自拟补肾壮骨方对PKP术后非伤椎再发骨折预防作用的临床研究

Clinical Study on Preventive Effect of Bushen Zhuanggu Prescription (补肾壮骨方) on Recurrent Fracture of Non-traumatic Vertebral after PKP

目的:观察自拟补肾壮骨方对骨质疏松性椎体压缩骨折(OVCF)PKP术后患者非伤椎椎体再发骨折的预防效果。方法:180例病情稳定的PKP术后患者随机分为常规用药对照组和中药观察组,每组90例;对照组给予口服维D钙咀嚼片,观察组加服中药补肾壮骨方,连续用药12个月。记录1年内非伤椎椎体骨折再发情况;分别于治疗前、治疗6和12个月测定两组患者L1～L4骨密度,采取空腹静脉血测定血清BALP、OPG、BGP含量;并监测用药安全性。结果:1年内补肾壮骨方观察组非伤椎骨折再发2例,对照组再发15例,两组再发率比较差异具有统计学意义(P<0.05);治疗后两组骨密度均有所增加,观察组治疗6、12个月及对照组治疗12个月骨密度检测值均高于治疗前,12个月观察组与对照组比较差异具有统计学意义(P<0.05);血清BALP、OPG、BGP检测结果显示观察组治疗6、12个月及对照组治疗12个月三者水平均高于治疗前,12个月观察组三者水平高于同期对照组水平(P<0.05);用药期间无明显不良反应发生。结论:补肾壮骨方可有效改善骨质疏松,对于OVCF患者PKP术后非伤椎椎体再发骨折具有预防作用。

Objective: To observe the preventive effect of Bushen Zhuanggu Prescription on recurrent fracture of non-traumatic vertebral after PKP on OVCF patients. Methods: 180 Cases after PKP were randomly divided into control group with conventional therapy and observation group with Chinese medicine, each contained 90 cases, control group treated with Calcium Carbonate with Vitamin D Chewable Tablet,observation group was given Bushen Zhuanggu Prescription on the basis of control group,they were treated for 12 months. The recurrent fracture of non-traumatic vertebral was recorded, BMD of L1~L4 was determined,serum BALP, OPG and BGP levels were determined, monitored safety. Results: 2 Cases of observation group got recurrent fracture of non-traumatic vertebral,15 Cases in control group got it, the difference between the recurrent rate of the two group was statistical significance ( P <0.05);BMD and serum BALP,OPG,BGP levels in the two groups were raised after treated, there were statistical significance in observation group after treatment 6 and 12 months to compare with pretherapy ( P <0.05), there were statistical significance in control group after treatment 12 months to compare with pretherapy ( P <0.05);there were significant differences between observation and control groups on above indexes after treatment 12 months( P <0.05);there was no adverse reactions during treatment. Conclusion: Bushen Zhuanggu Prescription can effectively improve osteoporosis,prevent recurrent fracture of non-traumatic vertebral after PKP on OVCF patients.