Article(id=1291339020378829014, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291338935477724120, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.01.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1708358400000, receivedDateStr=2024-02-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808814376, onlineDateStr=2026-08-04, pubDate=1737043200000, pubDateStr=2025-01-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808814376, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808814376, creator=13041195026, updateTime=1785808814376, updator=13041195026, issue=Issue{id=1291338935477724120, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='1', pageStart='1', pageEnd='148', issueExtLink='null', onlineDate='null', pubDate='1737043200000', pubDateStr='2025-01-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808794022, creator='13041195026', updateTime=1785808794022, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=26, endPage=30, ext={EN=ArticleExt(id=1291339020882145495, articleId=1291339020378829014, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To explore the clinical efficacy and safety of alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet in the treatment of postmenopausal osteoporosis (PMDP).
Methods The patients with postmenopausal osteoporosis were divided into control group and treatment group according to the cohort method according to the treatment regimen. The control group was treated with calcium carbonate D3 tablet (600 mg, 1 tablet a day) and alendronate sodium tablet (70 mg, once a week), while the treatment group was given injection of reacombinant teriparatide (200 U/20 μg, 20 μg every day) on the basis of the control group. Both groups were continuously treated for 6 months. The clinical efficacy was compared after 6 months of treatment. The bone mineral density (BMD) of lumbar spine, total hip and femoral neck and levels of bone metabolism indicators [osteocalcin (OCN), tartrate-resistant acid phosphatase-5b (TRAP-5b), procollagen type Ⅰ amino-terminal propeptide (PINP), C-terminal cross-linked peptide of type Ⅰ collagen (CTX-Ⅰ)]before treatment and after 6 months of treatment and bone pain [visual analogue scale (VAS)]and quality of life [European Foundation Osteoporosis Quality of Life Questionnaire (ECOS-16)]before treatment and after 3 and 6 months of treatment were recorded, and the adverse drug reactions within 6 months of treatment were compared.
Results Fifty-two cases in treatment group and 64 cases in control group were enrolled. After treatment, the total effective rates in treatment group and control group were 87.80% (36 cases/41 cases) and 68.29% (28 cases/41 cases), respectively (P<0.05). The BMD values of lumbar spine in treatment group and control group after treatment were (0.69±0.15) and (0.79±0.18) g·cm-2; the BMD values of total hip were (0.70±0.11) and (0.77±0.15) g·cm-2; the BMD values of femoral neck were (0.79±0.19) and (0.87±0.15) g·cm-2, respectively; the OCN levels were (7.42±1.53) and (5.37±1.16) μg·L-1; the PINP levels were (85.31±5.66) and (76.30±5.49) ng·mL-1; the TRAP-5b levels were (3.27±0.46) and (5.16±0.72) U·L-1; the CTX-I levels were (3.37±0.54) and (5.08±0.70) ng·mL-1; the VAS scores were (1.48±0.13) and (2.07±0.24) points; the ECOS-16 scores were (24.84±4.62) and (32.71±6.07) points, and there were statistical differences in the above indicators between treatment group and control group (all P<0.05). The main adverse drug reactions in treatment group were rash, dizziness and limb pain, and the main adverse drug reactions in control group were rash, dizziness, nausea, and limb pain, and the total incidence rates of adverse reactions in treatment group and control group were 12.20% (5 cases/41 cases) and 19.51% (8 cases/41 cases) (P>0.05).
Conclusion Alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet has a significant short-term efficacy on PMOP patients, and it can help to enhance the bone mineral density, reduce the symptoms of bone pain, and relieve the osteoporosis.
, authors=Yan ZHU
1a, Lei-yu QIU
1b, Huan-xing LU
1a, authorsList=Yan ZHU, Lei-yu QIU, Huan-xing LU, authorCompany=null, correspAuthors=Huan-xing LU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291339021595177176, articleId=1291339020378829014, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=阿仑膦酸钠联合特立帕肽治疗绝经后骨质疏松症患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 探究阿仑膦酸钠片联合注射用重组特立帕肽和碳酸钙D3片治疗绝经后骨质疏松症的临床疗效及安全性。
方法 将绝经后骨质疏松症患者根据队列法分为对照组和试验组，对照组服用碳酸钙D3片（600 mg，qd）与阿仑膦酸钠片（70 mg，qw）治疗，试验组在对照组治疗的基础上给予注射用重组特立帕肽（200 U/20 μg，qd），均持续治疗6个月。比较治疗6个月后的临床疗效差异；记录治疗前、治疗后6个月后的腰椎、全髋、股骨颈处的骨密度（BMD）水平、骨代谢指标[骨钙素（OCN）、抗酒石酸酸性磷酸酶-5b（TRAP-5b）、I型前胶原氨基端前肽（PINP）、I型胶原蛋白C末端交联肽（CTX-I）]水平；记录治疗前、3、6个月后骨痛情况[视觉模拟评分（VAS）]、生活质量[欧洲基金会骨质疏松生活质量问卷（ECOS-16）]；比较治疗6个月内药物不良反应发生情况。
结果 试验组和对照组分别纳入52例和64例。治疗后，试验组和对照组的总有效率分别为87.80%（36例/41例）和68.29%（28例/41例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组在腰椎处的BMD分别为（0.69±0.15）和（0.79±0.18）g·cm-2，在全髋处的BMD分别为（0.70±0.11）和（0.77±0.15）g·cm-2，在股骨颈处的BMD分别为（0.79±0.19）和（0.87±0.15）g·cm-2，OCN水平分别为（7.42±1.53）和（5.37±1.16）μg·L-1，PINP水平分别为（85.31±5.66）和（76.30±5.49）ng·mL-1，TRAP-5b水平分别为（3.27±0.46）和（5.16±0.72）U·L-1，CTX-Ⅰ水平分别为（3.37±0.54）和（5.08±0.70）ng·mL-1，VAS评分分别为（1.48±0.13）和（2.07±0.24）分，ECOS-16评分分别为（24.84±4.62）和（32.71±6.07）分。试验组的上述指标和对照组比较，在统计学上差异均有统计学意义（均P<0.05）。试验组的药物不良反应主要有皮疹、头晕、肢体疼痛，对照组的药物不良反应主要有皮疹、头晕、恶心、肢体疼痛。试验组和对照组的总药物不良反应发生率分别为12.20%（5例/41例）和19.51%（8例/41例），在统计学上差异无统计学意义（P>0.05）。
结论 阿仑膦酸钠片联合注射用重组特立帕肽和碳酸钙D3片治疗PMOP患者短期疗效显著，有助于提高患者骨密度，减轻其骨痛症状，缓解骨质疏松。
, authors=朱衍
1a, 邱雷雨
1b, 卢焕兴
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朱衍（1986-），男，主治医师，主要从事脊柱外科、骨质疏松方向的临床诊疗工作
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