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地舒单抗联合特立帕肽治疗绝经后骨质疏松症的临床研究

Clinical study on denosumab combine with teriparatide in treatment of postmenopausal osteoporosis
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摘要 目的 观察地舒单抗注射液联合特立帕肽注射液治疗绝经后骨质疏松症的临床疗效。方法 选择2022年1~12月南通市肿瘤医院收治的绝经后骨质疏松症患者91例,按照随机数字表法将所有患者分为对照组(45例)和治疗组(46例)。对照组在大腿或腹部皮下注射特立帕肽注射液20μg,1次/d,持续治疗6个月。治疗组在对照组的基础上在大腿、腹部或上臂部单次皮下注射地舒单抗注射液60 mg,6个月仅注射1次。比较两组的临床疗效、骨密度、骨代谢指标。结果 治疗后,治疗组的总有效率为89.13%,高于对照组的总有效率75.56%(P<0.05)。治疗后,两组腰椎L1-4、股骨颈、全髋骨密度均显著升高(P<0.05),且治疗组腰椎L1-4、股骨颈、全髋骨密度均高于对照组(P<0.05)。治疗后,两组血清β-胶原特殊序列(β-CTX)、抗酒石酸酸性磷酸酶-5b(TRAP-5b)、Ⅰ型胶原羧基末端肽(CTX-Ⅰ)水平显著下降,血清总I型胶原氨基端延长肽(TP1NP)、骨钙素(OCN)、骨保护素(OPG)水平显著升高(P<0.05),且治疗组血清β-CTX、TRAP-5b、CTX-Ⅰ水平低于对照组,血清TP1NP、OCN、OPG水平高于对照组(P<0.05)。结论 地舒单抗联合特立帕肽注射液治疗绝经后骨质疏松症可提高临床疗效,改善骨密度,调节骨代谢。 Objective To observe the clinical efficacy of Denosumab Injection combine with Teriparatide Injection in treatment of postmenopausal osteoporosis.Methods Women(91 cases)with postmenopausal osteoporosis in Nantong Tumor Hospital from January to December 2022 were divided into the control group(45 cases)and the treatment group(46 cases)according to the random number table method.Women in the control group were sc injected with Teriparatide Injection in the thighs or abdomen for 20μg,once daily,continuous treatment for 6 months.Women in the treatment group were a single sc injection with Denosumab Injection in the thighs,abdomen,or upper arms,on the basis of the control group,only one injection in 6 months.The clinical efficacies,the bone mineral density,and bone metabolism index in two groups were compared.Results After treatment,the total effective rate of the treatment group was 89.13%,which was higher than 75.56%of the control group(P<0.05).After treatment,the bone density of lumbar Li-4,femoral neck,and hip in two groups was significantly increased(P<0.05),and the bone density of lumbar Li-4,femoral neck,and hip in treatment group was higher than that in control group(P<0.05).After treatment,the serum levels ofβ-CTX,TRAP-5b,and CTX-I in two groups were significantly decreased,while the serum levels of TPINP,OCN,and OPG in two groups were significantly increased(P<0.05).The serum levels ofβ-CTX,TRAP-5b,and CTX-I in the treatment group were lower than those in the control group,but the serum levels of TPINP,OCN,and OPG in the treatment group were higher than those of control group(P<0.05).Conclusion Denosumab Injection combine with Teriparatide Injection can improve clinical efficacy,improve bone mineral density,and regulate bone metabolism in treatment of postmenopausal osteoporosis.
作者 丁勇平 黄红霞 缪华媛 郭小红 刘蓉 DING Yongping;HUANG Hongxia;MIAO Huayuan;GUO Xiaohong;LIU Rong(Department of Pharmacy,Nantong Tumor Hospital,Nantong Fifth People's Hospital,Nantong 226006,China;Department of Gynaecology,Nantong Tumor Hospital,Nantong Fifth People's Hospital,Nantong 226006,China)
出处 《现代药物与临床》 CAS 2024年第6期1554-1558,共5页 Drugs & Clinic
基金 江苏省卫生健康委医学科研立项项目(ZDXKA2021185)。
关键词 地舒单抗注射液 特立帕肽注射液 绝经后骨质疏松症 骨密度 β-胶原特殊序列 抗酒石酸酸性磷酸酶-5b Ⅰ型胶原羧基末端肽 总Ⅰ型胶原氨基端延长肽 骨钙素 骨保护素 Denosumab Injection Teriparatide Injection postmenopausal osteoporosis bone mineral density β-CTX TRAP-5b CTX-I TP1NP OCN OPG
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