目的 探讨杜仲壮骨丸联合地舒单抗治疗肝肾不足型绝经后骨质疏松症的临床疗效。方法 选取2022年1月—2025年10月武汉中西医结合骨科医院妇科收治的140例肝肾不足型绝经后骨质疏松症患者，按照随机数字表法分为对照组和治疗组，每组各70例。对照组患者给予地舒单抗注射液，60 mg/次，12周仅注射1次。治疗组在对照组的基础上给予口服杜仲壮骨丸，8～12丸/次，3次/d。两组用药12周。观察两组临床疗效，比较两组中医症状积分、视觉模拟疼痛量表（VAS）、髋关节功能评分（Harris）、WHO生活质量量表评分（WHOQOL-BREF）、骨密度指标、骨碱性磷酸酶（BALP）、β-胶原降解产物（β-CTX）、Ⅰ型胶原氨基端延长肽（PⅠNP）、骨钙素（BGP）、血清骨桥蛋白（OPN）、白细胞介素-6（IL-6）、血清骨硬化蛋白（SOST）、肿瘤坏死因子-α（TNF-α）水平。结果 治疗后，治疗组总有效率95.71%，显著高于对照组85.71%（P＜0.05）。治疗后，两组患者的头晕目眩积分、腰膝酸软积分、腰脊疼痛积分、下肢痿弱积分均低于同组治疗前（P＜0.05），且治疗后治疗组的头晕目眩积分、腰膝酸软积分、腰脊疼痛积分、下肢痿弱积分均低于对照组（P＜0.05）。治疗后，两组患者的Harris评分、WHOQOL-BREF评分高于治疗前，而VAS评分低于治疗前（P＜0.05），且治疗后治疗组的Harris评分、WHOQOL-BREF评分均高于对照组，而VAS评分低于对照组（P＜0.05）。治疗后，两组患者的腰椎L₁～L₄、股骨颈、全髋部的骨密度均高于同组治疗前（P＜0.05），且与对照组对比，治疗组腰椎L₁～L₄、股骨颈、全髋部的骨密度均升高（P＜0.05）。治疗后，两组BALP水平高于治疗前，而β-CTX水平低于治疗前；治疗组PⅠNP、BGP高于治疗前，而对照组PⅠNP、BGP较治疗前降低（P＜0.05），且治疗后治疗组BALP、PⅠNP、BGP高于对照组，β-CTX水平低于对照组（P＜0.05）。治疗后，两组患者OPN、IL-6、SOST、TNF-α水平均较治疗前降低（P＜0.05），且与对照组对比，治疗组的IL-6、OPN、SOST、TNF-α水平均降低（P＜0.05）。结论 杜仲壮骨丸与地舒单抗协同治疗肝肾不足型绝经后骨质疏松症效果显著，可改善临床症状及疼痛状态，并能调节骨代谢水平，明显提升生活质量，值得借鉴与应用。

Objective To explore the therapeutic effect of Duzhong Zhuanggu Pills combined with denosumab in treatment of postmenopausal osteoporosis with liver-kidney deficiency type. Methods A total of 140 patients with postmenopausal osteoporosis of the liver-kidney deficiency type who were admitted to Gynecology Department of Wuhan Integrated Traditional Chinese and Western Medicine Orthopedics Hospital from January 2022 to October 2025 were selected. They were divided into control group and treatment group according to random number table method, with 70 cases in each group. The control group patients were given Denosumab Injection, 60 mg/time, with only one injection given every 12 weeks. The treatment group patients were given oral Duzhong Zhuanggu Pills on basis of control group, 8 — 12 pills/time, 3 times daily. Both groups were administered the medication for 12 weeks. The clinical efficacy of two groups was observed, and Traditional Chinese medicine symptom score, visual analogue pain scale (VAS), hip joint function score (Harris), WHO Quality of Life Scale score (WHOQOL-BREF), bone density indicators, bone alkaline phosphatase (BALP), β-collagen degradation product (β-CTX), type I collagen amino-terminal propeptide (PⅠNP), osteocalcin (BGP), serum osteopontin (OPN), interleukin-6 (IL-6), serum osteosclerotic protein (SOST), and tumor necrosis factor-α (TNF-α) levels were compared between two groups. Results After treatment, the total effective rate of treatment group was 95.71%, significantly higher than that of control group (85.71%) (P< 0.05). After treatment, the scores of dizziness and vertigo, soreness and weakness of waist and knees, pain in lower back and spine, and weakness of lower limbs of patients in both groups were all lower than those before treatment in same group (P < 0.05), and the scores of dizziness and vertigo, soreness and weakness of the waist and knees, pain in lower back and spine, and weakness of lower limbs of treatment group after treatment were all lower than those of control group (P < 0.05). After treatment, Harris scores and WHOQOL-BREF scores of patients in both groups were higher than those before treatment, but VAS scores were lower than those before treatment (P< 0.05), and Harris scores and WHOQOL-BREF scores of treatment group were higher than those of control group, but VAS score was lower than that of control group (P < 0.05). After treatment, the bone density of lumbar vertebrae L₁-L₄, femoral neck, and entire hip in both groups was higher than that before treatment in same group (P < 0.05), and compared with control group, bone density of lumbar vertebrae L₁-L₄, femoral neck, and the entire hip in treatment group was increased (P < 0.05). After treatment, the levels of BALP in both groups were higher than those before treatment, while the level of β-CTX was lower than that before treatment; the levels of PⅠNP and BGP in treatment group were higher than those before treatment, while those in control group were lower than before treatment (P < 0.05), and after treatment, the levels of BALP, PⅠNP and BGP in treatment group were higher than those in control group, and the level of β-CTX was lower than that in the control group (P < 0.05). After treatment, the levels of OPN, IL-6, SOST, and TNF-α in both groups were lower than those before treatment (P < 0.05), and compared with control group, the levels of IL-6, OPN, SOST, and TNF-α in treatment group were lower (P < 0.05).Conclusion Duzhong Zhuanggu Pills combined with denosumab has a remarkable therapeutic effect in treatment of postmenopausal osteoporosis with liver-kidney deficiency type, and can alleviate clinical symptoms and pain conditions, regulate bone metabolism levels, significantly improve the quality of life, which is worthy of reference and application.

R982

武汉市医学科研项目（WZ21B02）