(117) 富血小板血浆对治疗勃起功能障碍有效且安全吗?临床研究前后数据的元分析

M. Savira, W. Atmoko
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引用次数: 0

摘要

勃起功能障碍(ED)是男性常见的健康问题,其发病率随着年龄的增长而增加。随着科技的进步,治疗勃起功能障碍的目的开始转向逆转病理,而不仅仅是缓解症状。富血小板血浆(PRP)是一种再生方式,在许多医学学科中广受欢迎。许多研究都认为 PRP 有助于改善勃起功能。然而,迄今为止还没有对 PRP 进行过相关的荟萃分析。 我们进行了一项单臂荟萃分析,根据手术前后的数据评估 PRP 治疗 ED 的效果。 我们在2023年6月系统检索了PubMed、Embase和Scopus,根据《系统综述和荟萃分析首选报告项目》(Preferred Reporting Items for Systematic Review and Meta-analysis)声明找到了相关文章。所有随机对照试验(RCT)、观察性研究和病例对照研究都被纳入其中,这些研究的受试者人数都在 10 人以上,并在 PRP 治疗后进行了至少 1 个月的随访,报告了国际勃起功能指数-勃起功能(IIEF-EF)评分。我们使用 RevMan 5.4 和 STATA18 对至少有 2 项研究报告的结果进行了汇总分析,并得出了 95% 的置信区间 (CI)。我们还进行了异质性检验和排除敏感性分析。 从已确定的 183 项研究中,共纳入了 3 项研究性临床试验、3 项观察性研究和 1 项病例对照研究,包括 236 名患者。汇总分析结果显示,在随访1个月、3个月和6个月时,PRP注射可使IIEF-EF评分显著增加3.87(95% CI:2.92,4.83,p<0.00001)、3.01(95% CI:2.27,3.74,p<0.0001)、3.29(95% CI:2.26,4.32,p<0.00001)。根据方案中或随访期间是否使用 PDE5i 对 IIEF-EF 进行的分组分析也发现了相同的结果。随访 6 个月后达到 MCID 的患者比例为 70%(95% CI:59%,80%)。在阴茎血流动力学方面,随访终点的收缩峰值速度和舒张末期速度均有显著改善。相反,IIEF评分中的性交满意度和总体满意度方面没有明显改善。最常见的并发症是一过性皮下瘀伤。有两个病例报告了无痛斑块的形成,但没有其他重大不良事件的报告。在进行排除敏感性分析后,结果一致。 PRP是一种很有前景的治疗ED的修复方法,可改善IIEF-EF评分和阴茎血液动力学。不过,还需要进一步的研究和人体试验来证实这种新型疗法的疗效和持久性,并找出最佳的给药方案。 不
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(117) Is Platelet-Rich Plasma Effective and Safe for Managing Erectile Dysfunction? A Meta-Analysis of Before-After Data from Clinical Studies
Erectile dysfunction (ED) is common health issues among men with increasing prevalence along with age. With the advancement of technology, the aim of therapy for ED is start to shift in reversing the pathology and not only relieving the symptoms. Platelet-rich plasma (PRP) are one of the regenerative modalities that has gained popularity in many medical disciplines. Many studies have been conducted that favour PRP in improving erectile function. However, no relevant meta-analysis of PRP have been performed to date. A single-arm meta-analysis were conducted to evaluate the outcome of PRP for the treatment of ED based on the data before and after the procedures. We systematically searched PubMed, Embase, Scopus in June 2023 to find the relevant articles based on the Preferred Reporting Items for Systematic Review and Meta-analysis statement. All randomized controlled trials (RCTs), observational, and case control studies in English with 10 or more subjects and a minimum of 1 month follow-up after PRP treatment reporting International Index of Erectile Function-Erectile Function (IIEF-EF) score were included. Pooled analysis on outcomes that were reported in at least 2 studies were performed using RevMan 5.4 and STATA18 with 95% confidence intervals (CIs). We also conduct heterogeneity test and a leave-one-out sensitivity analysis. A total of three RCTs, three observational studies and one case-control study, comprising 236 patients, were included from 183 studies identified. The pooled analysis showed that PRP injection significantly increased the IIEF-EF score by 3.87 (95% CI: 2.92, 4.83, p<0.00001), 3.01 (95% CI: 2.27, 3.74, p<0.0001), 3.29 (95% CI: 2.26, 4.32, p<0.00001), at 1, 3, and 6, months follow-up. Subgroup analysis of IIEF-EF based on the use of PDE5i in the protocol or during follow-up period also found the same finding result. The proportion of patient who met MCID after 6 months of follow of was 70% (95% CI: 59%, 80%). In term of penile hemodynamic, a significant improvement was found in peak systolic velocity and end diastolic velocity at the end-point of follow-up. On contrary, there was no significant improvement were found for IIEF score of intercourse satisfaction and overall satisfaction domain. The most common complication reported were transient subcutaneous bruising. Two cases reported a formation of painless plaque but no other major adverse events were reported. Consistent result was found after a leave-one-out sensitivity analysis. PRP is a promising restorative modality for ED with improvement in IIEF-EF score and penile hemodynamic. However, further studies and human trials are required to confirm the efficacy and durability of this novel treatment as well as to find out the best protocol of administration. No.
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