一项前瞻性、随机、开放标签、平行试验，比较α受体阻滞剂或 5α-还原酶抑制剂停药与继续联合治疗对良性前列腺增生男性下尿路症状维持的疗效。

A prospective, randomized, open-label, parallel trial comparing the efficacy of α-blocker or 5α-reductase inhibitor withdrawal to continued combination therapy on the maintenance of lower urinary tract symptoms in men with benign prostatic hyperplasia.

机构信息

Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.

Biostatistics Collaboration Unit, Medical Research Center, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Prostate. 2024 Mar;84(4):403-413. doi: 10.1002/pros.24663. Epub 2023 Dec 27.

DOI:10.1002/pros.24663

PMID:38149792

Abstract

BACKGROUND

It is uncertain how long combination therapy should be continued in patients with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). We investigated the withdrawal effects of α1-adrenergic receptor blocker (AB) or 5α-reductase inhibitor (5ARI) following successful combination therapy.

METHODS

This prospective, randomized, open-label, parallel trial enrolled 222 patients with BPH/LUTS who showed at least a seven-point improvement in International Prostate Symptom Score-total (IPSS-T) and a ≥ 20% reduction in prostate volume (PV) following the initiation of combination therapy. Patients were randomized in a 1:1:1 ratio into continued-combination, AB-withdrawal, and 5ARI-withdrawal groups. IPSS, overactive bladder symptom score, EuroQol-five-dimensional questionnaire (EQ-5D-5L), EuroQol-visual analog scale (EQ-VAS), prostate volume (PV), maximal flow rate, postvoid residual urine (PVR), and prostate-specific antigen level were assessed every 6 months for 24 months. The predictors of IPSS-T deterioration were evaluated.

RESULTS

At Month 24, IPSS-T deterioration (≥2 point) was observed in 20/72 (27.8%) and 19/72 (26.4%) patients in the AB- and 5ARI-withdrawal groups, respectively. Among them, 4/72 (5.6%) and 4/70 (5.7%) patients required readdition of the withdrawn drug (p = 0.868). In the continued combination group, EQ-VAS improved at Month 24 compared to baseline (p = 0.028). At Month 24, the AB-withdrawal group showed improvements in EQ-5D-5L, EQ-VAS, and PVR (all p < 0.005), while the 5ARI-withdrawal group showed improvement in IPSS-S (p = 0.011). Diabetes mellitus was associated with IPSS-T deterioration at Month 24 (p = 0.020).

CONCLUSIONS

In patients with BPH/LUTS who are reluctant to continue combination therapy, AB or 5ARI withdrawal may be offered in men with improvement in IPSS-T by at least seven points and reduction in PV by at least 20%.

摘要

背景

对于良性前列腺增生症（BPH）和下尿路症状（LUTS）患者，联合治疗应持续多长时间尚不确定。我们研究了成功接受联合治疗后停用α1-肾上腺素能受体阻滞剂（AB）或 5α-还原酶抑制剂（5ARI）的停药效果。

方法

这是一项前瞻性、随机、开放标签、平行试验，共纳入 222 例 BPH/LUTS 患者，这些患者在开始联合治疗后，国际前列腺症状评分总分（IPSS-T）至少改善 7 分，前列腺体积（PV）至少减少 20%。患者以 1:1:1 的比例随机分为继续联合治疗组、AB 停药组和 5ARI 停药组。在 24 个月的时间里，每 6 个月评估一次 IPSS、膀胱过度活动症症状评分、欧洲生活质量五维问卷（EQ-5D-5L）、欧洲生命质量视觉模拟量表（EQ-VAS）、前列腺体积（PV）、最大尿流率、残余尿量（PVR）和前列腺特异性抗原水平。评估 IPSS-T 恶化的预测因素。

结果

在第 24 个月时，AB 停药组和 5ARI 停药组分别有 20/72（27.8%）和 19/72（26.4%）的患者出现 IPSS-T 恶化（≥2 分）。其中，4/72（5.6%）和 4/70（5.7%）的患者需要重新服用停用的药物（p=0.868）。在继续联合治疗组，与基线相比，第 24 个月时 EQ-VAS 改善（p=0.028）。在第 24 个月时，AB 停药组的 EQ-5D-5L、EQ-VAS 和 PVR 均有改善（均 p<0.005），而 5ARI 停药组的 IPSS-S 有改善（p=0.011）。糖尿病与第 24 个月时的 IPSS-T 恶化相关（p=0.020）。