摘要
目的:观察益肝补肾壮骨方治疗肝肾亏虚型绝经后骨质疏松症伴骨关节炎的临床疗效和安全性。方法:将64例肝肾亏虚型绝经后骨质疏松症伴骨关节炎患者随机分为两组,对照组予阿仑磷酸钠、骨化三醇、钙尔奇D_(3)片、硫酸氨基葡萄糖酸盐治疗,观察组予益肝补肾壮骨方治疗,分别治疗12周。治疗前和治疗12周后,观察比较两组患者骨代谢指标(骨钙素(BGP)、Ⅰ型前胶原N-末端前肽(PⅠNP)、25-羟维生素D_(3)(25(OH)D_(3))、血清Ⅰ型胶原交联C-末端肽(β-CTX))、炎症指标(肿瘤坏死因子α(TNF-α)、白细胞介素6(IL-6)、超敏C反应蛋白(CRP)、血沉)水平变化情况、骨密度、关节Kellgren-Lawrence(K-L)分级、西安大略和麦克马斯特大学(WOMAC)骨关节炎指数评分、中医证候评分、总有效率、不良反应等。结果:治疗前两组患者各项指标比较差异无统计学意义(P>0.05)。治疗12周后两组患者各项指标较治疗前均有所改善,观察组患者β-CTX、WOMAC评分(功能活动、疼痛、总分)、炎症指标(TNF-α、IL-6、超敏CRP、血沉)、中医症候评分(腰膝酸软、关节疼痛、耳鸣健忘、口干咽燥、五心烦热及总分)低于对照组,总有效率高于对照组,差异有统计学意义(P<0.05)。观察组患者BGP、PⅠNP、25(OH)D_(3)、骨密度、不良反应发生率高于对照组,K-L分级改善优于对照组,但差异无统计学意义(P>0.05)。结论:益肝补肾壮骨方治疗肝肾亏虚型绝经后骨质疏松症伴骨关节炎可降低WOMAC评分和中医症候评分,改善临床症状,延缓关节炎退变程度,提高疗效,可能与降低炎症指标水平、改善骨代谢水平有关,用药安全性高,值得推广应用。
Objective:To observe the clinical efficacy and safety of Yigan Bushen Zhuanggu formula in post-menopausal osteoporosis with arthritis patients.Methods:64 liver and kidney deficiency post-menopausal osteoporosis with arthritis patients were randomly divided into two groups.The control group were given routine treatment of osteoporosis corrosive arthritis,while the observation group were given Yigan Bushen Zhuanggu formula.Before and after 12 weeks of treatment,the bone metabolic indicators(bone calcium(bone gla protein,BGP),type Ⅰ gel N-end prep(Type Ⅰ procollagen N-terminal propeptide,PⅠNP),25(OH)D3,sero-I adhesive platinum C-end beryllium(β-CrossLaps,β-CTX)),inflammation indicators(tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),high sensitivity C-Reactive Protein(hs-CRP),erythrocyte sedimentation rate(ESR)),bone mineral density,joint Kellgren-Lawrence(K-L),Western Ontario and McMaster Universities osteoarthritis index(WOMAC score),traditional Chinese medicine(TCM)syndrome score,effective rate,adverse reaction were compared between the two groups.Results:There were no statistically significant difference between the two groups before treatment(P>0.05).After treating 12 weeks,the two groups were improved comparing with each before treatment.The β-CTX,WOMAC score(functional activity,pain,total score),inflammatory indicators(TNF-α,IL-6,hs-CRP,ESR),TCM syndrome points(lumbar and knee tenderness,joint pain,tinnitus and forgetfulness,dry mouth and dry throat and total score)in the observation group were lower than the control group,the clinical efficacy was higher than the control group.The differences were statistically significant(P<0.05).The BGP,PⅠNP,25(OH)D3,BMD,adverse reactions were higher than those in the control group,K-L grade improved better than the control group,however,the difference was not significant(P>0.05).Conclusion:Yigan Bushen Zhuanggu formula in liver and kidney deficiency type post-menopausal osteoporosis with arthritis patients can reducing WOMAC score and TCM syndrome score,improving clinical symptoms,delaying arthritis degeneration degree,improving curative effect.The mechanism of action may be antagonistic inflammatory index level,improving bone metabolism level.The drug safety was high,which was worth promoting.
作者
邓敦
林蒙
张江南
丁宏峰
江敞
王文龙
王照晖
蒋正辉
DENG Dun;LIN Meng;ZHANG Jiangnan;DING Hongfeng;JIANG Chang;WANG Wenlong;WANG Zhaohui;JIANG Zhenghui(The First People's Hospital of Wenling,Wenling 317500,Zhejiang China;Taizhou University Affiliated Wenling Hospital,Wenling 317500,Zhejiang China;School of Medicine,Taizhou University,Taizhou 318001,Zhejiang China)
出处
《中国中医骨伤科杂志》
2025年第7期42-47,共6页
Chinese Journal of Traditional Medical Traumatology & Orthopedics
基金
浙江省中医药科研项目(2019ZB144,2024ZL1253)
温岭市科研项目(2024S00253)。
关键词
肝肾亏虚
绝经后骨质疏松症
骨关节炎
liver and kidney deficiency
post-menopausal osteoporosis
osteoarthritis
