INTERMITTENT CYCLICAL ETIDRONATE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
INTERMITTENT CYCLICAL ETIDRONATE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
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DOI：
10.1056/nejm199007123230201
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发表时间：
1990-07-12
影响因子：
158.5
通讯作者：
CHESNUT, CH
中科院分区：
文献类型：
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作者：
WATTS, NB;HARRIS, ST;CHESNUT, CH
背景。为了确定依替膦酸盐（一种抑制破骨细胞介导的骨吸收的双磷酸盐）治疗绝经后骨质疏松症的效果，我们对 429 名患有 1 至 4 处椎体压缩性骨折且有骨质减少影像学证据的女性进行了一项为期两年、双盲、安慰剂对照的前瞻性多中心研究。方法。患者被随机分配到第 1 至 3 天每天两次磷酸盐（1.0 g）或安慰剂治疗，第 4 至 17 天每天服用依替膦酸（400 mg）或安慰剂，第 18 至 91 天每天补充钙（500 mg）（第 1 组，安慰剂和安慰剂；第 2 组，磷酸盐和安慰剂；第 3 组，安慰剂和依替膦酸；第 4 组，磷酸盐和依替磷酸盐）。依替膦酸）。治疗周期重复八次。通过双光子吸收测量法测量脊柱的骨密度，并通过连续的放射线照片确定新椎体骨折的发生率。结果。两年后，接受依替膦酸钠治疗的患者（第 3 组和第 4 组）的平均 (.+-. SE) 脊柱骨密度显着增加（分别为 4.2 .+-. 0.8% 和 5.2 .+-. 0.7%；P < 0.017）。与未接受依替膦酸钠治疗的患者（第 1 组和第 2 组合并）相比，接受依替膦酸治疗的患者（第 3 组和第 4 组合并）新发椎骨骨折的发生率降低了一半（每 1000 患者年 29.5 例与 62.9 例骨折；P = 0.043）；在基线时脊柱骨矿物质密度最低的亚组患者中，治疗效果最为显着，其中骨折率降低了三分之二（每 1000 患者年 42.3 例骨折与 132.7 例骨折；P = 0.004）。添加磷酸盐没有带来明显的好处。治疗没有出现明显的不良反应。结论。依替膦酸钠间歇性周期性治疗两年可显着增加绝经后骨质疏松症女性的脊柱骨量并降低新椎体骨折的发生率。
Background. To determine the effects of etidronate (a bisphosphonate that inhibits osteoclast-mediated bone resorption) in the treatment of postmenopausal osteoporosis, we conducted a prospective, two-year, double-blind, placebo-controlled, multicenter study in 429 women who had one to four vertebral compression fractures plus radiographic evidence of osteopenia. Methods. The patients were randomly assigned to treatment with phosphate (1.0 g) or placebo twice daily on days 1 through 3, etidronate (400 mg) or placebo daily on days 4 through 17, and supplemental calcium (500 mg) daily on days 18 through 91 (group 1, placebo and placebo; group 2, phosphate and placebo; group 3, placebo and etidronate; and group 4, phosphate and etidronate). The treatment cycles were repeated eight times. The bone density of the spine was measured by dual-photon absorptiometry, and the rates of new vertebral fractures were determined from sequential radiographs. Results. After two years, the patients receiving etidronate (groups 3 and 4) had significant increases in their mean (.+-. SE) spinal bone density (4.2 .+-. 0.8 percent and 5.2 .+-. 0.7 percent, respectively; P < 0.017). The rate of new vertebral fractures was reduced by half in the etidronate-treated patients (groups 3 and 4 combined) as compared with the patients who did not receive etidronate (groups 1 and 2 combined) (29.5 vs. 62.9 fractures per 1000 patient-years; P = 0.043); the effect of treatment was most striking in the subgroup of patients with the lowest spinal bone mineral density at base line, in whom fracture rates were reduced by two thirds (42.3 vs. 132.7 fractures per 1000 patient-years; P = 0.004). The addition of phosphate provided no apparent benefit. There were no significant adverse effects of treatment. Conclusions. Intermittent cyclical therapy with etidronate for two years significantly increases spinal bone mass and reduces the incidence of new vertebral fractures in women with postmenopausal osteoporosis.