广州中医药大学学报2026，Vol.43Issue(2)：355-362,8.DOI:10.13359/j.cnki.gzxbtcm.2026.02.011
骨宝丸治疗肾阴阳虚型绝经后骨质疏松症的疗效及对骨代谢、骨密度和炎症因子的影响
Clinical Efficacy of Gubao Pill in Treating Postmenopausal Osteoporosis with Kidney Yin-Yang Deficiency Syndrome and Its Effects on Bone Metabolism,Bone Mineral Density and Inflammatory Factors
摘要
Abstract
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),N-terminal 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.关键词
骨宝丸/绝经后骨质疏松症/肾阴阳虚/骨密度/骨代谢/炎症因子/生活质量Key words
Gubao Pill/postmenopausal osteoporosis/kidney yin-yang deficiency/bone mineral density/bone metabolism/inflammatory factors/quality of life分类
医药卫生引用本文复制引用
李怡,招敏虹,李影雄,侯蕾,蔡海荣,胡瑶,蔡惠玲,林敏如..骨宝丸治疗肾阴阳虚型绝经后骨质疏松症的疗效及对骨代谢、骨密度和炎症因子的影响[J].广州中医药大学学报,2026,43(2):355-362,8.基金项目
国家自然科学基金面上项目(编号:82074342) （编号:82074342）
佛山市卫生健康局医学科研课题(编号:20240720A010057) （编号:20240720A010057）
广州市科技计划项目(编号:2024A04J3302) （编号:2024A04J3302）
广东省中医药局科研项目(编号:20251135 （）
20233019) （）
