目的 探讨地仲强骨胶囊联合阿法骨化醇治疗老年性骨质疏松症的临床疗效。方法 选取2018年1月—2019年5月于河南省洛阳正骨医院（河南省骨科医院）诊治的136例老年骨质疏松症患者，随机分为对照组和治疗组，每组各68例。对照组口服阿法骨化醇软胶囊，2粒/次，1次/d；治疗组患者在对照组基础上口服地仲强骨胶囊，3粒/次，3次/d。两组患者均连续治疗6个月。观察两组的临床疗效，比较两组治疗前后NRS评分、ODI评分、骨密度、骨形成和骨吸收标志物、细胞因子水平的变化情况。结果 治疗后，对照组总有效率75.0%，治疗组总有效率88.2%，两组比较差异具有统计学意义（P<0.05）。两组NRS和ODI评分均较治疗前显著下降，且治疗后治疗组NRS和ODI评分下降更明显（P<0.05）。两组腰椎L₂-L₄、股骨颈骨密度均较治疗前显著提高（P<0.05）；且治疗后治疗组腰椎L₂-L₄、股骨颈骨密度提高更明显（P<0.05）。两组患者骨保护素（OPG）、Ⅰ型前胶原氨基端前肽（PINP）、骨形态发生蛋白-2（BMP-2）水平均显著提高（P<0.05）；且治疗组治疗后OPG、PINP、BMP-2水平提高更明显（P<0.05）。治疗后，两组患者β-胶原降解产物（β-CTX）、I型胶原交联N-末端肽（NTX）水平均显著降低（P<0.05）；且治疗后治疗组β-CTX、NTX水平降低更明显（P<0.05）。治疗后，两组患者白细胞介素6（IL-6）、转化生长因子-α（TNF-α）水平均显著下降，胰岛素样生长因子（IGF-I）、转化生长因子-β（TGF-β）水平均显著提高（P<0.05）；且治疗后治疗组IL-6、TNF-α水平下降更明显，IGF-I、TGF-β水平提高更明显（P<0.05）。结论 地仲强骨胶囊联合阿法骨化醇治疗老年骨质疏松症具有良好的临床疗效，可有效提高骨密度，缓解患者疼痛症状，改善功能障碍，调节骨代谢，具有一定的临床推广应用价值。

Objective To explore the clinical effect of Dizhong Qianggu Capsules combined with alfacalcitol in treatment of senile osteoporosis. Methods 136 Cases with senile osteoporosis treated in Luoyang Orthopedic-Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital) from January 2018 to May 2019 were randomly divided into control group and treatment group with 68 cases in each group. The patients in the control group were po administered with Alfacalcidol Soft Capsules, 2 grains/time, once daily. The treatment group was po administered with Dizhong Qianggu Capsules on the basis of the control group, 3 grain/time, three times daily. All patients were treated for 6 months. The clinical efficacy was observed, and the changes of NRS score, ODI score, bone density, markers of bone formation and bone absorption, and cytokine levels before and after treatment in the two groups were compared. Results After treatment, the total effective rate was 75.0% in the control group and 88.2% in the treatment group, and the difference between the two groups was statistically significant (P<0.05). The NRS and ODI scores in both groups decreased significantly compared with those before treatment (P<0.05), and the NRS and ODI scores in the treatment group decreased more significantly after treatment (P<0.05). The bone density of lumbar L₂-L₄ and femoral neck in both groups was significantly higher than that before treatment (P<0.05). After treatment, lumbar L₂-L₄ and femoral neck bone mineral density increased more significantly in the treatment group (P<0.05). Two groups of patients with bone protection element (OPG), a former Ⅰ type collagen amino terminal propeptide (PINP), BMP-2 (BMP-2) levels were significantly increased (P<0.05); In addition, the OPG, PINP and BMP-2 levels in the treatment group increased more significantly after treatment (P<0.05). After treatment, the levels of collagen degradation products (β-CTX) and type I collagen cross-linked n-terminal peptide (NTX) were significantly reduced in both groups (P<0.05). Moreover, after treatment, the levels of β-CTX and NTX in the treatment group decreased more significantly (P<0.05). After treatment, the levels of interleukin 6 (IL-6) and transforming growth factor α (TNF-α) in both groups decreased significantly, but the levels of IGF-I and TGF-β increased significantly (P<0.05). After treatment, IL-6 and TNF-α levels in the treatment group decreased more significantly, and IGF-I and TGF-β levels increased more significantly (P<0.05). Conclusion Dizhong Qianggu Capsules combined with alfacalcitol has a good clinical effect in treatment of senile osteoporosis, and can effectively improve bone density, relieve pain symptoms, and can improve dysfunction and regulate bone metabolism, which has a certain clinical application value.

R977