摘要
目的比较地舒单抗在中国绝经后骨质疏松症患者应用3个月后的数字疼痛评分(numerical rating scales,NRS)和Oswestry功能障碍指数(Oswestry disability index,ODI),同时分析早期不良反应,为临床诊疗提供参考。方法采用前瞻性研究方法,选取自2020年9月至2021年10月门诊和住院的绝经后骨质疏松症患者260例,收集一般信息,包括年龄、身高、体重、骨密度、既往脆性骨折史、使用抗骨质疏松症药物史。所有研究对象均接受地舒单抗60 mg皮下注射治疗,同时给予钙剂、维生素D。治疗前及治疗后3个月均采用NRS对疼痛进行评分,采用ODI对功能改善情况进行评价。结果绝经后女性骨质疏松患者接受地舒单抗治疗3个月后,在不同年龄段、不同骨质疏松症程度、是否有脆性骨折史和是否有使用抗骨质疏松症药物史的患者中,NRS评分以及ODI较治疗前均是降低的,差异有统计学意义(P<0.05);另外,在既往有脆性骨折史(主要是椎体骨折)患者较无骨折史患者的NRS评分和ODI降低程度更明显,差异具有统计学意义(P<0.05);严重骨质疏松症患者较骨质疏松症患者NRS评分和ODI降低程度更明显,差异具有统计学意义(P<0.05);腰椎骨密度值与治疗前后NRS评分降低程度呈负相关(P=0.042)。260例患者中出现骨骼肌肉疼痛6例(2.3%),乏力5例(1.9%),皮疹4例(1.5%),泌尿系感染2例(0.7%),头晕2例(0.7%),发热2例(0.7%),低钙血症1例(0.4%),不良反应报告共22例,总体不良反应率为8.5%。结论地舒单抗在中国绝经后女性骨质疏松症患者的临床应用中,能早期改善疼痛症状以及功能障碍情况,不良反应发生率低。特别对于严重骨质疏松症、腰椎骨密度较低、合并有脆性骨折史(主要是椎体骨折)的绝经后女性骨质疏松患者应用效果更加显著。
Objective To compare the numerical rating scales(NRS)and Oswestry disability index(ODI)of denosumab in Chinese postmenopausal osteoporosis patients after 3 months,and analyze the early adverse reactions to provide reference for clinical diagnosis and treatment.Methods Using a prospective study method,260 patients with postmenopausal osteoporosis who were outpatients and inpatients in the Second Affiliated Hospital of Soochow University from September 2020 to October 2021 were selected,and general information,including age,height,weight,bone mineral density,history of fragility fractures,and use of anti-osteoporosis drugs.All subjects received denosumab 60 mg subcutaneously,and were given calcium and vitamin D at the same time.Pain was scored by NRS before treatment and 3 months after treatment,and functional improvement was assessed by ODI.Results After 3 months of denosumab treatment in postmenopausal women with osteoporosis,among patients with different age groups,different degrees of osteoporosis,history of fragility fractures,and history of use of anti-osteoporosis drugs,NRS score and ODI score were lower than those before treatment,and the difference was statistically significant(P<0.05).In addition,in patients with a history of fragility fractures(mainly vertebral fractures),the NRS scores and the ODI score decreased more significantly,and the difference was statistically significant(P<0.05);the NRS score and ODI score decreased more significantly in patients with severe osteoporosis than in patients with osteoporosis,and the difference was statistically significant(P<0.05);the BMD value of lumbar spine was negatively correlated with the reduction of NRS score before and after treatment(P=0.042).In this study,260 patients had musculoskeletal pain in 6(2.3%),fatigue in 5(1.9%),rash in 4(1.5%),urinary tract infection in 2(0.7%),and dizziness in 2(0.7%),2 case of fever(0.7%),1 case of hypocalcemia(0.4%),a total of 22 cases of adverse reactions were reported,and the overall adverse reaction rate was 8.5%.Conclusion Denosumab can improve pain symptoms and functional disability early in the clinical application of Chinese postmenopausal women with osteoporosis,and the incidence of adverse reactions is low.Especially for postmenopausal female osteoporosis patients with severe osteoporosis,low lumbar spine bone density,and a history of fragility fractures(mainly vertebral fractures),the application effect is more significant.
作者
魏祺
郑苗
翁程伟
朱柯雨
金星羽
刘炜峰
张东
翟巧成
张鹏
徐又佳
Wei Qi;Zheng Miao;Weng Chengwei;Zhu Keyu;Jin Xingyu;Liu Weifeng;Zhang Dong;Zhai Qiaocheng;Zhang Peng;Xu Youjia(The Osteoporosis Clinical Center,the Second Affiliated Hospital of Soochow University,Suzhou 215004,China;Department of Orthopaedics,the Second Affiliated Hospital of Soochow University,Suzhou 215004,China)
出处
《中华骨科杂志》
CAS
CSCD
北大核心
2022年第12期768-775,共8页
Chinese Journal of Orthopaedics
基金
国家重点研发计划资助(2021YFC2501700)
国家自然科学基金(82072474)
江苏省社会发展-临床前沿技术-重点项目(BE2019661)
姑苏卫生人才计划(GSWS2020024)
老年医学临床技术应用研究项目(LR2021022)。
