Institute for Integrated Sports Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Osteoporos Int. 2011 Oct;22(10):2735-42. doi: 10.1007/s00198-010-1495-8. Epub 2010 Nov 23.
A randomized controlled trial was performed to compare the short-term effects of alendronate (ALN) and ECT on pain and quality of life (QOL) in postmenopausal women with osteoporosis. Back pain and QOL [Short-Form Health Survey (SF-8)] significantly improved at 1, 3, and 6 months in both groups, with greater improvements in the ALN group than in the ECT group. These results suggested that ALN reduced back pain and improved QOL more markedly than ECT in postmenopausal osteoporotic women with back pain.
Intramuscular ECT is known to reduce pain via the central nervous system. A multicenter randomized controlled trial was performed to compare the short-term effects of ALN and ECT on pain and QOL in postmenopausal women with osteoporosis.
One hundred and 94 postmenopausal osteoporotic women with back pain (mean age 79.8 years, range 60-96 years) were randomly divided into two groups: the ALN group (35 mg weekly) and the ECT group (intramuscular 20 units a week). The duration of the study was 6 months. The trial was completed in 97 (100%) women of the ALN group and 96 (99.0%) women of the ECT group. Urinary levels of cross-linked N-terminal telopeptide of type I collagen (NTX), serum alkaline phosphatase (ALP), face scale score (FSS, back pain), and SF-8 (QOL) were monitored.
Urinary NTX levels significantly decreased at 3 months in the ALN group, but not in the ECT group. Serum ALP levels significantly decreased at 6 months in the both groups, with a greater reduction in the ALN group. The FSS and SF-8 significantly improved at 1, 3, and 6 months in both groups, with greater improvements in the ALN group than in the ECT group.
ALN suppressed bone turnover, reduced back pain, and improved QOL more markedly than ECT in postmenopausal osteoporotic women with back pain.
本研究旨在比较阿仑膦酸钠(ALN)与依降钙素(ECT)治疗绝经后骨质疏松症伴腰背疼痛患者的短期疗效。
本研究为多中心、随机对照试验,共纳入 194 例绝经后骨质疏松症伴腰背疼痛患者(平均年龄 79.8 岁,60-96 岁),按 1:1 比例随机分为 ALN 组(每周 35mg)和 ECT 组(每周 20 单位肌内注射),疗程 6 个月。
194 例患者中,1 例失访,97 例完成 ALN 组研究,96 例完成 ECT 组研究。与基线相比,两组患者治疗 3 个月时尿型胶原交联 N 末端肽(NTX)水平显著下降(P<0.05),6 个月时血清碱性磷酸酶(ALP)水平显著下降(P<0.05),且 ALN 组下降幅度大于 ECT 组。两组患者腰背疼痛评分(FSS)和健康调查简表 8 项(SF-8)评分于治疗 1、3、6 个月时均显著改善(P<0.05),且 ALN 组改善程度优于 ECT 组。
与 ECT 相比,ALN 能更显著地抑制骨转换、缓解腰背疼痛、改善绝经后骨质疏松症伴腰背疼痛患者的生活质量。