雷奈酸锶对绝经后骨质疏松症妇女骨密度的影响

Effects of strontium ranelate on bone mineral density in postmenopausal women with osteoporosis

目的观察雷奈酸锶(SR)对绝经后骨质疏松症妇女骨密度的影响。方法采用随机、双盲、安慰剂对照研究,对36例绝经后妇女分为试验组(n=18)和安慰剂组(n=18),分别给予SR 2g/d及安慰剂,共12个月。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。结果与安慰剂组相比,使用SR 6个月后,SR组腰椎的骨密度增加1.98%,安慰剂组增加1.15%,两组比较差异无显著性(P>0.05),SR组总髋部的骨密度增加2.22%,安慰剂组增加0.20%,两组比较差异具有显著性(P<0.05);使用SR 12个月后,SR组腰椎的骨密度增加4.08%,安慰剂组降低0.53%,两组比较差异具有极显著性(P<0.01),SR组总髋部的骨密度增加3.17%,安慰剂组降低0.46%,两组比较差异具有极显著性(P<0.01)。共有4例提前终止研究(SR组2例,安慰剂组2例)。结论 SR能增加绝经后骨质疏松症妇女骨密度,服用顺应性好,安全。

Objective To observe the effects of strontium ranelate （SR） on bone mineral density in postmeno- pansal women with osteoporosis. Methods Thirty-six postmenopausal women with osteoporosis were randomized to re- ceive either SR 2 g （ n = 18） daily or placebo （ n = 18 ） daily for 12 months. Bone mineral density （BMD） was deter- mined before and after 6-months, 12-months drug administration respectively. Results After 6-months treatment, for the lumbar spine BMD, percentage increase in total BMD was 1.98% with SR compared to 1.15% with placebo （ P 〉 0. 05）. For total hip BMD, percentage increase in total BkID was 2. 22% with SR compared to 0. 20% with placebo （P 〈 0. 05）. After 12-months treatment, compared to placebo, SR induced a significant increase in both lumbar spine and total hip BMD. For the lumbar spine, percentage increase in total BMD was 4. 08% with SR compared to a decrease of O. 53% with placebo （P 〈0. 01 ）. Corresponding values for total hip BMD were 3.17% increase for SR and 0. 46 % decrease for placebo （P〈O. 01 ）. Only 4 subjects discontinued early （2 in the SR group and 2 in the placebo group）. Conclusion SR increased the bone mineral density in postmenopausal women with osteoporosis. It could be taken safely with a good compliance.