目的 探討骨瓜提取物注射液聯(lián)合碳酸鈣D3片治療老年原發(fā)性骨質(zhì)疏松癥的療效及對骨密度、骨代謝的影響。方法 選擇2019年1月-2020年3月于河北省人民醫(yī)院就診的94例老年原發(fā)性骨質(zhì)疏松癥患者進(jìn)行研究，根據(jù)治療方案將患者分為對照組和觀察組，每組47例。對照組患者口服碳酸鈣D3片，600 mg/次，1次/d。觀察組在對照組治療的基礎(chǔ)上靜脈滴注骨瓜提取物注射液，100 mg中加入250 mL生理鹽水，1次/d。連續(xù)治療20 d后間隔10 d再進(jìn)行下1個(gè)療程，兩組患者均連續(xù)治療3個(gè)療程。觀察兩組患者的臨床療效，同時(shí)比較兩組治療前后的中醫(yī)證候積分、L₁-L₄骨密度（BMD）；膠原氨基端肽（P1NP）、Ⅰ型膠原羧基端肽交聯(lián)（β-CTX）、血清鈣（Ca）、磷（P）水平，以及Oswestry功能障礙指數(shù)（ODI）變化情況。結(jié)果 治療后，觀察組總有效率為95.74%，顯著高于對照組的82.98%（P<0.05）。治療后，兩組患者腰背疼痛、腰膝酸軟、下肢疼痛、下肢痿弱、步履艱難和目眩評分均顯著下降（P<0.05），且觀察組上述中醫(yī)癥狀體征評分明顯低于對照組（P<0.05）。治療后，兩組患者L₁-L₄骨密度值均升高（P<0.05），且觀察組明顯高于對照組（P<0.05）。治療后，兩組患者血清P1NP、β-CTX水平均顯著降低，血清鈣、血磷水平均顯著升高（P<0.05）；治療后，且觀察組骨代謝指標(biāo)水平明顯優(yōu)于對照組（P<0.05）。治療后，兩組患者ODI評分均顯著下降（P<0.05），且觀察組明顯低于對照組（P<0.05）。結(jié)論 骨瓜提取物注射液聯(lián)合碳酸鈣D3片治療老年原發(fā)性骨質(zhì)疏松癥療效較好，可有效減輕患者臨床癥狀，增加患者骨密度，調(diào)節(jié)骨代謝指標(biāo)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

河北省中醫(yī)藥管理局科研項(xiàng)目（2017174）