A controlled trial for preventing priapism in sickle cell anemia: hydroxyurea plus placebo vs hydroxyurea plus tadalafil.

All previous trials for priapism prevention have failed to demonstrate clear efficacy.

所有先前的阴茎勃起预防试验均未能证明明确的有效性。

We conducted a randomized, controlled, double-blindphase 2 feasibility trial comparing fixed moderate-dose hydroxyurea plus placebo (usual-care arm) with fixed moderate-dose hydroxyurea plus tadalafil (experimental arm) in 64 males (aged 18-40 years) with at least 3 episodes of SCA-related priapism in the past 12 months.

我们开展了一项随机、对照、双盲的2期可行性试验，比较了固定中等剂量的羟基脲加安慰剂（常规护理组）与固定中等剂量的羟基脲加他达拉非（实验组）在64名年龄在18-40岁之间、过去12个月内至少有3次与镰状细胞贫血（SCA）相关的阴茎持续勃起症（priapism）发作的男性中的效果。

Priapism data were obtained via daily text messages to the participants.

通过每天向参与者发送短信来获取阴茎持续勃起症的数据。

The trial's primary outcome measures were 100% recruitment, 98.4% retention, and 93.5% adherence rates.

该试验的主要结果指标包括100%的招募率、98.4%的留存率和93.5%的依从率。

Over a median of 10 months (interquartile range, 3-12), 2.5 and 3.02 priapism events per participant-month were recorded in the usual-care and the experimental arms, with an incidencerate ratio of 0.8 (95% confidence interval[CI], 0.3-1.9; P = .654).

在中位随访10个月（四分位数范围，3-12个月）期间，常规护理组和实验组每参与者每月分别记录了2.5和3.02次阴茎持续勃起事件，发生率比为0.8（95%置信区间[CI]，0.3-1.9；P = .654）。

The rates of serious adverse events (P = .999) and hospitalization (P = .289) were similar in the 2 arms.

两组严重不良事件的发生率（P = .999）和住院率（P = .289）相似。

Sperm concentration, motility, and normal morphology significantly decreased on hydroxyurea therapy but recovered to prehydroxyurea levels 3 months after therapy cessation.

在羟基脲治疗期间，精子浓度、活力和正常形态显著下降，但在治疗停止后3个月恢复到治疗前水平。

Post hoc, single-arm, pre-post analysis showed a 58.3% priapism incidencerate reduction in the usual-care arm (5.9-2.5 events per month; difference, 3.4; 95% CI, 1.1-5.8; P = .005) and a 66.3% priapism reduction in the experimental arm (8.9-3.02 events per month; difference, 5.9; 95% CI, 3.4-8.5; P < .001) compared with the prerandomization rates.

事后分析显示，在常规治疗组中，阴茎持续勃起症的发生率降低了58.3%（从每月5.9次减少到2.5次；差异，3.4；95%置信区间，1.1-5.8；P = .005），而在实验治疗组中，阴茎持续勃起症的发生率降低了66.3%（从每月8.9次减少到3.02次；差异，5.9；95%置信区间，3.4-8.5；P < .001），与随机化前的比率相比。

A randomized controlled trialfor priapism prevention is feasible in men with SCA.

在患有镰状细胞贫血的男性中，进行阴茎持续勃起症预防的随机对照试验是可行的。

This trial was registered at www.clinicaltrials.gov as #NCT05142254.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT05142254。