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低强度冲击波疗法(LI-ESWT)治疗糖尿病肾病:一项开放标签干预性临床试验的结果

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

作者信息

Skov-Jeppesen Sune Moeller, Yderstraede Knud Bonnet, Jensen Boye L, Bistrup Claus, Hanna Milad, Lund Lars

机构信息

Department of Urology, Odense University Hospital, Odense, Denmark.

OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.

出版信息

Int J Nephrol Renovasc Dis. 2021 Jul 13;14:255-266. doi: 10.2147/IJNRD.S315143. eCollection 2021.

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.

摘要

目的

低强度冲击波疗法(LI-ESWT)治疗与血管生成相关,被提议用于治疗不同类型的血管疾病。据推测,LI-ESWT可能通过血管内皮生长因子(VEGF)和一氧化氮(NO)的形成改善糖尿病肾病(DKD)患者的肾滤过屏障并阻止肾小球滤过率(GFR)下降的进程。我们展示了关于人类DKD患者接受LI-ESWT治疗的首批数据。

方法

本研究设计为一项干预性、前瞻性、单臂1期研究。我们调查了28例接受为期三周、共六次LI-ESWT治疗的DKD患者的GFR和蛋白尿变化。对患者进行了为期六个月的随访。在LI-ESWT治疗后研究了肾损伤标志物、血管内皮生长因子(VEGF)和一氧化氮代谢产物(NOx)的尿排泄情况。

结果

与基线相比,LI-ESWT治疗后长达六个月,GFR和蛋白尿均无显著变化。LI-ESWT治疗后一个月尿VEGF短暂降低,但LI-ESWT治疗后尿VEGF或NOx无其他显著变化。二次分析显示,基线时NOx水平较低的患者在LI-ESWT治疗后NOx升高。在首次LI-ESWT治疗后,肾损伤标志物三叶因子3(TFF3)急性升高,表明内皮细胞短暂修复。其他肾损伤标志物与LI-ESWT治疗相关保持稳定。

结论

LI-ESWT治疗未显著改善肾功能和白蛋白排泄。得出结论,LI-ESWT无害。应进行随机双盲研究以明确LI-ESWT辅助治疗是否优于DKD的标准治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccad/8286109/4e812f1eb4b7/IJNRD-14-255-g0001.jpg

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