复方骨肽注射液对骨质疏松症伴转子下粉碎性骨折患者内固定手术术后恢复的临床研究  

Clinical trial of compound ossotide injection on the recovery of patients with osteoporosis and subtrochanteric comminuted fracture after internal fixation

作　　者：安玉章 蒋电明[1] AN Yu-zhang;JIANG Dian-ming(Department of Orthopedics,The First Affiliated Hospital of Chongqing Medical University,Chongqing 400010,China)

机构地区：[1]重庆医科大学附属第一医院骨科,重庆400010

出　　处：《中国临床药理学杂志》2023年第13期1851-1855,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 探讨复方骨肽注射液对骨质疏松症伴转子下粉碎性骨折患者内固定手术术后恢复的影响。方法 将骨质疏松症伴转子下粉碎性骨折患者随机分为对照组和试验组。2组均给予外科内固定手术治疗,术后对照组给予碳酸钙D3片(每次600 mg,bid,口服)+阿法骨化醇软胶囊(每次0.5μg,qd,口服),试验组在对照组的基础上加用复方骨肽注射液(每次150 mg,qd,连用2周后停药1周,静脉滴注),2组均持续治疗3个月。比较2组关节功能、疼痛视觉模拟评分(VAS)、骨痂形成评分与骨痂骨密度以及药物不良反应发生情况。结果 试验过程中共脱落3例,最终试验组和对照组分别纳入45例。试验组和对照组的显效率分别为62.22%(28例/45例)和40.00%(18例/45例),差异有统计学意义(P<0.05)。治疗后6个月,试验组与对照组Harris量表评分分别为(83.55±5.77)和(80.07±5.34)分,美国特种外科医院膝关节(HSS)量表评分分别为(87.19±7.49)和(83.38±6.23)分,BBS量表评分分别为(39.77±3.48)和(37.14±3.92)分,VAS评分分别为(2.24±0.36)和(2.66±0.42)分,骨痂形成评分分别为(2.24±0.29)和(1.93±0.35)分,骨痂骨密度为分别为(0.61±0.08)和(0.55±0.09)g·cm^(-2),试验组上述指标与对照组比较,差异均有统计学意义(均P<0.05);试验组和对照组的总药物不良反应发生率分别为4.44%(2例/45例)和2.22%(1例/45例),2组比较,差异无统计学意义(P>0.05)。结论 骨质疏松症伴转子下粉碎性骨折患者内固定术后恢复中应用复方骨肽注射液可加快患者关节功能恢复,减轻疼痛,改善骨密度,促进骨折端愈合。Objective To explore the effects of compound ossotide injection on the recovery of patients with osteoporosis and subtrochanteric comminuted fracture after internal fixation.Methods Patients with osteoporosis and subtrochanteric comminuted fracture were randomly divided into control group and treatment group.Both groups were treated with surgical internal fixation.After operation,the control group was given calcium carbonate D3 tablets(600 mg each time,bid,orally)+alfacalcidol soft capsules(0.5μg each time,qd,orally).On the basis of the control group,the treatment group was treated with compound ossotide injection(150 mg each time,qd,for 2 weeks and then discontinued for 1 week,intravenous drip).Both groups were treated for 3 months.The joint function,pain visual analogue scale(VAS)score,callus formation score,callus bone density and adverse reactions were compared between the two groups.Results There were 3 patients out of the test,and there were 45 cases in treatment group and 45 cases in control group finally,respectively.The effective rates of the treatment group and the control group were 62.22%(28 cases/45 cases)and 40.00%(18 cases/45 cases),respectively,and the difference was statistically significant(P 0.05).At 6 months after treatment,Harris scores in treatment group and control group were(83.55±5.77)and(80.07±5.34)points,hospital for special surgery knee(HSS)scores were(87.19±7.49)and(83.38±6.23)points,BBS scores were(39.77±3.48)and(37.14±3.92)points,VAS scores were(2.24±0.36)and(2.66±0.42)points,scores of callus formation were(2.24±0.29)and(1.93±0.35)points,and callus bone density values were(0.61±0.08)and(0.55±0.09)g·cm^(-2),the difference was statistically significant(P<0.05).The difference in total incidence of adverse drug reactions between treatment group and control group was not statistically significant[4.44%(2 cases/45 cases)vs 2.22%(1 case/45cases),P<005].Conclusion Compound ossotide injection can accelerate the recovery of joint function,relieve pain,improve bone mineral densit

关 键 词：复方骨肽注射液 内固定手术 骨质疏松症 转子下粉碎性骨折 膝关节功能 骨代谢 

分 类 号：R97[医药卫生—药品]