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高能聚焦体外冲击波预防糖皮质激素诱导的股骨头坏死的发生:一项前瞻性随机对照试验。

High-energy focused extracorporeal shock wave prevents the occurrence of glucocorticoid-induced osteonecrosis of the femoral head: A prospective randomized controlled trial.

作者信息

Yang Xu, Shi Lijun, Zhang Tao, Gao Fuqiang, Sun Wei, Wang Peixu, Wu Xinjie, Li Zirong

机构信息

Department of Orthopedics, Peking University China-Japan Friendship Clinical Hospital, Beijing, 100029, China.

Centre for Osteonecrosis and Joint-Preserving & Reconstruction, Orthopaedic Department, China-Japan Friendship Hospital, Beijing, 100029, China.

出版信息

J Orthop Translat. 2022 Oct 6;36:145-151. doi: 10.1016/j.jot.2022.08.002. eCollection 2022 Sep.

Abstract

BACKGROUND

Studies have shown that high-energy focused extracorporeal shock wave therapy (HF-ESWT) has a certain therapeutic effect on glucocorticoid-induced osteonecrosis of the femoral head (ONFH). This study aimed to observe the efficacy and safety of HF-ESWT as a precautionary measure to reduce the probability of glucocorticoid-induced ONFH.

METHODS

A prospective randomized controlled trial was designed to evaluate whether HF-ESWT (Group A) can significantly prevent the incidence of glucocorticoid-induced ONFH relative to a control group without shockwave intervention (Group B). MRI was used to assess whether all participants experienced ONFH at 3, 6, and 12 months after the intervention. Continuous scoring was used to evaluate the intervention results: the 10-cm visual analog scale (VAS) was used to evaluate pain, and the hip Harris score (HHS) was used to evaluate the function of the hip joint. Any adverse events were recorded.

RESULTS

153 patients (89 females and 64 males) who had been allocated to group A (75 patients) or Group B (78 patients) were included in the final analysis. The patients were 45.0 ​± ​13.0 years old. There were significant differences between the two groups in MRI diagnosis of ONFH patients (2 cases in Group A, 9 cases in Group B; p ​= ​0.034). Significant differences between groups were found in bilateral hip function measured using the HHS at 6 months (Left p ​= ​0.026; Right p ​= ​0.033) and 12 months (Left p ​= ​0.018; Right p ​= ​0.038). However, there was no difference in the functional results measured at 3 months and the VAS at any points.

CONCLUSIONS

This study confirms that HF-ESWT can be successfully used to reduce the probability of glucocorticoid-induced ONFH. Pain and hip dysfunction are common clinical manifestations when ONFH is unavoidable. Therefore, HF-ESWT can be recommended for the prevention and intervention of ONFH high-risk populations receiving high-dose glucocorticoid therapy.

THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE

The effective prevention of HF-ESWT on ONFH after high-dose glucocorticoid application demonstrated its transformation potential as a preventive method in the clinical prevention of glucocorticoid-induced ONFH.

摘要

背景

研究表明,高能聚焦体外冲击波疗法(HF-ESWT)对糖皮质激素诱导的股骨头坏死(ONFH)具有一定的治疗作用。本研究旨在观察HF-ESWT作为一种预防措施,降低糖皮质激素诱导的ONFH发生概率的有效性和安全性。

方法

设计一项前瞻性随机对照试验,以评估HF-ESWT组(A组)相对于无冲击波干预的对照组(B组)是否能显著预防糖皮质激素诱导的ONFH的发生。在干预后3个月、6个月和12个月,使用磁共振成像(MRI)评估所有参与者是否发生ONFH。采用连续评分评估干预结果:使用10厘米视觉模拟量表(VAS)评估疼痛,使用髋关节Harris评分(HHS)评估髋关节功能。记录任何不良事件。

结果

最终分析纳入了分配至A组(75例患者)或B组(78例患者)的153例患者(89例女性和64例男性)。患者年龄为45.0±13.0岁。两组在ONFH患者的MRI诊断方面存在显著差异(A组2例,B组9例;p = 0.034)。在6个月(左侧p = 0.026;右侧p = 0.033)和12个月(左侧p = 0.018;右侧p = 0.038)时,使用HHS测量的双侧髋关节功能在两组之间存在显著差异。然而,在3个月时测量的功能结果以及在任何时间点的VAS方面没有差异。

结论

本研究证实,HF-ESWT可成功用于降低糖皮质激素诱导的ONFH的发生概率。当ONFH不可避免时,疼痛和髋关节功能障碍是常见的临床表现。因此,对于接受高剂量糖皮质激素治疗的ONFH高危人群,可推荐使用HF-ESWT进行预防和干预。

本文的转化潜力

高剂量糖皮质激素应用后HF-ESWT对ONFH的有效预防证明了其作为糖皮质激素诱导的ONFH临床预防中的一种预防方法的转化潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5cfb/9550842/5c5a1503c1f8/gr1.jpg

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