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| 不同药物对绝经后骨质疏松疗效观察及生活质量和药物经济学评价 |
| The efficacy of varied medicines and the evaluation of the quailty of life and pharmacoeconomics for postmenopausal osteoporosis |
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| DOI： |
| 中文关键词: 骨质疏松症 药物 生活质量 药物经济学 |
| 英文关键词:Osteoporosis Medicine Quality of life Pharmaeoeconomics |
| 基金项目:民政部老年学和老年医学“十一五’研究计划老年骨质疏松研究[民人教科字(2008)47-1] |
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| 中文摘要: |
| 目的 评价阿仑膦酸钠维D3片、鲑鱼降钙素注射剂和鼻喷剂治疗绝经后骨质疏松的疗效、安全性、生活质量改善和药物经济学。方法 将144例受试者随机分阿仑膦酸钠维D3片(A组)、鲑鱼降钙素注射剂(B组)和鼻喷剂组(C组)，单盲观察6个月，治疗前后测量骨密度(BMD)、检测血清1，25-双羟维生素D3[1，25.(OH)2D3]及进行生活质量评分；治疗前、治疗3个月和治疗6个月检测血清骨钙素(BGP)和抗酒石酸酸性磷酸酶5b(TRACP5b)；评价药物安全性和药物经济学。结果 治疗结束后，3组BMD和1，25-(OH)2D3明显增加(P<0.05)、BGP和TRACP5b明显下降(P<0.05)；3组问BMD、1，25-(OH)2D3、BGP和TRACPSb均无差异(P>0.05)；3组生活质量明显改善(P<0.05)。观察期间药物不良反应：A组主要为恶心、烧心、肌肉和骨骼疼痛等；B组主要为恶心、头晕、颜面潮红等；c组主要为颜面潮红、皮疹等，3组未发生严重不良事件，安全性均较好；3组退出率A组为6.25％、B组为14.58％、C组为10.42％，阿仑膦酸钠维D3片，1w服用1次，患者易依从医嘱。A、B、C 3组总体有效率分别为93.33％、92.68％和90.70％，3组间无差异(P>0.05)；A、B、C 3组成本效果比(C/E)依次为23.24、84.21和47.72。结论 6个月后阿仑膦酸钠维D3片、鲑鱼降钙素注射剂和鼻喷剂治疗绝经后骨质疏松均安全有效；阿仑膦酸钠维D，片依从性较好、不良反应少、治疗成本较低。 |
| 英文摘要: |
| Abstract：Objeetive To evaluate the efficacy，safety，the quality of life，and pharmacoeconomies using alendronate sodium，vitamin D3 tablets，and salcatonin in jectiort/nasal spray for postmenopausal osteoporosis．Methods One hundred and forty-four patients were randomly divided into alendronate sodium and vitamin D3 tablets group(group A)，salcatonin injection group(group B)，and salcatonin nasal spray group(group C)．This was a 6-month single blind study．Bone mineral density(BMD)，serum 1，25-(OH)2 D3，and the scores of quality of life were measured before and after the treatment．BGP and TRACP5b were measured 3-and 6-month after the treatment．The safety and pharmacoeconomics of the medicines were evaluated．Results BMD and 1，25-(OH)2D3 increased significantly in all the 3 groups after the treatment(P<0.05)．BGP and TRACP5b decreased significantly(P<0.05)．BMD，1，25-(OH)2D3,bGP，and TRACP5b were not different among the 3 groups(P>0.05)．The quality of life in all groups was improved significantly(P<0.05)．The adverse reactions observed were nausea，heartburn，muscle and bone pain in group A，nausea，dizziness，and flush in group B，and flush and rash in group C．No severe adverse reactions occurred in the 3 groups and the safety was satisfied．The drop rate in group A，B，and C was 6.25％，14.58％，and 10.42％，respectively．Alendronate sodium and vitamin D3 tablets were taken orally once a week with good patient compliance．The overall effectiveness in group A，B，and C was 93.33％，92.68％，and 90.70％，respectively．No differences were among the 3 groups(P>0.05)．The C/E of group A，B，and C was 23.24，84.21，and 47.72，respectively．Conclusion Alendronate sodium and vitamin D3 tablets and aalcatonin injection／nasal spray were effective and safe for the treatment of postmenopausal osteoporosis at 6 months．Alendronate sodium and vitamin D3 tablets had preferable compliance，less adverse reaction，and lower cost． |
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