雷奈酸锶对小榄地区老年妇女骨质疏松症患者的疗效及安全性

Efficacy and safety of strontium ranelate in the treatment of osteoporosis in senile women in Xiaolan area

目的评估雷奈酸锶对小榄地区老年女性骨质疏松症患者疗效及安全性。方法 94例老年女性骨质疏松症患者被随机分为雷奈酸锶+钙剂+骨化三醇组(SA),阿伦膦酸+钙剂+骨化三醇组(AL),钙剂+骨化三醇组(CA),进行随机、双盲、对照研究。分别在用药前、用药6个月、用药12个月测定受试者的骨密度及血骨转换生化指标。结果药物干预6个月,SR组腰椎及股骨颈骨密度均增加显著高于AL及CA组(P<0.05),AL组显著高于CA组(P<0.05);各组血清β-CTX均降低,SR组及AL组降幅显著高于CA组(P<0.05);SR组及CA组血清PINP及OC均升高,AL组降低,AL组与CA组及SR组比较有显著差异(P<0.05),SR组升幅显著高于CA组(P<0.05)。药物干预12个月,与基线相比较,SR组腰椎及股骨颈骨密度增加显著高于AL及CA组(P<0.05),AL组显著高于CA组P<0.05)。与基线相比较,各组血清β-CTX均降低,SR组及AL组降幅显著高于CA组(P<0.05);SR组及CA组血清PINP及OC均升高,AL组降低,AL组与CA组及SR组比较有显著差异(P<0.05),SR组升幅显著高于CA组(P<0.05)。雷奈酸锶治疗组有3例(9.1%)患者因恶心及纳差而退出研究,阿伦膦酸组未观察到明显不良反应。结论在老年女性骨质疏松症患者,雷奈酸锶疗效优于阿伦膦酸钠,雷奈酸锶胃肠道不良反应较多,影响长期治疗的依从性。

Objective To evaluate the efficacy and safety of strontium ranelate in the treatment of osteoporosis in senile women in Xiaolan area.Methods Ninety-four senile women with osteoporosis were randomly into strontium ranelate ＋calcitriol ＋alendronate group （ SA） , alendronate ＋calcium ＋calcitriol group （ AL） , and calcium ＋calcitriol group （ CA） .A randomized, double-blinded, and controlled study was performed.Bone mineral density （ BMD） and the biochemical markers of bone turnover of all the subjects were detected before the treatment and at the 6 th month and the 12 th month after the treatment.Adverse events and tolerability were recorded and assessed.Results After 6-month treatment, BMD of the lumbar vertebrae and the femoral neck in SR group increased significantly than that in AL group and CA group （P＆lt;0.05）.And BMD in AL group was significantly higher than that in CA group （P＆lt;0.05）.The serum levels of β-CTX decreased in all groups, while the decrease of the serum β-CTX level in SR group and AL group was significantly larger than that in CA group （ P＆lt;0.05 ） .The serum levels of PINP and OC increased in SR and CA groups, while decreased in AL group.The serum levels of PINP and OC in CA group had significant difference with that in CA group and SR group （P＆lt;0.05）.And the improvement in SR group was significantly bigger than that in CA group （P＆lt;0.05）.After 12-month treatment, compared with that at the baseline, BMD of the lumbar vertebrae and the femoral neck in SR group increased significantly than that in AL group and CA group （P＆lt;0.05）.And BMD in AL group was significantly higher than that in CA group （P＆lt;0.05）.Compared with that at the baseline, the serum level of β-CTX decreased in all groups,＆amp;nbsp;while the decrease of the serumβ-CTX level in SR group and AL group was significantly larger than that in CA group （P＆lt;0.05）. The serum levels of PINP and OC increased in SR and CA groups, while decreased in AL group.The serum levels of PINP and OC in CA group had significant difference with that in CA group and SR group （P＆lt;0.05）.And the improvement in SR group was significantly bigger than that in CA group （P＆lt;0.05）.Three patients （9.1%） in SR group withdrew from the study due to nausea and anorexia, while no adverse reactions were observed in AL and CA group.Conclusion The effect of strontium ranelate in the treatment of osteoporosis in senile women is better than that of alendronate.The occurrence of gastrointestinal adverse reaction of strontium ranelate is high, which could affect the compliance of long-term treatment.