骨痹通消颗粒辅助治疗肝肾亏虚型激素性股骨头坏死随机对照试验OA

Objective To observe the clinical efficacy of Gubi Tongxiao Granules as an adjuvant therapy in early-to-mid-stage steroid-induced osteonecrosis of the femoral head(SONFH)patients with Gan-Shen deficiency syndrome,and to explore part of its mechanism of action.Methods Totally 67 patients with early-to-mid-stage SONFH admitted to the Department of Orthopedics,First Affiliated Hospital of Anhui University of Chinese Medicine between June 2022 and June 2024 were recruited and randomly assigned to a control group and an observation group,with 30 cases in each group.Patients in the control group received conventional treatment plus a placebo,while those in the observation group took Gubi Tongxiao Granules in addition to conventional treatment for a 12-week course.Hip joint function(Harris Score),pain level[Visual Analogue Scale(VAS)],bone marrow edema grade,hip joint effusion grade,serum levels of hypoxia-inducible factor-1α(HIF-1α),vascular endothelial growth factor(VEGF),N-terminal mid-fragment osteocalcin(N-MID),procollagen type Ⅰ N-terminal propeptide(P1NP),osteocalcin(BGP),bone-specific alkaline phosphatase(BAP),tartrate-resistant acid phosphatase 5b(TRACP-5b),total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C),and high-density lipoprotein cholesterol(HDL-C)were observed.The total clinical effective rate and adverse reactions were recorded.Results Compared with pre-treatment levels within each group,both groups showed decreased VAS scores,bone marrow edema and hip joint effusion grades,N-MID,P1NP,TRACP-5b,and HDL-C levels post-treatment(P＜0.05),while Harris scores,HIF-1α,VEGF,BGP,BAP,and TC,TG,LDL-C levels increased(P＜0.05).The improvement in all indicators was superior in the observation group,as compared with the control group(P＜0.05).The total clinical effective rate in the observation group was 96.55％(28/29),higher than those of the control group[76.67％(23/30),x 2=7.07,P＜0.05].No severe adverse reactions were observed in either group during the treatment period.Conclusions As an adjunctive therapy for early to mid-stage SONFH patients with Gan-Shen deficiency syndrome,Gubi Tongxiao Granules demonstrated positive effects in improving patient function,pain,imaging findings,bone metabolism,and lipid profiles,with a high safety profile during the observation period of this study.Gubi Tongxiao Granules might be considered as an effective adjunctive treatment option for early to mid-stage SONFH patients.