目的 探讨肾骨胶囊联合依降钙素治疗骨质疏松症的临床疗效。方法 纳入2023年1月—2024年11月河北省沧州中西医结合医院收治的88例骨质疏松症患者，按随机数字表法分为对照组和治疗组，每组各44例。对照组皮下注射依降钙素注射液，10 IU/次，2次/周。治疗组在对照组的基础上口服肾骨胶囊，2粒/次，3次/d。两组均连续治疗6个月。比较两组临床疗效，治疗前后腰椎L1～L2和髋关节松质骨的骨密度、相关评分[Tinetti平衡与步态评估量表（POMA）、腰背痛视觉模拟量表（VAS）评分、16条目骨质疏松症患者健康相关生存质量评估问卷（ECOS-16）]及单核细胞与淋巴细胞比值（MLR）和血清肿瘤坏死因子-α（TNF-α）、骨转换标志物[β-Ⅰ型胶原C末端交联肽（β-CTX）、Ⅰ型胶原N端前肽（PⅠNP）、骨钙素N端中分子片段（N-MID）]水平。结果 治疗后，治疗组总有效率（95.45%）明显高于对照组（81.82%），两组比较差异有统计学意义（P＜0.05）。治疗后，两组腰椎L1～L2及髋关节松质骨的骨密度均增加（P＜0.05），且治疗组上述骨密度高于对照组（P＜0.05）。治疗后，两组POMA评分升高（P＜0.05），腰背痛VAS和ECOS-16评分降低（P＜0.05）；且治疗组上述评分均优于对照组（P＜0.05）。治疗后，两组MLR和血清TNF-α及骨转换标志物β-CTX、PⅠNP、N-MID均降低（P＜0.05），且治疗组上述指标均低于对照组（P＜0.05）。结论 肾骨胶囊联合依降钙素治疗骨质疏松症，能有效调节患者机体免疫炎症及骨代谢平衡状态，增加骨密度，利于患者腰背痛及步态与平衡能力好转，促进生活质量改善。

Objective To explore the clinical efficacy of Shengu Capsules combined with elcitonin in treatment of osteoporosis. Methods A total of 88 patients with osteoporosis admitted to Cangzhou Hospital of Integrated TCM-WM·Hebei from January 2023 to November 2024 were enrolled and divided into control group and treatment group by the random number table method, with 44 cases in each group. The control group was treated with subcutaneous injection of Elcitonin Injection, 10 IU per time, twice a week. On the basis of control group, the treatment group was po administered with Shengu Capsules, 2 capsules per time, three times a day. They were continuous treated for 6 months. The clinical efficacy, bone mineral density of cancellous bone at lumbar vertebrae L1 — L2 and hip joint, related scores [performance-oriented mobility assessment (POMA), visual analogue scale (VAS) for lumbodorsal pain, and the 16-item evaluation of quality of life in osteoporosis (ECOS-16)], monocyte-to-lymphocyte ratio (MLR), serum tumor necrosis factor-α (TNF-α), and bone turnover markers including β-cross laps of type Ⅰ collagen (β-CTX), procollagen type Ⅰ N-terminal propeptide (PⅠNP) and N-terminal midfragment of osteocalcin (N-MID) were compared between the two groups before and after treatment. Results After treatment, the total effective rate in treatment group was 95.45%, which was significantly higher than 81.82% in control group (P < 0.05). After treatment, the bone mineral density of cancellous bone at lumbar vertebrae L1 — L2 and hip joint was increased in both groups (P < 0.05), and the bone mineral density of cancellous bone at lumbar vertebrae L1 — L2 and hip joint in the treatment group was higher than that in the control group (P < 0.05). After treatment, the POMA scores were increased (P < 0.05), and the VAS and ECOS-16 scores for low back pain were decreased in both groups (P < 0.05). All the above scores in the treatment group were superior to those in the control group (P < 0.05). The levels of MLR, serum TNF-α,β-CTX, PⅠNP and N-MID were decreased in both groups after treatment (P < 0.05), and these indicators in the treatment group were lower than those in the control group (P < 0.05). Conclusion Shengu Capsules combined with elcitonin in treatment of osteoporosis can effectively regulate the immune inflammation and bone metabolism balance of patients, increase bone density, facilitate the improvement of low back pain, gait and balance ability of patients, and promote the improvement of quality of life.

河北省中医药管理局科研计划项目（2024460）