血塞通片联合特立帕肽治疗老年骨质疏松症的临床研究

Clinical study of Xuesaitong Tablets combined with teriparatide in treatment of senile osteoporosis

目的探讨血塞通片联合特立帕肽治疗老年骨质疏松症的临床疗效及安全性。方法选取南京医科大学第二附属医院2018年1月—2019年12月收治的80例老年骨质疏松症患者作为研究对象,将所有患者按照数字随机表法分为对照组和观察组,每组各40例。对照组患者皮下注射特立帕肽注射液,20μg/d,注射部位应选择大腿或腹部。观察组患者在对照组治疗的基础上口服血塞通片,1片/次,3次/d。两组均治疗2周。观察两组患者的临床疗效和不良反应发生情况,同时比较两组治疗前后的骨密度、骨代谢指标水平。结果治疗后,观察组的患者治疗总有效率为97.5%,显著高于对照组的70.0%(P<0.05)。治疗后,两组的腰椎骨、股骨颈和股骨大转子骨密度检测值明显升高(P<0.05),且观察组患者高于对照组(P<0.05)。治疗后两组患者血清I型胶原氨基端前肽(P1NP)、Ⅰ型胶原羧基端交联肽(CTX)水平均显著降低,骨钙素(BGP)和25-羟基维生素D(25(OH)D)水平均显著升高(P<0.05);且治疗后,观察组患者P1NP、CTX显著低于对照组,BGP、25(OH)D显著高于对照组(P<0.05)。治疗期间,两组患者不良反应发生率在整个治疗期间的对比没有统计学差异。结论血塞通片联合特立帕肽治疗老年骨质疏松可提高患者骨密度,改善相关骨代谢指标,安全有效,值得临床推广应用。

Objective To investigate the clinical efficacy and safety of Xuesaitong Tablets combined with teriparatide in treatment of senile osteoporosis. Methods Elderly patients(80 cases) with osteoporosis in the Second Affiliated Hospital of Nanjing Medical University from January 2018 to December 2019 were divided into control and observation groups by numerical random table method, each group had 40 cases. Patients in the control group were subcutaneously injected with Teriparatide Injection, 20 μg/d,and the injection site should be thigh or abdomen. Patients in the observation group were po administered with Xuesaitong Tablets on the basis of control group, 1 tablet/time, three times daily. Both groups were treated for 2 weeks. After treatment, the clinical efficacy and adverse reactions of two groups were observed, and the bone mineral density, and bone metabolism indexes before and after treatment in two groups were compared. Results After treatment, the total effective rate in the observation group was 97.5%,which was significantly higher than 70.0% in the control group(P < 0.05). After treatment, the bone mineral density of lumbar vertebrae, femoral neck, and greater trochanter in two groups were significantly increased(P < 0.05), and these indexes in the observation group were significantly higher than those in the control group(P < 0.05). After treatment, P1 NP and CTX levels in two groups were significantly decreased, while BGP and 25(OH) D levels were significantly increased(P < 0.05). After treatment, P1 NP and CTX in the observation group were significantly lower than those in the control group, and BGP and 25(OH) D were higher than those in the control group(P < 0.05). There was no statistical difference in the incidence of adverse reactions between two groups during the treatment. Conclusion Xuesaitong Tablets combined with teriparatide in treatment of senile osteoporosis can improve the bone density of patients, improve the related bone metabolism indexes, safe and effective, it is worthy of clinical application.