目的 探讨淫羊藿总黄酮胶囊联合阿仑膦酸钠治疗原发性骨质疏松症（肾阳虚证）的临床疗效。方法 选择2023年8月—2023年12月在焦作市人民医院和焦作市第二人民医院就诊的原发性骨质疏松症（肾阳虚证）患者140例，随机分为对照组（70例）和治疗组（70例）。对照组口服阿仑膦酸钠片，1片/次，1次/d。在对照组基础上，治疗组患者口服淫羊藿总黄酮胶囊，2粒/次，3次/d。两组患者均治疗6个月。观察两组患者临床疗效，比较治疗前后两组患者数字疼痛强度量表（NRS）评分，腰椎、股骨颈和桡尺骨骨密度，骨代谢指标骨钙素（OC）、Ⅰ型原胶原C-端前肽（PICP）、骨源性碱性磷酸酶（BALP），骨吸收标志物包括I型胶原交联C-末端肽（CTX）和抗酒石酸酸性磷酸酶（TRACP）水平，及炎症因子肿瘤坏死因子-α（TNF-α）、白细胞介素-17（IL-17）和生长分化因子15（GDF15）水平。结果 治疗后，对照组和治疗组的总有效率分别为80.00%、92.86%，两组比较差异具有统计学意义（P＜0.05）。治疗后，两组患者NRS评分比治疗前明显下降（P＜0.05），且治疗后治疗组评分降低更显著（P＜0.05）。治疗后，两组患者腰椎、股骨颈及尺桡骨骨密度及T值均显著增加（P＜0.05），且治疗组骨密度和T值相对于对照组增加更显著（P＜0.05）。治疗后，两组OC、PICP和BALP水平较治疗前显著升高，而CTX和TRACP则显著降低（P＜0.05），且治疗组这些骨代谢指标明显好于对照组（P＜0.05）。治疗后，两组患者TNF-α、IL-17和GDF15水平均显著降低（P＜0.05），且治疗组患者TNF-α、IL-17和GDF15水平比对照组降低更为显著（P＜0.05）。结论 淫羊藿总黄酮胶囊联合阿仑膦酸钠治疗原发性骨质疏松症（肾阳虚证）具有显著的疗效，可能与改善骨代谢及抑制炎症因子的表达有关。

Objective To investigate the clinical efficacy of Epimedium Total Flavonoids Capsules combined with alendronate sodium in treatment of primary osteoporosis (kidney-yang deficiency syndrome). Methods Patients (140 cases) with primary osteoporosis (kidney-yang deficiency syndrome) in Jiaozuo People’s Hospital and Jiaozuo Second People’s Hospital from August 2023 to December 2023 were randomly divided into control (70 cases) and treatment (70 cases) group. Patients in the control group were po administered with Alendronate Sodium Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Epimedium Total Flavonoids Capsules, 2 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical evaluations were evaluated, the NRS scores, bone mineral density of lumbar vertebra, femoral neck and radioulna, T scores of lumbar vertebra, femoral neck and radioulna, the levels of bone metabolism indexes OC, PICP, BALP, CTX and TRACP, and the levels of inflammatory factors TNF-a, IL-17 and GDF15 in two groups before and after treatment were compared. Results After treatment, the total effective rates in the control group and the treatment group were 80.00% and 92.86%, respectively, and the difference between the two groups was statistically significant (P < 0.05). After treatment, the NRS scores in two groups were significantly decreased compared with those before treatment (P < 0.05), and the scores in the treatment group were decreased more significantly (P < 0.05). After treatment, the bone mineral density and T value of the lumbar spine, femoral neck, ulna and radius were significantly increased in two groups (P < 0.05), and the bone mineral density and T value of the treatment group were increased more significantly compared with which in the control group (P < 0.05). After treatment, the levels of OC, PICP and BALP in two groups were significantly increased compared with those before treatment, while CTX and TRACP were significantly decreased (P < 0.05), and these bone metabolism indicators in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the levels of TNF-α, IL-17 and GDF15 in two groups were significantly reduced (P < 0.05), and the levels of TNF-α, IL-17 and GDF15 in the treatment group were more significantly reduced than those in the control group (P < 0.05). Conclusion Epimedium Total Flavonoids Capsules combined with alendronate sodium had a significant efficacy in treatment of primary osteoporosis (kidney-yang deficiency syndrome), which may be related to improving bone metabolism and inhibiting the expression of inflammatory factors.

R982

河南省医学科技攻关计划项目(LHGJ20210927,LHGJ20221011)