生骨胶囊联合PVP或PKP治疗原发性老年骨质疏松性胸腰椎骨折临床研究

Clinical Study on Shenggu Capsule Combined with PVP or PKP in Treatment of Primary Osteoporotic Thoracolumbar Vertebral Fracture of Elderly People

目的:观察生骨胶囊联合经皮椎体成形术或椎体(后凸)成形术治疗原发性老年骨质疏松性胸腰椎骨折患者的临床疗效,以及对骨密度、钙磷乘积、骨密度和椎体压缩度变化情况的影响,并观察该疗法的安全性。方法:将90例患者按随机数字表法分成治疗1组、治疗2组和治疗3组,每组30例。治疗1组采取经皮椎体成形术(percutaneous vertebroplasty,PVP)或经皮椎体后凸成形术(percutaneous kyphoplasty,PKP)联合口服生骨胶囊进行治疗;治疗2组采用PVP或PKP联合口服阿法骨化醇胶丸进行治疗;治疗3组只采用PVP或PKP术进行治疗。手术后观察患者的临床疗效、视觉模拟评分法(visual analoyue scale,VAS)评分、钙磷乘积值、椎体压缩度和骨密度情况。结果:手术后6个月治疗1组患者临床疗效以及VAS评分、骨密度和椎体压缩度指标与治疗2组比较,差异无统计学意义(P> 0. 05)、但治疗1组与治疗2组均优于治疗3组,差异有统计学意义(P <0. 05)。经手术后8周治疗,治疗1组和治疗2组均能改善患者血清钙磷乘积,差异均有统计学意义(P <0. 05),且治疗2组改善钙磷乘积的疗效优于治疗1组和治疗3组,差异有统计学意义(P <0. 05),但治疗2组引起高钙血症的不良反应高于治疗1组和治疗3组,差异有统计学意义(P <0. 05)。结论:生骨胶囊与阿法骨化醇胶丸均能提高原发性老年骨质疏松性胸腰椎压缩骨折PVP或PKP术后的临床疗效,改善远期骨密度和疼痛症状,并对维持骨折椎体PVP或PKP术后的压缩程度有辅助作用。可见,两者疗效相当。生骨胶囊对改善钙磷乘积的作用不如阿法骨化醇胶丸明显,但生骨胶囊引起高钙血症的不良反应更低。

Objective：To observe the clinical efficacy of Shenggu Capsule combined with percutaneous vertebroplasty or kyphoplasty in treatment of primary osteoporotic thoracolumbar fractures of elderly people, as well as the effect on bone mineral density, calcium phosphate and vertebral compression. The safety of the therapy was also observed. Methods ： Ninety patients were randomly divided into treatment 1 group, treatment 2 group and treatment 3 group ,with 30 patients in each group. The treatment group 1 was treated with percutaneous vertebroplasty （PVP） or percutaneous kyphoplasty （PKP） combined with oral Shenggu capsule;treatment group 2 was treated with PVP or PKP combined with oral AFA Alkali alcohol capsules ;patients in the third group were treated with PVP or PKP alone. The clinical efficacy, VAS score, calcium-phosphorus product value, vertebral body compression, and bone mineral density were observed after surgery. Results：After treatment, there was no significant difference in clinical efficacy and pain, bone mineral density and vertebral body compression index between the treatment group 1 and the treatment 2 group （ P 〉 0.05 ）, but that of the group 1 and group 2 was superior to that of the treatment group 3. The difference was statistically significant （ P 〈 0. 05）. After treatment, the serum calcium and phosphorus product of both treatment group 1 and treatment group 2 were improved, and the difference was statistically significant（ P 〈 0.05 ）. The therapeutic effect of the calcium and phosphorus product of the treatment group 2 was better than that of treatment group 1, and the difference was statistical（ P 〈 0.05 ）, but the adverse reaction levels that caused by hypercalcemia in group 2 were higher than those in the treatment group 1 and the treatment group 3. The difference was statistically significant （ P 〈 0.05 ）. Conclusion ： Both Shenggu capsule and Alfacalcitol capsules can improve the clinical efficacy of primary senile osteoporotic thoracolumbar compression fractures after PVP or PKP, improve long-term bone density and pain symptoms, and maintain fractures. The compression of the vertebral body PVP or PKP has an auxiliary effect. Obviously, the two are quite effective. The effect of Shenggu Capsule on improving calcium-phosphorus product was not as good as that of Alfacalciferol capsules, but adverse effects of Shenggu Capsule on hypercalcaemia were lower.