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Abstract：
OBJECTIVE: To explore the efficacy and safety of tibolone combined with zoledronic acid in the treatment of postmenopausal osteoporosis (PMO).
METHODS: We conducted a retrospective analysis of 121 PMO patients from March 2019 to July 2021. Patients were divided into two groups based on treatment regimen: an observation group (n=62) receiving zoledronic acid combined with tibolone and a control group (n=59) receiving tibolone monotherapy. We evaluated and compared therapeutic efficacy, bone mineral density, bone metabolism markers (osteocalcin, serum C-terminal telopeptide of type I collagen, and bone alkaline phosphatase), pain, knee joint function, incidence of fragility fractures, and adverse reactions. Logistic regression analysis was used to evaluate risk factors affecting treatment efficacy.
RESULTS: The observation group showed a significantly higher therapeutic effect (96.77%) compared to the control group (83.05%), and a lower incidence of fragility fractures (P=0.012). Before treatment, there were no significant differences in bone mineral density, bone metabolism markers, pain status, or knee function between the two groups (all P>0.05). However, after treatment, evaluations showed marked improvements in these parameters in both groups, with more significant enhancements observed in the observation group (all P<0.001). The incidence of adverse reactions did not significantly differ between the groups (20.97% vs 13.56%, P=0.282). Logistic regression analysis identified the use of tibolone combined with zoledronic acid as a protective factor for effective treatment.
CONCLUSIONS: Tibolone combined with zoledronic acid significantly increases bone mineral density, improves bone metabolism, and reduces pain in PMO patients, with a safety profile comparable to that of monotherapy. This regimen should be considered for clinical use in treating PMO.
METHODS: We conducted a retrospective analysis of 121 PMO patients from March 2019 to July 2021. Patients were divided into two groups based on treatment regimen: an observation group (n=62) receiving zoledronic acid combined with tibolone and a control group (n=59) receiving tibolone monotherapy. We evaluated and compared therapeutic efficacy, bone mineral density, bone metabolism markers (osteocalcin, serum C-terminal telopeptide of type I collagen, and bone alkaline phosphatase), pain, knee joint function, incidence of fragility fractures, and adverse reactions. Logistic regression analysis was used to evaluate risk factors affecting treatment efficacy.
RESULTS: The observation group showed a significantly higher therapeutic effect (96.77%) compared to the control group (83.05%), and a lower incidence of fragility fractures (P=0.012). Before treatment, there were no significant differences in bone mineral density, bone metabolism markers, pain status, or knee function between the two groups (all P>0.05). However, after treatment, evaluations showed marked improvements in these parameters in both groups, with more significant enhancements observed in the observation group (all P<0.001). The incidence of adverse reactions did not significantly differ between the groups (20.97% vs 13.56%, P=0.282). Logistic regression analysis identified the use of tibolone combined with zoledronic acid as a protective factor for effective treatment.
CONCLUSIONS: Tibolone combined with zoledronic acid significantly increases bone mineral density, improves bone metabolism, and reduces pain in PMO patients, with a safety profile comparable to that of monotherapy. This regimen should be considered for clinical use in treating PMO.
摘要：
目的：探讨替勃龙联合唑来膦酸治疗绝经后骨质疏松症(PMO)的疗效和安全性。
方法：我们对2019年3月至2021年7月的121例PMO患者进行了回顾性分析。根据治疗方案将患者分为两组：观察组（n=62）接受唑来膦酸联合替勃龙治疗，对照组（n=59）接受替勃龙单药治疗。我们评估并比较了治疗效果，骨矿物质密度，骨代谢标志物(骨钙蛋白，血清I型胶原C末端端肽，和骨碱性磷酸酶)，疼痛,膝关节功能,脆性骨折的发生率，和不良反应。采用Logistic回归分析评价影响治疗疗效的危险因素。
结果：观察组的治疗效果（96.77%）明显高于对照组（83.05%），脆性骨折发生率较低(P=0.012)。治疗前,骨密度没有显著差异，骨代谢标志物,疼痛状态,或膝关节功能差异均无统计学意义(均P>0.05)。然而,治疗后,评估显示两组的这些参数都有显著改善，在观察组中观察到更显著的增强(均P<0.001)。两组不良反应发生率无显著差异(20.97%vs13.56%,P=0.282）。Logistic回归分析确定使用替勃龙联合唑来膦酸作为有效治疗的保护因素。
结论：替勃龙联合唑来膦酸可显著增加骨密度，改善骨骼代谢，减少PMO患者的疼痛，具有与单一疗法相当的安全性。该方案应考虑用于临床治疗PMO。
方法：我们对2019年3月至2021年7月的121例PMO患者进行了回顾性分析。根据治疗方案将患者分为两组：观察组（n=62）接受唑来膦酸联合替勃龙治疗，对照组（n=59）接受替勃龙单药治疗。我们评估并比较了治疗效果，骨矿物质密度，骨代谢标志物(骨钙蛋白，血清I型胶原C末端端肽，和骨碱性磷酸酶)，疼痛,膝关节功能,脆性骨折的发生率，和不良反应。采用Logistic回归分析评价影响治疗疗效的危险因素。
结果：观察组的治疗效果（96.77%）明显高于对照组（83.05%），脆性骨折发生率较低(P=0.012)。治疗前,骨密度没有显著差异，骨代谢标志物,疼痛状态,或膝关节功能差异均无统计学意义(均P>0.05)。然而,治疗后,评估显示两组的这些参数都有显著改善，在观察组中观察到更显著的增强(均P<0.001)。两组不良反应发生率无显著差异(20.97%vs13.56%,P=0.282）。Logistic回归分析确定使用替勃龙联合唑来膦酸作为有效治疗的保护因素。
结论：替勃龙联合唑来膦酸可显著增加骨密度，改善骨骼代谢，减少PMO患者的疼痛，具有与单一疗法相当的安全性。该方案应考虑用于临床治疗PMO。
