密骨颗粒干预中老年骨量减少临床研究

Clinical Study of Migu Granule on Middle-aged and Elderly Patients with Osteopenia

目的:探讨密骨颗粒干预对中老年骨量减少的临床疗效。方法:采用多中心随机对照研究,将入选的骨质疏松患者随机分为两组。治疗组给予密骨颗粒,对照组采用钙尔奇D,均干预并随访1年,比较两组患者干预前与干预后3个月、6个月、9个月、12个月的生理功能(PCS)、心理功能(MCS)评分,以及干预前与干预6个月、干预12个月的腰椎及髋部骨密度(BMD)、T值;结果:对照组患者的PCS评分在治疗后9个月、12个月与治疗前比较明显提高(P<0.01,P<0.001);治疗组患者的PCS评分在治疗后6个月、9个月、12个月与治疗前比较明显提高(P<0.01,P<0.001,P<0.001);两组间比较,在治疗9个月、12个月后PCS改变量治疗组优于对照组(P=0.03,P=0.02)。对照组患者的MCS评分在治疗后9个月、12个月与治疗前比较明显提高(均P<0.01);治疗组患者的MCS评分在治疗后6个月、9个月、12个月与治疗前比较明显提高(均P<0.001);两组间比较治疗组明显优于对照组(P=0.00,P=0.00,P=0.02)。腰椎BMD在治疗前与治疗6个月后、12个月后,治疗前后各自组内比较、两组之间比较,差异均无统计学意义(P> 0.05)。患者髋部BMD在治疗前与治疗6个月后、12个月后,治疗组内前后比较差异无统计学意义(P> 0.05),对照组治疗前后差异有统计学意义(P<0.05),两组之间比较治疗后差异均无统计学意义(P> 0.05)。结论:密骨颗粒和钙尔奇D两药均有延缓骨量减少的作用,但密骨颗粒在改善患者生活质量方面更具优势,可作为钙尔奇D有效的替代药。

Objective:To explore the clinical curative effect of Migu Granule on middle-aged and elderly patients with osteopenia. Methods:In the multi-center randomized controlled study,patients with osteoporosis were randomly divided into two groups.The treatment group was given Migu Granule (密骨颗粒),and the control group was given Calci D,both of which were intervened and followed up for 1 year. The PCS and MCS scores of the two groups before the intervention,3 months,6 months,9 months and 12 months after treatment,and the lumbar and hip BMD and T value of the two groups before the intervention,6 months and 12 months after treatment were compared. Results:The PCS scores of the physiological function of the control group 9 and12 months after treatment were significantly improved compared with those before treatment(P<0.01,P<0.001). The PCS scores of the treatment group 6 months,9 months,and 12 months after treatment were significantly higher than those before treatment(P<0.01,P<0.001,P<0.001). Comparing the two groups,the changes of PCS scores in the treatment group were better than those in the control group after 9 months and 12 months of treatment(P= 0.03,P= 0.02). The MCS scores of the control group 9 and 12 months after treatment were significantly improved compared with those before treatment(all P<0.01). The MCS scores of the treatment group 6 months,9 months,and 12 months after treatment were significantly improved compared with those before treatment(all P<0.001). Comparing the two groups,the changes of MCS scores in the treatment group were better than those in the control group(P= 0.00,P= 0.00,P= 0.02). There were no statistically significant differences of lumbar BMD between before treatment and 6 months and 12 months after treatment in the treatment group and the control group,and there was no significant difference between the two groups(P> 0.05). The hip BMD before the intervention,6 months and 12 months after intervention in the treatment group were not statistically from each other(P> 0.05). The differences in the control group between before the intervention and after the intervention was statistically significant(P<0.05). There was no statistically significant difference between the two groups(P> 0.05). Conclusions:Both Migu Granule and Calci D have the effect of delaying osteopenia,but Migu Granule is more advantageous in improving the life quality of patients and may be a clinically effective alternative to Calci D.