仙灵骨葆胶囊联合唑来膦酸治疗骨质疏松性椎体压缩性骨折的临床研究

目的探究仙灵骨葆胶囊联合唑来膦酸治疗骨质疏松性椎体压缩性骨折的疗效。方法选取2014年1月—2016年1月天津中医药大学第一附属医院收治的骨质疏松性椎体压缩性骨折行经皮椎体成形术的112例患者,随机分为对照组和治疗组,每组各56例。两组均行经皮椎体成形术,对照组术后第3天静脉滴注唑来膦酸注射液,5 mg/次,1次/年。治疗组患者在对照组的治疗基础上口服仙灵骨葆胶囊,3粒/次,2次/d,3个月为一个疗程,共服用2个疗程。观察两组的临床疗效,同时比较治疗前,治疗3、6个月时腰椎、股骨前端的骨密度、VAS评分和PINP水平的变化情况,比较两组治疗前后椎体后凸Cobb角及其恢复率。结果治疗后,对照组和治疗组的总有效率分别为82.14%、96.43%,两组比较差异有统计学意义(P0.05)。治疗后,两组患者腰椎、股骨前端骨密度均明显提高,VAS评分和PINP水平均明显降低,同组治疗前后差异有统计学意义(P0.05);治疗后,治疗组患者腰椎、股骨前端骨密度高于对照组,治疗组VAS评分和PINP水平低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组椎体后凸Cobb角均较治疗前显著降低,同组治疗前后差异有统计学意义(P0.05);治疗后治疗组椎体后凸Cobb角低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组椎体后凸Cobb角恢复率明显高于对照组,两组比较差异具有统计学意义(P0.05)。结论仙灵骨葆胶囊联合唑来膦酸治疗骨质疏松性压缩性骨折具有较好的临床疗效,可增加患者骨密度,有效减轻患者疼痛感,促进椎体压缩性骨折的愈合,具有一定的临床推广应用价值。

Clinical study on Xianling Gubao Capsule combined with zoledronic acid in treatment of osteoporotic vertebral compression fractures

Objective To investigate the clinical effect of Xianling Gubao Capsule combined with zoledronic acid in treatment of osteoporotic vertebral compression fractures. Methods Patients (112 cases) with osteoporotic vertebral compression fractures in First Teaching Hospital of Tianjin University of TCM from January 2014 to January 2016 were divided into control (56 cases) and treatment (56 cases) groups based on different treatments. Both groups were given vertebral plasty. Patients in the control group were iv administered with Zoledronic acid Injection after surgery for 3 d, 5 mg/time, once a year. Patients in the treatment group were po administered with Xianling Gubao Capsules on the basis of the control group, three grains/time, twice daily. Three months were as one treatment course, and they were treated for two courses. After treatment, the clinical efficacy was evaluated, and bone density of lumbar spine, femoral front-end, VAS score, and PINP levels before treatment, three and six months of treatment in two groups were compared. The vertebral convex Cobb Angle and its recovery rates in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 82.14% and 96.43%, respectively, and there was difference between two groups (P < 0.05). After treatment, bone density of lumbar spine and femoral front-end in two groups were significantly increased, but VAS score and PINP levels were significantly decreased, and the difference was statistically significant in the same group (P < 0.05). After treatment, bone density of lumbar spine and femoral front-end in the treatment group were higher than those in the control group, and VAS score and PINP levels were lower than those in the control group, with significant difference between two groups (P < 0.05). After treatment, the vertebral convex Cobb Angle in two groups significantly decreased, and the difference was statistically significant in the same group (P < 0.05). After treatment, the vertebral convex Cobb Angle in the treatment group was lower than that in the control group, with significant difference between two groups (P < 0.05). After treatment, the recovery rate of vertebral convex Cobb Angle was higher than that in the control group, with significant difference between two groups (P < 0.05). Conclusion Xianling Gubao Capsule combined with zoledronic acid has a obvious clinical effect in treatment of osteoporotic vertebral compression fractures, and it can increase bone density, alleviate pain effectively, also can promote the healing of vertebral compression fractures, which has a certain clinical application value.