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唑来膦酸与阿仑膦酸钠治疗绝经后骨质疏松症的效果和安全性比较 被引量:21

Comparison of the efficacy and safety of zoledronic acid and alendronate in the treatment of postmenopausal osteoporosis
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摘要 目的 比较唑来膦酸与阿仑膦酸钠治疗绝经后骨质疏松症(PMOP)的效果和安全性,为唑来膦酸的安全应用提供临床依据.方法 选择我院2013年1月至2014年1月收治的符合入组标准的PM0P患者作为研究对象,共计入组210例PMOP患者,将患者随机分为唑来膦酸组(105例)与阿仑膦酸钠组(105例).唑来膦酸组患者每年1次静脉滴注唑来膦酸注射液5 mg,阿仑膦酸钠组每周服用1次阿仑膦酸钠70 mg.两组疗程均为24个月.治疗前后采用双能X线骨密度仪测定腰椎和髋部的骨密度;进行疼痛状况的VAS评分;行胸、腰椎正侧位X线检查;记录不良反应发生情况.结果 唑来膦酸组和阿仑膦酸钠组治疗后腰椎、髋部骨密度分别为(-1.56±0.35)g/cm2和(-2.21±0.54)g/cm2、(-1.91 ±0.32)g/cm2和(-2.16±0.26)g/cm2,均较治疗前明显增加,差异均有统计学意义(t值分别为6.253和3.633,5.834和3.251,P均<0.05),但唑来膦酸组的腰椎、髋部骨密度增加量均比阿仑膦酸钠组有显著提高,差异均有统计学意义(t值分别为4.421、5.262,P均<0.05).阿仑膦酸钠组和唑来膦酸组治疗后12、24个月VAS评分分别为(4.02±0.50)分和(3.01±0.44)分、(2.95±0.36)分和(1.82±0.24)分,均较治疗前明显降低,差异均有统计学意义(P均<0.05),唑来膦酸组治疗后12、24个月VAS评分均明显低于阿仑膦酸钠组,差异有统计学意义(t值分别为3.513、3.647,P均<0.05).阿仑膦酸钠组发热发生率为2.86%(3/105),低于唑来膦酸组30.48%(32/105),差异有统计学意义(χ2=32.901,P<0.01).结论唑来膦酸注射液与阿仑膦酸钠均能有效治疗PMOP,但唑来膦酸增加骨密度效果更好,减轻骨痛程度,且依从性更好,虽然增加了不良反应发生率,但耐受性良好. Objective To compare the efficacy and safety of zoledronic acid and alendronate in the treatment of postmenopausal osteoporosis and to provide a clinical basis for the safe use of zoledronic acid.Methods Two hundred and ten female patients with postmenopausal osteoporosiswomen in Xuanwu Hospital Capital Medical University from January 2013 to January 2014 were selected as research objects,they were randomly divided into zoledronic acid group(105 cases)and alendronate group(105 cases),patients in the zoledronic acid group were given intravenous infusion of zoledronic acid injection 5 mg one time a year,the alendronate group were given alendronate 70 mg one week,both group had been treated for 24 months.The bone mineral density of the lumbar spine and hip was measured by dual energy X-ray absorptiometry before and after treatment,and the VAS score of the pain status was measured.The chest and lumbar spine were examined by X-ray,and the adverse reactions were recorded.Results After treatment,the BMD of the lumbar spine and hip of the zoledronic acid group and alendronate group were(-1.56 ± 0.35)g/ cm2and(-2.21 ± 0.54)g/ cm2, (-1.91±0.32)g/ cm2 and(-2.16 ± 0.26)g/ cm2,which were higher than those before treatment.The differences were statistically significant(t=6.253,3.633,5.834,3.251,P<0.05).But the BMD of the lumbar spine and hip in the zoledronic acid group was significantly higher than that in the alendronate group,the difference was statistically significant(t=4.421,5.262,P<0.05).The VAS scores of the alendronate group and the zoledronic acid group at 12 months,24 months after treatment were(4.02±0.50)points and(3.01±0.44) points,(2.95 ± 0.36)points and(1.82 ± 0.24)points,which were significantly lower than those before the treatment,the differences were statistically significant(P<0.05).The VAS score of zoledronic acid group at 12 months,24 months after treatment were significantly lower than those of the alendronate group,the differences were statistically significant(t=3.513,3.647,P<0.05).The fever incidence of the alendronate group was 2.86%(3/105),lower than that of the zoledronic acid group(30.48%(32/105)),the difference was statistically significant(χ2=32.901,P<0.01).Conclusion Zoledronic acid injection and alendronate are effective in the treatment of PMOP,but zoledronic acid has better effect on increasing bone density,reducing the degree of bone pain,with better compliance.Although it has increased the incidence of adverse reactions,it is well tolerated.
出处 《中国综合临床》 2017年第12期1134-1137,共4页 Clinical Medicine of China
关键词 唑来膦酸 阿仑膦酸钠 绝经 骨质疏松症 效果 安全性 Zoledronic Acid Alendronate Menopause Osteoporosis Efficacy Safety
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