Abstract: OBJECTIVE: To investigate the efficacy and safety of intravenous cervus and cucumis polypeptides for treating avascular necrosis of the femoral head(ANFH) in regard to pain and hip function in a randomized clinical trial.METHODS: A total of 96 subjects with ANFH who were recruited at the Orthopaedic Hospital Affiliated with Hebei United University and Qian Hai Femoral Head Hospital of Beijing were assigned by lottery to an intervention group(n = 48) or a control group(n = 48). All subjects underwent physical therapy and rehabilitation exercises. In addition,subjects in the intervention group were given intravenous infusions of cervus and cucumis polypeptides. Visual analogue scale(VAS), Harris hip score,and radiography or magnetic resonance imaging were applied to assess all subjects at the beginning of treatment and 3, 6, and 9 months afterward. All the subjects were followed up for 2 years.RESULTS: At the beginning of treatment, there were no statistically significant differences between the two groups in terms of the general condition of patients or the VAS and Harris hip scores(all P > 0.05). At 3, 6, and 9 months after treatment,however, the VAS score decreased and the Harris hip score increased in all patients, with the improvement of intervention group significantly greater than that of the control group(P < 0.05).The total effectiveness rates for the intervention and control groups were 89.58% and 70.83%, respectively, with the difference being statistically significant(P < 0.05). There was no statistically significant difference between the two groups in terms of the safety of the injections(P > 0.05).CONCLUSION: Intravenous infusion of cervus and cucumis polypeptides relieved pain and improved hip function of subjects with ANFH.Thus, the intravenous infusion of cervus and cucumis polypeptides was a safe, effective treatment for ANFH.

Key words: Femur head necrosis, Pain measurement, Cervus and cucumis polypeptide injection, Randomized clinical trial