【目的】 评价骨宝丸治疗肾阴阳虚型绝经后骨质疏松症的临床疗效及安全性，并探讨其对骨代谢、骨密度和炎症因子 的影响。【方法】 选取 2024 年 9 月至 2025 年 2 月佛山市妇幼保健院和中医院骨科收治的肾阴阳虚型绝经后骨质疏松症患者 164例，采用随机数字表法将患者随机分为治疗组和对照组，每组各82例。对照组给予常规西医治疗，治疗组在对照组基础 上加用骨宝丸治疗，疗程均为3个月。观察2组患者治疗前后血清骨代谢指标[Ⅰ型胶原交联C末端肽（β-CTX）、Ⅰ型前胶原 氨基末端肽（PINP）、骨钙素（BGP）、骨碱性磷酸酶（BALP）]、骨代谢调节因子[硬骨素（SOST）、骨桥蛋白（OPN）]、炎症因子 [肿瘤坏死因子α（TNF-α）、白细胞介素1（IL-1）、白细胞介素6（IL-6）、白细胞介素17（IL-17）]、骨密度（腰椎、股骨颈及全 髋部）、中医证候积分、疼痛数字评分量表（NRS）评分、中国骨质疏松症生活质量量表（COQOL）评分、Oswestry功能障碍指 数（ODI）评分的变化情况，并评价2组患者的临床疗效和用药安全性。【结果】（1）疗效方面，治疗3个月后，治疗组的总有效 率为 95.12%（78/82），对照组为 79.27%（65/82），组间比较（χ2检验），治疗组的疗效明显优于对照组（P＜0.05）。（2）骨代谢指 标方面，治疗后，2组患者的血清β-CTX水平均较治疗前显著降低（P＜0.05），血清PINP、BGP、BALP水平均较治疗前显著 升高（P＜0.05），且治疗组对血清β-CTX水平的降低幅度及对血清PINP、BGP、BALP水平升高幅度均明显优于对照组（P＜ 0.01）。（3）骨代谢调节因子方面，治疗后，2组患者血清SOST水平均较治疗前显著降低（P＜0.05），血清OPN水平均较治疗前 显著升高（P＜0.05），且治疗组对血清 SOST 水平的降低幅度及对血清 OPN 水平的升高幅度均明显优于对照组（P＜0.01）。 （4）炎症因子方面，治疗后，2组患者血清 TNF-α、IL-1、IL-6、IL-17水平均较治疗前显著降低（P＜0.05），且治疗组的降 低幅度均明显优于对照组（P＜0.01）。（5）骨密度方面，治疗后，2组患者的腰椎、股骨颈、全髋骨骨密度均较治疗前显著升 高（P＜0.05），且治疗组的升高幅度均明显优于对照组（P＜0.01）。（6）临床量表评分方面，治疗后，2组患者的中医证候积分 和NRS、COQOL、ODI评分均较治疗前显著降低（P＜0.05），且治疗组的降低幅度均明显优于对照组（P＜0.01）。（7）安全性方 面，对照组的不良反应发生率为3.66%（3/82），治疗组为4.88%（4/82），组间比较，差异无统计学意义（P＞0.05）。【结论】 骨 宝丸治疗肾阴阳虚型绝经后骨质疏松症患者疗效显著，能有效改善患者临床症状，促进骨形成，增加骨密度，抑制炎症反 应，提高生活质量，且安全性良好，其作用机制可能与调节骨代谢标志物、骨代谢调节因子及炎症因子有关。

Objective To evaluate the clinical efficacy and safety of Gubao Pill in treating postmenopausal osteoporosis （PMOP） with kidney yin-yang deficiency syndrome， and to investigate its effects on bone metabolism，bone mineral density （BMD），and inflammatory factors. Methods A total of 164 PMOP patients with kidney yin-yang deficiency syndrome， admitted to the Orthopedics Departments of Foshan Maternal and Child Health Hospital and Foshan Hospital of Traditional Chinese Medicine between September 2024 and February 2025， were selected and randomly divided into a treatment group and a control group （n=82 each） using a random number table method. The control group received conventional western medicine treatment， while the treatment group received additional Gubao Pill based on the control group’s regimen. The treatment course for both groups was 3 months. Changes in serum bone metabolism markers [β-C-terminal telopeptide of type I collagen （β-CTX），Nterminal propeptide of type I procollagen （PINP）， osteocalcin （BGP）， bone alkaline phosphatase （BALP）]， bone metabolism regulators [sclerostin （SOST），osteopontin （OPN）]，inflammatory factors [tumor necrosis factor- α（TNF- α），interleukin-1（IL-1），interleukin-6（IL-6），interleukin-17（IL-17）]， BMD （lumbar spine， femoral neck， and total hip）， traditional Chinese medicine（TCM） syndrome scores， pain Numerical Rating Scale （NRS） scores，Chinese Osteoporosis Quality of Life Scale （COQOL） scores，and Oswestry Disability Index （ODI） scores were observed before and after treatment. The clinical efficacy and medication safety were evaluated for both groups. Results （1） Therapeutic effect：After 3 months of treatment，the total effective rate was 95.12% （78/82） in the treatment group，significantly higher than 79.27% （65/82） in the control group. The intergroup comparison （by chi-square test） showed that the efficacy in the treatment group was significantly superior to that in the control group（P＜0.05）.（2） Bone metabolism markers：After treatment，serum β-CTX levels significantly decreased （P＜0.05）， while serum PINP， BGP， and BALP levels significantly increased （P＜0.05） in both groups compared to pre-treatment levels. The treatment group showed significantly greater reductions in serum β-CTX and significantly greater increases in serum PINP，BGP，and BALP than the control group （P＜0.01）. （3） Bone metabolism regulators： After treatment， serum SOST levels significantly decreased （P＜0.05） and serum OPN levels significantly increased （P＜0.05） in both groups compared to pre-treatment levels. The treatment group demonstrated significantly greater reductions in serum SOST and significantly greater increases in serum OPN than the control group （P＜0.01）.（4） Inflammatory factors：After treatment，serum levels of TNF-α， IL-1， IL-6， and IL-17 significantly decreased （P＜0.05） in both groups compared to pre-treatment levels， with the treatment group showing significantly greater reductions than the control group （P＜0.01）.（5） BMD： After treatment，BMD of lumbar spine，femoral neck，and total hip significantly increased （P＜0.05） in both groups compared to pre-treatment levels，and the treatment group exhibited significantly greater increases than the control group （P＜0.01）.（6） Clinical scale scores：After treatment，TCM syndrome scores，pain NRS scores， COQOL scores， and ODI scores significantly decreased （P＜0.05） in both groups compared to pre-treatment levels， with the treatment group showing significantly greater improvements than the control group （P＜0.01）. （7）Safety：The incidence of adverse reactions was 4.88% （4/82） in the treatment group and 3.66% （3/82） in the control group，with no statistically significant difference between the groups （P > 0.05）. Conclusion Gubao Pill is significantly effective and safe in treating PMOP patients with kidney yin-yang deficiency syndrome. It can effectively alleviate clinical symptoms，promote bone formation，increase BMD，inhibit inflammatory responses， and improve quality of life. The underlying mechanism may be associated with the regulation of bone metabolism markers，bone metabolism regulators，and inflammatory factors.

R271.9

国家自然科学基金面上项目（编号：82074342）；佛山市卫生健康局医学科研课题（编号：20240720A010057）；广州市科技计划 项目（编号：2024A04J3302）；广东省中医药局科研项目（编号：20251135；20233019）