016/j.amjmed.2014.03.019
复制
发表时间：
2014-07
影响因子：
5.9
通讯作者：
Casella, James F.
中科院分区：
文献类型：
--
作者：
Burnett, Arthur L.;Anele, Uzoma A.;Trueheart, Irene N.;Strouse, John J.;Casella, James F.
缺血性阴茎异常勃起是一种阴茎勃起障碍，具有严重的生理和心理后果，其成功的预防性治疗是有限的。我们进行了一项随机、双盲、安慰剂对照的临床试验，通过系统给药方案评估西地那非预防镰状细胞病相关的复发性缺血性阴茎异常勃起的疗效和安全性。13例镰状细胞病患者报告阴茎异常勃起复发，每周至少两次，随机接受西地那非50 mg或安慰剂，每日一次，与睡眠或性活动无关，持续8周，随后开放标签使用该西地那非方案，持续8周。通过意向治疗或符合方案分析，西地那非组和安慰剂组之间阴茎异常勃起频率降低50%没有差异（P = 1.0）。然而，在开放标签评估期间，意向治疗分析的8例患者中有5例（62.5%）和符合方案分析的3例患者中有2例（66.7%）符合该主要疗效结局。研究组间不良反应发生率无显著差异，尽管在“治疗期间”监测的患者中，严重阴茎异常勃起发作减少了4倍。通过系统给药使用西地那非可能提供一种预防镰状细胞病患者复发性缺血性阴茎异常勃起的策略。
Successful preventive therapy for ischemic priapism, a disorder of penile erection with major physical and psychologic consequences, is limited. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease. Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily, unassociated with sleep or sexual activity, for 8 weeks, followed by open-label use of this sildenafil regimen for an additional 8 weeks. Priapism frequency reduction by 50% did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses (P = 1.0). However, during open-label assessment, 5 of 8 patients (62.5%) by intention-to-treat analysis and 2 of 3 patients (66.7%) by per protocol analysis met this primary efficacy outcome. No significant differences were found between study groups in rates of adverse effects, although major priapism episodes were decreased 4-fold in patients monitored “on-treatment.” Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease.
登录
查看更多内容
影响因子：
3.5
作者：
Bennett, Nelson;Mulhall, John
通讯作者：
Mulhall, John
影响因子：
4.5
作者：
El-Bahnasawy, MS;Dawood, A;Farouk, A
通讯作者：
Farouk, A
影响因子：
2.6
作者：
Kanika, N. D.;Melman, A.;Davies, K. P.
通讯作者：
Davies, K. P.
DOI：
10.1073/pnas.0407183102
发表时间：
2005-02-01
影响因子：
11.1
作者：
Champion, HC;Bivalacqua, TJ;Burnett, AL
通讯作者：
Burnett, AL
影响因子：
2.4
作者：
Burnett, Arthur L.;Bivalacqua, Trinity J.
通讯作者：
Bivalacqua, Trinity J.