Article(id=1291404731302273653, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404681641713991, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.07.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734710400000, receivedDateStr=2024-12-21, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824481081, onlineDateStr=2026-08-04, pubDate=1744819200000, pubDateStr=2025-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824481081, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824481081, creator=13701087609, updateTime=1785824481081, updator=13701087609, issue=Issue{id=1291404681641713991, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1744819200000', pubDateStr='2025-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824469242, creator='13701087609', updateTime=1785824469242, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=927, endPage=931, ext={EN=ArticleExt(id=1291404731499405942, articleId=1291404731302273653, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of salmon calcitonin combined with calcium carbonate D
3 in the treatment of disuse osteoporosis patients after ankle fracture surgery, 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 salmon calcitonin nasal spray combined with calcium carbonate D3 tablets in the treatment of disuse osteoporosis patients after ankle fracture surgery.
Methods The disuse osteoporosis patients with postoperative ankle fractures were randomly divided into control group and treatment group using a random number table method. The control group was treated with calcium carbonate D3 tablets 600 mg per time, twice daily, while the treatment group received salmon calcitonin nasal spray 200 U per time, once daily, in addition to the treatment in the control group. Both groups were treated for 6 months. The clinical efficacy, bone metabolic markers (osteocalcin, alkaline phosphatase), changes in bone mineral density (BMD) and postoperative pain level (VAS) were compared between the two groups, the safety evaluation was also conducted.
Results A total of 3 cases dropped out during the trial. Ultimately, the treatment group and the control group included 63 and 62 patients, respectively. After treatment, the overall effective rates for the treatment group and the control group were 93.65% (59 cases/63 cases) and 75.81% (47 cases/62 cases), respectively, with statistically significant difference (P<0.01). After 3 months of treatment, the BMD of the control and treatment groups were (0.87±0.09) and (0.93±0.08) g·cm-2, respectively; serum osteocalcin levels were (20.10±3.20) and (22.80±3.50) ng·mL-1, respectively; alkaline phosphatase levels were (74.50±12.30) and (80.10±13.20) U·L-1, respectively; after 6 months of treatment, the BMD values for the control and treatment groups were (0.90±0.08) and (1.01±0.07) g·cm-2, respectively; serum osteocalcin levels were (21.00±3.40) and (24.60±3.40) ng·mL-1, respectively; alkaline phosphatase levels were (76.00±12.50) and (84.90±13.80) U·L-1, respectively; statistically significant differences were observed for the above indicators between the experimental and control groups (P<0.05, P<0.001). After 3 months of treatment, the visual analog scale (VAS) scores of the control and treatment groups were (5.30±1.30) and (4.50±1.20) points, respectively; after 6 months of treatment, the VAS scores were (4.20±1.10) and (2.90±1.00) points, respectively; the differences between the treatment and control groups were statistically significant (all P<0.001). The main adverse drug reactions in the treatment group were nasal discomfort and nausea, while the control group were gastrointestinal discomfort. The total incidence of adverse drug reactions in the treatment and control groups were 7.94% (5 cases/63 cases) and 4.84% (3 cases/62 cases), respectively, without statistically significant difference between the two groups (P>0.05).
Conclusion Salmon calcitonin nasal spray combined with calcium carbonate D3 tablets can significantly increases BMD in disuse osteoporosis patients after ankle fracture surgery, reduce the risk of disuse osteoporosis, with good safety.
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3治疗踝关节骨折术后废用性骨质疏松患者的临床研究, 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 观察鲑降钙素鼻喷雾剂联合碳酸钙D3片治疗踝关节骨折术后废用性骨质疏松患者的临床疗效及安全性。
方法 将踝关节骨折术后废用性骨质疏松患者按随机数表法分为对照组和试验组。对照组用碳酸钙D3片治疗，每次600 mg，bid；试验组在对照组治疗的基础上，给予鲑降钙素鼻喷雾剂治疗，每次200 U，qd。2组患者均治疗6个月。比较2组患者的临床疗效、骨代谢标志物（骨钙素、碱性磷酸酶）、骨密度变化和术后疼痛程度（VAS），并进行安全性评价。
结果 试验过程中共脱落3例，最终试验组和对照组分别入组63例与62例。治疗后，试验组和对照组的总有效率分别为93.65%（59例/63例）和75.81%（47例/62例），在统计学上差异有统计学意义（P<0.01）。治疗3个月后，对照组和试验组的骨密度分别为（0.87±0.09）和（0.93±0.08）g·cm-2，血清骨钙素分别为（20.10±3.20）和（22.80±3.50）ng·mL-1，碱性磷酸酶分别为（74.50±12.30）和（80.10±13.20）U·L-1；治疗6个月后，对照组和试验组的骨密度分别为（0.90±0.08）和（1.01±0.07）g·cm-2，血清骨钙素分别为（21.00±3.40）和（24.60±3.40）ng·mL-1，碱性磷酸酶分别为（76.00±12.50）和（84.90±13.80）U·L-1，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（P<0.05，P<0.001）。治疗3个月后，对照组和试验组的VAS评分分别为（5.30±1.30）和（4.50±1.20）分，治疗6个月后分别为（4.20±1.10）和（2.90±1.00）分，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（P<0.001）。试验组的药物不良反应主要有鼻腔不适和轻度恶心，对照组的药物不良反应主要有胃肠道不适。试验组和对照组的药物不良反应总发生率分别为7.94%（5例/63例）和4.84%（3例/62例），在统计学上差异无统计学意义（P>0.05）。
结论 鲑降钙素鼻喷雾剂联合碳酸钙D3片能够显著提高踝关节骨折术后废用性骨质疏松患者的骨密度，降低废用性骨质疏松的风险，且安全性良好。
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李明艳（1981-），女，副主任医师，主要从事四肢骨折及关节周围韧带损伤方面的研究
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