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低强度体外冲击波治疗糖尿病患者勃起功能障碍。

Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients.

机构信息

Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.

Medispec Ltd., Gaithersburg, Maryland, USA.

出版信息

Sex Med Rev. 2021 Oct;9(4):619-627. doi: 10.1016/j.sxmr.2019.06.007. Epub 2019 Aug 1.

DOI:10.1016/j.sxmr.2019.06.007
PMID:31378506
Abstract

INTRODUCTION

The cause of erectile dysfunction (ED) in diabetic patients is complex and involves both neurogenic and vasculogenic components and is often hard to treat.

AIM

To study the effect of low-intensity extracorporeal shock wave therapy (Li-ESWT) therapy on a subgroup of diabetic patients with ED who are responders (PDE5I-R) and non-responders (PDE5I-NR) to phosphodiesterase 5 inhibitors (PDE5I).

METHODS

Analysis of pooled data from 5 double-blind, sham-controlled trials was performed. In this sub-analysis, of 350 patients in the PDE5I-R group and with vasculogenic ED, we found 61 patients with diabetes mellitus who underwent LI-ESWT. Another 48 patients (of 53) belonged to the PDE5I-NR group. Baseline efficacy was evaluated with the International Index of Erectile Function-Erectile Function domain questionnaire (IIEF-EF) for the PDE5I-R and with Erection Hardness Score, IIEF-EF, and flow-mediated dilation technique for the PDE5I-NR.

MAIN OUTCOME MEASURES

Change in the IIEF-EF score after treatment of diabetes-induced ED with Li-ESWT in the PDE5i-R group vs the PDE5i-NR group.

RESULTS

LI-ESWT therapy was found to be effective in both subgroups of diabetic patients. Minimally clinical important difference in IIEF-EF score was achieved in 50%, 79.5%, 77.3%, and 65.9% of the subjects in the active group in after the sixth shockwave (SW) treatment evaluation (just before initiating the seventh SW session) and at 1 month, 6 months, and 12 months after the last SW treatment, respectively. The difference among the groups was significant (P < .05) after the sixth treatment and in all the follow-up periods. In the PDE5I-NR group, 55% of the active group were converted to PDE5I-5-R after LI-ESWT. The difference between the active and sham groups was statistically significant in all the tested measures (P < .001).

CONCLUSION

LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups. Spivak L, Shultz T, Appel B, et al. Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients. Sex Med Rev 2021;9:619-627.

摘要

简介

糖尿病患者勃起功能障碍(ED)的病因复杂,涉及神经源性和血管源性因素,且往往难以治疗。

目的

研究低强度体外冲击波治疗(Li-ESWT)对磷酸二酯酶 5 抑制剂(PDE5I)反应者(PDE5I-R)和无反应者(PDE5I-NR)的糖尿病 ED 患者亚组的疗效。

方法

对 5 项双盲、假对照试验的汇总数据进行分析。在这项亚分析中,在 PDE5I-R 组和血管性 ED 的 350 名患者中,我们发现 61 名患有糖尿病的患者接受了 Li-ESWT。另外 48 名(53 名中的 48 名)属于 PDE5I-NR 组。PDE5I-R 组采用国际勃起功能指数-勃起功能域问卷(IIEF-EF)评估基线疗效,PDE5I-NR 组采用勃起硬度评分、IIEF-EF 和血流介导扩张技术评估。

主要观察指标

Li-ESWT 治疗糖尿病诱导的 ED 后,PDE5I-R 组与 PDE5I-NR 组 IIEF-EF 评分的变化。

结果

Li-ESWT 治疗在糖尿病患者的两个亚组中均有效。在第 6 次冲击波(SW)治疗评估(在开始第 7 次 SW 治疗前)和 1 个月、6 个月和 12 个月后末次 SW 治疗后,主动组有 50%、79.5%、77.3%和 65.9%的受试者达到 IIEF-EF 评分的最小临床重要差异。组间差异在第 6 次治疗和所有随访期均有统计学意义(P <.05)。在 PDE5I-NR 组,55%的主动组在 Li-ESWT 后转换为 PDE5I-5-R。主动组与假手术组在所有测试指标上的差异均有统计学意义(P <.001)。

结论

Li-ESWT 治疗 PDE5I-R 和 PDE5I-NR 组 ED 安全有效。

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