Cranney A, Waldegger L, Zytaruk N, Shea B, Weaver B, Papaioannou A, Robinson V, Wells G, Tugwell P, Adachi J D, Guyatt G
Division of Rheumatology, Queen's University, Etherington Hall (Room 2004), Stuart street, Kingston, Ontario, CANADA, K7L 3N6.
Cochrane Database Syst Rev. 2003(4):CD004523. doi: 10.1002/14651858.CD004523.
Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated.
To systematically review the efficacy of risedronate on bone density, and fracture reduction in postmenopausal women.
The Cochrane Controlled Trials Registry Medline, and Current Contents were searched from 1990 - 2001. The electronic search was supplemented by handsearching four osteoporosis journals and their conference proceedings, as well as contacting content experts and industry sources for unpublished data.
We included eight trials that randomised women to risedronate or an alternative (placebo or calcium and /or vitamin D) and measured bone mineral density for at least one year.
For each trial three independent reviewers assessed the methodological quality and abstracted data. Data was extracted for outcomes of fracture, bone mineral density and adverse events. The more conservative random effects model was used to pool data. The quality of trials was assessed according to the Jadad five-point scale.
Both vertebral and non-vertebral fractures were statistically and clinically reduced with risedronate. Eleven out of one hundred women who received risedronate had a vertebral fracture compared to 17 out of one hundred of those who received an alternative treatment (pooled relative risk for vertebral fractures of 0.64 (95% CI 0.52 - 0.77). Three percent of participants who received risedronate had a non-vertebral fracture compared to 4.6% of those who received an alternative treatment (pooled relative risk for nonvertebral fractures of 0.73 (95% CI 0.61 - 0.87). The weighted mean difference for the percent change from baseline for bone mineral density with 5 mg daily for lumbar spine, femoral neck and trochanter was 4.54% (95%CI 4.12 - 4.97), p<0.01; 2.75% (95% CI 2.32 - 3.17), p<0.01; and 4.38% (95% CI 3.51 - 5.25), p<0.01 respectively.
REVIEWER'S CONCLUSIONS: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.
绝经后骨质疏松症会导致骨量减少和微结构恶化,从而增加低创伤骨折的易感性。利塞膦酸盐是第三代双膦酸盐,多项临床试验表明,它可降低绝经后骨质疏松症女性的骨折风险并提高骨密度。已知第一代和第二代双膦酸盐有胃肠道副作用,而利塞膦酸盐的耐受性可能更好。
系统评价利塞膦酸盐对绝经后女性骨密度及降低骨折风险的疗效。
检索了1990年至2001年的Cochrane对照试验注册库、Medline和《现刊目次》。电子检索辅以手工检索四种骨质疏松症期刊及其会议论文集,并联系内容专家和行业来源获取未发表的数据。
我们纳入了八项试验,这些试验将女性随机分为利塞膦酸盐组或其他组(安慰剂或钙和/或维生素D),并至少测量一年的骨密度。
对于每项试验,三名独立的评审员评估方法学质量并提取数据。提取骨折、骨密度和不良事件的结果数据。采用更保守的随机效应模型汇总数据。根据Jadad五分制评估试验质量。
利塞膦酸盐在统计学和临床上均降低了椎体和非椎体骨折的发生率。接受利塞膦酸盐治疗的100名女性中有11名发生椎体骨折,而接受其他治疗的100名女性中有17名发生椎体骨折(椎体骨折的合并相对风险为0.64(95%CI 0.52 - 0.77))。接受利塞膦酸盐治疗的参与者中有3%发生非椎体骨折,而接受其他治疗的参与者中有4.6%发生非椎体骨折(非椎体骨折的合并相对风险为0.73(95%CI 0.61 - 0.87))。每日服用5mg利塞膦酸盐时,腰椎、股骨颈和转子骨密度较基线变化百分比的加权平均差分别为4.54%(95%CI 4.12 - 4.97),p<0.01;2.75%(95%CI 2.32 - 3.17),p<0.01;4.38%(95%CI 3.51 - 5.25),p<0.01。
有充分证据证明利塞膦酸盐在降低椎体和非椎体骨折方面的疗效。此外,随机试验的证据表明,利塞膦酸盐能够做到这一点,而不会增加因不良反应导致的总体停药风险。