目的 探讨芪骨胶囊联合阿仑膦酸钠维D3治疗老年骨质疏松患者的安全性与有效性。方法 选取2019年6月—2020年12月在空军军医大学第二附属医院诊治的94例老年骨质疏松患者，按照入组顺序分成对照组和治疗组，每组各47例。对照组口服阿仑膦酸钠维D3片，1片/次，1次/周；治疗组患者在对照组的基础上口服芪骨胶囊，3粒/次，1次/d。两组患者治疗25周。观察两组患者临床疗效，比较治疗前后两组患者NRS评分、Oswestry功能障碍指数和生活质量评分，及血清耐酒石酸酸性磷酸酶5b（TRACP-5b）、Ⅰ型胶原交联氨基末端肽（NTX）和Ⅰ型原胶原氨基末端原肽（PINP）水平。结果 治疗后，对照组总有效率显著低于治疗组（82.98%vs 95.74%，P<0.05）。治疗后，两组NRS评分和Oswestry功能障碍指数显著下降，而生活质量评分显著升高（P<0.05），且治疗组各指标比对照组改善更显著（P<0.05）。治疗后，两组患者血清TRACP-5b和NTX水平显著降低，而PINP水平显著升高（P<0.05），且治疗组相对于对照组改善更显著（P<0.05）。结论 芪骨胶囊联合阿仑膦酸钠维D3治疗老年骨质疏松疗效确切，可显著改善患者疼痛症状和生活质量，平衡骨转换和骨形成水平。

Objective To investigate the safety and effectiveness of Qigu Capsules combined with alendronate sodium and vitamin D3 in treatment of senile osteoporosis. Methods Patients (94 cases) with senile osteoporosis in the Second Affiliated Hospital of PLA Air Force Military Medical University from July 2019 to December 2020 were divided into control and treatment groups according the order of entry, and each group had 47 cases. Patients in the control group were po administered with Alendronate Sodium and Vitamin D3 Tablets, 1 tablet/time, once weekly. Patients in the treatment group were po administered with Qigu Capsules, 3 grains/time, once daily. Patients in two groups were treated for 25 weeks. After treatment, the clinical efficacy was evaluated, the NRS score, Oswestry dysfunction index and quality of life score, the levels of serum TRACP-5b, NTX, and PINP in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the control group was significantly lower than that of the treatment group (82.98% vs 95.74%, P < 0.05). After treatment, the NRS score and Oswestry dysfunction index in two groups were significantly decreased, while the quality of life score was significantly increased (P < 0.05), and the improvement of each index in the treatment group was more significant than that in the control group (P < 0.05). After treatment, the serum levels of TRACP-5b and NTX in two groups were significantly decreased, while the level of PINP was significantly increased (P < 0.05), and the treatment group improved more significantly than the control group (P < 0.05). Conclusion The curative effect of Qigu Capsules combined with alendronate sodium and vitamin D3 in treatment of senile osteoporosis is definite, and can significantly improve the pain symptoms and quality of life, and balance the level of bone turnover and bone formation.

R977

陕西省重点研发计划项目（2017SF-223）