青娥丸方防治骨质疏松性椎体压缩性骨折行球囊扩张椎体后凸成形术后椎体高度再丢失临床研究

Clinical Study on Qing’e Wan Prescription for Prevention and Treatment of Recurrent Vertebral Height Loss After Percutaneous Kyphoplasty of Osteoporotic Vertebral Compression Fracture

目的:观察青娥丸方防治球囊扩张椎体后凸成形术(PKP)术后椎体高度再丢失的临床疗效并分析其作用机制。方法:选取80例因骨质疏松性椎体压缩性骨折住院行PKP患者,随机分为对照组与治疗组各40例。对照组术后予常规抗骨质疏松药物阿仑膦酸钠片及钙尔奇-D口服,治疗组在对照组基础上口服青娥丸方。比较2组治疗前后骨密度(BMD)水平、椎体高度再丢失比,并比较2组临床疗效。结果:治疗前,2组BMD T值比较,差异无统计学意义(P>0.05);治疗后,2组BMD T值均升高(P<0.05),且治疗组高于对照组(P<0.05)。治疗前、术后当天以及术后1个月、术后6个月2组椎体高度丢失比比较,差异均无统计学意义(P>0.05)。治疗后,治疗组总有效率71.4%,高于对照组39.4%(P<0.05);2组椎体高度恢复比比较,差异无统计学意义(P>0.05)。术后1个月,2组椎体高度再丢失比比较,差异无统计学意义(P>0.05);术后6个月,治疗组椎体高度再丢失比小于对照组(P<0.05)。结论:骨质疏松性椎体压缩性骨折患者行PKP术后,在口服阿仑膦酸钠片和钙尔奇D的基础上应用青娥丸方,可有效预防椎体高度再丢失,并提高BMD水平。

Objective: To observe the clinical effect of Qing’e Wan Prescription on prevention and treatment of recurrent vertebral height loss after percutaneous kyphoplasty(PKP) and to analyze its action mechanism. Methods:A total of 80 cases of hospitalized patients with osteoporotic vertebral compression fracture undergoing PKP were selected and randomly divided into the control group and the treatment group,with 40 cases in each group. After surgery,the control group was given the oral administration of routine anti-osteoporosis drugs like Alendronate Sodium Tablets and Caltrate-D,and the treatment group was additionally given the oral administration of Qing’e Wan Prescription based on the treatment of the control group. The levels of bone mineral density(BMD) and the recurrence rates of vertebral height loss before and after treatment were compared between the two groups;the clinical effects were compared between the two groups. Results:Before treatment,there was no significant difference being found in the comparison of T values of BMD between the two groups(P>0.05). After treatment,T values of BMD in the two groups were increased(P<0.05),and the value in the treatment group was higher than that in the control group(P<0.05). Before treatment,on the day of surgery,in one month after surgery and in six months after surgery,there was no significant difference being found in the comparison of the recurrence rates of vertebral height loss between the two groups(P>0.05). After treatment,the total effective rate was 71.4% in the treatment group,higher than that of 39.4% in the control group(P<0.05). There was no significant difference being found in the comparison of the recovery rates of vertebral height between the two groups(P>0.05). In one month after surgery,there was no significant difference being found in the comparison of the recurrence rates of vertebral height loss between the two groups(P>0.05). In six months after surgery,the recurrence rate of vertebral height loss in the treatment group was lower than that in the control group(P<0.05). Conclusion:Based on the oral administration of Alendronate Sodium Tablets and Caltrate-D,the additional application of Qing’e Wan Prescription for patients with osteoporotic vertebral compression fracture after PKP can effectively prevent the recurrence of vertebral height loss and improve BMD levels.