密固达治疗绝经后骨质疏松患者的3年临床疗效分析

发布时间：2018-04-11 14:15

本文选题：绝经后骨质疏松 + 唑来膦酸　；参考：《青岛大学》2017年硕士论文

【摘要】：目的分析绝经后骨质疏松患者3年间每年输注一次唑来膦酸(Zoledronic acid,商品名:密固达)后的长期疗效、抗骨折作用、缓解疼痛作用、安全性等。方法本实验是一项临床回顾性研究,查阅2011年2月至2016年12月间就诊于青岛大学附属医院的绝经后骨质疏松患者住院或门诊诊疗记录,选取绝经后妇女、平均年龄63.4岁的骨质疏松患者259人入组,根据其治疗情况共分为4组,其中Z0组65人口服骨化醇及钙剂,Z1、Z2、Z3组患者在服用骨化醇及钙剂的基础上:Z1组65人在第1天(初次接受注射时视为第1天)接受一次唑来膦酸(5mg)静脉滴注,Z2组64人分别在第1天、第12个月时接受唑来膦酸共两次注射,Z3组65人分别在第1天、12个月和24个月时接受唑来膦酸共三次注射。观察所有患者至第36个月。通过分析各组各时期腰椎1-4(L1-4)、股骨颈、全髋骨密度(BMD)变化、新发骨折情况、疼痛评分、生化指标、不良反应和不良事件发生率,评价唑来膦酸的长期疗效、抗骨折作用、缓解疼痛效果、生化指标影响和药物安全性。结果各组入组患者年龄、各部位骨密度、疼痛评分、生化指标等相似。(1)骨密度变化:Z3组各部位的骨密度在各时期持续增加,第36个月时L1-4、股骨颈、全髋骨密度分别较第一次注射唑来膦酸前增加了(0.104g/cm2,15.55%)、(0.106g/cm2,15.78%)、(0.114g/cm2,16.94%);Z1、Z2组在注射唑来膦酸后骨密度均有增加,在终止治疗后各部位骨密度进行性下降。(2)新发骨折:Z0组(n=8,12.31%)、Z1组(n=5,7.69%)、Z2组(n=2,3.13%)、Z3组(n=1,1.5%),四组新发骨折比较有统计学意义(P=0.048),其中Z3组明显低于Z0组(P=0.016)。(3)疼痛缓解情况:Z3组各时期疼痛评分持续下降;Z1、Z2组在注射唑来膦酸后疼痛评分均有下降,在终止治疗后疼痛评分进行性升高。(4)生化指标:各组各时期血钙、血磷、甲状旁腺素、尿素氮、肌酐水平与前一时期比较无明显差异;Z3组碱性磷酸酶(ALP)持续下降;Z1、Z2组在注射唑来膦酸后碱性磷酸酶水平均有下降,在终止治疗后碱性磷酸酶进行性升高。(5)不良反应及不良事件:接受唑来膦酸注射后有更多的不良反应,如发热、流感样症状、肌痛、关节痛等,多在每次治疗后3天内出现,所有接受第一次注射后的患者不良反应发生率为43.6%,第二、三次分别为13.2%、4.6%;历次注射后均无严重不良事件发生。结论(1)唑来膦酸注射液能有效提升骨密度。(2)较于输注一或两次唑来膦酸后即终止的患者,连续输注三次骨密度呈递增趋势。(3)连续输注三次唑来膦酸降低了新发骨折发生率。(4)持续输注唑来膦酸能有效改善疼痛。(5)多次输注唑来膦酸能持续降低碱性磷酸酶水平。(6)输注唑来膦酸有更多不良反应,但第二、三次治疗后不良反应明显少于第一次。
[Abstract]:Objective to analyze the long-term effect of Zoledronic acidic acid once a year in postmenopausal osteoporosis patients, the effect of anti-fracture, analgesic effect, safety and so on.Methods from February 2011 to December 2016, the clinical data of postmenopausal osteoporosis patients who were admitted to Qingdao University Hospital from February 2011 to December 2016 were reviewed, and postmenopausal women were selected.259 patients with osteoporosis, with an average age of 63.4 years, were divided into 4 groups according to their treatment.At the 12th month, 65 patients in Z3 group received zoledronic acid for three injections at the first day, 12 months and 24 months, respectively.All patients were observed until 36 th month.The long-term efficacy and anti-fracture effect of zoledronic acid were evaluated by analyzing the changes of BMDs, new fractures, pain scores, biochemical indexes, adverse reactions and adverse events in the lumbar vertebrae 1-4, femoral neck and total hip bone density in each group.Pain relief effects, biochemical indicators and drug safety.Results the age, bone mineral density (BMD), pain score, biochemical index and so on were similar to those of the patients in each group.) the bone mineral density of each part of group Z3 continued to increase at every stage, and at 36-month, L1-4, neck of femur, and so on.The bone density of total hip was increased by 0.104 g / cm ~ (-2) and 0.106 g / cm ~ (2) ~ (15.78) g / cm ~ (2) and 0.114 g / cm ~ (2) 路cm ~ (2) ~ (16. 94) respectively compared with that before the first injection of zoledronic acid. The bone mineral density of group Z _ (1) and Z _ (2) increased after the injection of zoledronic acid.The pain score of Z1Z2 group decreased after zoledronic acid injection.Biochemical parameters: blood calcium, blood phosphorus, parathyroid hormone, urea nitrogen, serum calcium, phosphorus, parathyroid hormone, urea nitrogen in each group.There was no significant difference in creatinine level between Z3 group and the previous period. The ALP level of Z3 group continued to decrease. The ALP level of Z1Z2 group decreased after zoledronic acid injection.Adverse reactions and adverse events: more adverse reactions, such as fever, flu-like symptoms, myalgia, arthralgia, etc., occurred within 3 days of each treatment, after injection of zoledronic acid.The incidence of adverse reactions after the first injection was 43.6, and the second and third were 13.24.6. there were no serious adverse events after each injection.Conclusion 1) Zoledronic acid injection can effectively increase bone mineral density (BMD) in patients with one or two doses of zoledronic acid.Continuous infusion of trizoledronic acid decreased the incidence of new fracture. 4) continuous infusion of zoledronic acid can effectively improve pain. 5) multiple infusion of zoledronic acid can continuously reduce alkaline phosphatase.Level 6) Infusion of zoledronic acid had more adverse reactions,However, the second and third treatment of adverse reactions were significantly less than the first.
【学位授予单位】：青岛大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R580

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