Clinical trial of alendronate tablets combined with alfacalcidolon capsules in the treatment of perimenopausal women with osteoporosis
10.13699/j.cnki.1001-6821.2017.06.005
- VernacularTitle: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
- Author:
Yi-Yan QIU
1
;
Peng-Fei CHEN
;
Yang CHEN
;
Wen-Yu ZHOU
;
Xiao-Long XIA
;
Xin-Jian YANG
Author Information
1. 深圳市第二人民医院
- Keywords:
alendronate sodium tablet;
alfacalcidolon capsule;
perimenopausal osteoporosis;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(6):496-498
- CountryChina
- Language:Chinese
-
Abstract:
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 chnical 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:AQP1 were (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) pg · 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.
