摘要
目的评价阿仑膦酸盐预防和治疗男性骨质疏松症的效果和可能的不良反应。方法电子检索:MEDLINE(1990-2005)、EMBASE(1990-2005)、 Cochrane图书馆临床对照试验资料库(2005年第3期)、Current Controlled Trials、The National Research Register、中国生物医学义献数据库 (1990-2005)和中文科技期刊全文数据库(1990-2005)、中文学术期刊全文数据库(1990-2005),并手工检索相关领域其他杂志。检索时间截止至2005年11月。所有检索均不受语种限制。纳入以有骨质疏松症高危风险或患骨质疏松症男性为研究对象、比较阿仑膦酸盐与其它疗法疗效的随机对照试验,评价纳入研究的质量,并用RevMan 4．28软件进行Meta分析。结果共纳入7个随机对照试验,包括817例患者。Meta分析结果显示,阿仑膦酸盐+钙剂对提高骨质疏松症高危男性患者腰椎骨密度的作用优于单用钙剂[SMD 0．59,95％CI(0．15,1．03),P=0．009];对于降低骨折风险,阿仑膦酸盐+钙剂与单用钙剂相似;对于降低脊柱骨折的风险,2年以上疗程的阿仑膦酸盐治疗优于α-骨化醇,但是对于非脊椎骨折,两者疗效相似;阿仑膦酸盐提高骨密度的效果优于α-骨化醇、钙剂;在预防骨质疏松症、提高骨密度方面,阿仑膦酸盐不如降钙素、α-骨化醇、甲状旁腺激素;阿仑膦酸盐联合甲状旁腺激素优于单独使用阿仑膦酸盐;阿仑膦酸盐联合甲状旁腺激素与单独使用甲状旁腺激素比较,两者对提高骨密度的疗效相似。结论阿仑膦酸盐预防和治疗男性骨质疏松症的疗效优于钙剂;对于提高骨密度,阿仑膦酸盐不如降钙素、α-骨化醇;长期使用阿仑膦酸盐比α-骨化醇更能减少脊柱骨折的风险。阿仑膦酸盐联合甲状旁腺激素与单用甲状旁腺激素比较,两者在治疗男性骨质疏松症方面的效果相似。今后尚需开展更多高质量特别是多中心研究以增加证据的强度。
Objective To systematically review the efficacy and adverse events of alendronate on bone mineral density and fractures in men with osteoporosis.
Methods We electronically searched MEDLINE （1990 to 2005）, EMBASE （1990 to 2005）, The Cochrane Library （Issue 3, 2005）, Controlled Trials Register and The National Research Register, CBM disc, VIP, and CNKI. We also handsearched some related journals. The search was conducted in Nov., 2005. The quality of included randomized controlled trials （RCTs） was evaluated and meta-analysis was conducted by RevMan 4.2.8.
Results We identified 7 studies including 817 patients. Sufficient evidence showed that alendronate plus calcium was superior as preventive treatment to calcium in increasing the bone mineral density （SMD 0.59, 95% CI 0.15 to 1.03, P=0.009） of the lumbar spine. The incidence of withdrawal and lost to follow-up due to adverse events of the alendronate plus calcium was lower than that of calcium （RR 0.32, 95% CI 0.11 to 0.87）. Two studies showed that alendronate was superior to placebo in increasing the bone mineral density in men with osteoporosis but with no significantly statistical difference in reducing fractures. Two studies showed alendronate was superior to alfacalcidol in increasing the bone mineral density and reducing the vertebral fractures in men with osteoporosis. One study showed alendronate was not superior to calcitonin or alfacalcidol in increasing the bone mineral density in men at high risk of osteoporosis. One study comparing anledronate or parathyroid hormone with combination of these drugs in men with osteoporosis suggested that anledronate wasn＇t superior to parathyroid hormone in increasing the bone mineral density, and the combination did not show any difference compared to parathyroid hormone alone.
Conclusions Alendronate is more effective in prevention and treatment of men with osteoporosis compared to placebo. Alendronate is more effective than alfacalcidol in increasing bone mineral density and reducingvertebral fractures in men with osteoporosis. Alendronate is not superior to alfacalcidol or calcitonin in increasing the bone mineral density in preventing men osteoporosis. Alendronate compared to combination of parathyroid hormone does not show more effectiveness in increasing the bone mineral density in men with osteoporosis. More RCTs of high quality, especially multiple center trials are needed to generate stronger evidence.
出处
《中国循证医学杂志》
CSCD
2006年第3期195-201,共7页
Chinese Journal of Evidence-based Medicine
关键词
阿仑膦酸盐
男性骨质疏松
预防
治疗
系统评价
Alendronate
Prevention
Treatment
Men osteoporosis
Systematic review
