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系统文献回顾和荟萃分析骶神经调节(SNM)在神经源性下尿路功能障碍(nLUTD)患者中的应用:20 多年的经验和未来方向。

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years' Experience and Future Directions.

机构信息

Department of Neuro-Urology, Marien Hospital Herne, University Hospital Ruhr-Universität Bochum, Bochum, Germany.

Medtronic International, Tolochenaz, Switzerland.

出版信息

Adv Ther. 2021 Apr;38(4):1987-2006. doi: 10.1007/s12325-021-01650-9. Epub 2021 Mar 13.

Abstract

INTRODUCTION

Sacral neuromodulation (SNM) has been used in carefully selected patients with neurogenic lower urinary tract dysfunctions (nLUTD) for over two decades.

METHODS

The aim of the current work was to perform a systematic literature review and meta-analysis of studies reporting the safety and effectiveness of SNM in patients with nLUTD (neurogenic detrusor overactivity, non-obstructive urinary retention, or a combination of both). For this purpose a systematic literature research was conducted using Embase (OvidSP), MEDLINE (OvidSP), MEDLINE In-Process Citations & Daily Update (OvidSP), MEDLINE (OvidSP) e-Pub ahead of print, Cochrane Central Register of Controlled Trials (CENTRAL), NIH Clinicaltrials.gov, and WHO International Clinical Trials Registry Platform (ICTRP) between 1998 and March 2020, supplemented by a hand search.

RESULTS

Forty-seven studies were included in the systematic literature review. Twenty-one studies comprising a total of 887 patients were included in the meta-analysis of test SNM. The pooled success rate of SNM test stimulation was 66.2% (95% CI 56.9-74.4). Depending on neurogenic conditions test success rates varied greatly. Twenty-four studies with a total of 428 patients were included in the meta-analysis of permanent SNM. The success rate of pooled permanent SNM was 84.2% (95% CI 77.8-89.0). Among the identified studies, the most common adverse events (AEs) were loss of effectiveness, infection, pain at implant site, and lead migration with AE rates of 4.7%, 3.6%, 3.2%, and 3.2%, respectively. Limitations entail lower level of evidence (Oxford classification 3-4) of included studies, significant risk of bias, small sample sizes in some studies, the inclusion of retrospective case series, substantial between-study heterogeneity, heterogeneous patient populations, insufficient disease classification, and variations in terms of outcome parameters as well as techniques. Furthermore, long-term data are limited.

CONCLUSION

This meta-analysis supports not only the benefits of permanent SNM for various nLUTDs but also high overall success rates, similar to idiopathic patients. Current data of the analyzed studies showed that SNM is safe for these patients. However, more vigorous studies and/or registries are needed before definitive conclusions can be drawn.

摘要

简介

骶神经调节(SNM)已在经过精心选择的患有神经源性下尿路功能障碍(nLUTD)的患者中使用了二十多年。

方法

本研究的目的是对报告 SNM 治疗 nLUTD(神经源性逼尿肌过度活动、非梗阻性尿潴留或两者兼有)患者的安全性和有效性的研究进行系统的文献回顾和荟萃分析。为此,我们使用 Embase(OvidSP)、MEDLINE(OvidSP)、MEDLINE 正在处理的引文和每日更新(OvidSP)、MEDLINE(OvidSP)电子预印本、Cochrane 对照试验中心注册库(CENTRAL)、美国国立卫生研究院临床试验.gov 和世界卫生组织国际临床试验注册平台(ICTRP)进行了系统的文献检索,检索时间为 1998 年至 2020 年 3 月,同时辅以手工检索。

结果

共有 47 项研究被纳入系统文献回顾。21 项研究共纳入 887 例患者,其中 21 项研究共纳入 428 例患者进行了永久性 SNM 的荟萃分析。SNM 测试刺激的总成功率为 66.2%(95%CI 56.9-74.4)。根据神经源性条件的不同,测试成功率差异很大。24 项研究共纳入 428 例患者进行了永久性 SNM 的荟萃分析。永久性 SNM 的总成功率为 84.2%(95%CI 77.8-89.0)。在确定的研究中,最常见的不良事件(AE)是疗效丧失、感染、植入部位疼痛和导线迁移,其发生率分别为 4.7%、3.6%、3.2%和 3.2%。纳入研究的局限性包括证据水平较低(牛津分类 3-4)、存在较大的偏倚风险、一些研究样本量较小、纳入回顾性病例系列研究、研究间异质性较大、患者人群异质性较大、疾病分类不足、以及结果参数和技术的差异。此外,长期数据有限。

结论

这项荟萃分析不仅支持永久性 SNM 对各种 nLUTD 的益处,还支持其总体高成功率,与特发性患者相似。目前分析研究的数据表明,SNM 对这些患者是安全的。然而,在得出明确的结论之前,还需要更有力的研究和/或登记。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f45/8004509/18fee7b30805/12325_2021_1650_Fig1_HTML.jpg

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