阿仑膦酸盐治疗原发性骨质疏松症的临床研究

目的观察阿仑膦酸盐治疗原发性骨质疏松症患者的疗效、安全性和耐受性。方法对照观察阿仑膦酸盐使用６个月前后疼痛、骨密度、血常规、血生化、副作用等方面的变化。结果患者在３个月内疼痛缓解,全身各部位骨密度上升,其中男、女性腰椎总骨密度分别上升３．１％、３．５％,副作用轻微且多在用药初期即可自行缓解。结论阿仑膦酸盐治疗原发性骨质疏松症疗效好、安全、耐受性好     

阿伦膦酸盐降低骨质疏松性椎体骨折风险的作用

骨质疏松症已成为全球严重的公共卫生问题,防治骨质疏松症和骨质疏松性骨折已成为目前关注的课题。骨质疏松性骨折最常见于椎体。阿伦膦酸盐是临床上治疗骨质疏松症的常用药物。众多文献表明,阿伦膦酸盐能明显增加患者骨密度（BMD）,使其发生椎体骨折和再骨折的危险性降低。与其他抗重吸收药物比较,阿伦膦酸盐增加BMD的作用较强。但目前尚未有文献对阿伦膦酸盐预防椎体强化术后椎体再骨折的疗效进行明确报道。     

双膦酸盐类药物治疗骨质疏松症

目的 评价不同类型双膦酸盐药物的临床疗效。方法 骨质疏松妇女360人,随机分成3组,所有患者每天在接受元素钙500 mg和维生素D200IU治疗的同时,分别接受羟乙膦酸钠、阿伦膦酸钠和利塞膦酸钠治疗,其中羟乙膦酸钠200 mg,bid,用2周,间歇11周后再次重复;阿伦膦酸钠10mg,qd;利塞膦酸钠5 mg,qd。3种药物治疗时间均为1年。观察内容包括:骨痛,尿N肽端交联Ⅰ型胶原,NTx和血清骨碱性磷酸酶,BAP,骨密度,不良反应,脊柱新骨折。结果 3组患者经1年治疗,与用药前比较,骨痛症状均有不同程度改善;骨代谢指标N肽端交联Ⅰ型胶原和骨碱性磷酸酶均明显下降(P<0.01);腰椎和髋部骨量均有显著上升(P<0.01):其中阿伦膦酸钠治疗组骨密度腰椎L2-4上升5.51％,股骨颈上升2.66％,股骨粗隆上升4.37％,Ward’s区上升3.13％;利塞膦酸钠治疗组骨密度腰椎L2-4上升4.18％,股骨颈上升2.05％,股骨粗隆上升2.81％,Ward’s区上升3.08％;羟乙膦酸钠治疗组骨密度腰椎L2-4上升3.70％,股骨颈上升1.84％,股骨粗隆上升1.96％,Ward’s区上升1.50％;新骨折发生羟乙膦酸钠组4人,阿伦膦酸钠和利塞膦酸钠组均为1人;各组均未见明显不良反应。 结论双膦酸盐治疗骨质疏松症疗效确切,新型双膦酸盐阿伦膦酸钠和利塞膦酸钠更方便、高效。     

唑来膦酸盐与骨质疏松症

目的 双膦酸盐是目前抗骨质疏松治疗最常用药物.唑来膦酸盐是每年1次静脉注射用双膦酸盐,探讨唑来膦酸盐对骨质疏松的治疗作用及安全性分析.方法 PubMed上检索应用唑来膦酸盐治疗骨质疏松及其他疾病的相关文献并进行分析.结果 HORIZON-PFT 3年研究表明唑来膦酸盐与安慰剂比较,能明显降低椎体、非椎体骨折风险,增加骨密度,降低骨转换标志物水平,增加骨小梁容量.在90 d内行髋部骨折外科治疗的患者中进行的HORIZON-RFT研究发现唑来膦酸盐与安慰剂比较能够明显降低再发骨折风险,降低全因死亡率,增加髋部及股骨颈骨密度.绝经后低骨密度妇女从阿伦膦酸钠改为唑来膦酸盐3个月内平均骨转换标志物水平先下降,后逐渐增至绝经前妇女正常范围,且可维持腰椎骨密度值12个月.另一研究表明与阿伦膦酸钠比较,唑来膦酸盐能更迅速的降低骨吸收标志物,抑制骨吸收.在安全性方面唑来膦酸盐可能的副作用包括急性一过性不良反应,如发热、肌痛、流感样症状,主要为轻到中度,常发生在静脉输注后3 d内,3～7 d左右缓解.研究表明唑来膦酸盐短期内可能引起肾功能的变化,但长期对肾功能未发现明显影响.颌骨骨质疏松性坏死可能与唑来膦酸盐相关,但发生率较低,且多发生在恶性肿瘤如多发性骨髓瘤和转移癌的患者中,尚未证实颌骨骨质疏松性坏死风险增高与用于治疗骨质疏松症批准剂量的唑来膦酸盐有关.其他少见的副作用包括房颤,无症状及一过性低钙血症,尚需要大样本长期研究证实.结论 每年1次唑来膦酸盐是治疗绝经后骨质疏松新的选择.     

肺癌病人Ki－ras基因点突变与术后长期生存关系的研究

本研究应用ＰＣＲ及寡核苷酸探针杂交技术，研究肺癌组织Ｋｉ－ｒａｓ基因点突变与肺癌病人术后长期生存的关系。结果显示：（１）６０例肺癌中Ｋｉ－ｒａｓ点突变率为４１．６７％。（２）小细胞肺癌Ｋｉ－ｒａｓ突变率较鳞癌、腺癌高，分别为５０％、４３．４８％和４０．７４％。（３）有Ｋｉ－ｒａｓ点突变组肺癌病人，其术后１、３、５年生存率分别为６４．０％、３６．０％和２４．０％；而无点突变组肺癌病人术后１、３、５年生存率分别为７４．２９％、５１．４３％和４０．０％。本研究结果表明：研究肺癌的Ｋｉ－ｒａｓ基因点突变，对判断肺癌病人的预后，指导术后的综合治疗，具有重要的临床意义。     

安氟醚及异氟醚对阿曲库铵临床药效的影响

目的：观察吸入１％安氟醚或等效浓度异氟醚对阿曲库铵临床药效的影响。方法：３０例择期手术病人随机分为三组，分别吸入６７％Ｎ２Ｏ（Ⅰ组），１％安氟醚（Ⅱ组）或０．６７％异氟醚（Ⅲ组）后观察阿曲库铵临床药效。结果：静注阿曲库铵０．５ｍｇ／ｋｇ后，Ⅰ、Ⅱ和Ⅲ组的起效时间分别是２．２±０．４２分、２．１±０．４２分和２．１±０．３４分（Ｐ＞０．０５），作用时间分别是４５．８５±３．７分、５５．２５±６．４７分和５５．８８±８．２５分（Ｐ＜０．０１）；维持９０％～９５％颤搐抑制所需阿曲库铵的静脉滴注速度分别为６．２７７±１．０９２μｇ·ｋｇ－１·ｍｉｎ－１、４．２７２±０．５８５μｇ·ｋｇ－１·ｍｉｎ－１和４．５０５±０．７１６μｇ·ｋｇ－１·ｍｉｎ－１（Ｐ＜０．０１）。结论：１％安氟醚及等效浓度的异氟醚均可增强阿曲库铵的临床药效，但两者之间的增强无显著差异。     

III期肺癌外科治疗生存率及手术适应证探讨

１９７０年－１９８７年外科治疗２４８例ＩＩＩ期肺癌，术后５年生存率为２０．６％。影响生存率的主要因素如下：（１）Ｐ－ＴＮＭ分期：ＩＩＩａ和ＩＩＩｂ期预后差别明显，５年生存率分别为２４．６％和９．２％。ＩＩＩａ期中Ｔ３Ｎ０Ｍ０预后最佳，ＩＩＩｂ期中仅Ｔ４Ｎ０Ｍ０预后较好，Ｔ４Ｎ２Ｍ０，Ｔ３－４Ｎ３Ｍ０无术后存在３年者。（２）Ｎ２转移的水平，有１组Ｎ２转移的预后明显优于２组以上Ｎ２转移者。（３）病理类     

老年人和老年慢性阻塞性肺疾病患者的骨密度改变

骨质疏松是一种以骨量减少为特征的常见疾病，其早期重要诊断方法之一是测定骨密度。我们对２２例青年健康组、３６例老年健康组、３０例老年慢阻肺组进行骨密度测定，结果表明老年健康组股骨骨密度，即股骨颈、股骨三角、股骨粗隆骨密度分别为（０．８４８±０．１３４）、（０．６７９±０．１５２）、（０．７７３±０．１２１）；青年健康组分别为（１．００９±０．１４５）、（０．８９８±０．５６４）、（０．８５３±０．１２２），老年健康组股骨密度较青年组低。而老年慢阻肺组分别为（０．７８０±０．１２６）、（０．６００±０．１２６）、（０．６８７±０．１６４），较老年健康组股骨密度也减低。分析其原因除了与增龄引起钙缺乏、激素分泌水平低、活动量减少、免疫力低下有关外，还与缺氧引起各脏器受损，致胃肠道钙吸收障碍有关。     

罗库溴铵的自动化反馈控制给药

目的：本实验设计了一种比例－积分（ＰＩ）控制器，自动化反馈控制罗库溴铵的持续静脉输注，并研究了吸入麻醉药七氟醚对罗库溴铵的肌松作用的影响。方法：选择１４例ＡＳＡ分级Ⅰ～Ⅱ级的手术病人，随机分成七氟醚麻醉组（７例）和芬太尼复合麻醉组（７例）两组。０．６ｍｇ／ｋｇ（２×ＥＤ９５）罗库溴铵静注气管插管后，ＰＩ控制器开始控制罗库溴铵的持续静脉输注，将肌松维持在设定点ＴＨ＝５％的水平。结果：维持９５％的神经肌肉阻滞，芬太尼复合麻醉组罗库溴铵的持续输注速率为８．６±１．１μｇ·ｋｇ－１·ｍｉｎ－１；七氟醚组为４．７±１．２μｇ·ｋｇ－１·ｍｉｎ－１。七氟醚显著地降低了罗库溴铵的输注需要量（Ｐ＜０．０１）。控制器性能指标平均超调七氟醚组为０．６０％±０．４６％，复合麻醉组为０．４２％±０．６７％；平均标准差分别为１．８０％±０．６８％和２．１６％±０．７５％。结论：控制器能够将肌松控制在稳态水平，且能满足手术所要求的较高肌松水平。七氟醚显著地强化了罗库溴铵的肌松作用。     

早期乳腺癌的保守性手术治疗

本研究旨在讨论早期乳腺癌保守性手术的治疗和整形效果，作者于１９８４年～１９９５年对６８例早期乳腺癌患者分为局部切除加术后根治性放疗组（局切组，ｎ＝３３）和局部切除加腋淋巴清扫加术后根治性放疗组（局加腋组，ｎ＝３５）行保守性手术治疗。治疗效果：局切组与局加腋组３年、５年、１０年的生存率分别为９７．０％、７８．８％、７２．７％和９４．３％、８０．０％、７７．１％，远处转移率分别为６．１％、１２．１％、３．０％和８．６％、１７．１％、８．６％，局部复发率分别为６．１％、６．１％、３．０％和５．７％、５．７％、２．９％，两组无显著差异（Ｐ＞０．０５）。整形效果：效果满意者，两组分别为６０．６％和６５．７％；效果一般者，两组分别为３３．３％和１１．４％（Ｐ＞０．０５）。影响整形效果的因素有：乳房类型、手术切口、患者年龄及术后放疗。作者认为，对早期乳腺癌行保守性手术治疗是安全的，在乳腺切口距肿瘤缘２ｃｍ～３ｃｍ完整切除肿瘤，并行患乳整形术以及对侧乳房酌情行缩小成形术，可取得较满意的整形效果。     

The efficacy and tolerability of once-weekly alendronate 70 mg on bone mineral density and bone turnover markers in postmenopausal Chinese women with osteoporosis

Osteoporosis has become an important health problem in postmenopausal Chinese women. Bisphosphonates currently are the preferred therapy for treating osteoporosis. However, the use of daily regimen of alendronate in women at risk for osteoporosis has been relatively low in China because of its dosing inconvenience. To determine the efficacy and tolerability of once-weekly alendronate 70 mg in Chinese, a multicenter, randomized, double blind, placebo controlled study was performed in China. Five hundred and sixty postmenopausal women (≤85 years old) with osteoporosis were randomly assigned to receive either alendronate 70 mg or placebo once-weekly for 12 months. All women received calcium 500 mg daily and vitamin D 200 IU daily. A significant increase in lumbar spine BMD was already evident at 6 months of alendronate treatment (P < 0.001). The alendronate group showed significant increase (P < 0.001) in BMD at 12 months at both the spine and hip when compared with the placebo group (lumbar spine 4.87% vs. 0.4%, femoral neck 2.47% vs. 0.31%, trochanter 3.24% vs. 0.78%, total hip 2.56% vs. 0.28%, respectively). The percentage of women with ≥0% and ≥3% BMD increase in lumbar spine was significantly greater in women with alendronate than placebo (P < 0.001). Significant reduction in urine N-telopeptide (NTx) and serum bone-specific alkaline phosphatase were evident at 6 and 12 months, respectively, with alendronate treatment. No significant differences in the incidence of adverse experiences and upper gastrointestinal adverse experiences were seen. We conclude that once-weekly alendronate 70 mg is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis in Chinese women.     

The Efficacy and Tolerability of Alendronate in Postmenopausal Osteoporotic Chinese Women: A Randomized Placebo-Controlled Study

Osteoporosis is a growing health problem in Asian women and it is expected that half of the world's hip fractures will occur in Asia in 50 years' time. As the use of hormonal replacement therapy (HRT) is extremely low in postmenopausal Asian women, nonhormonal agents will be more acceptable for the treatment and prevention of osteoporosis. The efficacy, tolerability, and acceptability of alendronate, an amino-bisphosphonate, for Asian women was evaluated in 70 osteoporotic southern Chinese women in a prospective, randomized, double-blind study. The subjects were randomized to receive either alendronate 10 mg daily or placebo, plus calcium supplementation 500 mg daily. The baseline L 1–4 and hip bone mineral density (BMD) were similar between both groups. At the end of 1 year, there was an increase of 5.8% in the lumbar spine BMD and 3.4% at the total hip with alendronate treatment when compared with baseline values (P < 0.001). Alendronate treatment for 1 year resulted in significant improvement in BMD at all sites measured when compared with placebo. There was also marked reduction in serum alkaline phosphatase (ALP) and urinary n-telopeptide (NTx) in the alendronate group when compared with the placebo group (ALP 25% versus 2%, NTx 75% versus 14%, both P < 0.005). The changes in ALP and NTx at 6 and 12 months correlated with the change in BMD at all sites measured at 1 year (P all <0.05). Alendronate was well tolerated and accepted, although two cases of gastric ulcer were reported. We conclude that alendronate is an effective and well-accepted agent for the treatment of osteoporosis in Asian women. Received: 30 September 1999 / Accepted 6 April 2000     

Alendronate for osteoporosis in men with androgen-repleted hypogonadism

Male hypogonadism is associated with low bone mineral density (BMD) and an increased risk of fractures. Testosterone replacement therapy improves BMD in young hypogonadal men. This effect is milder in older patients, who are at greater risk for fractures. We studied the effects of alendronate or placebo on BMD in 22 osteoporotic men, 29–69 years of age (mean, 50.2±11.2 years) with long-standing hypogonadism, receiving standard testosterone replacement treatment. Alendronate 10 mg daily ( n =11) increased lumbar-spine BMD by 6.0 and 8.4% at 6 and 12 months, respectively, compared with –0.5% at 6 months and +3.3% at 12 months in the placebo group ( n =11; P <0.005). Alendronate also increased mean femoral-neck BMD by 1.9% after 1 year, compared to a 1.4% decrease with placebo ( P <0.005), and increased the total body bone mineral content by 4.4%, compared to a 0.6% decrease with placebo ( P =0.07). After 6 months alendronate suppressed urinary deoxypyridinoline by 50% ( P <0.005), compared to a 24% decrease in the placebo group. Both the alendronate and placebo groups continued with alendronate 70 mg once weekly for the following 2 years. Lumbar-spine BMD during this open-label study phase did not change significantly in the group originally treated with alendronate, but continued to increase in the placebo-alendronate group by 5.4, 6.5, and 6.2% after 18 (6 months of alendronate), 24 and 36 months, respectively ( P <0.05). Femoral-neck BMD continued to increase in both groups receiving active therapy; in the alendronate-alendronate group by 3.7, 2.7, and 5.2% after 18, 24, and 36 months, respectively ( P =0.01), and in the placebo-alendronate group by 0.7 and 1.9% at 24 (first 12 months of alendronate) and 36 months, respectively ( P <0.05). Our results support the long-term administration of alendronate along with testosterone replacement to men with hypogonadism-induced osteoporosis.     

Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis

Alendronate has recently been approved for the prevention and treatment of postmenopausal osteoporosis, and its efficacy has been demonstrated in many Western countries. Our present study was performed to evaluate the effect of alendronate on bone mineral density (BMD) and its tolerability in Thais. Eighty postmenopausal women with osteoporosis participated in this study. After giving informed consent, the subjects were randomly allocated either 10mg alendronate or placebo in a double-blind fashion. All patients received a supplement of 500mg elemental calcium daily. BMD at the lumbar spine, femoral neck, and distal forearm was measured at baseline and 6 and 12 months after treatment. Biochemical markers of bone resorption were determined at baseline and 6 months after treatment. Baseline characteristics were similar in both alendronate- and placebo-treated groups. Ten subjects discontinued the study. Of 70 subjects, 32 received 10mg alendronate daily and the remaining subjects received placebo. At 1 year, BMD in the alendronate-treated group had increased from baseline by 9.2%, 4.6%, and 3.1% at lumbar spine, femoral neck, and distal forearm, respectively. These percentages were greater than those in controls (4.1%, 0.6%, and 1.0%, respectively). Urinary N-terminal telopeptide (NTx)-I and serum C-terminal telopeptide (CTx)-I levels decreased in both groups after 6 months of treatment. However, more reduction was demonstrated in the alendronate-treated group (71.9% vs. 28.4%, P 0.01, and 84.7% vs. 33.1%, P 0.01, respectively). Compliance with treatment and drug tolerability were good in both alendronate and placebo groups. We concluded that treatment with alendronate 10mg daily for Thai postmenopausal women with osteoporosis significantly increased BMD at all skeletal sites and reduced biochemical markers of bone resorption. It was well tolerated without any serious side effects.     

Alendronate for the Treatment of Osteoporosis in Men

The incidence of osteoporotic fracture in males is approximately one-third of that observed in women, but information on specific therapies is almost exclusively limited to bisphosphonate alendronate. The most important study with this compound included 241 men, randomized to receive either alendronate 10 mg/day or placebo. In another study 134 men were given either 10 mg alendronate or alfacalcidiol 1 microg/day. After 24 months, the treatment with alendronate bone mineral density (BMD) significantly increased in both studies by 7-10% at the lumbar spine and by 2.5-5.2% at the femoral neck. These changes were associated with decreases in vertebral fracture rate and in stature loss, both statistically significant when the data of the two trials were meta-analysed. The BMD changes after alendronate therapy were comparable to those observed in postmenopausal osteoporosis. This was confirmed in a trial specifically designed to compare alendronate efficacy in men and postmenopausal women with either primary or secondary osteoporosis. Gender-comparative efficacy data can also be inferred from clinical trials in glucocorticoid-induced osteoporosis of alendronate, risedronate, and etidronate, carried out in both women and men. By combining the results of all these trials, bisphosphonate efficacy in terms of both BMD changes and fracture incidence appears to be moderate in premenopausal women but quite obvious and comparable in males and postmenopausal women.     

Comparison of Bone and Total Alkaline Phosphatase and Bone Mineral Density in Postmenopausal Osteoporotic Women Treated with Alendronate

Alendronate therapy in osteoporotic women decreases bone turnover and increases bone mineral density (BMD). Optimal patient management should include verification that each patient is responding to therapy. Markers of bone turnover and BMD have both been proposed for this purpose. We have investigated changes resulting from alendronate therapy with an enzyme immunoassay for bone alkaline phosphatase (BAP) and compared it with total alkaline phosphatase (TAP) and BMD of the lumbar spine, hip, and total body. Subjects were drawn from a multicenter randomized, placebo-controlled trial of alendronate in postmenopausal women with osteoporosis. BAP and TAP levels were measured at baseline and following 3, 6 and 12 months of therapy with either placebo (n= 180) or alendronate 10 mg/day (n= 134). All subjects also received 500 mg/day supplemental calcium. BMD was measured at baseline and following 3, 6, 12, 18, 24 and 36 months of therapy. To compare BAP, TAP and BMD at each site for identifying women that experienced a skeletal effect of alendronate, we calculated least significant change (LSC) values from the long-term intraindividual variability in each placebo-treated woman. Median levels of BAP decreased by 34%, 44% and 43% at 3, 6 and 12 months, respectively, in alendronate-treated women (p<0.0001 compared with baseline and with placebo). These changes were significantly greater (p<0.0001) than changes observed for TAP. Following 6 months of alendronate therapy, 90% of the women had experienced a decrease in BAP exceeding the LSC compared with only 71% for TAP. The greatest number of women similarly identified with BMD at any site (i.e. a gain in BMD exceeding the LSC) was 81% for spinal BMD at 36 months. All other sites were less than 70% at 36 months. Short-term changes in BAP and TAP were modestly associated with subsequent changes in BMD at all sites (Spearman’s rho −0.22 to −0.52, p<0.05). Compared with TAP and BMD, BAP testing rapidly and sensitively identified skeletal effects of alendronate thus enabling appropriate drug monitoring of osteoporotic women. Though BAP and TAP changes were modestly predictive of BMD changes, the value of the bone marker tests is their ability to detect rapidly a skeletal effect of therapy. Received: 19 May 2000 / Accepted: 31 October 2000     

Treatment of Male Osteoporosis: Recent Advances with Alendronate

Overall, the data from the two alendronate studies clearly document the efficacy and safety of alendronate in osteoporotic men. The positive effects of alendronate on BMD, markers and fractures are very consistent between studies. Importantly, they are also very consistent with the results of multiple clinical studies conducted in postmenopausal women with osteoporosis. Treatment with 10 mg alendronate for 2 years produced significant and clinically meaningful increases in BMD, similar to those previously observed in postmenopausal women. Data from studies including men and women confirm the similarity of response suggested by single-gender studies. Consistent with much larger studies in postmenopausal women, alendronate 10 mg/day also reduced the incidence of new vertebral fracture and, correspondingly, reduced height loss. The safety and tolerability of alendronate in men was favorable and consistent with the safety profile previously observed in postmenopausal women. Alendronate represents an important and needed therapeutic advancement in the management of osteoporosis in men.     

不同给药方案阿仑膦酸钠治疗绝经后妇女骨质疏松症18个月效果研究

目的阿仑膦酸钠是临床治疗绝经后妇女骨质疏松症的首选药物。本实验观察阿仑膦酸钠不同给药方案对绝经后妇女骨质疏松症的治疗效果以及不良反应的发生情况。方法本实验为开放、随机、平行对照临床研究。纳入西安两社区绝经后妇女共80名,年龄49～79岁,绝经年限3～31年。实验分为低剂量组和常规剂量组。低剂量组为每两周口服阿仑膦酸钠一次,每次70mg,疗程18个月。常规剂量组为每周口服阿仑膦酸钠一次,每次70mg,疗程18个月。两组同时每日服用钙尔奇D3600mg。实验主要观察指标为:第二腰椎到第四腰椎(L2-L4)、股骨颈、大转子、股骨干骨密度值变化,血液指标(血钙、血磷、碱性磷酸酶),肝肾功能指标(丙氨酸氨基转移酶、血肌酐),不良反应及新发骨折情况。结果 80例患者全部进入结果分析:①骨密度测定:每组患者治疗18个月后L2-L4、股骨颈、股骨大转子、股骨干的骨密度与治疗前相比均明显升高,差异有显著性意义(P﹤0.05)。低剂量组与常规剂量组相比L2-L4骨密度、股骨颈骨密度、股骨干骨密度值差异无统计学意义(P﹥0.05),表明两种给药方案相比增加骨密度效果相似。②两组患者血液指标及肝肾功能指标治疗前后均在正常范围内,显示两种用药方法均安全可靠。③不良反应主要为上腹部不适,两组不良反应差异有统计学意义(P﹤0.05),低剂量组显著低于常规剂量组。④两组患者均无新发骨折病例。结论阿仑膦酸钠治疗绝经后妇女骨质疏松症安全有效,低剂量用药方案与常规剂量用药方案相比增加骨密度效果和药物安全性相似,用药更加简单方便,不良反应更小,经济效益更高,是临床值得推荐的用药方案。     

Multinational, Placebo-Controlled, Randomized Trial of the Effects of Alendronate on Bone Density and Fracture Risk in Postmenopausal Women with Low Bone Mass: Results of the FOSIT Study

This randomized, double-masked, placebo-controlled trial evaluated the safety, tolerability and effects on bone mineral density (BMD) of alendronate in a large, multinational population of postmenopausal women with low bone mass. At 153 centers in 34 countries, 1908 otherwise healthy, postmenopausal women with lumbar spine BMD 2 standard deviations or more below the premenopausal adult mean were randomly assigned to receive oral alendronate 10 mg (n = 950) or placebo (n = 958) once daily for 1 year. All patients received 500 mg elemental calcium daily. Baseline characteristics of patients in the two treatment groups were similar. At 12 months, mean increases in BMD were significantly (p相似文献   

Alendronate has a residual effect on bone mass in postmenopausal Danish women up to 7 years after treatment withdrawal

Alendronate has been shown to reduce bone turnover and increase bone mass. However, little is known about the duration of the effect on bone after treatment withdrawal. The aim of this study was to investigate the long-term effects on bone mineral density (BMD) and bone turnover of various alendronate regimens after treatment withdrawal. In this study, we followed 203 postmenopausal women who previously participated in two alendronate randomized placebo-controlled trials. Daily oral treatment with various doses of alendronate (2.5-20 mg) were given for 2, 4, or 6 yr followed by no treatment for 7, 5, or 3 yr, respectively. Bone mineral density of the lumbar spine, hip, and forearm was measured by dual-energy x-ray absorptiometry. Biochemical markers of bone turnover were induced serum C-terminal telopeptides of type I collagen (CTX) and osteocalcin. Women who received alendronate (2.5-10 mg per day) for 2 yr had a 3.8% higher BMD compared to those receiving placebo when assessed 7 yr after withdrawal. The residual effect was proportionally larger in women who had received treatment for 4 (5.9%, P=0.02) or 6 yr (8.6%, P=0.002), respectively. However, the largest residual effect was found in women treated with alendronate 20 mg per day for 2 yr (9.7%, P=0.01 vs. placebo). The rate of bone loss after alendronate withdrawal was comparable to the bone loss observed in the placebo group. Bone markers tended to reverse back to normal levels, but were still affected even several years after withdrawal of treatment. This study has demonstrated that the efficacy of alendronate in preventing bone loss was proportional to the duration of treatment. The rate of bone loss after withdrawal of alendronate corresponded to the normal postmenopausal rate of bone loss. A residual effect on BMD was found up to 7 yr after treatment withdrawal.