首页|期刊导航|中国中医骨伤科杂志|益肾强骨合剂联合地诺单抗对骨转移瘤患者骨相关事件的预防效果及对骨代谢指标的影响

益肾强骨合剂联合地诺单抗对骨转移瘤患者骨相关事件的预防效果及对骨代谢指标的影响OA

Yishen Qianggu Mixture Combined with Denosumab in Preventing Skeletal Related Events and Modulating Bone Metabolism Markers in Patients with Bone Metastasis

中文摘要英文摘要

目的:探讨院内制剂益肾强骨合剂联合地诺单抗对骨转移瘤患者骨相关事件(SREs)的预防效果及对骨代谢指标的影响,明确中西医结合方案的临床优势.方法:选取86例骨转移瘤患者,随机分为观察组和对照组(各43例).对照组予地诺单抗治疗,观察组加用益肾强骨合剂,均治疗6个月.统计两组患者骨相关事件发生率及首次发生时间,检测治疗前后β-CTX、PⅠNP、血钙等骨代谢指标,评估数字疼痛评分法(NRS)评分改善情况及不良反应.结果:观察组骨相关事件总发生率(11.63%)显著低于对照组(30.23%),首次骨相关事件发生时间中位数((5.21±0.67)个月)显著晚于对照组((3.15±0.52)个月),差异有统计学意义(P<0.05);治疗后观察组β-CTX、血钙水平低于对照组,PⅠNP水平高于对照组,NRS评分改善总有效率(90.70%)高于对照组(72.09%),差异有统计学意义(P<0.05);两组患者不良反应发生率差异无统计学意义(P>0.05).结论:益肾强骨合剂联合地诺单抗可降低骨转移瘤患者骨相关事件风险,调节骨代谢,改善疼痛,且安全性良好,优于单纯地诺单抗方案.

Objective:To explore the preventive effect of the hospital-prepared Yishen Qianggu mixture combined with denosumab on skeletal related events(SREs)and its influence on bone metabolism markers in patients with bone metasta-ses,and to clarify the clinical advantages of the integrated traditional Chinese and Western medicine regimen.Methods:A total of 86 patients with bone metastases were randomly divided into an observation group and a control group,with 43 cases in each group.The control group was treated with denosumab alone,while the observation group was additionally given Yishen Qianggu mixture,and both groups received treatment for 6 months.The incidence and first occurrence time of SREs in the two groups were counted.Bone metabolism markers including β-CTX,PⅠNP and serum calcium were detec-ted before and after treatment.The improvement in NRS pain scores and the incidence of adverse reactions were evalua-ted.Results:The total incidence of SREs in the observation group(11.63%)was significantly lower than that in the con-trol group(30.23%),and the median time to first SRE occurrence in the observation group((5.21±0.67)months)was significantly later than that in the control group((3.15±0.52)months)(P<0.05).After treatment,the levels of β-CTX and serum calcium in the observation group were lower than those in the control group,while the level of PⅠNP was high-er.The total effective rate of NRS pain score improvement in the observation group(90.70%)was higher than that in the control group(72.09%)(P<0.05).There was no signifi-cant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Yishen Qianggu mix-ture combined with denosumab can reduce the risk of SREs,regulate bone metabolism and improve pain in patients with bone metastases,demonstrating favorable safety and superior efficacy compared to denosumab monotherapy.

但丹;浦飞飞

武汉市中西医结合医院(武汉市第一医院)(武汉,430022)武汉市中西医结合医院(武汉市第一医院)(武汉,430022)

医药卫生

骨转移瘤益肾强骨合剂地诺单抗骨相关事件骨代谢指标

bone metastasisYishen Qianggu mixturedenosumabskeletal related eventsbone metabolism markers

《中国中医骨伤科杂志》 2026 (9)

14-18,5

国家自然科学基金项目(82274559,82474545)中国博士后科学基金项目(2024T170247,2024M750820)湖北省中医药管理局中医药科研项目(ZY2025Q039)武汉市自然科学基金项目(2024040801020366)

10.20085/j.cnki.issn1005-0205.260903

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