甲状旁腺激素（1-34)治疗绝经后骨质疏松症疗效的系统评价

目的 评价甲状旁腺激素(1-34)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(1966～2008.7)、EMBASE (1974～2008.7)、Cochrane图书馆临床试验资料库(2008年第二期)、Current Controlled Trials、The National Reseach Register、中国生物医学文献数据库(1983～2008.7)、中国期刊全文数据库(1994～2008.7),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2008年7月.纳入以患绝经后骨质疏松症的女性为研究对象、比较甲状旁腺激素(1-34)与其他疗法疗效的随机对照试验,评价纳入研究的质量,并用RevMan 5.0软件进行Meta分析.结果 纳入8个随机对照试验,包括2513例患者. PTH(1-34)(单用或与其他药物联用)增加腰椎和髋部等部位的骨密度优于对照组;减少椎体骨折风险达68%(RR=0.32,95% CI: 0.23～0.45,P＜0.00001),减少非椎体骨折风险为43%(RR=0.57,95% CI: 0.39～0.85,P=0.005).因副作用导致的退出和失访在PTH(1-34)组多于对照组[Peto-OR=1.56,95%CI 1.15～2.12,P=0.004].结论 PTH(1-34)治疗绝经后骨质疏松症疗效肯定,能提高腰椎及髋部等部位的骨密度,降低椎体和非椎体骨折的风险.骨量严重低下和有骨质疏松性骨折的绝经后女性是PTH(1-34)较适合的人群.     

甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症有效性及安全性评价——Meta分析

目的 评价甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症有效性及安全性差异.方法 通过检索Pubmed、Cochrane图书馆、EMbase、Highwire、中国生物医学文献数据库CBM、CNKI等中外生物医学数据库,收集有关应用甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症的临床随机对照试验,检索文献日期从2002年1月至2012年9月.采用Cochrane系统评价方法,按照纳入和排除标准限定研究对象,评估所纳入研究的文献质量,并提取有效数据后采用RevMan5.0软件进行Meta分析.结果 共纳入应用甲状旁腺素与二磷酸盐对比治疗绝经妇女骨质疏松症的临床对照研究9项(共1287例).结果 显示:在有效性方面,甲状旁腺素组比二磷酸盐组能提高绝经妇女骨质疏松症者腰椎BMD[WMD=3.96,95%CI(3.10,4.82)]和股骨颈BMD[WMD=2.05,95%CI(0.27,3.83)],而后者比前者更能提高髋BMD[WMD=-1.07,95%CI(-1.72,-0.41)];在安全性方面,甲状旁腺素组不良事件总发生率低于二磷酸盐组[WMD=0.87,95%CI(0.59,1.30)].二者背痛与非椎体骨折发生率无显著差异,但前者血钙、尿钙超出正常水平发生率显著高于后者{血钙:[WMD=13.68,95%CI(6.12,30.59)];尿钙:[WMD=2.21,95%CI(1.14,4.26)]}.结论 甲状旁腺素类药物比二磷酸盐类药物更能提高绝经妇女骨质疏松症病人腰椎、股骨颈BMD,改善骨质量的疗效肯定,且安全性较高.但在临床使用中,要定时监测患者血钙、尿钙水平,进一步提高用药安全性.     

骨质疏松症患者腰椎平均BMD与腰椎椎体骨折相关性研究

目的 探讨骨质疏松症患者腰椎平均骨密度(BMD)与腰椎椎体骨折的关系.方法 选择2010年1月~2011年1月来我院治疗骨质疏松性椎体骨折96例患者为骨折组,42例无腰椎椎体骨折者作为对照组.采用双能X线骨密度仪对两组患者腰椎正位(L2-4)BMD进行测定.结果 骨质疏松患者腰椎椎体骨折组患者BMD相对对照组较低,差异具有统计学意义(P<0.05).结论 腰椎BMD降低与绝经后妇女的骨质疏松性椎体骨折相关.     

椎体成形术与非手术治疗骨质疏松性椎体压缩骨折的系统评价

目的 系统评价椎体成形术和非手术治疗骨质疏松椎体压缩性骨折的治疗效果.方法 应用Cochrane系统评价方法计算机检索Cochrane Library、PubMed、EMBASE、中国生物医学文献数据库、中国期刊全文数据库和维普数据库,并手工检索相关领域杂志.检索不受语种限制,时间均从建库至2011年11月.收集以椎体成形术和非手术治疗骨质疏松性椎体压缩骨折的所有随机对照试验(RCTs).进行资料提取和质量评价,用RevMan 5.0软件进行统计学分析.结果 最终纳入7个RCTs,共614例患者.研究结果显示:与保守治疗相比,随访1、4、12、24、48w时椎体成形术在缓解疼痛方面更明显;在新发骨折发生方面,两种治疗方法无统计学意义.与安慰剂相比,随访4w时椎体成形术在缓解疼痛、提高腰部功能活动及改善生活质量方面并无明显优势.结论 与保守治疗相比,椎体成形术在缓解疼痛方面具有一定的优势,但是远期疗效还需更大量的高质量文献提供科学的证据.由于纳入研究质量和病例数量的局限,上述结论尚需要更多高质量的随机对照试验进一步验证.     

利塞膦酸盐影响原发性绝经后骨质疏松性骨折发生率的Meta分析

[目的]系统评价利塞膦酸盐影响原发性绝经后骨质疏松性骨折发生率的有效性和安全性.[方法]按照Cochrane协作网制订的检索策略进行检索,计算机检索MEDLINE(1966～2010年12月)、EMBASE(1974～2010年12月)、Cochrane图书馆(2010年第12期)、中国生物医学文献数据库(CBM,1978～2010年12月)、中国期刊全文数据库(CNKI,1994～2010年12月)、中文科技期刊全文数据库(VIP,1989～2010年12月)及万方数据库(1979～2010年12月).手工检索相关的中英文骨科杂志和会议论文.纳人利塞膦酸盐影响原发性绝经后骨质疏松性骨折发生率的所有随机对照试验,由2名评价员独立提取资料,并对其方法学质量进行评价.对符合纳人标准的研究用RevMan 5.0软件进行Meta分析.[结果]共纳人7个随机对照试验.10 359例患者.Meta分析结果显示:利塞膦酸盐可以降低原发性绝经后骨质疏松性椎体骨折发生率[RR=0.66,95% CI(0.57,0.77)P < 0.000 011;利塞膦酸盐可以降低原发性绝经后骨质疏松性非椎体骨折发生率[RR =0.69,95% CI(0.52,0.90)P=0.007];利塞膦酸盐可以降低原发性绝经后骨质疏松性髋部骨折发生率[RR = 0.66,95% CI(0.49,0.90)P = 0.008]o[结论]利塞膦酸盐有利于降低原发性绝经后骨质疏松性骨折的发生率,但限于纳入研究在方法学方面的局限性,尚需开展大样本、高质量的RCT进一步论证其疗效和安全性.     

绝经后女性骨质疏松性椎体骨折与腰椎体骨密度的相关性

随着我国步入老龄化社会,骨质疏松症的患病率明显升高。骨质疏松症最严重的危害来自骨质疏松性骨折,绝经后女性尤其多见。由于脊柱独特的解剖学和生物力学特点,骨质疏松患者更易发生椎体骨折。骨密度测量是诊断骨质疏松的金标准。本文通过回顾近年来相关文献,探讨腰椎体骨密度检测对绝经后女性骨质疏松性椎体骨折的意义,发现:绝经后骨质疏松性椎体骨折患者的BMD水平比绝经后骨质疏松症但无脊椎骨折者明显减少;绝经后骨质疏松症患者的BMD水平越低,其发生椎体骨折的风险越高;有椎体骨折史的绝经后骨质疏松症患者的BMD水平与发生再次椎体骨折的风险呈负相关。药物干预通常可明显提高绝经后骨质疏松症患者的BMD水平,同时还可减少椎体骨折的发生。尚存在一些不足:腰椎骨密度可能出现假性增高;需进一步探讨预测骨质疏松性椎体骨折的骨密度阈值;药物干预的研究中BMD水平与椎体骨折发生的相关性并没有得到深入研究;缺少大规模的绝经后骨质疏松性椎体骨折的流行病学,现有研究也大都存在病例收集方法不规范、样本量小、年龄分布存在差异等不足。对绝经后骨质疏松性椎体骨折的深入研究需要多学科共同协作。     

绝经后骨质疏松症中医临床实践指南编制要点解读

为了使指南使用者了解绝经后骨质疏松症中医临床实践指南的编制过程,笔者针对编制过程中的要点问题予以解读。主要包括4项内容,分别是临床问题/结局指标的收集与遴选、证据获取、证据质量评价、推荐意见形成。其中,临床问题的收集与遴选分为3轮,第一轮是广泛收集本指南需要解决的临床问题,第二轮是对第一轮收集的临床问题进行重要性评分,第三轮是通过共识会议法,最终确定19个临床问题及结局指标。证据获取方面,首先检索中英文数据库,然后进行文献的合并与查重,文献的初筛,文献的分类、再筛选,最终纳入系统评价1篇,随机对照研究114篇。证据质量评价及推荐意见形成均按照GRADE原则完成。推荐意见形成过程中,需要注意虽然中医药文献的证据质量普遍偏低,但并不等于中药本身的疗效不佳。需要专家结合临床经验进行全面评估,形成推荐意见。本编制要点解读可使绝经后骨质疏松症中医临床实践指南的制定更加公开透明,并为今后中医临床实践指南的制定提供参考。     

系统评价再评价在中药治疗绝经后骨质疏松症中的应用

目的运用AMSTAR 2方法质量评分和PRISMA报告质量评分定性定量再评价中药治疗绝经后骨质疏松症的系统评价/Meta分析,以期为临床决策者提供科学的参考证据。方法运用计算机检索国内外8大中英文数据库:中国知网(CNKI)、维普(VIP)、中国生物医学文献数据库(CBM)、万方数据库、The Cochrane Library、Embase、PubMed、Web of Science,收集中药治疗绝经后骨质疏松症的系统评价/Meta分析,检索时间从数据库建库至2020年2月。运用AMSTAR 2和PRISMA对中药治疗绝经后骨质疏松症系统评价/Meta分析的文献质量进行综合评估。运用GRADE对所有纳入文献的结局指标进行质量分级。采用多元线性回归分析法分析与纳入文献整体质量评分相关的因素及其效应量。结果共纳入12篇合格文献,运用Excel 2013进行数据提取并进行AMSTAR 2方法学质量评分和PRISMA报告学质量评分,结果显示所有纳入文献的质量偏低。主要存在项目注册、检索、方法学使用、质量报告影响、发表偏倚等方面的问题。GRADE证据质量评分偏低,以低质量为主。结论中药治疗绝经后骨质疏松症系统评价/Meta分析的文献质量不高。研究发现,文献质量受方法学使用和质量报告影响较大。研究者需按循证医学的要求和方法从方法学质量和报告学质量方面着手,不断加强以期进一步提高文献质量。今后的研究需要基于统一的标准与指标,采用科学的方法学进行统计分析,进一步提高中药临床治疗绝经后骨质疏松症的科学性、真实性与准确性。     

激素替代联合二磷酸盐预防和治疗绝经后骨质疏松症疗效的系统评价

目的 评价联合与单一用激素替代和二磷酸盐预防和治疗绝经后骨质疏松的疗效性和安全性.方法 计算机检索MEDLINE(1966～2008.10)、Embase(1984～2005)、PubMed(1966～2008.10)、Cocharane图书馆(CENTRAL 2008年第三期)、中国生物医学文献光盘数据库(1978～2006年)和中国期刊全文数据(1979～2008.10),并手工检索相关领域其他杂志.对纳入文献进行质量评价.数据分析采用RevMan 5.0,对于异质性小的研究合并效应量.结果 共纳入13 个随机对照试验,包括3341 例患者.Meta 分析结果显示:①联合治疗组与二磷酸盐单一用药组比较,在增加腰椎骨密度和减少骨折风险方面无明显差别,在降低骨转化标志物及药物副作用方面无优势.②联合治疗组与激素替代单一治疗组比较,在增加腰椎骨密度、药物副作用方面具有明显优势,在减少骨折风险、降低骨转化标志物方面无明显差别.结论 激素替代联合二磷酸盐预防和治疗绝经后骨质疏松症疗效优于激素替代单一治疗,但与二磷酸盐单一治疗比较并没有优势,且副作用明显增加.     

维生素K2防治绝经后骨质疏松症作用的荟萃分析

目的 为了确定维生素K2对绝经后骨质疏松症(postmenopausal osteoporosis, PMOP)患者的预防和治疗作用,我们对22项随机对照试验进行了荟萃分析。方法 在PubMed、Cochrane Library、Embase数据库和三个中文数据库(CBM、CNKI和万方)检索了2020年6月1日之前发布的相关随机对照试验(RCT),以维生素K2与安慰剂或其他抗骨质疏松药物预防和治疗PMOP进行比较。使用固定效应或随机效应模型计算合并风险比(RR)、平均值(MD)和95％置信区间(CI)。结果 包括7 154名绝经女性参与的22项随机对照试验符合纳入标准。补充维生素K2 12个月后改善绝经后女性腰椎骨密度优于对照组(P = 0.03),PMOP亚组腰椎骨密度改善较对照组差异有统计学意义 (P = 0.03)。补充维生素K2预防绝经后女性椎体骨折发生率优于对照组(RR = 0.52, 95 % CI: 0.36~0.74, P = 0.003),PMOP亚组椎体骨折发生率低于对照组(P = 0.006)。补充维生素K2显著降低低羧化骨钙素(ucOC)(P <0.001)。补充维生素K2药物不良反应略高于对照组(RR=1.29, 95 % CI:1.03~1.63, P = 0.03)。结论 补充维生素K2 12个月后有效改善绝经后女性腰椎骨密度,预防椎体骨折,降低ucOC,PMOP患者获益更大。口服维生素K2被认为是安全的。     

Effect of raloxifene on the risk of new vertebral fracture in postmenopausal women with osteopenia or osteoporosis: a reanalysis of the Multiple Outcomes of Raloxifene Evaluation trial

Raloxifene reduces vertebral fracture risk in postmenopausal women with osteoporosis and established osteoporosis, but its efficacy in women with osteopenia has not been studied. The objective of this study was to evaluate the effect of raloxifene hydrochloride on the risk of vertebral fractures in postmenopausal women with osteopenia and to compare this effect with that in women with osteoporosis as defined by the bone mineral density (BMD) T-score at the hip. We studied the 3204 postmenopausal women with osteopenia or osteoporosis without vertebral fractures at baseline in the Multiple Outcomes of Raloxifene Evaluation trial. Compared with placebo, 60 mg/day raloxifene reduced the risk of new vertebral fractures at 3 years independent of baseline total hip BMD. The relative risk for new vertebral fractures for the raloxifene group compared with placebo was 0.53 (95% CI, 0.32-0.88) for those with osteopenia and 0.31 (0.06-0.71) for those with osteoporosis. In raloxifene-treated women the rate of vertebral fracture was similar in women with osteoporosis (2%) to that in women with osteopenia (1.9%). For clinically apparent vertebral fractures, the relative risk of fracture in the osteopenia group for raloxifene was 0.25 (0.04-0.63) compared with placebo. There were no new clinical vertebral fractures in women with osteoporosis receiving raloxifene, whereas four occurred in the placebo group. We conclude that treatment with 60 mg/day raloxifene significantly decreases the risk of new vertebral fractures and new clinical vertebral fractures in postmenopausal women without baseline vertebral fracture who have osteopenia or osteoporosis.     

Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy.

Although low absolute values of bone mineral density (BMD) predict increased fracture risk in osteoporosis, it is not certain how well increases in BMD with antiresorptive therapy predict observed reductions in fracture risk. This work examines the relationships between changes in BMD after 1 year or 3 years of raloxifene or placebo therapy and the risk for new vertebral fractures at 3 years. In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis were randomized to placebo or raloxifene 60 mg/day or 120 mg/day. Relationships between baseline BMD and changes in BMD from baseline with the risk of new vertebral fractures were analyzed in this cohort using logistic regression models with the raloxifene doses pooled. As has been observed in other populations, women with the lowest baseline lumbar spine or femoral neck BMD in the MORE cohort had the greatest risk for vertebral fractures. Furthermore, for any percentage change, either increase or decrease in femoral neck or lumbar spine BMD at 1 year or 3 years, raloxifene-treated patients had a statistically significantly lower vertebral fracture risk compared with placebo-treated patients. The decrease in fracture risk with raloxifene was similar across the range of percentage change in femoral neck BMD observed at 3 years; patients receiving raloxifene had a 36% lower risk of vertebral fracture compared with those receiving placebo. At any percentage change in femoral neck and lumbar spine BMD observed at 1 year, raloxifene treatment decreased the risks of new vertebral fractures at 3 years by 38% and 41%, respectively. The logistic regression model showed that the percentage changes in BMD with raloxifene treatment accounted for 4% of the observed vertebral fracture risk reduction, and the other 96% of the risk reduction remains unexplained. The present data show that the measured BMD changes observed with raloxifene therapy are poor predictors of vertebral fracture risk reduction with raloxifene therapy.     

Effect of raloxifene combined with monofluorophosphate as compared with monofluorophosphate alone in postmenopausal women with low bone mass: a randomized,controlled trial

Raloxifene effectively reduces the incidence of vertebral fractures in patients with postmenopausal osteoporosis. Recent data suggest that low-dose monofluorophosphate (MFP) plus calcium reduces the vertebral fracture rate in postmenopausal women with moderate osteoporosis. The objective of this study was to evaluate the combination of raloxifene and MFP in the treatment of postmenopausal women with osteopenia, osteoporosis and severe osteoporosis. A total of 596 postmenopausal women with osteopenia, osteoporosis and severe osteoporosis (mean femoral neck T-score of –2.87 SD) were randomized to treatment with 60 mg/day raloxifene HCl and 20 mg/day fluoride ions (as MFP) or 20 mg/day fluoride and placebo for 18 months. All patients received calcium (1000 mg/day) and vitamin D (500 IU/day) supplements. Changes in bone mineral density (BMD), as primary endpoint, and the rate of osteoporotic fractures and biochemical markers, as secondary endpoints, were assessed. As compared with MFP, raloxifene plus MFP was associated with significantly greater mean increases in the BMD of the femoral neck (1.37% versus 0.33%; P=0.004), total hip (0.89% versus –0.42%; P<0.001) and lumbar spine (8.80% versus 5.47% P<0.001). In the raloxifene plus MFP group, 16 patients sustained 17 osteoporotic fractures, as compared with 22 patients sustaining 34 incident osteoporotic fractures in the MFP group (P=0.313). One patient in the raloxifene plus MFP group sustained multiple osteoporotic fractures, as compared with eight patients in the MFP group (P=0.020). MFP alone significantly increased the serum bone alkaline phosphatase (bone ALP) and the urinary C-terminal crosslinking telopeptide of type I collagene (U-CTX). The addition of raloxifene in the combination arm blunted the rise in bone ALP, which remained nevertheless significant, and abolished the increase in U-CTX. The combination of raloxifene with MFP was generally well tolerated. This study demonstrates that, in postmenopausal women with osteopenia, osteoporosis and severe osteoporosis, the combination therapy of raloxifene plus MFP favorably influences the BMD and the bone formation and resorption balance, and may reduce the risk of multiple osteoporotic fractures compared to MFP alone.     

绝经后妇女骨质疏松性椎体骨折与腰椎骨密度的关系

目的探讨绝经后妇女骨质疏松性椎体骨折与腰椎骨密度的关系。方法选择骨质疏松性椎体骨折的绝经后妇女23例为骨折组,无椎体骨折的25例绝经后骨质疏松妇女为对照组。两组的年龄、绝经年限、身高、体重、体重指数差异无显著性,均行胸腰椎正侧位X线摄片。用双能X线吸收仪（DXA）测量的腰椎（L2-4）前后位骨密度（BMD）、骨矿含量（BMC）和T值。结果骨折组BMD、BMC和T值均低于对照组（P〈0.01）。结论腰椎BMD降低与绝经后妇女的骨质疏松性椎体骨折相关。绝经后骨质疏松妇女应重视BMD变化,预防椎体骨折的发生。     

连续注射唑来膦酸两年治疗绝经后骨质疏松疗效观察

目的观察唑来膦酸治疗绝经后妇女原发性骨质疏松症的有效性和安全性。方法采用随机对照研究,观察期为2年。175名患者随机分为两组,87例原发性骨质疏松症妇女口服元素钙500mg(碳酸钙)和阿法骨化醇1w后给予密固达（唑来膦酸,5mg/100mL）静脉输液,并通过骨密度仪记录治疗前后骨密度及肾功能的变化、骨折事件发生及不良反应。对照组88人,口服骨化醇及钙剂。结果输注唑来膦酸后患者髋关节及腰椎2-4骨密度较对照组明显提高,疼痛较前明显缓解,肾功能无损害,连续输注患者无一例腰椎骨折发生,输注后2d内不良反应以低热、关节痛、肌痛、流感样症状等,1例出现房颤。结论唑来膦酸对绝经后妇女骨质疏松症的治疗安全有效,能够降低骨折的风险,其长期疗效需进一步随访研究,不良反应包括心房纤颤发生率的增加。     

Anabolic agents for treating postmenopausal osteoporosis.

The main efficacy criterion for drugs against osteoporosis is protection against fractures. Many resorption-inhibiting agents meet this criterion, including estrogens, alendronate, risedronate, raloxifene, calcitonin, and calcium-vitamin D supplements). Conversely, among anabolic agents, only parathyroid hormone (PTH) is known to reduce the fracture risk, the mechanism being increased bone matrix production by osteoblasts with no alterations in the mechanical properties of bone. Although fluoride salts induce a marked increase in bone mineral density (BMD), there is no evidence that this protects against vertebral or peripheral fractures. Growth hormone, IGF-I, statins, and strontium ranelate are under investigation. A recent controlled clinical trial in 1,637 women with osteoporosis showed that daily subcutaneous injections of PTH (1-34) (20 or 40 microg) for 21 months reduced the fracture risk. With 20 microg/day, the reductions were 65% for vertebral fractures and 57% for extravertebral fractures, 11% of patients had moderate postinjection hypercalcemia, and BMD increased by 9% at both the lumbar spine and the femoral neck. These findings open up the exciting possibility that PTH used alone or in combination with resorption-inhibiting agents may be helpful. To date, PTH is the only anabolic agent that has proved capable of reducing the risk of vertebral and extravertebral fractures in women with established postmenopausal osteoporosis.     

Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial

Prevalent vertebral fractures and baseline bone mineral density (BMD) predict subsequent fracture risk. The objective of this analysis is to examine whether baseline vertebral fracture severity can predict new vertebral and nonvertebral fracture risk. In the randomized, double-blind 3-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis (low BMD or prevalent vertebral fractures) were randomly assigned to placebo, raloxifene 60 mg/day, or raloxifene 120 mg/day. Post hoc analyses studied the association between baseline fracture severity and new fracture risk in the placebo group and the effects of placebo, raloxifene 60 mg/day, and raloxifene 120 mg/day on new fracture risk in women with the most severe prevalent vertebral fractures (n = 614). Vertebral fracture severity was visually assessed using semiquantitative analysis of radiographs and categorized by estimated decreases in vertebral heights. Reported new nonvertebral fractures were radiographically confirmed. Baseline vertebral fracture severity predicted vertebral and nonvertebral fracture risk at 3 years. In women without prevalent vertebral fractures, 4.3 and 5.5% had new vertebral and nonvertebral fractures, respectively. In women with mild, moderate, and severe prevalent vertebral fractures, 10.5, 23.6, and 38.1% respectively had new vertebral fractures, whereas 7.2, 7.7, and 13.8% respectively experienced new nonvertebral fractures. Number of prevalent vertebral fractures and baseline BMD also predicted vertebral fracture risk, but the severity of prevalent vertebral fractures was the only predictor of nonvertebral fracture risk and remained a significant predictor after adjustment for baseline characteristics, including baseline BMD. In patients with severe baseline vertebral fractures, raloxifene 60 mg/day decreased the risks of new vertebral [RR 0.74 (95% Cl 0.54, 0.99); P = 0.048] and nonvertebral (clavicle, humerus, wrist, pelvis, hip, and leg) fractures [RH 0.53 (95% CI 0.29, 0.99); P = 0.046] at 3 years. To prevent one new fracture at 3 years in women with severe baseline vertebral fractures with raloxifene 60 mg/day, the number needed to treat (NNT) was 10 for vertebral and 18 for nonvertebral fractures. Similar results were observed in women receiving raloxifene 120 mg/day. In summary, baseline vertebral fracture severity was the best independent predictor for new vertebral and nonvertebral fracture risk. Raloxifene decreased new vertebral and nonvertebral fracture risk in the subgroup of women with severe vertebral fractures at baseline. These fractures may reflect architectural deterioration, independent of BMD, leading to increased skeletal fragility.     

二膦酸盐治疗骨质疏松及骨量减少的随机对照研究

目的观察第三代二膦酸盐利塞膦酸钠片防治原发性骨质疏松症的有效性和安全.方法选择年龄在41～75岁女性,自然停经1年以上,按人选时间顺序随机分配到治疗组和对照组各24例.治疗组服用利塞膦酸钠片5 mg/d和凯思立D1片/d;对照组服用安慰剂加凯思立D1片/d,两组均观察1年.结果43例患者遵照方案完成12个月治疗与观察,治疗组腰椎骨密度提高20.06%,股骨颈骨密度提高24.95%,两组差异有统计学意义（P＜0.05）;12个月时治疗组和对照组的总有效率分别为95.65%和45.00%.髋部（三角区、大转子）骨密度变化百分比,两组差异无统计学意义（P＞0.05）.治疗后两组骨代谢指标血ALP、尿NTX/Cr均较治疗前降低.结论利塞膦酸钠是一种防治原发性骨质疏松症的安全有效的药物.     

甲磺酸去铁胺辅助治疗绝经后骨质疏松症的可行性和安全性研究

目的观察甲磺酸去铁胺辅助治疗绝经后骨质疏松的可行性和安全性研究。方法 178例绝经后骨质疏松症女性分为治疗组与对照组,对照组给予雷洛昔芬(60 mg/d)治疗,治疗组在给予雷洛昔芬治疗的基础上添加甲磺酸去铁胺辅助治疗。治疗为期6个月,比较治疗前后两组患者不良反应、骨密度、骨代谢指标的差异和临床疗效。结果截止治疗时间为止,治疗组患者的治疗总有效率为100%,明显高于对照组的84. 27%,差异有统计学意义(P0. 05);两组患者治疗后的腰椎正位、股骨颈骨密度较治疗前均显著上升,且治疗组BMD升高较对照组更为显著,差异均有统计学意义(P0. 05);治疗组的血清骨钙素(OC)、甲状旁腺素(PTH)、血清I型胶原C端肽(CTX-I)、血清铁蛋白水平较治疗前明显改变且改变幅度均明显大于对照组,差异均有统计学意义(P0. 05)。治疗期间两组患者均无明显不良反应发生。结论甲磺酸去铁胺辅助雷洛昔芬治疗能明显提高绝经后骨质疏松患者的骨密度,改善骨代谢指标,且不增加不良反应的基础上增加治疗有效率。     

Treatment with raloxifene for 2 years increases vertebral bone mineral density as measured by volumetric quantitative computed tomography

Volumetric quantitative computed tomography (vQCT), using multiple thin-slice acquisition, measures three-dimensional volumetric bone mineral density (BMD, mg/cm3). vQCT is often used to measure BMD of lumbar vertebrae and may detect early changes in trabecular, cortical, or integral BMD that extend beyond the technical limits of areal dual X-ray absorptiometry (DXA) BMD measurements. The objective of this study was to determine the effect of 2 years of raloxifene (RLX) treatment on several volumetric BMD measures in a subset of postmenopausal women (n=58) enrolled in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial. Patients in this study were randomized to one of three treatment groups: placebo (n=21), RLX 60 mg/day (n=17), or RLX 120 mg/day (n=20), and all patients received daily calcium (500 mg) and vitamin D (400-600 IU) supplementation. Data from the raloxifene treatment groups were pooled for each analysis. Following 2 years of raloxifene treatment, there was a significant percent change from baseline in the vQCT regions of interest (ROIs) of midintegral BMD, total trabecular BMD, and total integral BMD (P<0.05) compared to placebo, while there was no significant change in the spinal DXA BMD measurement. These data provide the first longitudinal assessment by vQCT of changes in vertebral bone density after 2 years of treatment with raloxifene. vQCT appears to be a valuable technique for measuring the effects of raloxifene treatment in this population of postmenopausal women with osteoporosis.