目的 探讨龟鹿补肾丸联合阿法骨化醇治疗骨质疏松症的临床疗效。方法 纳入2023年3月—2024年12月河北省沧州中西医结合医院收治的80例骨质疏松症患者，按照随机数字表法平均分为对照组和治疗组。对照组早餐后温水送服阿法骨化醇软胶囊，2粒/次，1次/d。在此基础上，治疗组早、晚餐后温水送服龟鹿补肾丸，6 g/次，2次/d。两组疗程均为6个月。比较两组临床疗效，治疗前后腰椎L2～L4、股骨颈、全髋部部位的骨密度、腰背疼痛视觉模拟量表（VAS）、症状自评量表（SCL-90）、中国人骨质疏松症生存质量简明量表（COQOL）评分及血清Ⅰ型胶原N端前肽（PⅠNP）、β-Ⅰ型胶原C末端交联肽（β-CTX）、基质金属蛋白酶-9（MMP-9）、白细胞介素-17（IL-17）水平和系统性免疫炎症指数（SII）。结果 治疗组总有效率为92.50%，较对照组的75.00%更高（P＜0.05）。治疗后，两组腰椎L2～L4、股骨颈、全髋部骨密度均升高（P＜0.05）；且治疗组各部位骨密度均高于对照组（P＜0.05）。治疗后，两组腰背疼痛VAS、SCL-90和COQOL评分均降低（P＜0.05）；且治疗组上述评分均低于对照组（P＜0.05）。治疗后，两组血清PⅠNP、β-CTX、MMP-9、IL-17水平和SII均降低（P＜0.05）；且治疗组上述血清指标均低于对照组（P＜0.05）。结论 龟鹿补肾丸联合阿法骨化醇治疗骨质疏松症，能有效减轻患者腰背疼痛症状，改善心理状态和生存质量，进一步调节机体骨代谢异常及免疫炎症反应，减轻骨微结构损伤，增加骨密度，安全性亦较佳。

Objective To investigate the clinical efficacy of Guilu Bushen Pills combined with alfacalcidol in treatment of osteoporosis. Methods A total of 80 patients with osteoporosis admitted to Cangzhou Hospital of Integrated TCM-WM·Hebei from March 2023 to December 2024 were enrolled and randomly divided into a control group and a treatment group using a random number table method, with 40 patients in each group. The control group received Alfacalcidol Soft Capsules orally with warm water after breakfast (2 capsules once daily). On this basis, the treatment group received Guilu Bushen Pills orally with warm water after breakfast and dinner (6 g twice daily). The treatment course for both groups was 6 months. Clinical efficacy was compared between the two groups. Bone mineral density at the lumbar spine (L2—L4), femoral neck, and total hip; scores of the visual analogue scale (VAS) for low back pain, symptom checklist-90 (SCL-90), and Chinese Osteoporosis Quality of Life Short Scale (COQOL); as well as serum levels of procollagen type Ⅰ N-terminal propeptide (PⅠNP), β-C-terminal cross-linked telopeptide of type Ⅰ collagen (β-CTX), matrix metalloproteinase-9 (MMP-9), interleukin-17 (IL-17), and the systemic immune-inflammation index (SII) were measured before and after treatment. Results The total effective rate in the treatment group (92.50%) was higher than that in the control group (75.00%, P < 0.05). After treatment, bone mineral density at the lumbar spine (L2—L4), femoral neck, and total hip increased in both groups (P < 0.05); the treatment group had higher bone mineral density at all these sites compared with the control group (P < 0.05). After treatment, the VAS, SCL-90, and COQOL scores decreased in both groups (P < 0.05); the treatment group showed significantly lower scores than the control group (P < 0.05). After treatment, serum levels of PⅠNP, β-CTX, MMP-9, IL-17, and SII decreased in both groups (P < 0.05); the treatment group had lower levels of the above serum indicators than the control group (P < 0.05). Conclusion Guilu Bushen Pills combined with alfacalcidol in the treatment of osteoporosis can effectively relieve low back pain, improve psychological status and quality of life, further regulate bone metabolism abnormalities and immune-inflammatory responses, alleviate bone microstructural damage, and increase bone mineral density, with favorable safety.

R982

河北省中医药类科学研究课题计划项目(2024460)