The Therapeutic Effect of Huo Xue Tong Luo Capsules in Association Research Circulation Osseous (ARCO) Stage II Osteonecrosis of the Femoral Head: A Clinical Study With an Average Follow-up Period of 7.95 Years.

Xiao-Ming He,Qiu-Shi Wei,Min-Cong He,Qing-Wen Zhang,Zhen-Qiu Chen,Wei He,Peng Yang

doi:10.3389/fphar.2021.773758

Abstract

Background: Huo Xue Tong Luo (HXTL) capsules are an oral preparation that could relieve pain and ameliorate osteonecrosis in patients with asymptomatic osteonecrosis of femoral head (ONFH). We wanted to verify whether it could be a treatment option for ARCO stage II ONFH. Methods: A total of 44 patients (66 hips) with ARCO stage II ONFH were recruited from June 1996 to October 2013 (clinical trial registry number: ChiCTR-RPC-15006,290). HXTL capsules were given under a specific protocol, and the endpoint was set as femoral head collapse. The clinical indicators [including visual analog scale (VAS) and Harris Hip Score (HHS)] and radiological indicators [including Tonnis classification, ARCO stage, Japanese Investigation Committee (JIC) classification, lateral preserved angle (LPA), anterior preserved angle (APA), and combined preserved angle (CPA)] before and after treatment were compared. Kaplan–Meier survival analysis and Cox regression analysis were used to identify the risk factors associated with femoral head collapse. Result: Twenty-six males and 18 females with an average age of 38.3 ± 2.8 were followed for an average of 7.95 years. Forty-six of the 66 (69.7%) hips had no progression in pain or collapse, and patients exhibited a higher HHS (p < 0.05) after therapy. Twenty of the 66 (30.3%) hips progressed in Tonnis classification and ARCO stage, but only one of the 66 (1.5%) hips required total hip arthroplasty (THA). The Kaplan–Meier survivorship curve suggested that the survival rates were 96.97% at 5 years, 69.15% at 10 years, and 40.33% at 15 years. Patients with type A necrotic lesions on anteroposterior (AP) and frog-leg lateral (FLL) radiographs revealed 100% survival rates. Multivariate Cox regression analysis revealed that patients with an LPA ≤ 60.9 exhibited a 3.87 times higher risk of collapse of the femoral head [95% confidence interval (CI), 1.241–5.673] than did those patients with an LPA>60.9. Conclusion: HXTL capsules could be a treatment option for ARCO stage II ONFH, resulting in improved hip function and delayed progression to femoral head collapse, especially when the anterior and lateral portions of the femoral head were not affected. However, an LPA of less than 60.9° may be a risk factor for collapse of the femoral head. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=10829, identifier ChiCTR-OPC-15007030

Highlights

Osteonecrosis of femoral head (ONFH) commonly occurs in young and middle-aged adults and is associated with impaired blood supply to the femoral head secondary to the use of glucocorticoids or other factors (Cohen-Rosenblum and Cui, 2019)
In a previous clinical trial, we used Huo Xue Tong Luo (HXTL) capsules to treat asymptomatic ONFH patients, and the results showed that HXTL capsules can significantly relieve pain in patients who become symptomatic and suppress necrosis progression toward femoral head collapse in the short to mid term (Wei QS. et al, 2019)
Thirty-seven patients had steroid-induced ONFH (SONFH), 20 patients had alcohol-associated ONFH (AONFH), and nine patients were diagnosed with idiopathic ONFH (IONFH) without obvious cause

Summary

Introduction

Osteonecrosis of femoral head (ONFH) commonly occurs in young and middle-aged adults and is associated with impaired blood supply to the femoral head secondary to the use of glucocorticoids or other factors (Cohen-Rosenblum and Cui, 2019). There are a variety of hip preservation methods for the treatment of ONFH before collapse occurs (Mont et al, 2015). Studies show that Chinese herbal medicine has the potential to improve the blood flow to the necrotic femoral head, which is critical for the preservation of the hip (Wang et al, 2011; Jiang et al, 2015; Yu et al, 2016; Zhang et al, 2018). Huo Xue Tong Luo (HXTL) capsules, containing seven vasoactive herbal compounds, have been shown to delay joint collapse in patients with asymptomatic ONFH Huo Xue Tong Luo (HXTL) capsules are an oral preparation that could relieve pain and ameliorate osteonecrosis in patients with asymptomatic osteonecrosis of femoral head (ONFH). We wanted to verify whether it could be a treatment option for ARCO stage II ONFH

Methods

Results

Discussion

Conclusion