O'Donnell S, Cranney A, Wells G A, Adachi J D, Reginster J Y
Ottawa Hospital, Division of Rheumatology, 1053 Carling Ave, Ottawa, Ontario, Canada.
Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD005326. doi: 10.1002/14651858.CD005326.pub3.
Strontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known.
To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis.
We searched MEDLINE (1996 to March 2005), EMBASE (1996 to week 9 2005), the Cochrane Library (1996 to Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors.
We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate versus placebo reporting fracture incidence, bone mineral density (BMD), health related quality of life or safety in postmenopausal women. Treatment (versus prevention) population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T score < -2.5 SD.
Two reviewers independently determined study eligibility, assessed trial quality and extracted the relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose of strontium ranelate and treatment duration. Where possible, meta-analysis was conducted using the random effects model.
Four trials met the inclusion criteria. Three included a treatment population (0.5 to 2 g of strontium ranelate daily) and one a prevention population (0.125 g, 0.5 g and 1 g daily). A 37% reduction in vertebral fractures (RR 0.63, 95% CI 0.56, 0.71) and a 14% reduction in non-vertebral fractures (RR 0.86, 95% CI 0.75, 0.98) were demonstrated over three years with 2 g of strontium ranelate daily in a treatment population. An increase in BMD was shown at all BMD sites after two to three years in both populations. Lower doses of strontium ranelate were superior to placebo and the highest dose demonstrated the greatest reduction in vertebral fractures and increase in BMD. An increased risk of diarrhea with 2 g of strontium ranelate was found; however, adverse events did not affect the risk of discontinuing treatment nor did it increase the risk of serious side effects, gastritis or death. Additional data suggests that the risk of vascular and nervous system side-effects is slightly increased with taking 2 g of strontium ranelate daily over three to four years.
AUTHORS' CONCLUSIONS: There is silver level evidence (www.cochranemsk.org) to support the efficacy of strontium ranelate for the reduction of fractures (vertebral and to a lesser extent non-vertebral) in postmenopausal osteoporotic women and an increase in BMD in postmenopausal women with/without osteoporosis. Diarrhea may occur however, adverse events leading to study withdrawal were not significantly increased with taking 2 g of strontium ranelate daily. Potential vascular and neurological side-effects need to be further explored.
雷奈酸锶是一种治疗骨质疏松症的新药物，因此，需要了解其益处和危害。
确定雷奈酸锶治疗和预防绝经后骨质疏松症的疗效和安全性。
我们检索了MEDLINE（1996年至2005年3月）、EMBASE（1996年至2005年第9周）、Cochrane图书馆（1996年至2005年第1期）、相关文章的参考文献列表以及过去两年的会议论文集。还向作者索取了其他数据。
我们纳入了至少为期一年的随机对照试验（RCT），比较雷奈酸锶与安慰剂，报告绝经后女性的骨折发生率、骨矿物质密度（BMD）、健康相关生活质量或安全性。治疗（相对于预防）人群定义为患有椎体骨折和/或腰椎BMD T评分＜-2.5 SD的女性。
两名评审员独立确定研究的合格性，评估试验质量并提取相关数据。分歧通过协商解决。RCT按雷奈酸锶剂量和治疗持续时间分组。尽可能使用随机效应模型进行荟萃分析。
四项试验符合纳入标准。三项纳入了治疗人群（每日雷奈酸锶0.5至2克），一项纳入了预防人群（每日0.125克、0.5克和1克）。在治疗人群中，每日服用2克雷奈酸锶，三年期间椎体骨折减少37%（RR 0.63，95% CI 0.56，0.71），非椎体骨折减少14%（RR 0.86，95% CI 0.75，0.98）。在这两个人群中，两到三年后所有BMD部位的BMD均有所增加。较低剂量的雷奈酸锶优于安慰剂，最高剂量显示椎体骨折减少最多且BMD增加最多。发现每日服用2克雷奈酸锶会增加腹泻风险；然而，不良事件既未影响停药风险，也未增加严重副作用、胃炎或死亡的风险。其他数据表明，连续三到四年每日服用2克雷奈酸锶会使血管和神经系统副作用风险略有增加。
