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富血小板血浆腔内注射治疗轻中度勃起功能障碍患者的潜在作用:一项基于 GRADE 的随机对照试验系统评价和荟萃分析。

The potential role of intracavernosal injection of platelet-rich plasma for treating patients with mild to moderate erectile dysfunction: A GRADE-Assessed systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Urology, Faculty of Medicine, Universitas Airlangga, Surabaya; Dr. Soetomo General-Academic Hospital, Surabaya.

Department of Urology, Faculty of Medicine, Universitas Airlangga, Surabaya; Universitas Airlangga Teaching Hospital, Surabaya.

出版信息

Arch Ital Urol Androl. 2024 Oct 2;96(3):12687. doi: 10.4081/aiua.2024.12687.

Abstract

INTRODUCTION

Platelet-rich plasma (PRP) has shown positive effects on enhancing erectile function in animal studies. Human clinical trials are limited and provide contradictory results. This review aims to conduct a meta-analysis of the available Randomized controlled trials (RCT) to assess the efficacy of PRP in males with ED.

METHODS

A systematic review was carried out following the Cochrane Handbook of Intervention and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered in PROSPERO (CRD42023441655).

RESULTS

A total of three RCTs were included in the analysis for a total of 221 patients with mild to moderate ED. The patients receiving PRP reported significantly better improvement of IIEFEF score during 1,3- and 6-months follow-up compared to the placebo group (mean difference [MD] 2.66, 95% confidence interval [CI] 1.48 to 3.83, p < 0.01; MD 2.11, 95%CI 0.13 to 4.09, p = 0.04; MD 2.99, 95%CI 1.79 to 4.19, p < 0.01). The pooled analysis indicated that attainment of minimally clinical important difference (MCID) was significantly higher in patients receiving PRP compared to the placebo group during one and 6-month follow-up (odds ratio [OR] 5.51, 95%CI 1.2 to 254, p = 0.03; OR 5.64, 95%CI 2.05 to 15.55, p < 0.01; respectively). Encouragingly, no major AEs were reported in all three trials in the PRP and placebo groups (p = 0.99).

CONCLUSIONS

This review highlights the potential role of PRP in providing short-term improvement of erectile function parameters for up to 6 months in mild to moderate ED patients. Future RCTs with longer-duration follow-ups and more standardized treatment protocols are necessary to gain sufficient details on PRP's long-term effectiveness and safety.

摘要

简介

富含血小板的血浆(PRP)已在动物研究中显示出对增强勃起功能的积极作用。人体临床试验有限,结果相互矛盾。本综述旨在对现有的随机对照试验(RCT)进行荟萃分析,以评估 PRP 在 ED 男性中的疗效。

方法

按照 Cochrane 干预手册和系统评价和荟萃分析的首选报告项目(PRISMA)进行系统评价,并在 PROSPERO(CRD42023441655)中进行注册。

结果

共有三项 RCT 纳入分析,共纳入 221 名轻度至中度 ED 患者。接受 PRP 的患者在 1、3 和 6 个月随访期间报告的 IIEF-EF 评分显著改善,与安慰剂组相比(平均差异 [MD] 2.66,95%置信区间 [CI] 1.48 至 3.83,p < 0.01;MD 2.11,95%CI 0.13 至 4.09,p = 0.04;MD 2.99,95%CI 1.79 至 4.19,p < 0.01)。汇总分析表明,与安慰剂组相比,接受 PRP 的患者在 1 个月和 6 个月随访时达到最小临床重要差异(MCID)的比例显著更高(比值比 [OR] 5.51,95%CI 1.2 至 254,p = 0.03;OR 5.64,95%CI 2.05 至 15.55,p < 0.01;分别)。令人鼓舞的是,在 PRP 和安慰剂组的所有三项试验中均未报告重大不良事件(p = 0.99)。

结论

本综述强调了 PRP 在轻度至中度 ED 患者中提供长达 6 个月的勃起功能参数短期改善的潜力。需要进行具有更长随访时间和更标准化治疗方案的未来 RCT,以充分了解 PRP 的长期有效性和安全性。

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