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阿仑膦酸钠片联合阿法骨化醇胶囊治疗围绝经期骨质疏松的临床研究 被引量:24

Clinical trial of alendronate tablets combined with alfacalcidolon capsules in the treatment of perimenopausal women with osteoporosis
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摘要 目的观察阿仑膦酸钠片联合阿法骨化醇胶囊治疗围绝经期骨质疏松的临床疗效及安全性。方法将56例围绝经期骨质疏松患者随机分为对照组28例和试验组28例。对照组阿法骨化醇每次0.25μg,qd,口服;试验组在对照组治疗的基础上,予以阿仑膦酸钠每次70 mg,qd,口服。比较2组患者的临床疗效、血清水通道蛋白1(AQP1)、基质金属蛋白酶2(MMP-2)、骨碱性磷酸酶(BALP)、Ⅰ型胶原C端肽(CTX-Ⅰ)水平及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92.86%(26/28例)和71.43%(20/28例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的AQP1分别为(23.53±3.02),(30.65±4.31)μg·L^(-1);MMP-2分别为(60.37±8.35),(66.45±8.47)μg·L^(-1);BALP分别为(20.04±2.57),(24.38±3.32)μg·L^(-1);CTX-I分别为(0.75±0.06),(0.83±0.09)ng·L^(-1),差异均有统计学意义(P<0.05)。试验组发生的药物不良反应主要有腹泻和恶心,对照组发生的药物不良反应主要有便秘和恶心。2组患者的药物不良反应发生率均为7.14%,差异无统计学意义(P>0.05)。结论阿仑膦酸钠片联合阿法骨化醇胶囊治疗围绝经期骨质疏松的临床疗效确切,能够显著降低患者的血清AQP1、MMP-2、BALP及CTX-Ⅰ水平,且不增加药物不良反应的发生率。 Objective To observe the clinical efficacy and safety of alendronate tablets combined with alfacalcidolon capsules in the treatment of perimenopausal women with osteoporosis.Methods A total of 56 perimenopausal women with osteoporosis were randomly divided into control group and treatment group with 28 cases per group.Control group was treated with alfacalcidolon capsule 0.25 μg qd oral.Treatment group was given alendronate sodium tablet 70 mg qd oral,on the basis of control group.The clinical efficacy,serum aquaporin 1(AQP1),matrix metalloproteinase 2(MMP-2),bone alkaline phosphatase(BALP),type I collagen C end peptide(CTX-Ⅰ) and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 92.86%(26/28 cases) and 71.43%(20/28 cases) with significant difference(P〈0.05).After treatment,the main indexes in treatment and control groups were compared:AQP1were(23.53±3.02),(30.65±4.31) μg · L^-1;MMP-2 were(60.37 ±8.35),(66.45 ±8.47) μg · L^-1;BALP were(20.04±2.57),(24.38±3.32) μg · L^-1;CTX-Ⅰ were(0.75 ± 0.06),(0.83 ±0.09) ng · L^-1,the differences were statistically significant(P〈0.05).The adverse drug reactions in treatment group were based on diarrhea and nausea,which in control group was based on diarrhea and nausea.The incidence of adverse drug reactions in two groups were 7.14%without significant difference(P〉0.05).Conclusion Alendronate tablets combined with alfacalcidolon capsules have a definitive clinical efficacy in the treatment of perimenopausal women with osteoporosis,which can significantly reduce the serum levels of AQP1,MMP-2,BALP and CTX-Ⅰ,without increasing the incidence of adverse drug reactions.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2017年第6期496-498,共3页 The Chinese Journal of Clinical Pharmacology
基金 广东省中医药局基金资助项目(20141257)
关键词 阿仑膦酸钠片 阿法骨化醇胶囊 围绝经期骨质疏松 安全性 alendronate sodium tablet alfacalcidolon capsule perimenopausal osteoporosis safety
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