A comparison of teriparatide and calcitonin therapy in postmenopausal Asian women with osteoporosis: a 6‐month study

ABSTRACT

Objective: The number of hip fractures is expected to double in the next 20 years, with current estimates that Asia will account for 37% of these cases. As bone mineral density (BMD) may be used as a measure of fracture risk, we sought to compare the effects of teriparatide with salmon calcitonin treatment on changes in BMD, biochemical bone markers, and safety in postmenopausal Asian women with osteoporosis.

Methodology: A total of 104 patients (?n = 47 teriparatide [20?µg/day subcutaneously] and n = 57 calcitonin [100?IU/day subcutaneously]) were enrolled in Hong Kong, Singapore, Philippines, Malaysia, and Thailand. Calcium (≥ 500?mg/day) and vitamin D (200–400?IU/day) supplements were taken throughout the 6‐month controlled, randomized study.

Results: Teriparatide was associated with a 5.03 ± 4.77% increase in lumbar spine BMD (?p < 0.0001, mean ± SD change from baseline), whereas changes in lumbar spine BMD for patients on calcitonin were not statistically significant (mean change of 0.36 ± 4.12%, p = 0.16). Comparison of the two groups indicated that teriparatide treatment improved lumbar spine BMD statistically significantly more than calcitonin (?p < 0.0001). No statistically significant changes were observed for total hip or femoral neck BMD. Serum bone-specific alkaline phosphatase (BSAP) increased by 55.9% (median change from baseline, p < 0.0001) in the teriparatide group, and remained stable with calcitonin (5.0% change, p = 0.24); osteocalcin increased by 156.15% (median change from baseline, p < 0.0001) with teriparatide, and decreased with calcitonin (–15.25%, p = 0.03). Similar rates of adverse events were observed, with nausea and dizziness the most commonly reported for both groups (teriparatide versus calcitonin, 13.0% versus 23.2% p = 0.21, 10.9% versus 21.4% p = 0.19, respectively). There were no clinically relevant changes observed in laboratory parameters.

Conclusions: Both treatments were similarly tolerated, however teriparatide was associated with greater increases in lumbar spine BMD and bone formation markers, demonstrating the unique mechanism of action and safety of this treatment for osteoporosis in these Asian women.     

阿仑膦酸钠联合阿托伐他汀治疗糖尿病合并骨质疏松的评价

目的分析糖尿病合并骨质疏松症患者应用阿仑膦酸钠联合阿托伐他汀治疗的临床效果。方法选择2013年4月~2014年8月来医院治疗的160例糖尿病合并骨质疏松症患者,按照随机数字表法分为试验组和对照组,各80例。试验组采用阿仑膦酸钠联合阿托伐他汀治疗,对照组患者仅服用阿仑膦酸钠治疗。观察治疗前后骨密度变化;比较疼痛改善状况及不良反应。结果试验组患者显效62例,好转13例,无效5例,总有效率93.75%,显著高于对照组患者(P<0.05);治疗前,2组患者在腰椎正位、前臂、股骨颈及股骨粗隆等部位的骨密度无显著性差异(P>0.05);治疗后,2组患者在腰椎正位、前臂、股骨颈及股骨粗隆等部位的骨密度均较治疗前显著增高(P<0.05),但试验组患者的骨密度增高更明显(P<0.05);治疗后,2组患者发生恶心、便秘、头痛、腹痛腹胀等不良反应的情况无显著性差异(P>0.05)。结论阿仑膦酸钠联合阿托伐他汀治疗糖尿病合并骨质疏松,能够显著缓解患者的疼痛状况,显著提高腰椎正位、前臂、股骨颈及股骨粗隆等部位的骨密度,具有一定的安全性。     

Treatment with alendronate plus calcium,alendronate alone,or calcium alone for postmenopausal low bone mineral density

ABSTRACT

Objective: Bisphosphonates such as alendronate are widely used for postmenopausal osteoporosis. Supplemental calcium is also generally recommended. This trial directly compares alendronate to supplemental calcium and examines the effect of calcium supplementa­tion on alendronate treatment.

Methods: This 2-year, randomized, double-blind, multicenter trial enrolled healthy, postmenopausal women with low bone mineral density (BMD). Patients with a dietary calcium intake ≥?800?mg/day received daily vitamin D 400?IU and alendronate 10?mg/calcium-placebo, alendronate 10?mg/elemental calcium 1000?mg, or alendronate-placebo/calcium 1000?mg (2:2:1). Endpoints included BMD, bone turnover markers (BTMs), and adverse events.

Results: Randomized patients (N = 701) were an average of 20.4 years postmenopausal. After 24 months, increases in lumbar spine BMD differed significantly between patients receiving calcium alone (0.8%) and either alendronate alone (5.6%) or alendronate + calcium (6.0%) (?p < 0.001). Significant differences were also seen at the trochanter and femoral neck (?p < 0.001). BTMs were significantly lower with alendronate-containing treatments than calcium alone (?p < 0.001). Addition of calcium supplementation to alendronate did not signif­icantly increase BMD compared to alendronate alone (?p = 0.29 to 0.97), but did result in a statistically significant, though small, additional reduction in urinary NTx. Adverse events were similar among treatment groups. Limitations include no assessment of vitamin D levels and a discontinuation rate of approximately 30%, although discontinuation rates were similar among treatment groups.

Conclusions: In postmenopausal women with a daily intake of ≥?800?mg calcium and 400?IU vitamin D, 24-month treatment with alendronate 10?mg daily with or without calcium 1000?mg resulted in significantly greater increases in BMD and reduction of bone turnover than supplemental calcium alone. Addition of supplemental calcium to alendronate treatment had no effect on BMD and resulted in a small, though statistically significant, additional reduction in NTx.     

Serum levels of immunoreactive bone sialoprotein in osteoporosis: positive relations to established biochemical parameters of bone turnover

Bone Sialoprotein (BSP), synthesized by osteoblasts and osteoclasts, is a highly glycosylated and phosphorylated protein, accounting for approximately 5-10% of noncollagenous proteins of bone extracellular matrix. The present study investigates possible correlations between serum values of immunoreactive Bone Sialoprotein in relation to established bone turnover markers like osteocalcin (OC), bone alkaline phosphatase (B-ALP) and the c-terminal extension peptide of type-I-Procollagen (PICP) in 170 osteoporosis patients (female n = 144, male n = 26) in order to evaluate the usefulness of BSP in the diagnosis of bone disease. Fasting venous blood samples were collected from our osteoporosis outpatients in the morning and stored at -80 degrees C until processing. Serum levels of BSP were determined by RIA, OC and B-ALP were measured by IRMA, and PICP was assessed employing an ELISA technique. A significant correlation was found between BSP serum values and B-ALP (r = 0.532, p = 0.0001). Median serum BSP levels were 8.0 micrograms/l, median B-ALP values were 22.39 U/ml in these patients. Also a significant correlation was observed between BSP and OC (r = 0.588, p = 0.0001), more pronounced in the female patient group (r = 0.632, p < 0.0001). A weak association between BSP and PICP in the female group was detected (r = 0.398, p = 0.0001). In the female group BSP was inversely related to serum estradiol levels (r = -0.274, p = 0.002) as to BMD (DEXA) at the lumbar spine and femoral neck. In conclusion, BSP might be a useful marker of non-collagenous organic bone matrix in laboratory assessment of bone turnover, being inversely related to BMD at lumbar spine and femoral neck and showing significant correlations to established markers of bone turnover like B-ALP and OC.     

A comparison of teriparatide and calcitonin therapy in postmenopausal Asian women with osteoporosis: a 6-month study

OBJECTIVE: The number of hip fractures is expected to double in the next 20 years, with current estimates that Asia will account for 37% of these cases. As bone mineral density (BMD) may be used as a measure of fracture risk, we sought to compare the effects of teriparatide with salmon calcitonin treatment on changes in BMD, biochemical bone markers, and safety in postmenopausal Asian women with osteoporosis. METHODOLOGY: A total of 104 patients (n = 47 teriparatide [20 g/day subcutaneously] and n = 57 calcitonin [100 IU/day subcutaneously]) were enrolled in Hong Kong, Singapore, Philippines, Malaysia, and Thailand. Calcium (> or = 500 mg/day) and vitamin D (200-400 IU/day) supplements were taken throughout the 6-month controlled, randomized study. RESULTS: Teriparatide was associated with a 5.03 +/- 4.77% increase in lumbar spine BMD (p < 0.0001, mean +/- SD change from baseline), whereas changes in lumbar spine BMD for patients on calcitonin were not statistically significant (mean change of 0.36 +/- 4.12%, p = 0.16). Comparison of the two groups indicated that teriparatide treatment improved lumbar spine BMD statistically significantly more than calcitonin (p < 0.0001). No statistically significant changes were observed for total hip or femoral neck BMD. Serum bone-specific alkaline phosphatase (BSAP) increased by 55.9% (median change from baseline, p < 0.0001) in the teriparatide group, and remained stable with calcitonin (5.0% change, p = 0.24); osteocalcin increased by 156.15% (median change from baseline, p < 0.0001) with teriparatide, and decreased with calcitonin (-15.25%, p = 0.03). Similar rates of adverse events were observed, with nausea and dizziness the most commonly reported for both groups (teriparatide versus calcitonin, 13.0% versus 23.2% p = 0.21, 10.9% versus 21.4% p = 0.19, respectively). There were no clinically relevant changes observed in laboratory parameters. CONCLUSIONS: Both treatments were similarly tolerated, however teriparatide was associated with greater increases in lumbar spine BMD and bone formation markers, demonstrating the unique mechanism of action and safety of this treatment for osteoporosis in these Asian women.     

阿仑膦酸钠治疗绝经后妇女骨质疏松症1年临床疗效观察

目的观察阿仑膦酸钠对绝经后妇女骨质疏松症的治疗作用。方法口服阿仑膦酸钠,70 mg每周1次,连用1年,分别在6个月和12个月观察骨密度、U-Ca、U-Cr和U-Ca/U-Cr。结果治疗后6个月和12个月,腰椎L2-4、股骨颈、大转子和全髋骨密度较治疗前都有显著提高（P〈0.05）,治疗12个月后与治疗6个月后比较差异也有统计学意义（P〈0.05）;治疗6个月后和治疗12个月后U-Ca和U-Ca/U-Cr较治疗前都有显著降低（P〈0.05）,且治疗12个月后U-Ca和U-Ca/U-Cr与治疗6个月后比较差异也有统计学意义（P〈0.05）;而U-Cr治疗前后差异则无统计学意义（P〉0.05）。结论阿仑膦酸钠对绝经后妇女骨质疏松症有很好的治疗作用。     

Full length parathyroid hormone,PTH(1-84), for the treatment of severe osteoporosis in postmenopausal women

ABSTRACT

Objective: To review and analyse the evidence supporting the use of full length parathyroid hormone, PTH(1-84), in the treatment of osteoporosis based on a search of several literature sources; articles selected for review were published between 1990 and 2008.

Background: PTH(1-84) is approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture in Europe. It was well tolerated in clinical trials and demonstrated bone building properties and fracture prevention particularly for the lumbar spine in the treatment of postmenopausal women.

Results: The TOP clinical trial showed that PTH(1-84) treatment for 18 months resulted in a 61% reduction (p = 0.001) in new vertebral fracture incidence when compared with placebo and reduced the risk of a first vertebral fracture by 68% (p = 0.006) in women without a prevalent fracture at baseline. PTH(1-84) increased bone mineral density (BMD) at vertebral and non-vertebral sites the lumbar spine BMD increasing regardless of T-score, age, prior osteoporosis therapy or number of years post-menopause. The PaTH study showed that treatment with PTH(1-84) for 12 months increased BMD at the trabecular spine and hip. Lumbar spine BMD gains were largest with sequential administration of PTH(1-84) followed by alendronate but were smaller with concurrent administration involving anabolic and antiresorptive agents. Lumbar spine BMD increases were also seen in trials involving PTH with raloxifene and PTH in combination with hormone replacement therapy.

Conclusions: PTH(1-84) has demonstrated effective bone building qualities and extends the therapeutic options available to osteoporotic women. The use of PTH(1-84) followed by sequential administration of an antiresorptive has proved effective at increasing trabecular BMD and points towards new treatment regimens offering improvements in BMD and fracture prevention.     

Recombinant full-length parathyroid hormone (1-84)

Full-length parathyroid hormone (PTH) 1-84 is a recombinant version of human PTH. It is approved in the EU for the treatment of postmenopausal women with osteoporosis who have a high risk of fractures. Once-daily subcutaneous administration of PTH(1-84) stimulates new bone formation and increases bone mass. In the pivotal, randomised, double-blind, multicentre, 18-month TOP trial in 2532 postmenopausal women with osteoporosis, subcutaneous PTH(1-84) 100 microg/day significantly reduced the incidence of new or worsened vertebral fractures relative to placebo (primary endpoint). Moreover, the increase from baseline in bone mineral density (BMD) at the lumbar spine, total hip, femoral neck and trochanter was also significantly greater than in the placebo group. In another well designed study (PaTH; n = 238), 1 year of subcutaneous PTH(1-84) 100 microg/day followed by 1 year of alendronate 10 mg/day resulted in significantly greater increases in total spine, femoral neck and total hip BMD at 24 months compared with patients who received placebo for the second year. During the first year, PTH(1-84) in combination with alendronate was no more effective than PTH(1-84) monotherapy in terms of increasing areal lumbar spine BMD. PTH(1-84) is generally well tolerated, although patients should be monitored for elevated serum calcium.     

骨吸收抑制剂治疗绝经后骨质疏松的临床评价

目的　评价不同类型骨吸收抑制剂在临床原发性骨质疏松症治疗中的疗效。方法　30 0例原发性骨质疏松症患者分成三组 ,每组 10 0例 ,所有患者均排除继发性骨质疏松。性激素类组 :服用利维爱 2 5mg ,隔日 1次 ;降钙素组 :密钙息 5 0IU ,肌注 ,第 1周每天 1次 ,第 2周隔日 1次 ,以后每周 2次 ;二膦酸盐组 :阿仑膦酸钠 10mg ,每天 1次。治疗 2年后随访 :腰椎骨密度 (BMD)、胫骨骨超声 (QUS)、尿羟脯氨酸 (HOP)、骨钙素和新骨折。结果　临床骨痛降钙素缓解速度最快 ,性激素类药物可迅速有效地缓解妇女更年期症状。治疗 2年后 ,腰椎骨密度明显上升 (P <0 0 5 ) ,二膦酸盐组上升 5 1% ,性激素类组上升 4 2 % ,降钙素上升 0 97% ;胫骨骨超声显著提高 (P <0 0 5 ) ,性激素组上升 2 1% ,降钙素组 1 8% ,二膦酸盐组 1 7% ;新骨折共 4例 :二膦酸盐组 2例 ,降钙素组和性激素组各 1例 ;尿羟脯氨酸仅二膦酸盐组明显下降 ;骨钙素各组无明显变化。结论　骨吸收抑制剂是骨质疏松治疗的重要手段 ,性激素类药物是治疗伴有绝经后综合症骨质疏松患者的首选药物 ,二膦酸盐对骨量较低且伴有骨痛的患者有良好的疗效 ,降钙素治疗骨质疏松疼痛临床疗效显著。     

阿法骨化醇对大剂量糖皮质激素治疗肾小球疾病所致的骨质疏松的影响

目的：观察阿法骨化醇联合钙剂对肾脏病患者发生糖皮质激素性骨质疏松的预防作用。方法：28例病人随机分为治疗组16例,阿法骨化醇1μg日一次口服和碳酸钙750 mg日三次口服;对照组12例,碳酸钙750 mg日三次口服。治疗前及以后每3个月检查血清白蛋白、钙、磷、24小时尿蛋白定量、甲状旁腺素,腰椎和股骨颈骨密度,观察6个月。结果：两组患者腰椎和股骨颈骨密度均呈下降趋势,治疗6个月时,治疗组骨密度高于对照组（腰椎0.967±0.105,0.896±0.131,P〈0.05;股骨颈1.078±0.124,0.925±0.107,P〈0.05）,对照组骨密度较治疗前明显下降。结论：阿法骨化醇合用钙剂对预防慢性肾脏病患者发生糖皮质激素性骨质疏松是安全有效的药物。     

骨松宝胶囊联合胰岛素注射液治疗2型糖尿病性骨质疏松症的临床研究

目的观察骨松宝胶囊联合胰岛素注射液治疗2型糖尿病性骨质疏松症的临床疗效。方法选取西安市第五医院2013年7月—2014年7月收治的2型糖尿病性骨质疏松患者98例,随机分为治疗组和对照组,每组各49例。对照组餐前皮下注射胰岛素注射液,起始剂量为4~6 U/次,3次/d。根据患者血糖监测结果,适当调整剂量。治疗组在对照组的基础上口服骨松宝胶囊,2粒/次,3次/d。两组患者均连续治疗1年。观察两组的临床疗效,同时比较两组患者治疗前后骨密度(BMD)、血钙、骨钙素(BGP)、血磷、骨特异性碱性磷酸酶(B-ALP)以及骨痛症状评分的变化。结果治疗后,对照组和治疗组的总有效率分别为79.6%、93.9%,两组比较差异有统计学意义(P0.05)。治疗后,两组患者腰椎、股骨颈、股骨大转子的BMD显著升高,同组治疗前后差异有统计学意义(P0.05);且治疗组这些指标改善幅度明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者B-ALP均显著降低,BGP均显著升高,同组治疗前后差异有统计学意义(P0.05);且治疗组这些观察指标明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者骨痛症状评分显著降低,同组治疗前后差异有统计学意义(P0.05);且治疗组骨痛症状评分下降明显优于对照组,两组比较差异具有统计学意义(P0.05)。结论骨松宝胶囊联合胰岛素注射液治疗2型糖尿病性骨质疏松症疗效较好,能显著改善患者骨痛症状,具有一定的临床推广应用价值。     

金天格胶囊联合骨化三醇治疗骨质疏松的临床研究

目的探讨金天格胶囊联合骨化三醇软胶囊治疗骨质疏松的临床疗效。方法选取2018年5月—2019年5月在宁夏回族自治区人民医院治疗的120例骨质疏松患者为研究对象,将所有患者随机分为对照组和治疗组,每组各60例。对照组患者口服骨化三醇软胶囊,1粒/次,2次/d;治疗组患者在对照组基础上口服金天格胶囊,3粒/次,3次/d。两组患者持续治疗6个月。观察两组的临床疗效,比较两组的视觉模拟评分法(VAS)评分、血钙(S-Ca)、血磷(S-P)、骨碱性磷酸酶(B-ALP)、骨钙素(BGP)和骨密度(BMD)水平。结果治疗后,对照组和治疗组的总有效率分别为83.33%、96.67%,两组比较差异有统计学意义(P0.05)。治疗后,两组患者S-P、B-ALP水平均显著降低,S-Ca水平明显升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组患者S-P、B-ALP、S-Ca水平明显优于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组患者股骨颈BMD、腰椎L2-L4 BMD和BGP水平均显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组患者股骨颈BMD、腰椎L2-L4 BMD和BGP水平均明显高于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组患者VAS评分显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组患者VAS评分显著低于对照组,两组比较差异有统计学意义(P0.05)。结论金天格胶囊联合骨化三醇软胶囊治疗骨质疏松具有较好的临床疗效,可减少疼痛,增加骨密度,改善血清因子水平,安全性较高,具有一定的临床推广应用价值。     

Comparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised,placebo-controlled study

SUMMARY

Objective: To compare the effects of alendronate (ALN) 70mg once weekly (OW) and risedronate (RIS) 5mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in postmenopausal women with osteoporosis.

Research design and methods: This was a 3-month, randomised, double-blind, placebo-controlled study with a double-blind extension to 12 months. The study enrolled 549 postmenopausal women (ALN 219, RIS 222 and placebo (PBO) 108) who were >60 years of age at outpatient centres.

Main outcome measures: The primary endpoint was reduction in urine N-telopeptides of type 1 collagen (NTx) corrected for creatinine level at 3 months. Secondary parameters included change in BMD at the spine and hip at 6 and 12 months, NTx at 1,6 and 12 months, and serum bone-specific alkaline phosphatase (BSAP) at 1, 3, 6 and 12 months. Adverse experiences (AEs) were recorded throughout the study for an assessment of treatment safety profiles and tolerability.

Results: Over 3 months, ALN produced a significantly greater mean reduction in urine NTx than did RIS (?52% vs ?32%, p?<?0.001), which was maintained at 12 months. ALN produced a significantly greater mean BMD increase than did RIS at 6 months, and it was maintained at 12 months at the lumbar spine (4.8% vs 2.8%, p?<?0.001) and total hip (2.7% vs 0.9%, p?<?0.001), as well as at the trochanter and femoral neck. Significant reductions in BSAP with ALN compared to RIS were maintained over the 12 months of treatment. Study size did not allow for meaningful assessment of differences in fracture rates. Tolerability was generally similar between ALN, RIS and PBO, and the incidence of upper GIAEs causing discontinuation and oesophageal AEs was similar in the ALN and RIS groups.

Conclusion: In this study, ALN 70?mg OW produced a 50% greater reduction in bone resorption as measured by urine NTx and significantly greater increases in lumbar spine and hip BMD than did RIS 5?mg daily. The treatments had similar safety profiles and were generally well-tolerated. Additional studies are needed comparing OW ALN with OW RIS, which became available after the commencement of the present study.     

分析绝经后骨质疏松症应用阿仑膦酸钠与激素替代疗法的治疗效果

目的分析绝经后骨质疏松症应用阿仑膦酸钠与激素替代疗法治疗的临床效果。方法70例绝经后骨质疏松症患者作为研究对象,依据随机数字表法分为对照组与观察组,每组35例。对照组患者口服替勃龙治疗,观察组患者口服阿仑膦酸钠治疗。比较两组患者骨密度、临床疗效与雌二醇(E2)、促卵泡生成素(FSH)水平。结果治疗前,对照组患者的腰椎1-4骨密度为(0.820±0.020)g/cm^2,右侧股骨颈骨密度为(0.746±0.019)g/cm^2;观察组的腰椎1-4骨密度为(0.821±0.020)g/cm^2,右侧股骨颈骨密度为(0.745±0.021)g/cm^2。治疗后,对照组的腰椎1-4骨密度为(0.851±0.018)g/cm^2,右侧股骨颈骨密度为(0.764±0.022)g/cm^2;观察组的腰椎1-4骨密度为(0.856±0.014)g/cm^2、右侧股骨颈骨密度为(0.762±0.018)g/cm^2。治疗后,两组患者腰椎1-4及右侧股骨颈骨密度均优于本组治疗前,差异具有统计学意义(P<0.05)。治疗后,两组患者腰椎1-4及右侧股骨颈的骨密度比较,差异无统计学意义(P>0.05)。观察组治疗总有效率为100%,与对照组的100%比较,差异无统计学意义(P>0.05)。治疗前,对照组患者E2水平为(32.04±25.08)pg/ml,FSH水平为(72.54±32.08)mIU/ml;观察组患者E2水平为(33.54±29.10)pg/ml,FSH水平为(69.09±27.08)mIU/ml。治疗前,两组患者E2及FSH水平比较,差异无统计学意义(P>0.05)。治疗后,对照组患者E2水平为(64.32±28.54)pg/ml,FSH水平为(45.08±25.27)mIU/ml;观察组患者E2水平为(33.62±22.08)pg/ml,FSH水平为(71.04±22.42)mIU/ml。治疗后,对照组患者E2水平高于本组治疗前,FSH水平低于本组治疗前,差异具有统计学意义(P<0.05)。治疗后,观察组患者E2及FSH水平与本组治疗前比较,差异无统计学意义(P>0.05)。结论阿仑膦酸钠与激素代替疗法均能有效提高绝经后骨质疏松症患者的骨密度,但是与激素代替疗法相比,阿仑膦酸钠对患者的血清E2、FSH水平影响较小。     

联用补肾壮骨汤、阿仑膦酸钠治疗绝经后妇女骨质疏松症的疗效分析

分析联合应用补肾壮骨汤、阿仑膦酸钠治疗绝经后骨质疏松症患者的临床价值.本文选取2018年4月至2019年12月在该院收治的62例绝经后骨质疏松症患者作为研究对象,采用随机数字表法将其分为研究组及对照组.研究组(n=31)予以补肾壮骨汤、阿仑膦酸钠联合治疗,对照组(n=31)应用阿仑膦酸钠治疗,记录两组治疗前后中医证候积...     

肾骨颗粒联合复方骨肽治疗骨质疏松症的临床研究

目的探讨肾骨颗粒联合复方骨肽注射液治疗骨质疏松症的临床疗效。方法选取2017年5月—2018年5月在重庆市黔江中心医院进行治疗的136例骨质疏松症患者作为研究对象,根据用药的差别将患者分为对照组(68例)和治疗组(68例)。对照组患者肌肉注射复方骨肽注射液,4mL/次,1次/d;治疗组在对照组治疗的基础上口服肾骨颗粒,2g/次,3次/d。两组患者连续治疗4周。观察两组患者的临床疗效,比较治疗前后两组的视觉模拟量表评分(VAS)、Oswestry功能障碍指数(ODI)评分、骨质疏松症生活质量评分(OQOLS)、各部位骨密度和血清学指标。结果治疗后,对照组和治疗组的总有效率分别为80.88%、95.59%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者VAS评分、ODI评分显著降低,OQOLS评分显著升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组VAS评分、ODI评分和OQOLS评分明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者股骨颈、Ward氏三角区、腰椎L_(1-4)的BMD均显著升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组股骨颈、Ward氏三角区、腰椎L_(1-4)的BMD明显高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清抗酒石酸酸性磷酸酶(TRACP)、N端骨钙素(N-MID)水平显著降低,骨碱性磷酸酶(B-ALP)、I型前胶原氨基端前肽(PINP)、硬骨素(SOST)、骨钙素(BGP)水平显著升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组血清学指标明显优于对照组,两组比较差异具有统计学意义(P0.05)。结论肾骨颗粒联合复方骨肽注射液治疗骨质疏松症能够显著改善患者相关症状,改善骨代谢指标和骨密度,提高患者生活质量,具有一定的临床推广应用价值。     

阿仑膦酸钠对类风湿关节炎患者骨质疏松或骨量减少的疗效观察

目的 观察阿仑膦酸钠对类风湿关节炎(RA)合并骨质疏松或骨量减少的患者骨密度(BMD)的影响.方法 将42例RA患者随机分成2组,所有患者均服用MTX 10 mg/周、叶酸片5 mg/d和钙尔奇-D 600 mg/d,治疗组加用阿仑膦酸钠70 mg/周,2组共服药6个月.使用双能X线吸收仪分别检测治疗前和治疗6个月后腰椎(L1～4)后前位、股骨颈、大转子、Ward区部位的BMD,评估RA疾病活动度并分析二者间的相关性.结果 治疗6个月后治疗组RA患者的腰椎BMD与基线相比明显上升(P<0.05),并且高于对照组(P<0.05).而股骨颈、Ward区和大转子部位的BMD有所增加,但与基线及对照组相比,差异无统计学意义.21例治疗组患者经过6个月治疗后腰椎BMD的变化与RA疾病活动性指标如ESR、CRP、RF、HAQ评分、关节肿胀个数、关节压痛个数和DAS28均无相关性(P>0.05).结论 与MTX联用,阿仑膦酸钠可增加骨质疏松或骨量减少RA患者的腰椎BMD,是治疗RA伴发骨质疏松或骨量减少的有效手段.     

Relationship between change in femoral neck bone mineral density and hip fracture incidence during treatment with strontium ranelate

ABSTRACT

Objective: Strontium ranelate (SR) increases bone mineral density (BMD) in postmenopausal osteoporotic women and reduces vertebral and non-vertebral fracture incidence. Hip fracture reduction has also been observed during 3-year treatment with SR in osteoporotic women at high risk of hip fracture. The objective of this study is to analyse the association between BMD changes and hip fracture incidence during treatment with SR.

Material and methods: In this post-hoc analysis, 465 women aged over 74 years with low BMD at the femoral neck (T-score ≤ –2.4 according to NHANES normative values) were selected from the population of a recently published study (the Treatment of Peripheral Osteoporosis Study – TROPOS). BMD was assessed at the femoral neck at baseline and after a follow-up of 3 years. Hip fractures were reported by study investigators.

Results: After adjusting for age, body mass index, femoral neck BMD at baseline and number of prevalent vertebral fractures, we found that for each 1% increase in femoral neck BMD observed after 3 years, the risk to experience a hip fracture after 3 years decreased by 7% (95% CI: 1–14%) (?p = 0.04). In patients experiencing a hip fracture over 3 years of treatment with SR, femoral neck BMD increased by (mean [SE]) 3.41 (1.02)% compared to 7.23 (0.81)% in patients without hip fracture (?p = 0.02).

Conclusion: In this post-hoc analysis of women undergoing 3 years of SR treatment, an increase in femoral neck BMD is associated with a decrease in hip fracture incidence.     

辛伐他汀和鲑降钙素注射液联合金天格胶囊治疗老年骨质疏松性Ⅰ度胸腰椎压缩性骨折的临床疗效

目的探讨辛伐他汀和鲑降钙素注射液联合金天格胶囊治疗老年骨质疏松性Ⅰ度胸腰椎压缩性骨折的临床疗效。方法选取建平县医院2018年10月—2019年10月收治的老年骨质疏松性Ⅰ度胸腰椎压缩性骨折患者126例,采用随机数字表法分为对照组与观察组,各63例。对照组予以辛伐他汀联合鲑降钙素注射液治疗,观察组在对照组基础上联合金天格胶囊治疗。比较2组临床疗效,治疗前后视觉模拟评分法(VAS)评分,治疗前后股骨颈、腰椎正位的骨密度。结果观察组总有效率高于对照组(P<0.05)。治疗前2组VAS评分比较,差异无统计学意义(P>0.05);治疗后2组VAS评分低于治疗前,且观察组低于对照组(P<0.05)。治疗前2组股骨颈、腰椎正位骨密度比较,差异无统计学意义(P>0.05);治疗后2组股骨颈、腰椎正位骨密度高于治疗前,且观察组高于对照组(P<0.05)。结论辛伐他汀和鲑降钙素注射液联合金天格胶囊治疗老年骨质疏松性Ⅰ度胸腰椎压缩性骨折的临床疗效确切,可有效减轻患者的疼痛,并改善其骨密度。     

续断壮骨胶囊联合依降钙素治疗骨质疏松症的临床研究

目的 探讨续断壮骨胶囊联合依降钙素治疗骨质疏松的临床疗效。方法 选取2020年9月—2022年5月秦皇岛市第一医院收治的128例骨质疏松症患者,随机分为对照组（64例）和治疗组（64例）。对照组患者肌肉注射依降钙素注射液,10 U/次,2次/周。在对照组的基础上,治疗组口服续断壮骨胶囊,2粒/次,3次/d。两组患者用药24周。观察两组患者临床疗效,比较治疗前后两组患者患者症状缓解时间,视觉模拟疼痛评分法（VAS）评分,腰椎L2、腰椎L4、股骨颈的骨密度（BMD）,血清炎性因子胰岛素样生长因子-1(IGF-1)、抗酒石酸酸性磷酸酶-5b(TRACP-5b)、白细胞介素-6(IL-6)和骨碱性磷酸酶（BSAP）水平,及不良反应情况。结果 治疗后,治疗组患者临床有效率为（98.43%）,明显高于对照组（84.38%,P<0.05）。治疗后,治疗组症状缓解时间均早于对照组（P<0.05）。治疗后,两组患者VAS评分明显降低,而腰椎L2、腰椎L4、股骨颈的骨密度（BMD）均高于治疗前（P<0.05）,且治疗组骨疼痛程度及骨密度均明显好于对照组（P<0.05）。治疗后,两组...