目的 探讨恒古骨伤愈合剂联合唑来膦酸注射液治疗早期股骨头坏死的临床疗效。方法 选取2023年1月—2024年6月在宜兴市人民医院就诊的早期股骨头坏死患者共计78例，患者按随机数字表法分为对照组和治疗组，每组39例。对照组患者静脉滴注唑来膦酸注射液，1瓶加入100 mL生理盐水充分稀释，至少持续15 min，治疗1次。治疗组在对照组基础上饭后1 h口服恒古骨伤愈合剂，25 mL/次，1次/2 d，持续治疗12个月。对比两组患者的临床疗效、关节功能、疼痛程度、影像学评分、血清指标。结果 治疗组的总有效率为94.87%，对照组的总有效率为76.92%，组间差异显著（P＜0.05）。治疗后，两组的髋关节功能量表（Harris）评分显著升高，数字疼痛量表（NRS）评分显著降低（P＜0.05）；治疗组的Harris评分高于对照组，NRS评分低于对照组（P＜0.05）。治疗后，两组的股骨头形态、坏死面积、骨关节炎评分显著减小（P＜0.05）；治疗组治疗后的影像学各项评分低于对照组（P＜0.05）。两组治疗后的血清视黄醇结合蛋白4、网膜素1水平显著升高，血清Dickkopf-1（DKK-1）水平显著降低（P＜0.05）；治疗组治疗后的血清视黄醇结合蛋白4、网膜素1水平高于对照组，血清DKK-1水平低于对照组（P＜0.05）。结论 恒古骨伤愈合剂联合唑来膦酸注射液可提高早期股骨头坏死的临床疗效，减轻疼痛程度，改善关节功能，与减轻炎症和抑制骨破坏有关。

Objective To investigate the clinical efficacy of Henggu Gushangyu Mixture combined with Zoledronic Acid Injection in treatment of early femoral head osteonecrosis. Methods A total of 78 patients with early femoral head osteonecrosis who received treatment at Yixing People’s Hospital from January 2023 to June 2024 were selected. The patients were divided into control group and treatment group using a random number table method, with 39 cases in each group. The control group patients received intravenous infusion of Zoledronic Acid Injection, diluted thoroughly with 100 mL physiological saline in one bottle for at least 15 min, and treated once. The treatment group received oral administration of Henggu Gushangyu Mixture, 25 mL/time, once every 2 d, on the basis of the control group for 12 months after meals. The clinical efficacy, joint function, pain level, imaging score, and serum indicators were compared between two groups of patients. Results The total effective rate of the treatment group was 94.87%, while the total effective rate of the control group was 76.92%, with significant differences between two groups (P< 0.05). After treatment, Harris score significantly increased, while the NRS score significantly decreased in two groups (P < 0.05).The Harris score of the treatment group was higher than that of the control group, but the NRS score was lower than that of the control group (P < 0.05). After treatment, the scores of femoral head morphology, necrotic area, and osteoarthritis of two groups significantly decreased (P < 0.05). The imaging scores of the treatment group were lower than those of the control group after treatment (P < 0.05). After treatment, the serum levels of retinol binding protein 4 and omentin-1 significantly increased in two groups, while the serum level of Dickkopf-1 (DKK-1) significantly decreased (P < 0.05). The serum levels of retinol binding protein 4 and omentin-1 in the treatment group were higher than those in the control group after treatment, but the serum level of DKK-1 was lower than that in the control group (P < 0.05). Conclusion The combination of Henggu Gushangyu Mixture and Zoledronic Acid Injection can improve the clinical efficacy of early femoral head osteonecrosis, alleviate pain, improve joint function, and is related to reducing inflammation and inhibiting bone destruction.

R982

无锡市卫生健康委科研项目（Q202119）