雷洛昔芬治疗绝经后妇女骨质疏松症的系统评价

Treatment of osteoporosis in postmenopausal women with raloxifene: a systematic review

目的评价雷洛昔芬治疗绝经后骨质疏松症的疗效和安全性。方法计算机检索MEDLINE、EMBASE、Cochrane图书馆临床对照试验注册中心、中国生物医学文献数据库、中国期刊全文数据库、数字化期刊全文数据库,并手工检索相关领域其他杂志。检索不受语种限制,时间截止至2012年11月。以患绝经后骨质疏松症的女性为研究对象、比较雷洛昔芬与安慰剂的随机对照试验,评价纳入研究的质量,用RevMan5.1软件进行Meta分析,并采用GRADE系统评价证据质量评价。结果纳入11个随机对照试验,包括21028例患者。患者腰椎BMD升高达2.39%,且60 mg/d剂量提高腰椎BMD强于30 mg/d组,但60 mg/d与120 mg/d以上剂量组间效果无差别,能有效降低椎体骨折发生率,降低幅度达40%。基于上述系统评价结果,采用GRADE系统评价证据质量及推荐等级,证据总体质量评级为低质量,推荐强度为弱推荐。结论雷洛昔芬治疗绝经后骨质疏松症疗效肯定,能提高腰椎骨密度,降低椎体骨折的风险,但尚无证据支持其能降低非椎体骨折发生率。

Objective To evaluate the therapeutic efficacy and safety of raloxifene on postmenopausal osteoporosis. Methods Literatures in database, including MEDLINE, EMBASE, Coehrane Library Controlled Clinical Trial Register, the Chinese Biomedical Literature Database, China Academic Journal, and digitized journals full-text databases, were retrieved using the computer screening. Magazines on relevant areas were searched manually. No language restriction existed during the whole process of retrieving, and the deadline was November 2012. Postmenopausal women with osteoporosis were the objects in this study, and the randomized controlled trials comparing the therapeutic efficacy of raloxifene and placebo were included. The quality of the included studies was evaluated, and a RevMan 5.1 software was used for meta-analysis. The quality of evidence was evaluated using the GRADE system. Results A total of 11 randomized controlled trials, including 21,028 patients, were included in the study. After the treatment of raloxifene, the bone mineral density of the lumbar vertebrae in patients increased by 2.39%, and the increasing effect of 60mg/d was better than that of 30mg/d. No difference between the effect of 60mg/d and 120mg/d was observed. The incidence of vertebral fractures was effectively reduced, with a reduction up to 40%. Based on these system evaluation results, the quality of evidence and the recommended level were evaluated using GRADE system. The overall quality of the evidence was low, and the strength of recommendation was weak. Conclusion The therapeutic efficacy of raloxifene on postmenopausal osteoporosis is confirmed. It can increase the bone mineral density of the lumbar vertebrae and reduce the risk of vertebral fractures. But there is no evidence to support that it can reduce the incidence of non- vertebral fractures.