Low-Intensity Shockwave Therapy (LI-ESWT) in Diabetic Kidney Disease: Results from an Open-Label Interventional Clinical Trial.

IF 2.1 Q2 UROLOGY & NEPHROLOGY
Sune Moeller Skov-Jeppesen, Knud Bonnet Yderstraede, Boye L Jensen, Claus Bistrup, Milad Hanna, Lars Lund
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引用次数: 3

Abstract

Purpose: Treatment with low-intensity shockwave therapy (LI-ESWT) is associated with angiogenesis and is suggested as a treatment for different types of vascular diseases. It was hypothesized that LI-ESWT improves the renal filtration barrier and halts the progression of GFR decline in diabetic kidney disease (DKD) potentially through VEGF and NO formation. We present the first data on LI-ESWT in human DKD.

Methods: The study was designed as an interventional, prospective, one-arm, Phase 1 study. We investigated change in GFR and albuminuria in 28 patients with DKD treated with six sessions of LI-ESWT over three weeks. The patients were followed for six months. Urine excretion of kidney injury markers, vascular endothelial growth factor (VEGF) and nitric oxide metabolites (NOx) was studied after LI-ESWT.

Results: There were no significant changes in GFR and albuminuria up to six months after LI-ESWT compared to baseline. Urine VEGF was transiently reduced one month after LI-ESWT, but there were no other significant changes in urine VEGF or NOx after LI-ESWT. Secondary analysis showed that NOx increased after LI-ESWT in patients who had low levels of NOx at baseline. Kidney injury marker trefoil factor 3 (TFF3) increased acutely after the first session of LI-ESWT indicating transient endothelial repair. Other markers of kidney injury were stable in relation to LI-ESWT.

Conclusion: LI-ESWT treatment did not significantly improve kidney function and albumin excretion. It is concluded that LI-ESWT is not harmful. A randomized blinded study should be performed to clarify whether adjunctive treatment with LI-ESWT is superior to standard treatment of DKD.

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低强度冲击波治疗(LI-ESWT)治疗糖尿病肾病:一项开放标签介入临床试验的结果
目的:低强度冲击波治疗(LI-ESWT)与血管生成有关,被建议作为不同类型血管疾病的治疗方法。假设LI-ESWT可能通过VEGF和NO的形成改善肾脏滤过屏障并阻止糖尿病肾病(DKD)中GFR下降的进展。我们提出了LI-ESWT在人类DKD中的第一个数据。方法:该研究被设计为一项介入性、前瞻性、单臂、一期研究。我们研究了28名DKD患者在三周内接受6次LI-ESWT治疗的GFR和蛋白尿的变化。这些病人被跟踪了六个月。研究LI-ESWT后尿中肾损伤标志物、血管内皮生长因子(VEGF)和一氧化氮代谢产物(NOx)的变化。结果:与基线相比,LI-ESWT后6个月的GFR和蛋白尿没有显著变化。LI-ESWT后1个月尿VEGF短暂降低,但LI-ESWT后尿VEGF或NOx无其他显著变化。二次分析显示,在基线时NOx水平较低的患者中,LI-ESWT后NOx升高。肾损伤标志物三叶因子3 (TFF3)在第一次LI-ESWT后急剧升高,表明短暂的内皮修复。与LI-ESWT相关的其他肾损伤标志物是稳定的。结论:LI-ESWT治疗未显著改善肾功能和白蛋白排泄。结果表明LI-ESWT对人体无害。应该进行一项随机盲法研究,以阐明LI-ESWT辅助治疗是否优于DKD的标准治疗。
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来源期刊
CiteScore
3.90
自引率
5.00%
发文量
40
审稿时长
16 weeks
期刊介绍: International Journal of Nephrology and Renovascular Disease is an international, peer-reviewed, open-access journal focusing on the pathophysiology of the kidney and vascular supply. Epidemiology, screening, diagnosis, and treatment interventions are covered as well as basic science, biochemical and immunological studies. In particular, emphasis will be given to: -Chronic kidney disease- Complications of renovascular disease- Imaging techniques- Renal hypertension- Renal cancer- Treatment including pharmacological and transplantation- Dialysis and treatment of complications of dialysis and renal disease- Quality of Life- Patient satisfaction and preference- Health economic evaluations. The journal welcomes submitted papers covering original research, basic science, clinical studies, reviews & evaluations, guidelines, expert opinion and commentary, case reports and extended reports. The main focus of the journal will be to publish research and clinical results in humans but preclinical, animal and in vitro studies will be published where they shed light on disease processes and potential new therapies and interventions.
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