[Medium- and long-term clinical efficacy of Jianpi Huogu (Kanggu) Formula in treatment of early-stage femoral head necrosis].

A long-term follow-up non-randomized controlled study was conducted to evaluate the medium-and long-term efficacy of the Jianpi Huogu(Kanggu) Formula in treating early-stage(ARCO Ⅰ-Ⅱ stage) femoral head necrosis, thereby providing evidence for the early prevention and treatment of the disease with TCM, improvement of symptoms, and delay of disease progression. Patients who received Jianpi Huogu(Kanggu) Formula(experimental group, n=61) or formula combined with TCM infusion therapy(control group, n=168) between January 2003 and June 2020, with a follow-up of ≥3 years, were included. Clinical and imaging data at baseline and annual follow-ups were collected, and 40 matched pairs(80 cases) were selected using propensity score matching. The primary endpoints were clinical efficacy(hip pain scores, hip flexion function scores, walking distance scores, and total scores of clinical efficacy) and the Beijing University of Chinese Medicine X-ray Evaluation(BUCMXE), including femoral head morphology scores, osteoarthritis scores, necrotic lesion density scores, and total scores of BUCMXE. The efficacy of the two groups was compared before treatment and at 3, 5, and 10 years post-treatment. Clinical efficacy showed that, compared with pre-treatment, both groups had significantly reduced hip pain scores and improved hip flexion function scores, walking distance scores, and total scores of clinical efficacy at 3, 5, and 10 years(P<0.001). Imaging evaluation showed that, compared with pre-treatment, femoral head morphology scores in experimental group increased at 3(0.65±1.00, P<0.05), 5(0.70±1.02, P<0.001) and 10 years(0.80±1.08, P<0.05); osteoarthritis scores increased at 3(0.32±0.66, P<0.05) and 5 years(0.32±0.67, P<0.05); necrotic lesion density scores decreased at 3(1.18±0.50, P<0.05) and 5 years(1.19±0.52, P<0.05); total scores of BUCMXE increased at 3(2.15±1.29, P<0.05) and 5 years(2.22±1.32, P<0.05). Compared with control group, the femoral head morphology scores increased in experimental group(P<0.05). These results confirm that the Jianpi Huogu(Kanggu) Formula can significantly improve clinical symptoms(pain and joint function) in patients with ARCO Ⅰ-Ⅱ stage femoral head necrosis. Medium-and long-term imaging data suggest slow disease progression(scores not reaching grade Ⅰ pathological criteria). For patients with ARCO Ⅰ stage or mild disease, monotherapy with this formula may be considered.