目的 探讨骨瓜提取物注射液联合碳酸钙D3片治疗老年原发性骨质疏松症的疗效及对骨密度、骨代谢的影响。方法 选择2019年1月-2020年3月于河北省人民医院就诊的94例老年原发性骨质疏松症患者进行研究，根据治疗方案将患者分为对照组和观察组，每组47例。对照组患者口服碳酸钙D3片，600 mg/次，1次/d。观察组在对照组治疗的基础上静脉滴注骨瓜提取物注射液，100 mg中加入250 mL生理盐水，1次/d。连续治疗20 d后间隔10 d再进行下1个疗程，两组患者均连续治疗3个疗程。观察两组患者的临床疗效，同时比较两组治疗前后的中医证候积分、L₁-L₄骨密度（BMD）；胶原氨基端肽（P1NP）、Ⅰ型胶原羧基端肽交联（β-CTX）、血清钙（Ca）、磷（P）水平，以及Oswestry功能障碍指数（ODI）变化情况。结果 治疗后，观察组总有效率为95.74%，显著高于对照组的82.98%（P<0.05）。治疗后，两组患者腰背疼痛、腰膝酸软、下肢疼痛、下肢痿弱、步履艰难和目眩评分均显著下降（P<0.05），且观察组上述中医症状体征评分明显低于对照组（P<0.05）。治疗后，两组患者L₁-L₄骨密度值均升高（P<0.05），且观察组明显高于对照组（P<0.05）。治疗后，两组患者血清P1NP、β-CTX水平均显著降低，血清钙、血磷水平均显著升高（P<0.05）；治疗后，且观察组骨代谢指标水平明显优于对照组（P<0.05）。治疗后，两组患者ODI评分均显著下降（P<0.05），且观察组明显低于对照组（P<0.05）。结论 骨瓜提取物注射液联合碳酸钙D3片治疗老年原发性骨质疏松症疗效较好，可有效减轻患者临床症状，增加患者骨密度，调节骨代谢指标含量，改善腰背功能。

Objective To investigate the effect of Gugua Extract Injection combined with Calcium Carbonate and Vitamin D3 Tablets in treatment of primary senile osteoporosis, and its effect on bone density and bone metabolism. Methods A total of 94 elderly patients with primary osteoporosis admitted to Hebei General Hospital from January 2019 to March 2020 were selected for the study. According to the treatment plan, the patients were divided into control group and observation group, with 47 patients in each group. Patients in the control group were po administered with Calcium Carbonate and Vitamin D3 Tablets, 600 mg/time, once daily. Patients in the observation were injected with Gugua Extract Injection intravenously on the basis of control group, 250 mL normal saline was added into 100 mg, once daily. Continuous treatment for 20 days was followed by another course of treatment at an interval of 10 days. Patients in both groups received three courses of treatment consecutively. The clinical efficacy of two groups was observed, and the TCM syndrome score, BMD of L₁-L₄, the levels of P1NP, β-CTX, serum calcium (Ca), phosphorus (P), and Oswestry disability index changes before and after treatment were compared between two groups. Results After treatment, the total effective rate of the observation group was 95.74%, significantly better than 82.98% of the control group (P<0.05). After treatment, the scores of TCM symptoms and signs were significantly decreased in two groups (P<0.05), and the scores of TCM symptoms and signs in the observation group were significantly lower than those in the control group (P<0.05). After treatment, the BMD of patients in two groups was increased (P<0.05), and the observation group was significantly higher than the control group (P<0.05). After treatment, the serum levels of P1NP and β-CTX in two groups were significantly reduced, but the levels of Ca and P were significantly increased (P<0.05). After treatment, the bone metabolism index levels of the observation group was significantly better than those of the control group (P<0.05). After treatment, ODI score in two groups decreased significantly (P<0.05), and the ODI score in the observation group was significantly lower than that in the control group (P<0.05). Conclusion Gugua Extract Injection combined with Calcium Carbonate and Vitamin D3 Tablets has a good effect in treatment of primary osteoporosis in the elderly, which can effectively reduce the clinical signs and symptoms, increase the patient's bone density, regulate the content of bone metabolism index, and improve the lumbago and back function.

R977

河北省中医药管理局科研项目（2017174）