目的 探討金天格膠囊聯(lián)合地舒單抗治療原發(fā)性骨質疏松癥的臨床療效。方法 2022年12月—2024年12月河北省第七人民醫(yī)院骨科收治的102例原發(fā)性骨質疏松癥患者，按照隨機數(shù)字法分為對照組和治療組，每組51例。對照組患者腹部皮下注射地舒單抗注射液，60 mg/次，1次/6個月。治療組在對照組的治療基礎上口服金天格膠囊，一次3粒，3次/d。兩組治療6個月。觀察兩組的臨床療效，比較兩組中醫(yī)癥狀積分、骨密度、Ⅰ型膠原C端肽（CTX-Ⅰ）、血清骨鈣素（BGP）、血清抗酒石酸酸性磷酸酶-5b（TRACP-5b）、Ⅰ型前膠原氨基端原肽（PINP）、生長分化因子（GDF15）、白細胞介素-17（IL-17）、胰島素樣生長因子（IGF-1）、腫瘤壞死因子-α（TNF-α）水平的變化情況。結果 治療后，治療組總有效率是98.04%，顯著高于對照組的84.31%（P＜0.05）。治療后，兩組下肢抽搐評分、腰酸膝軟無力評分、持重困難評分、腰脊痛評分均顯著降低（P＜0.05）；治療后，與對照組對比，治療組患者下肢抽搐評分、腰酸膝軟無力評分、持重困難評分、腰脊痛評分均更低（P＜0.05）。治療后，兩組股骨頸、腰椎L_2～4、橈骨遠端的骨密度值均顯著升高（P＜0.05）；治療后，與對照組對比，治療組股骨頸、腰椎L_2～4、橈骨遠端的骨密度值均更高（P＜0.05）。治療后，兩組CTX-Ⅰ、TRACP-5b較治療前顯著降低，而BGP、PINP顯著升高（P＜0.05）；治療后，與對照組對比，治療組CTX-Ⅰ、TRACP-5b均更低，BGP、PINP更高（P＜0.05）。治療后，兩組GDF15、IL-17、TNF-α水平均顯著降低，而IGF-1升高（P＜0.05）；治療后，與對照組對比，治療組GDF15、IL-17、TNF-α水平均更低，且IGF-1水平更高（P＜0.05）。結論 金天格膠囊聯(lián)合地舒單抗治療原發(fā)性骨質疏松癥具有較好的治療效果，可以降低中醫(yī)癥狀評分，提高骨密度，調節(jié)骨代謝及炎性因子相關指標。

Objective To explore the clinical study of Jintiange Capsules combined with denosumab in treatment of primary osteoporosis. Methods From December 2022 to December 2024, 102 patients with primary osteoporosis admitted to the Department of Orthopedics of the Seventh People’s Hospital of Hebei Province were divided into control group and treatment group according to the random number method, with 51 cases in each group. Patients in control group were subcutaneously injected with Denosumab Injection on the abdomen, 60 mg each time, once for 6 months. Patients in treatment group took Jintiange Capsules orally on the basis of control group, 3 capsules each time, 3 times daily. The two groups were treated for 6 months. The clinical efficacy of two groups was observed. The changes of TCM symptom scores, bone mineral density, CTX-Ⅰ, BGP, TRACP-5b, PINP, GDF15, IL-17, IGF-1, and TNF-α were compared between two groups. Results After treatment, the total effective rate of treatment group was 98.04%, significantly higher than that of control group (84.31%, P < 0.05). After treatment, the scores of lower extremity convulsions, low back and knee weakness, difficulty in holding weight, and low back and spine pain in both groups were significantly decreased (P < 0.05). After treatment, compared with control group, the scores of lower extremity convulsions, low back and knee weakness, difficulty in holding weight, and low back and spine pain in the treatment group were all lower (P < 0.05). After treatment, the bone mineral density values of the femoral neck, lumbar L_2-4 and distal radius in both groups increased significantly (P < 0.05). After treatment, compared with control group, the bone mineral density values of the femoral neck, lumbar L_2-4, and the distal radius in treatment group were all higher (P < 0.05). After treatment, CTX-I and TRACP-5b in both groups were significantly decreased compared with those before treatment, but BGP and PINP were significantly increased (P < 0.05). After treatment, compared with control group, CTX-I and TRACP-5b in treatment group were both lower, and BGP and PINP were higher (P < 0.05). After treatment, the levels of GDF15, IL-17, and TNF-α in both groups decreased significantly, but IGF-1 increased (P < 0.05). After treatment, compared with control group, the levels of GDF15, IL-17, and TNF-α in treatment group were all lower, and the level of IGF-1 was higher (P < 0.05). Conclusion Jintiange Capsules combined with denosumab has a good therapeutic effect in treatment of primary osteoporosis, and can reduce the TCM symptom score, increase bone density, and regulate bone metabolism and related indicators of inflammatory factors.

R982

河北省醫(yī)學科學研究課題計劃項目（20211314）