臭氧疗法治疗股骨头坏死：一种新治疗方法的初步试验。

Treatment of Femoral Head Osteonecrosis with Ozone Therapy: Pilot Trial of a New Therapeutic Approach.

机构信息

Department of Anesthesiology, Pain & Sleep Medicine, Aviation General Hospital of China Medical University and Beijing Institute of Translational Medicine, Chinese Academy of Sciences, Beijing, China; Savaid Medical School, University of Chinese Academy of Sciences, Beijing, China; School of Medical Science and Engineering, Beijing Advanced Innovation Center for Biomedical Engineering, Beihang University, Beijing, China.

Department of Orthopedics, Aviation General Hospital of China Medical University and Beijing Institute of Translational Medicine, Chinese Academy of Sciences, Beijing, China.

出版信息

Pain Physician. 2022 Jan;25(1):E43-E54.

PMID:35051151

Abstract

BACKGROUND

Osteonecrosis of the femoral head (ONFH) is a progressive and painful disorder due to impaired blood supply to the femoral head, yet little is known about the effect of ozone therapy in femoral head necrosis.

OBJECTIVES

We aimed to evaluate the clinical and radiographic outcomes of ozone therapy in the treatment of ONFH.

STUDY DESIGN

Nonrandomized clinical trial.

SETTINGS

The study was conducted in a single-center, academic institution.

METHODS

A total of 71 patients (107 hip joints) with Association Research Circulation Osseous (ARCO) stage-I, II, III, and IV ONFH were included and assigned to undergo either intraarticular O2-O3 mixture hip injections with ozonated autohemotherapy (ozone therapy group, n = 39, 58 hip joints) or protected weight bearing (control group, n = 32, 49 hip joints). The primary outcomes included the Visual Analog Scale (VAS) for pain intensity and Harris Hip Score (HHS) for hip function. The secondary outcomes included bone marrow edema examination, and conversion to total hip arthroplasty (THA).

RESULTS

Ozone therapy effectively improves VAS for pain intensity and HHS during the follow-up period compared to the control group. Ozone therapy showed a significant resolution of bone marrow edema of the femoral head compared to the control group (P < 0.001). Thirteen of the 49 hips (26.53%) in the control group underwent THA, whereas only 6 hips (10.34%) in the ozone therapy group required THA during a 30-month follow-up (P = 0.041). The cumulative analysis revealed a low rate of conversion to THA in the ozone therapy group (logrank test; P = 0.022).

LIMITATIONS

The study is limited by a single treatment protocol in addition to the lack of a randomized design.

CONCLUSIONS

Ozone therapy was associated with significant pain relief, improvement in hip function, and bone marrow edema resolution that may delay the need for THA in patients affected by ONFH.Institutional Review Board (IRB) approval number: HK2018-10-28.Clinical trials registration number: ChiCTR1900023449.

摘要

背景

股骨头坏死（ONFH）是一种由于股骨头血供受损而导致的进行性和疼痛性疾病，但对于臭氧治疗在股骨头坏死中的作用知之甚少。

目的

我们旨在评估臭氧治疗治疗股骨头坏死的临床和影像学结果。

研究设计

非随机临床试验。

设置

该研究在一家单中心学术机构进行。

方法

共纳入 71 例（107 髋）ARCO 分期 I、II、III 和 IV 期 ONFH 患者，分为关节内 O2-O3 混合液髋关节注射联合臭氧自体血疗法（臭氧治疗组，n=39，58 髋）或保护性负重（对照组，n=32，49 髋）。主要结局包括疼痛强度的视觉模拟量表（VAS）和髋关节功能的 Harris 髋关节评分（HHS）。次要结局包括骨髓水肿检查和全髋关节置换术（THA）的转换。

结果

与对照组相比，臭氧治疗在随访期间有效改善了疼痛强度的 VAS 和 HHS。臭氧治疗组与对照组相比，股骨头骨髓水肿明显缓解（P<0.001）。对照组 49 髋中有 13 髋（26.53%）行 THA，而臭氧治疗组在 30 个月的随访中仅有 6 髋（10.34%）需要 THA（P=0.041）。累积分析显示臭氧治疗组 THA 转化率较低（logrank 检验；P=0.022）。