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低强度冲击波疗法治疗 Peyronie 病:前瞻性、随机、假对照试验的长期结果。

Low-intensity shockwave therapy in Peyronie's disease: long-term results from a prospective, randomized, sham-controlled trial.

机构信息

Department of Urology, 'Martha-Maria' Hospital Nuremberg, Nuremberg, Germany.

Department of Urology, Goldstadt Clinic, Pforzheim, Germany.

出版信息

Int J Impot Res. 2022 Aug;34(5):487-494. doi: 10.1038/s41443-021-00447-2. Epub 2021 May 18.

Abstract

Low-intensity shockwave therapy (LiST) is an effective treatment for pain reduction in patients with Peyronie's disease (PD). We aimed to report the long-term results of a previously published randomized, sham-controlled trial on LiST for PD management. For the initial study, 102 patients with stable PD were randomly assigned to six sessions of LiST (n = 51) or sham (n = 51) therapy. All participants were subsequently contacted for an additional evaluation at 3 years after completion of the initial treatment and 63 of them (LiST = 34 and sham therapy = 29) presented for the evaluation. Among them, improvement of pain was reported in 23 participants (LiST = 16, sham = 7, p = 0.005) at 4 weeks and in 22 (LiST = 15, sham = 7, p = 0.031) at 3 years. We detected a mean difference of 2.2 points (95%CI: 0.9-3.5, p = 0.002) in the visual analog pain scale at 4 weeks and a mean difference of 2.5 points (95%CI: 1-4, p = 0.002) at 3 years between the two groups. No treatment-related complications occurred during the sessions or the follow-up period. Regarding the improvement of penile curvature or sexual function, no significant differences between the two groups were observed. Overall, LiST constitutes a safe and effective therapeutic approach for pain management both in the short- and long term.

摘要

低强度冲击波疗法(LiST)是治疗 Peyronie 病(PD)患者疼痛的有效方法。我们旨在报告先前发表的一项 LiST 治疗 PD 管理的随机、假对照试验的长期结果。在初始研究中,102 名稳定 PD 患者被随机分配接受六次 LiST(n=51)或假对照(n=51)治疗。所有参与者在初始治疗完成后 3 年进行了额外的评估,其中 63 人(LiST=34,假对照治疗=29)进行了评估。其中,23 名参与者(LiST=16,假对照=7,p=0.005)在 4 周时报告疼痛改善,22 名参与者(LiST=15,假对照=7,p=0.031)在 3 年时报告疼痛改善。我们在 4 周时在视觉模拟疼痛量表上检测到两组之间的平均差异为 2.2 分(95%CI:0.9-3.5,p=0.002),在 3 年时检测到平均差异为 2.5 分(95%CI:1-4,p=0.002)。在治疗过程中和随访期间均未发生与治疗相关的并发症。关于阴茎弯曲或性功能的改善,两组之间没有观察到显著差异。总体而言,LiST 构成了一种安全有效的短期和长期疼痛管理治疗方法。

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