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

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D,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D,[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组间BMD、1,25-(OH)2D3、BGP和TRACP5b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、84.2l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D3片依从性较好、不良反应少、治疗成本较低.%Objective To evaluate the efficacy, safety, the quality of life, and pharmacoeconomics using alendronate sodium, vitamin D3 tablets, and salcatonin injectionasal 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)2D3, 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 ＜ O. 05 ). BMD, 1,25-(OH) 2 D3, s GP, and TRACP5b were not different among the 3 groups (P ＞ 0.05 ). The quality of life in all groups was improved significantly ( P ＜ O. 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 salcatonin injectionasal 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.