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体外冲击波疗法治疗慢性前列腺炎/慢性盆腔疼痛综合征的疗效及临床预测因素:一项前瞻性随机双盲安慰剂对照临床试验

Outcomes and clinical predictors of extracorporeal shock wave therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome: a prospective randomized double-blind placebo-controlled clinical trial.

作者信息

Sakr Ahmed M, Fawzi Amr M, Kamel Mostafa, Ali Maged M

机构信息

Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

Prostate Cancer Prostatic Dis. 2022 Mar;25(1):93-99. doi: 10.1038/s41391-021-00464-8. Epub 2021 Oct 11.

DOI:10.1038/s41391-021-00464-8
PMID:34635804
Abstract

OBJECTIVES

To report the one-year results of ESWT on CPPS patients and the possible clinical characteristics that may affect its efficacy.

PATIENTS & METHODS: A prospective randomized clinical study between January 2017 and January 2021 on 155 adult patients with chronic pelvic pain syndrome. All patients were initially evaluated with a thorough history and physical examination. Baseline symptoms evaluation of each participant was assessed using NIH-CPSI score, IPSS, VAS, and IIEF-5 score. Patients were randomized into two groups: a verum treatment group and a placebo treatment group. Patients of verum group in the lithotomy position received a perineally applied ESWT treatment once a week for four weeks with 3000 impulses each. Patients of placebo group received the same therapy head of the same device with a layer of air-filled microspheres to absorb the shock waves. The previously mentioned validated scores were reassessed on regular follow-up visits at one, three, six, and 12 months after the completion of ESWT.

RESULTS

A statistically significant improvement was noticed in the mean values of NIH-CPSI, IPSS, VAS, and IIEF-5 of the patients of verum group over the follow-up period with also statistically significant difference between both groups. At the first visit of follow-up after ESWT, 63 (82.8%) patients had ≥6 points decrease in the NIH-CPSI total score, while 13 (17.2%) patients did not. Univariate and multivariate analyses of the clinical characteristics between the responders and non-responders showed that those patients with history of psychological disorders or had higher initial NIH-CPSI score had a significantly lower response rate to ESWT (p = 0.005, 0.02 & p = 0.002, 0.004 respectively). ROC curve of NIH-CPSI score showed that a score of 32 was the cut-off point above which the response to ESWT decreased.

CONCLUSION

ESWT is an effective treatment option for CPPS. Its efficacy remained throughout long-term follow up. High initial NIH-CPSI score and history of psychological problems are significant predictors for it.

摘要

目的

报告体外冲击波疗法(ESWT)治疗慢性前列腺炎/慢性盆腔疼痛综合征(CPPS)患者的一年结果以及可能影响其疗效的临床特征。

患者与方法

2017年1月至2021年1月对155例成年慢性盆腔疼痛综合征患者进行一项前瞻性随机临床研究。所有患者最初均进行了全面的病史和体格检查。使用美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)评分、国际前列腺症状评分(IPSS)、视觉模拟评分法(VAS)和国际勃起功能指数-5(IIEF-5)评分对每位参与者进行基线症状评估。患者被随机分为两组:真治疗组和安慰剂治疗组。真治疗组患者取截石位,每周接受一次经会阴应用的ESWT治疗,共四周,每次3000次脉冲。安慰剂组患者使用同一设备的相同治疗头,并带有一层充气微球以吸收冲击波。在ESWT完成后的1、3、6和12个月定期随访时,重新评估上述经过验证的评分。

结果

在随访期间,真治疗组患者的NIH-CPSI、IPSS、VAS和IIEF-5平均值有统计学意义的改善,两组之间也有统计学意义的差异。在ESWT后的首次随访中,63例(82.8%)患者的NIH-CPSI总分下降≥6分,而13例(17.2%)患者未下降。对反应者和无反应者的临床特征进行单因素和多因素分析表明,有心理障碍病史或初始NIH-CPSI评分较高的患者对ESWT的反应率显著较低(分别为p = 0.005、0.02和p = 0.002、0.004)。NIH-CPSI评分的ROC曲线显示,32分为分界点,高于该分数对ESWT的反应下降。

结论

ESWT是CPPS的一种有效治疗选择。其疗效在长期随访中持续存在。初始NIH-CPSI评分高和有心理问题病史是其重要预测因素。

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