目的 探讨金天格胶囊联合地舒单抗治疗原发性骨质疏松症的临床疗效。方法 2022年12月—2024年12月河北省第七人民医院骨科收治的102例原发性骨质疏松症患者，按照随机数字法分为对照组和治疗组，每组51例。对照组患者腹部皮下注射地舒单抗注射液，60 mg/次，1次/6个月。治疗组在对照组的治疗基础上口服金天格胶囊，一次3粒，3次/d。两组治疗6个月。观察两组的临床疗效，比较两组中医症状积分、骨密度、Ⅰ型胶原C端肽（CTX-Ⅰ）、血清骨钙素（BGP）、血清抗酒石酸酸性磷酸酶-5b（TRACP-5b）、Ⅰ型前胶原氨基端原肽（PINP）、生长分化因子（GDF15）、白细胞介素-17（IL-17）、胰岛素样生长因子（IGF-1）、肿瘤坏死因子-α（TNF-α）水平的变化情况。结果 治疗后，治疗组总有效率是98.04%，显著高于对照组的84.31%（P＜0.05）。治疗后，两组下肢抽搐评分、腰酸膝软无力评分、持重困难评分、腰脊痛评分均显著降低（P＜0.05）；治疗后，与对照组对比，治疗组患者下肢抽搐评分、腰酸膝软无力评分、持重困难评分、腰脊痛评分均更低（P＜0.05）。治疗后，两组股骨颈、腰椎L_2～4、桡骨远端的骨密度值均显著升高（P＜0.05）；治疗后，与对照组对比，治疗组股骨颈、腰椎L_2～4、桡骨远端的骨密度值均更高（P＜0.05）。治疗后，两组CTX-Ⅰ、TRACP-5b较治疗前显著降低，而BGP、PINP显著升高（P＜0.05）；治疗后，与对照组对比，治疗组CTX-Ⅰ、TRACP-5b均更低，BGP、PINP更高（P＜0.05）。治疗后，两组GDF15、IL-17、TNF-α水平均显著降低，而IGF-1升高（P＜0.05）；治疗后，与对照组对比，治疗组GDF15、IL-17、TNF-α水平均更低，且IGF-1水平更高（P＜0.05）。结论 金天格胶囊联合地舒单抗治疗原发性骨质疏松症具有较好的治疗效果，可以降低中医症状评分，提高骨密度，调节骨代谢及炎性因子相关指标。

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

河北省医学科学研究课题计划项目（20211314）