两种阿仑膦酸钠制剂对原发性骨质疏松症患者骨密度和骨转换指标的影响比较

Effects of two kinds of alendronate sodium formulations on bone mineral density and bone turnover markers of primary osteoporotic patients

目的回顾性分析两种阿仑膦酸钠制剂固邦佳和福美加对原发性骨质疏松症患者骨密度和骨转换指标的作用,比较两种药物的临床疗效。方法从2012年1月至2020年4月就诊的原发性骨质疏松症中筛选出规律就诊且接受阿仑膦酸钠(70 mg/周)治疗至少1年的患者作为研究对象。按照药品商品名分为固邦佳组和福美加组,对两组患者的基线指标进行倾向性匹配,最终每组分别纳入118例,所有患者均服用碳酸钙作为基础治疗。收集所有患者基线及用药1年后腰椎1-4、股骨颈和全髋部的骨密度(bone mineral density,BMD),Beta-1型胶原交联C-末端肽(Beta-CrossLaps of type 1 collagen containing cross-linked C-telopeptide,β-CTX)、血清骨钙素(osteocalcin,OC)和25羟维生素D[25-hydroxy-vitamin D,25OHD]等指标,进行组间及药物治疗前后的比较。结果本研究纳入的患者平均年龄为(64.37±7.48)岁,女性患者共223例,占94.49%(223/236)。与基线相比,用药1年后两组腰椎1-4、股骨颈和全髋部BMD均有显著提高,差异均有统计学意义(P<0.05)。用药1年后固邦佳组腰椎1-4、股骨颈和全髋部BMD分别上升4.40%、2.36%和2.30%;而福美加组分别上升4.37%、2.17%和2.66%。两组患者腰椎1-4、股骨颈和全髋部BMD变化率组间比较差异均无统计学意义(P>0.05)。与基线相比,两组患者用药1年后β-CTX和OC均有显著下降,而25OHD均有显著上升(P<0.05)。两组患者β-CTX和OC变化率组间比较差异均无统计学意义(P>0.05),福美加组25OHD的变化率高于固邦佳组(P=0.020)。结论服用阿仑膦酸钠1年能够显著增加原发性骨质疏松症患者的骨密度和降低骨转换指标水平,固邦佳和福美加两种制剂对骨密度和骨转换指标的作用类似。

Objective A retrospective study on the effects of two kinds of alendronate(ALN)sodium formulations on bone mineral density(BMD)and bone turnover markers of primary osteoporotic patients was carried out to compare the efficacy of GuBangJia and Fosamax plus.Methods Primary osteoporotic patients who visited Shanghai Sixth People's Hospital from January 2012 to April 2020 and received ALN treatment(70 mg/week)for at least 1 year were chosen as subjects.The two groups were propensity-matched by baseline parameters according to the drug trad name into the GuBangJia and Fosamax plus groups.Eventually 118 patients were included in each group separately,all of whom were taking calcium tablets as basic supplement.The BMD of lumbar spine 1-4,femoral neck,and total hip,bone turnover markersβ-CTX level,OC,and 25OHD were measured at baseline and 1 year after treatment.Results The average age of patients were(64.37±7.48)years,and there were 233 female patients,accounting for 94.49%.Compared to the baseline,the two groups showed significant increase in the BMD of lumbar spine 1-4,femoral neck,and total hip after 1 year of treatment,respectively(P<0.05).After 1 year of treatment,change in BMD in GuBangJia group of L1-4,femoral neck,and total hip was 4.40%,2.36%,and 2.30%respectively,while in Fosamax plus group was 4.37%,2.17%,and 2.66%.There were no significant difference in BMD change in lumbar spine 1-4,femoral neck,and total hip between the two groups(P>0.05).Compared to the baseline,the two groups showed significant decrease inβ-CTX and OC,and significant increases in 25OHD after 1 year of treatment,respectively(P<0.05).There were no significant difference in the change ofβ-CTX and OC between the two groups(P>0.05).The change rate of 25OHD was higher in the Fosamax plus group than in the GuBangJia group(P=0.020).Conclusions Alendronate significantly increase the BMD and decrease the bone turnover markers in primary osteoporotic patients.GuBangJia and Fosamax plus have similar effects on BMD and bone turnover markers,and this study provides a practical basis for clinical treatment and medication of osteoporotic patients.