摘要
目的:探讨唑来膦酸静脉滴注联合仙灵骨葆胶囊和醋酸钙胶囊口服对骨质疏松性椎体压缩骨折(osteoporotic vertebral compression fractures,OVCF)经皮椎体成形术(percutaneous vertebroplasty,PVP)后疗效和安全性的影响。方法:将符合要求的56例OVCF患者随机分为2组,每组28例,于PVP术后1 d分别采用唑来膦酸静脉注射联合仙灵骨葆胶囊和醋酸钙胶囊口服治疗(唑来膦酸联合仙灵骨葆组)与阿法骨化醇软胶囊联合醋酸钙胶囊口服治疗(阿法骨化醇组)。阿法骨化醇软胶囊,每日1次,每次0.5 μg,长期服用;醋酸钙胶囊,每日1次,每次0.6 g,长期服用;唑来膦酸注射液,每次5 mg静脉滴注,每年1次;仙灵骨葆胶囊,每次2粒,每日3次,连续服用6个月。记录并比较2组患者腰背部疼痛视觉模拟量表(visual analogue scale,VAS)评分、矢状位Cobb角和手指骨密度T值及Oswestry功能障碍指数(Oswestry disability index,ODI),并观察并发症发生情况。结果:①腰背部疼痛VAS评分。时间因素和分组因素存在交互效应( F=70.156,P =0.031);2组患者腰背部疼痛VAS评分比较,差异有统计学意义,即存在分组效应( F=4.529,P =0.035);2组患者手术前后不同时间点腰背部疼痛VAS评分的差异有统计学意义,即存在时间效应( F=65.024,P =0.010);2组患者腰背部疼痛VAS评分随时间均呈下降趋势,但2组的下降趋势不完全一致[(6.53±2.31)分,(3.05±1.05)分,(2.25±1.26)分, F=49.128,P =0.002;(6.89±2.07)分,(3.21±1.27)分,(3.08±2.14)分, F= 35.459 ,P =0.031];术前和术后3 d,2组患者的腰背部疼痛VAS评分比较,差异均无统计学意义( t=3.181,P=0.618;t=6.532,P =0.420);术后6个月,唑来膦酸联合仙灵骨葆组的腰背部疼痛VAS评分低于阿法骨化醇组( t=4.103,P =0.002)。②矢状位Cobb角。时间因素和分组因素存在交互效应( F=45.752,P =0.014);2组患者矢状位Cobb角比较,差异有统计学意义,即存在分组效应( F=3.259,P =0.032);2组患者手术前后不�
Objective: To explore the influence of intravenous drip infusion of zoledronic acid combined with oral applications of Xianling Gubao(仙灵骨葆,XLGB)capsules and calcium acetate capsules on curative effects and safety of percutaneous vertebroplasty(PVP)for treatment of osteoporotic vertebral compression fractures(OVCF). Methods: Fifty-six patients with OVCF were enrolled in the study and were randomly divided into 2 groups,28 cases in each group.The patients were treated with intravenous drip infusion of zoledronic acid combined with oral applications of XLGB capsules and calcium acetate capsules(group A)and oral applications of alfacalcidol soft capsules and calcium acetate capsules(group B)respectively at postoperative day 1.The alfacalcidol soft capsules were taken once a day,0.5 μg at a time for long-term application.The calcium acetate capsules were taken once a day,0.6 g at a time for long-term application.The intravenous drip infusion of zoledronic acid was performed once a year,5 mg at a time.The XLGB capsules were taken three times a day,2 capsules at a time for consecutive 6 months.The low back pain visual analogue scale(VAS)scores,sagittal Cobb angle,T-value of bone density of fingers and Oswestry disability index(ODI)were recorded and compared between the 2 groups,and the complications were observed. Results: There was interaction between time factor and group factor in low back pain VAS scores( F=70.156,P =0.031).There was statistical difference in low back pain VAS scores between the 2 groups,in other words,there was group effect( F=4.529,P= 0.035).There was statistical difference in low back pain VAS scores between different timepoints before and after the surgery,in other words,there was time effect( F=65.024,P= 0.010).The low back pain VAS scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(6.53+/-2.31,3.05+/-1.05,2.25+/-1.26 points, F=49.128,P =0.002;6.89+/-2.07,3.21+/-1.27,3.08+/-2.14 point
作者
金军伟
赵刚
胡付立
JIN Junwei;ZHAO Gang;HU Fuli(The 152nd Central Hospital of PLA,Pingdingshan 467000,Henan,China)
出处
《中医正骨》
2019年第7期15-20,共6页
The Journal of Traditional Chinese Orthopedics and Traumatology
关键词
脊柱骨折
骨折
压缩性
骨质疏松性骨折
椎体成形术
唑来膦酸
仙灵骨葆胶囊
阿法骨化醇胶囊
醋酸钙胶囊
临床试验
spinal fractures
fractures,compression
osteoporotic fractures
vertebroplasty
zoledronic acid
Xianling Gubao capsules
alfacalcidol capsules
calcium acetate capsules
clinical trial
