Article(id=1292135472504008717, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135444850955150, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.09.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1773417600000, receivedDateStr=2026-03-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998703361, onlineDateStr=2026-08-06, pubDate=1778947200000, pubDateStr=2026-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998703361, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998703361, creator=13701087609, updateTime=1785998703361, updator=13701087609, issue=Issue{id=1292135444850955150, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1778947200000', pubDateStr='2026-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998696767, creator='13701087609', updateTime=1786014392260, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201276780081469, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135444850955150, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201276784275774, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135444850955150, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1232, endPage=1237, ext={EN=ArticleExt(id=1292135472743084046, articleId=1292135472504008717, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of denosumab combined with teriparatide in patients with osteoporotic fractures after PKP, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of denosumab injection combined with teriparatide injection in patients with osteoporotic fractures after percutaneous kyphoplasty (PKP).

Methods

Patients with osteoporotic fractures treated with PKP in our hospital were divided into treatment group and control group according to different medication regimens. On the basis of conventional treatment, the control group was subcutaneously injected with teriparatide injection at a dose of 20 μg once daily for consecutive 12 months. The treatment group was additionally subcutaneously injected with denosumab injection on the basis of the control group’s regimen, at a dose of 60 mg once every 6 months, with a total of 2 administrations. The clinical efficacy, bone mineral density (BMD), bone metabolism indicators, pain relief and functional recovery status and incidence of refracture, and safety evaluation were compared between the two groups.

Results

A total of 108 patients were enrolled, including 53 in control group and 55 in treatment group. After treatment, the total effective rate was 90.91% (50 cases/55 cases) in treatment group and 75.47% (40 cases /53 cases) in control group; lumbar vertebrae L2-4 BMD levels were (0.88±0.13) and (0.82±0.11) g·cm-2, respectively; femoral neck BMD levels were (0.81±0.14) and (0.75±0.13) g·cm-2, respectively; greater trochanter BMD levels were (0.69±0.08) and (0.65±0.08) g·cm-2, respectively; total hip BMD levels were (0.85±0.16) and (0.78±0.16) g·cm-2, respectively; the receptor activator of nuclear factor-κB ligand (RANKL) levels were (4.82±1.24) and (5.53±1.29) pg·mL-1, respectively; total procollagen type Ⅰ N-terminal propeptide (T-P1NP) levels were (44.93±9.12) and (40.58±8.95) ng·mL-1, respectively; β-cross-linked C-telopeptide of type 1 collagen (β-CTX) levels were (0.38±0.08) and (0.43±0.07) ng·mL-1, respectively; N-terminal midfragment of osteocalcin (N-MID) levels were (19.32±2.97) and (17.93±2.59) ng·mL-1, respectively; the visual analog scale (VAS) scores were (1.88±0.66) and (2.16±0.55) points, respectively; the oswestry disability index (ODI) scores were (10.83±1.73) and (12.12±2.89) points, respectively; the incidence of refracture within 1 year of treatment was 0% (0 cases/55 cases) and 9.43% (5 cases /53 cases). The aforementioned indicators showed statistically significant differences between the two groups (P<0.05, P<0.01). The main adverse drug reactions in treatment group include nausea, muscle pain and injection site reactions; the control group included nausea, muscle pain, palpitations and injection site reactions, and both groups had mild adverse drug reactions. The total incidence of adverse drug reactions in treatment group and control group were 12.73% (7 cases/55 cases) and 9.43% (5 cases/53 cases), respectively, with no statistically significant difference (P>0.05).

Conclusion

Denosumab injection combined with teriparatide injection in the treatment of patients with osteoporotic fractures after PKP surgery can significantly improve clinical efficacy and bone density, promote bone formation, reduce the recurrence of fractures, and has favorable safety.

, authors=Kun YE1, Jie YANG1, Jia-xing YOU1, He-jun YU2, Hai-feng ZHU2, Zhao-bo HUANG2, Chao LIU2, authorsList=Kun YE, Jie YANG, Jia-xing YOU, He-jun YU, Hai-feng ZHU, Zhao-bo HUANG, Chao LIU, authorCompany=null, correspAuthors=He-jun YU, 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=1292135473087016975, articleId=1292135472504008717, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=地舒单抗联合特立帕肽治疗骨质疏松性骨折PKP术后患者的临床研究, 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

观察地舒单抗注射液联合特立帕肽注射液治疗骨质疏松性骨折行经皮椎体后凸成形术(PKP)术后患者的临床疗效和安全性。

方法

将我院收治的骨质疏松性骨折行PKP后患者按照用药方案不同分为试验组和对照组。对照组在常规治疗方案基础上皮下注射特立帕肽注射液,每次20 μg,qd,连续治疗12个月。试验组在对照组基础上皮下注射地舒单抗注射液,每次60 mg,每6个月给药1次,共给药2次。对比2组的临床疗效、骨密度(BMD)、骨代谢、疼痛缓解及功能恢复情况和再骨折发生情况,并进行安全性评价。

结果

共纳入108例患者,对照组53例,试验组55例。治疗后,试验组与对照组的临床总有效率分别为90.91%(50例/55例)和75.47%(40例/53例),腰椎L2~4 BMD分别为(0.88±0.13)和(0.82±0.11)g·cm-2,股骨颈BMD分别为(0.81±0.14)和(0.75±0.13)g·cm-2,大转子BMD分别为(0.69±0.08)和(0.65±0.08)g·cm-2,全髋BMD分别为(0.85±0.16)和(0.78±0.16)g·cm-2,核因子κB受体活化因子配体(RANKL)分别为(4.82±1.24)和(5.53±1.29)pg·mL-1,总Ⅰ型胶原氨基端延长肽(T-P1NP)分别为(44.93±9.12)和(40.58±8.95)ng·mL-1,β-胶原特殊序列(β-CTX)分别为(0.38±0.08)和(0.43±0.07)ng·mL-1N端中段骨钙素(N-MID)分别为(19.32±2.97)和(17.93±2.59)ng·mL-1,疼痛视觉模拟评分(VAS)评分分别为(1.88±0.66)和(2.16±0.55)分,Oswestry功能障碍指数(ODI)分别为(10.83±1.73)和(12.12±2.89)分,治疗1年的骨折再发生率分别为0%(0例/55例)和9.43%(5例/53例),上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。试验组的主要药物不良反应包括恶心、肌肉疼痛和注射部位反应;对照组包括恶心、肌肉疼痛、心悸和注射部位反应,2组药物不良反应均为轻度。试验组和对照组的药物不良反应总发生率分别为12.73%(7例/55例)和9.43%(5例/53例),在统计学上差异无统计学意义(P>0.05)。

结论

地舒单抗注射液联合特立帕肽注射液治疗骨质疏松性骨折行PKP术后患者可以显著提高临床疗效及骨密度,促进骨形成,降低骨折再发生,且安全性良好。

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叶琨(1985-),男,硕士研究生,主治医师,主要从事骨质疏松、骨与关节创伤、关节外科相关的临床工作和研究

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虞和君,主任医师 MP: 13857188600 E-mail:
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叶琨(1985-),男,硕士研究生,主治医师,主要从事骨质疏松、骨与关节创伤、关节外科相关的临床工作和研究

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地舒单抗联合特立帕肽治疗骨质疏松性骨折PKP术后患者的临床研究
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叶琨 1 , 杨杰 1 , 尤加省 1 , 虞和君 2 , 朱海锋 2 , 黄兆波 2 , 刘超 2
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(9): 1232-1237
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (9) : 1232 -1237
地舒单抗联合特立帕肽治疗骨质疏松性骨折PKP术后患者的临床研究
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叶琨1, 杨杰1, 尤加省1, 虞和君2 , 朱海锋2, 黄兆波2, 刘超2
作者信息
  • 1.浙江大学 医学院 附属邵逸夫医院钱塘院区 骨科,浙江 杭州 310018
  • 2.浙江大学 医学院 附属邵逸夫医院 骨科,浙江 杭州 310016
通讯作者:
虞和君,主任医师 MP: 13857188600 E-mail:
作者简介:

叶琨(1985-),男,硕士研究生,主治医师,主要从事骨质疏松、骨与关节创伤、关节外科相关的临床工作和研究

Clinical trial of denosumab combined with teriparatide in patients with osteoporotic fractures after PKP
Kun YE1, Jie YANG1, Jia-xing YOU1, He-jun YU2 , Hai-feng ZHU2, Zhao-bo HUANG2, Chao LIU2
Affiliations
  • 1.Department of Orthopedics, Qiantang Campus of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou 310018, Zhejiang Province, China
  • 2.Department of Orthopedics, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou 310016, Zhejiang Province, China
出版时间: 2026-05-17 doi: 10.13699/j.cnki.1001-6821.2026.09.006
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目的

观察地舒单抗注射液联合特立帕肽注射液治疗骨质疏松性骨折行经皮椎体后凸成形术(PKP)术后患者的临床疗效和安全性。

方法

将我院收治的骨质疏松性骨折行PKP后患者按照用药方案不同分为试验组和对照组。对照组在常规治疗方案基础上皮下注射特立帕肽注射液,每次20 μg,qd,连续治疗12个月。试验组在对照组基础上皮下注射地舒单抗注射液,每次60 mg,每6个月给药1次,共给药2次。对比2组的临床疗效、骨密度(BMD)、骨代谢、疼痛缓解及功能恢复情况和再骨折发生情况,并进行安全性评价。

结果

共纳入108例患者,对照组53例,试验组55例。治疗后,试验组与对照组的临床总有效率分别为90.91%(50例/55例)和75.47%(40例/53例),腰椎L2~4 BMD分别为(0.88±0.13)和(0.82±0.11)g·cm-2,股骨颈BMD分别为(0.81±0.14)和(0.75±0.13)g·cm-2,大转子BMD分别为(0.69±0.08)和(0.65±0.08)g·cm-2,全髋BMD分别为(0.85±0.16)和(0.78±0.16)g·cm-2,核因子κB受体活化因子配体(RANKL)分别为(4.82±1.24)和(5.53±1.29)pg·mL-1,总Ⅰ型胶原氨基端延长肽(T-P1NP)分别为(44.93±9.12)和(40.58±8.95)ng·mL-1,β-胶原特殊序列(β-CTX)分别为(0.38±0.08)和(0.43±0.07)ng·mL-1N端中段骨钙素(N-MID)分别为(19.32±2.97)和(17.93±2.59)ng·mL-1,疼痛视觉模拟评分(VAS)评分分别为(1.88±0.66)和(2.16±0.55)分,Oswestry功能障碍指数(ODI)分别为(10.83±1.73)和(12.12±2.89)分,治疗1年的骨折再发生率分别为0%(0例/55例)和9.43%(5例/53例),上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。试验组的主要药物不良反应包括恶心、肌肉疼痛和注射部位反应;对照组包括恶心、肌肉疼痛、心悸和注射部位反应,2组药物不良反应均为轻度。试验组和对照组的药物不良反应总发生率分别为12.73%(7例/55例)和9.43%(5例/53例),在统计学上差异无统计学意义(P>0.05)。

结论

地舒单抗注射液联合特立帕肽注射液治疗骨质疏松性骨折行PKP术后患者可以显著提高临床疗效及骨密度,促进骨形成,降低骨折再发生,且安全性良好。

地舒单抗注射液  /  特立帕肽注射液  /  骨质疏松性椎体压缩骨折  /  经皮椎体后凸成形术
Objective

To observe the clinical efficacy and safety of denosumab injection combined with teriparatide injection in patients with osteoporotic fractures after percutaneous kyphoplasty (PKP).

Methods

Patients with osteoporotic fractures treated with PKP in our hospital were divided into treatment group and control group according to different medication regimens. On the basis of conventional treatment, the control group was subcutaneously injected with teriparatide injection at a dose of 20 μg once daily for consecutive 12 months. The treatment group was additionally subcutaneously injected with denosumab injection on the basis of the control group’s regimen, at a dose of 60 mg once every 6 months, with a total of 2 administrations. The clinical efficacy, bone mineral density (BMD), bone metabolism indicators, pain relief and functional recovery status and incidence of refracture, and safety evaluation were compared between the two groups.

Results

A total of 108 patients were enrolled, including 53 in control group and 55 in treatment group. After treatment, the total effective rate was 90.91% (50 cases/55 cases) in treatment group and 75.47% (40 cases /53 cases) in control group; lumbar vertebrae L2-4 BMD levels were (0.88±0.13) and (0.82±0.11) g·cm-2, respectively; femoral neck BMD levels were (0.81±0.14) and (0.75±0.13) g·cm-2, respectively; greater trochanter BMD levels were (0.69±0.08) and (0.65±0.08) g·cm-2, respectively; total hip BMD levels were (0.85±0.16) and (0.78±0.16) g·cm-2, respectively; the receptor activator of nuclear factor-κB ligand (RANKL) levels were (4.82±1.24) and (5.53±1.29) pg·mL-1, respectively; total procollagen type Ⅰ N-terminal propeptide (T-P1NP) levels were (44.93±9.12) and (40.58±8.95) ng·mL-1, respectively; β-cross-linked C-telopeptide of type 1 collagen (β-CTX) levels were (0.38±0.08) and (0.43±0.07) ng·mL-1, respectively; N-terminal midfragment of osteocalcin (N-MID) levels were (19.32±2.97) and (17.93±2.59) ng·mL-1, respectively; the visual analog scale (VAS) scores were (1.88±0.66) and (2.16±0.55) points, respectively; the oswestry disability index (ODI) scores were (10.83±1.73) and (12.12±2.89) points, respectively; the incidence of refracture within 1 year of treatment was 0% (0 cases/55 cases) and 9.43% (5 cases /53 cases). The aforementioned indicators showed statistically significant differences between the two groups (P<0.05, P<0.01). The main adverse drug reactions in treatment group include nausea, muscle pain and injection site reactions; the control group included nausea, muscle pain, palpitations and injection site reactions, and both groups had mild adverse drug reactions. The total incidence of adverse drug reactions in treatment group and control group were 12.73% (7 cases/55 cases) and 9.43% (5 cases/53 cases), respectively, with no statistically significant difference (P>0.05).

Conclusion

Denosumab injection combined with teriparatide injection in the treatment of patients with osteoporotic fractures after PKP surgery can significantly improve clinical efficacy and bone density, promote bone formation, reduce the recurrence of fractures, and has favorable safety.

denosumab injection  /  teriparatide injection  /  osteoporotic vertebral compression fracture  /  percutaneous vertebroplasty
叶琨, 杨杰, 尤加省, 虞和君, 朱海锋, 黄兆波, 刘超. 地舒单抗联合特立帕肽治疗骨质疏松性骨折PKP术后患者的临床研究. 中国临床药理学杂志, 2026 , 42 (9) : 1232 -1237 . DOI: 10.13699/j.cnki.1001-6821.2026.09.006
Kun YE, Jie YANG, Jia-xing YOU, He-jun YU, Hai-feng ZHU, Zhao-bo HUANG, Chao LIU. Clinical trial of denosumab combined with teriparatide in patients with osteoporotic fractures after PKP[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (9) : 1232 -1237 . DOI: 10.13699/j.cnki.1001-6821.2026.09.006
  • 浙江省自然科学基金资助项目(LMS25B010001)
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doi: 10.13699/j.cnki.1001-6821.2026.09.006
  • 接收时间:2026-03-14
  • 首发时间:2026-08-06
  • 出版时间:2026-05-17
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  • 收稿日期:2026-03-14
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浙江省自然科学基金资助项目(LMS25B010001)
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    1.浙江大学 医学院 附属邵逸夫医院钱塘院区 骨科,浙江 杭州 310018
    2.浙江大学 医学院 附属邵逸夫医院 骨科,浙江 杭州 310016

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虞和君,主任医师 MP: 13857188600 E-mail:
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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