阿仑膦酸钠治疗绝经后骨质疏松症的疗效分析

目的观察阿仑膦酸钠治疗绝经后骨质疏松症患者的骨密度变化。方法回顾性分析门诊120例绝经后骨质疏松患者,其中对照组88例,单纯补充钙剂(600 mg/日)及活性维生素D(0.25μg/日),治疗组32例,补充钙剂及活性维生素D的基础上同时服用阿仑膦酸钠70mg每周一次。观察两组治疗一年后骨密度的变化。结果对照组腰椎2-4部位骨密度由治疗前(0.763±0.098)g/cm2降至治疗后(0.742±0.095)g/cm2,差异有统计学意义(P=0.000);股骨颈部位骨密度由基线水平(0.637±0.073)g/cm2降至(0.601±0.078)g/cm2,差异有统计学意义(P=0.006)。阿仑膦酸钠治疗后腰椎2-4骨密度由(0.729±0.122)g/cm2升至(0.743±0.129)g/cm2,差异有统计学意义(P=0.007);股骨颈部位骨密度由治疗前(0.599±0.086)g/cm2升至治疗后(0.635±0.112)g/cm2,差异有统计学意义(P=0.000)。结论阿仑膦酸钠可增加绝经后骨质疏松患者的骨密度;单纯补充钙剂及维生素D治疗不能防止绝经后妇女骨量的进一步丢失。     

血清镁浓度与绝经后骨质疏松症患者骨转换指标和骨密度的相关性研究

目的确定绝经后骨质疏松骨密度(bone mineral density,BMD)和血清骨代谢标志物(bone turnover marker,BTM)酒石酸抗性酸性磷酸酶-5b(tartrate-resistant acid phosphatase-5b,TRAP-5b)、骨特异性碱性磷酸酶(bone-specific alkaline phosphatase,BSAP)、雌二醇(E_2)和镁(Mg~(2+))离子浓度的相关性。方法选取123例绝经后骨质疏松症妇女和97名无骨质疏松症的健康绝经后妇女作为研究对象。采用双能X射线吸收测量扫描评估不同骨骼部位的BMD。通过酶联免疫吸附测定法测量E_2、BSAP和TRAP-5b的血清水平。使用比色光谱技术测定血清Mg~(2+)水平。结果骨质疏松女性血清BTM水平显著高于对照组。BSAP具有中等敏感性(76. 8%)和特异性(84. 7%)(截止点为21. 27 U/L)。在3. 46 U/L的截止点,TRAP-5b的灵敏度为86. 8%,特异性为90. 8%。骨质疏松症患者血清Mg~(2+)浓度显著低于对照组。Mg~(2+)水平与BMD值呈正相关。此外,Mg~(2+)浓度与E_2水平呈正相关。脊柱骨密度与BSAP水平呈负相关。结论本研究表明,BMD与BTM呈负相关,与E_2和Mg~(2+)呈正相关。     

阿仑膦酸钠治疗绝经后骨质疏松症

目的　探讨阿仑膦酸钠治疗绝经后骨质疏松症的临床疗效 ,评价其安全性。方法　 5 5例绝经后骨质疏松症患者作为期 1年的随机双盲、安慰剂平行对照研究 ;113例绝经后骨质疏松症患者作为期半年的开放前瞻性研究。用药半年比较治疗前后骨密度和药物的副作用。用双能量X线骨密度测量仪测定骨密度。结果　用药组治疗 1年时 ,腰椎骨密度、股骨颈骨密度分别平均增加 4 7%±3 0 %、1 4 %± 3 7% ,安慰剂组增加 0 1%± 4 1%、- 1 3%± 5 8% ,差异有显著性 (P <0 0 5 )。用药组骨转换指标Ca/Cr、Hop/Cr在 3个月时降低到最低点 ;ALP在 6个月时降低到最低点 (P <0 0 1)。在开放组中 ,腰椎骨密度、股骨颈骨密度平均分别增加 4 5 %± 4 3% (P <0 0 1)、1 5 %±5 2 % (P <0 0 1) ,用药前后差异有显著性。主要副作用为消化道反应 (13 3% )、其次为皮疹和头昏 ,均为轻度、一过性 ,继续用药后自然缓解。结论　阿仑膦酸钠治疗绝经后骨质疏松症有效并且安全。     

葛根素联合阿仑膦酸钠治疗绝经后骨质疏松症的效果观察

目的探索葛根素联合阿仑膦酸钠对绝经后骨质疏松症的影响。方法 148例绝经后骨质疏松症患者随机分为治疗组(n=74)和对照组(n=74)。对照组给予阿仑膦酸钠治疗,治疗组给予葛根素联合阿仑膦酸钠治疗,为期治疗6个月。检测治疗后两组患者髋部及腰椎的骨密度改变,同时测定血清雌二醇(estradiol,E2)、骨代谢指标[骨钙素(osteocalcin,BGP)、骨源性碱性磷酸酶(bone alkaline phosphatase,BALP)、抗酒石酸酸性磷酸酶-5b(tartrate-resistant acid phosphatase-5b,TRAP-5b)]、免疫因子[白细胞介素-6(interleukin-6,IL-6)、转化生长因子-β(transforming growth factor-β,TGF-β)、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)以及白细胞-10(IL-10)]水平的变化,并记录治疗期间出现的药物不良反应。结果治疗前,两组的骨密度、骨代谢指标和免疫因子比较差异无统计学意义(P0.05)。治疗6个月后,两组髋部及腰椎骨密度都有不同程度的升高,其中治疗组骨密度变化更明显,和对照组比较差异有统计学意义(P0.05);同时各组血清BALP、BGP、TRAP-5b、IL-10、IL-6和TNF-α水平均降低,TGF-β1及E2水平均升高,而治疗组改变更明显,两组比较差异有统计学意义(P0.05)。两组患者治疗均未发现明显药物不良反应。结论葛根素联合阿仑膦酸钠可以通过降低骨转换率及减少免疫因子表达来改善绝经后女性骨质疏松患者髋部及腰部的骨密度,且安全性高。     

阿仑膦酸钠治疗绝经后妇女骨质疏松症3年临床观察

目的 观察阿仑膦酸钠治疗绝经后妇女骨质疏松症3年疗效.方法 选取2005年8月至2006年1月骨质疏松门诊PMOP患者115例,口服阿仑膦酸钠70 mg 每周1次,同时每天补充钙剂800 mg和活性维生素D 0.25 μg,疗程3年.定期测定治疗前后的腰椎、股骨颈与全髋骨密度值(BMD)及骨转换标记物.统计分析采用SPSS 13.0软件.结果 治疗3年后,腰椎、股骨颈和全髋部位骨密度均较治疗前显著提高(P<0.01),增幅分别为8.1%、3.5%和4.0%.治疗6个月,血清ALP、骨钙素和尿钙/肌酐比值分别下降16.7%、24.1%和13.4%,均较治疗前显著下降(P<0.01),其后各骨转换标记物仍维持较低水平,但无进一步下降.Pearson相关分析显示治疗6个月时骨钙素和尿钙/尿肌酐比值的变化与3年后腰椎、股骨颈和全髋部位BMD的变化值均呈负相关(P<0.01),血清ALP与腰椎BMD的变化值呈负相关(r=-0.231,P<0.01).治疗期间新发骨折4例.结论 阿仑膦酸钠是治疗中国PMOP患者安全而有效的药物,治疗6月可显著降低骨转换标记物,3年中显著增加骨密度,而且,早期骨转换标记物的下降与3年后骨密度的改善呈负相关.     

阿仑膦酸钠联合替勃龙治疗绝经后骨质疏松症疗效分析

目的探讨阿仑膦酸钠联合替勃龙治疗绝经后骨质疏松症的临床疗效。方法回顾性分析自2010-01—2015-12诊治的300例绝经后骨质疏松症,150例采用阿仑膦酸钠联合替勃龙治疗(观察组),150采用阿仑膦酸钠治疗(对照组),比较2组治疗期间不良反应情况、末次随访时临床疗效,治疗前、治疗后6个月、治疗后12个月股骨颈骨密度、骨碱性磷酸酶(BALP)、羟基末端肽(CTX)、钙调节激素25(OH)D3。结果 300例均获得随访,随访时间平均14.34(3~21)个月。治疗期间观察组不良反应较对照组少,末次随访时观察组临床疗效较对照组优,差异有统计学意义(P <0.05)。治疗后6个月、12个月观察组股骨颈骨密度、BALP、CTX、25(OH)D3较对照组明显改善,差异有统计学意义(P <0.05)。结论采用阿仑膦酸钠联合替勃龙治疗绝经后骨质疏松症可提高骨密度,改善骨代谢,临床疗效满意,安全性良好。     

阿仑膦酸钠对绝经后骨质疏松合并骨关节炎患者骨强度的影响

目的探讨阿仑膦酸钠对绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)合并骨关节炎(osteoarthritis,OA)患者骨强度的影响。方法选取华北理工大学附属医院骨质疏松门诊2016年5月至2019年10月诊治的144例患者,根据其诊断分为OP+OA组(73例)和OP组(71例)。两组患者口服阿仑膦酸钠(1次/周),连续治疗12个月。比较两组患者治疗前后股骨颈截面面积(CSA)、股骨颈截面转动力矩(CSMI)、股骨颈截面模量(Z)、股骨颈皮质厚度(CT)、股骨颈屈曲应力比(BR)、骨密度、疼痛视觉模拟评分(VAS)、Lysholm膝关节评分、生化指标变化。结果两组患者治疗后CSA、CSMI、Z、腰椎和股骨颈骨密度、Lysholm膝关节评分高于治疗前(P<0.05),而在治疗12个月后OP+OA组患者腰椎、股骨颈骨密度高于OP组(P<0.05)。两组患者治疗后BR、VAS评分低于治疗前(P<0.05),而在治疗后12个月OP+OA组患者BR、VAS评分低于OP组(P<0.05)。结论阿仑膦酸钠应用于绝经后骨质疏松合并骨关节炎患者治疗,不仅可以提高骨密度、改善关节症状,还能提高髋部骨强度。     

葛根素联合阿仑膦酸钠对绝经后骨质疏松大鼠氧化应激、炎症反应及骨代谢的影响

目的观察研究葛根素联合阿仑膦酸钠对绝经后骨质疏松大鼠氧化应激、炎症因子和骨代谢的影响。方法实验分为假手术组、去卵巢组、A药组、B药组和AB药组,构建绝经后骨质疏松大鼠动物模型,分别给予不同药物干预。分别检测血清氧化应激、炎性因子、骨代谢指标及骨密度,观察骨组织形态结构。结果去卵巢组大鼠血清SOD和GSH-Px水平较假手术组均显著降低(P<0.05),AB药组较去卵巢组均显著升高(P<0.05);去卵巢组大鼠血清H2O2和MDA水平较假手术组均显著升高(P<0.05),AB药组较去卵巢组均显著降低(P<0.05)。去卵巢组大鼠血清炎性因子和骨代谢指标较假手术组均显著升高(P<0.05),AB药组较去卵巢组均显著下降(P<0.05)。去卵巢组大鼠骨组织BMD较假手术组显著降低(P<0.05),AB药组较去卵巢组显著升高(P<0.05)。去卵巢组骨皮质明显变薄,骨小梁明显稀疏,排列紊乱,髓腔扩大。AB药组骨皮质轻微改变,骨小梁明显增多,排列规则,髓腔明显变小。结论葛根素联合阿仑膦酸钠具有协同抑制绝经后骨质疏松大鼠氧化应激和炎症反应,降低氧化应激和炎性因子分泌,调节骨代谢,改善骨组织形态学结构,发挥抗骨质疏松作用。     

绝经后妇女骨代谢生化指标与骨密度相关性研究

目的探讨绝经女性骨密度与骨代谢生化指标血清抗酒石酸酸性磷酸酶5b的关系。方法 选取我科2007 -2009年人院的绝经女性115例,采用DPX2L型双能X线骨密度检测仪,测定腰椎 (L2 ~L4)及股骨上端[包括股骨颈（NECK)、华氏三角（Ward)及股骨粗隆（TROCH)]的骨密度 (BMD)值;根据Tscore值将人选者分为骨量正常组（48例)和骨质疏松组（67例）。并选未绝经女性 30例,骨密度检查正常者为对照组,采用酶联免疫法测定各组血清骨特异性碱性磷酸酶（ALP)、血清 骨钙素（BGP)、血清抗酒石酸酸性磷酸酶（TRAP-5b)的浓度,并比较三组骨代谢生化指标的变化,并 对BMD与各项骨代谢指标进行相关性分析。结果绝经女性骨质疏松组各部位BMD值均低于骨量 正常组(P<0. 05);骨质疏松组血中ALP、BGP、TRAP-5b浓度均显著高于骨量正常组（P <0. 05 ),骨 量正常组血清ALP、BGP、TRAP-5b浓度显著高于对照组,差异有统计学意义（P < 0. 05 )。对照组各部 位的骨密度值与骨代谢生化指标无明显相关性（P>0.05),在绝经女性骨质疏松组中,ALP和TRAP- 5b与腰椎（L2 ~L4)及股骨颈部位的BMD有一定的关系,呈负相关（r分别为-0. 248、- 0. 364、- 0.434、-0.386 )。结论绝经女性骨质疏松为高转换型,血清ALP、BGP、TRAP-5b浓度变化可反映 骨代谢活动,绝经女性BMD的降低与骨转换率升高有关。检测代谢指标有助于早期防治骨质疏松症 (OP)。     

骨代谢指标在老年骨质疏松性骨折后变化的临床应用

目的 通过测定老年骨质疏松患者骨折后骨代谢生化指标,揭示骨代谢指标在老年骨折患者中的变化规律,提供早期控制老年骨质疏松性骨折后骨吸收的依据,有利于加强骨形成的能力,缩短骨折愈合时间,防止再次骨折及并发症的发生.方法 对82例(男33例,女49例)60岁以上髋部骨折及椎体压缩骨折患者和61例(男29例,女32例)老年健康对照组进行血清骨特异性碱性磷酸酶(Serum Bone Alkaline Phosphates,BALP)、骨钙素(bone gla-containing protein BGP)和血清抗洒石酸酸性磷酸酶5b(tart rate-resistant acid phosphates isoform-5b)测定.结果 (1)老年骨质疏松性骨折患者中TRACP-5b水平明显高于对照组(P<0.001),且女性骨转换高于男性;老年骨质疏松骨折患者BALP水平高于正常组(P<0.01).(2)骨折后骨转换指标(BAP,TRACP-5b)与骨密度呈负相关.结论 骨折后患者骨吸收增加,女性骨转换高于男性,女件骨折后更加重骨质疏松,不利于骨折后愈合,而骨折后监测骨代谢指标,提供早期控制骨吸收的依据,女性更应长期监测骨代谢并抗骨吸收治疗,利于加强骨形成的能力,缩短患者卧床时间,防止再次骨折及并发症.     

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.     

阿伦膦酸盐对绝经后骨质疏松妇女骨密度的影响

为了解阿伦膦酸盐对骨密度的影响及其安全性和耐受性,对２０名绝经后骨质疏松的妇女中进行阿伦膦酸盐（ａｌｅｎｄｒｏｎａｔｅ）１０ｍｇ／天和安慰剂的随机、双盲、前瞻性研究,为期一年。结果显示,１年后阿伦膦酸盐组与安慰剂组相比,骨密度平均增长率：椎骨分别为４．８７％与－０．２３％;股骨颈分别为６．８９％与－１．８４％,（Ｐ＜０．０５）。副反应仅为轻微胃肠道反应。结论：阿伦膦酸盐能有效增加骨密度,且药物安全,耐受性好     

阿伦磷酸钠对绝经后2型糖尿病合并骨质疏松症患者骨代谢的影响

目的 探讨阿伦膦酸钠对绝经后2型糖尿病合并骨质疏松症患者骨代谢及骨密度的影响。方法 选择2012年1月至2013年1月在本院接受治疗的绝经后2型糖尿病合并骨质疏松症患者51例,给予阿伦膦酸钠治疗6个月。采用美国Norland双光能X线骨密度检测仪对所有患者进行腰椎L2-L4和左侧股骨近端（包括Neck、Troch、Ward三角区)骨密度测量,并测定身高、体重、空腹血糖(FBG)、HbAlc、PTH、OC、CTX、25（OH）VD、BALP等。对比治疗前后骨密度及骨代谢标志物变化。结果 用阿伦膦酸钠治疗6个月使绝经后2型糖尿病合并骨质疏松症患者的FBG、2hPG 、HbA1c降低,治疗前与治疗后相比较,差异有统计学意义（P〈0.05）。血Ca、P浓度治疗前与治疗后相比较,差异无统计学意义(P＞0.05)。骨代谢标志物CTX治疗前与治疗后相比,差异有统计学意义（P〈0.05）。OC 、PTH、BALP、25OHVD治疗前与治疗后相比较,差异无统计学意义(P>0.05)。治疗前腰椎和股骨颈骨密度与治疗后相比较,差异有统计学意义（P〈0.05）。Torch 、Ward部位骨密度治疗前与治疗后相比较,差异没有统计学意义(P＞0.05)。结论 阿伦膦酸钠治疗绝经后2型糖尿病合并骨质疏松症疗效明显,短时间内可改善骨代谢指标和提高腰椎骨密度。     

Effects of denosumab on bone turnover markers in postmenopausal osteoporosis

Denosumab, a fully human monoclonal antibody to RANKL, decreases bone remodeling, increases bone density, and reduces fracture risk. This study evaluates the time course and determinants of bone turnover marker (BTM) response during denosumab treatment, the percentage of denosumab‐treated women with BTMs below the premenopausal reference interval, and the correlations between changes in BTMs and bone mineral density (BMD). The BTM substudy of the Fracture REduction Evaulation of Denosumab in Osteoporosis every 6 Months (FREEDOM) Trial included 160 women randomized to subcutaneous denosumab (60 mg) or placebo injections every 6 months for 3 years. Biochemical markers of bone resorption (serum C‐telopeptide of type I collagen [CTX] and tartrate‐resistant acid phosphatise [TRACP‐5b]) and bone formation (serum procollagen type I N‐terminal propeptide [PINP] and bone alkaline phosphatase [BALP]) were measured at baseline and at 1, 6, 12, 24, and 36 months. Decreases in CTX were more rapid and greater than decreases in PINP and BALP. One month after injection, CTX levels in all denosumab‐treated subjects decreased to levels below the premenopausal reference interval. CTX values at the end of the dosing period were influenced by baseline CTX values and the dosing interval. The percentage of subjects with CTX below the premenopausal reference interval before each subsequent injection decreased from 79% to 51% during the study. CTX and PINP remained below the premenopausal reference interval at all time points in 46% and 31% denosumab‐treated subjects, respectively. With denosumab, but not placebo, there were significant correlations between CTX reduction and BMD increase (r = ?0.24 to ?0.44). The BTM response pattern with denosumab is unique and should be appreciated by physicians to monitor this treatment effectively. © 2011 American Society for Bone and Mineral Research.     

阿仑膦酸钠治疗绝经后骨质疏松性骨痛的研究

目的 观察用阿仑膦酸钠治疗６０例绝经后妇女的骨质疏松有痛的疗效。方法 对照阿仑膦酸钠使用６个月前后疼痛,骨密度的变化。结果 经治疗６个月后效果良好,骨痛缓解有效率达９３．３％,骨密度增加显,－／ｘ±ｓ由用药前的０．４６７ｇ／ｃｍ＾２±０．０３６增加到用药后的０．５２８ｇ／ｃｍ＾２±０．０３７,Ｐ〈０．０１。结论 阿仑膦酸钠通过抑制骨吸收的作用使失衡的骨代谢得以恢复,为治疗绝经后骨质疏松提供了一个     

Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy

Patients treated with bisphosphonates for osteoporosis may discontinue or require a switch to other therapies. Denosumab binds to RANKL and is a potent inhibitor of bone resorption that has been shown to increase bone mineral density (BMD) and decrease fracture risk in postmenopausal women with osteoporosis. This was a multicenter, international, randomized, double‐blind, double‐dummy study in 504 postmenopausal women ≥ 55 years of age with a BMD T‐score of ?2.0 or less and ?4.0 or more who had been receiving alendronate therapy for at least 6 months. Subjects received open‐label branded alendronate 70 mg once weekly for 1 month and then were randomly assigned to either continued weekly alendronate therapy or subcutaneous denosumab 60 mg every 6 months and were followed for 12 months. Changes in BMD and biochemical markers of bone turnover were evaluated. In subjects transitioning to denosumab, total hip BMD increased by 1.90% at month 12 compared with a 1.05% increase in subjects continuing on alendronate (p < .0001). Significantly greater BMD gains with denosumab compared with alendronate also were achieved at 12 months at the lumbar spine, femoral neck, and 1/3 radius (all p < .0125). Median serum CTX levels remained near baseline in the alendronate group and were significantly decreased versus alendronate (p < .0001) at all time points with denosumab. Adverse events and serious adverse events were balanced between groups. No clinical hypocalcemic adverse events were reported. Transition to denosumab produced greater increases in BMD at all measured skeletal sites and a greater reduction in bone turnover than did continued alendronate with a similar safety profile in both groups. Copyright © 2010 American Society for Bone and Mineral Research     

Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis

The effects of 3 years of oral risedronate treatment on bone quality and remodeling were assessed in women with postmenopausal osteoporosis. Transiliac bone biopsies were obtained at baseline and after treatment with placebo or risedronate 5 mg/day in 55 women (placebo, n = 27; risedronate 5 mg, n = 28); these pairs of samples allowed comparison of treatment effects vs. both baseline values and between treatment groups. A further 15 women (placebo, n = 6; risedronate 5 mg, n = 9) had measurements from a posttreatment biopsy, but not from a baseline biopsy. Samples were examined for qualitative changes (e.g., osteomalacia, peritrabecular fibrosis, and woven bone); no histological abnormalities were found to be associated with treatment. Among women with both baseline and posttreatment biopsies, risedronate-treated women experienced a moderate and expected reduction from baseline in bone turnover, which was reflected in mean decreases in mineralizing surface of 58% and in activation frequency of 47%. Histomorphometrical parameters indicated that bone formation rate decreased significantly from baseline with risedronate treatment, reflecting a decrease in bone turnover; bone mineralization was normal following treatment. Basic multicellular unit (BMU) balance tended to improve in the risedronate-treated women, whereas it tended to worsen in the placebo-treated women, although these changes were not statistically significant. There were no significant changes in structural parameters with treatment. The effects of 3 years of risedronate treatment on bone histology and histomorphometry reflect the antiresorptive mechanism of action, and are consistent with the antifracture efficacy and favorable bone safety profile demonstrated in large clinical trials.