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作者:佚名  来源:本站整理  发布时间:{$WriteTime}
社区骨质疏松高危人群的筛查及
预防骨折的干预研究
 
硕士研究生
:马 
     
:刘  教授
第四军医大学西京医院骨科,西安 710032
 
骨质疏松症及其严重并发症骨折已成为威胁老年人健康的主要问题。了解骨质疏松症高危人群并提前给予有效的干预措施,可能会在改善老年人骨痛程度、防止跌到后发生骨折等方面起到一定作用,从而提高老年人的生活质量,减少因骨质疏松骨折后导致的老年人死亡率的增加。本研究方案的主要目的是筛查社区骨质疏松高危人群,开展健康教育,营养、生活方式等综合社区的干预模式,探索适应国情的切实可行的低成本、广受益的骨质疏松骨折防治策略。本研究是一个针对绝经期两年以上中老年妇女的随机、多中心的大规模临床试验,以探讨有效的骨质疏松干预模式;观察骨质疏松性骨折的控制率,以及老年人骨痛、跌倒次数、生活质量方面的改善情况。
研究方法:①试验对象:女性,55-75之间,绝经两年以上,根据研究方案制定的入选和排除标准,共筛选出600名骨质疏松高危人群为受试者。②分组方案:平均分为4组给予相应干预:A组:+活性VitD(骨化三醇)组:定期健康教育,每日补充钙剂600mg+活性VitD(骨化三醇1,25(OH)2D3)0.25μgB组:钙+普通VitD组:定期健康教育,每日补充钙剂600mg+VitD800IUC组:强化运动组:定期健康教育,用统一宣教的骨骼健康运动内容进行培训,有组织地规律的参加运动项目并记录;D组:对照组:维持原有生活方式,定期健康教育。③有效性评价:主要指标:比较各组之间1年内临床椎体和非椎体骨折的发生率。统计分析各干预组能否降低骨折发生的危险性及何种干预最为有效;次要指标:比较各组之间1年内的骨痛程度、跌倒次数、生活质量方面的差异。统计分析各干预组能否减少跌倒次数、减轻骨痛、提高生活质量。④安全性评价:以不良事件的发生率和实验室检查来进行评价。   
结果:干预前的一般情况及人口学特征未见统计学差异。干预结束时,有效性评价:①各组一年前后骨痛评分(VAS)差值:A干预组为-0.71±1.04B干预组为-0.47±0.75C干预组为-0.62±0.81D对照组为0.19±0.47,各干预组与对照组组间差别比较有统计学意义(P0.001。②各组一年后的跌倒例数:A干预组32例,B干预组38例,C干预组31例,D对照组56例,各干预组与对照组比较均有统计学意义,(P0.005),各干预组之间比较没有统计学意义。③干预期间新骨折发生,A干预组1例(0.68%)、B干预组2例(1.44%)、C干预组0例(0.00%)、D干预组2例(1.41%),经过Fisher确切概率检验,结果P=0.4942,组间差别无统计学意义。
安全性评价:干预期间未发生与干预用药有关的严重不良事件,干预期间受试者的一般情况和实验室检查均无显著变化。        
结论:在为期一年的骨质疏松高危人群的社区干预中,+活性VitD(骨化三醇)组在改善骨质疏松症高危人群生活质量方面最为明显,运动组和钙+普通VitD组次之,对照组最差,无明显改善。然而对预防骨质疏松性骨折方面是否有效,还需继续观察。 
关键词:骨质疏松高危人群;筛查;预防骨折;干预研究
 
 
Candidate for master: Ma Yu
Supervisor: Prof.Liu Jian
Department of Orthopaedics,XiJing Hospital, Fourth Military Medical University, Xi’an 710032, China
 
 Osteoporosis and its consequences has become a major problem threatening the health of the elderly. Investigate osteoporosis risk factors and the potential for effective interventions study, Play a part in improve the level of Pain in the elderly may prevention of falls bone fracture directions. Accordingly boost aged people quality of life. Decrease with osteoporosis bone fracture induce aged people mortality rate to increase. Investigation syllabus Screening community osteoporosis high-risk group,Program healthy education nourishment,mode of life community intervention.Exploration accommodation feasible low cost, prevention and cure osteoporosis bone fracture. Investigation to aim directly at age critique above two years women random multicentric large scale clinical trial, Of effective intervention models of osteoporosis observed fracture control rate to improve the quality of life of older persons.
Research methods:Subjects,female age55-75, menostasis above two years.Based on the program selection and exclusion criteria established,600 were selected as subjects at high risk of osteoporosis, Divide into groups program:divided into 4 groups corresponding to the average intervention,Agroup Ca+VitD2(calcitriol),Regular health education.Dailysupplement of calcium600mg+VitD2(calcitriol)1,25(OH)2D3) 0.25
μg. Bgroup:Ca+general VitD,Regular health education.Dailysupplement
of Ca+VitD800IU. C group: Strengthening exercise group Regular health education,unified Sports training. D group:control group,maintain the original way of life.Effectiveness evaluation:Key indicators:Between groups were compared 1 year of clinical vertebral and non vertebral fracture incidence, Statistical analysis of whether the intervention group decreased fracture risk and what interventions are most effective; Secondary indicators: Between the groups compared the bone pain levels within 1 year and fall times differences in quality of life. Statistical analysis of the intervention group was able to reduce the times of falls, reduce bone pain, improve quality of life.Safety Evaluation: To the incidence of adverse events and laboratory tests to be evaluated.
Result: The general condition before treatment and was no statistical difference in demographic characteristics.The end of treatment, Effectiveness Evaluation: Each group before and after the pain score difference of one year, A group -0.71±1.04; B group -0.47±0.75; C group-0.62±0.81; D group 0.19±0.47. The intervention group and control group statistically significant difference compared.b(P0.001). Fall times:
A group 32 case, B group 38 case, C group 31 case, D group 56 case. The intervention group and control group were statistically significant.(P0.005). The intervention was not statistically significant between groups. P0.005.Intervening period the incidence of new fractures A group
1 case(0.68%), B group 2 case(1.44%), C group0 case(0.00%), D group 2 case(1.44%). After Fisher exact test( P=0.4942), no significant difference.
No serious adverse events about group were report.
   Conclusion: During the one-year osteoporosis intervention in high risk communitiesA group Ca+VitD2(calcitriol) The effect of prevention and treatment of osteoporosis and improved quality of life is most evident, Calcium+ordinary VitD and exercise group efficacy general. Control group, the worst was not improved. However, the effectiveness for preventing fractures, need to continue to observe.
 
 
 
 
 
 
 
 
Key words high risk of osteoporosisscreening;prevention of fractures ;intervention

 
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