基于中医学“治未病”理论研究密骨颗粒治疗骨量减少的多中心临床试验

A Pragmatic Multi-Centered Randomized Controlled Trial: Intervention of Osteopenia with the Use of Migu Granule Based on the Theory of “Preventive Treatment of Disease” in Chinese Medicine

目的探讨密骨颗粒治疗骨量减少的有效性及临床应用的安全性。方法采用实用性随机对照方法,将6家分中心分为试验组和对照组,试验组给予密骨颗粒,对照组给予钙尔奇D,疗程为12个月,治疗前、治疗后6、12月时行骨代谢、骨密度、血常规、肝肾功能等检查,并记录VAS与SF-36评分,观察患者的不良反应。结果①两组患者腰椎BMD值治疗前后无变化;试验组髋部BMD在治疗12月时优于对照组(P <0.05)。②两组患者骨代谢比较,PTH、β-CTX、BGP、S-Ca与治疗前比较均有上升(P <0.05),组间比较差异无统计学意义(P> 0.05);25-羟维生素D(25-Hydroxyvitamin D,25-OH-D)治疗6、12月均有下降(P <0.05);PINP试验组无变化,对照组在治疗后6、12月均有下降(P <0.05);ALP两组治疗前后均无变化(P>0.05);试验组S-P在治疗后12月时升高(P <0.05),对照组无明显变化(P> 0.05)。③两组患者治疗后6、9、12月腰痛VAS评分均下降(P <0.05),组间比较差异均无统计学意义(P> 0.05)。试验组在治疗9、12月后患者的SF-36PCS及MCS功能评分高于对照组,差异有统计学意义(P <0.05);④两组均未出现严重不良反应。结论密骨颗粒可以增加髋骨骨量,减少骨量丢失,降低患者躯体疼痛,提高患者的生活质量,并且有较好的安全性。

Objective To evaluate the effectiveness and side-effect of treatment with Migu Granules for treatment of osteopenia. Methods The 6 clinical centers were divided into a treatment group(n=118) and a control group(n=73). The patients in the treatment group were treated with Migu Granule. Calcium D 600 was used in the control group. Patients received intervention for 6-months, and follow-up were conducted every 3 months and changes in VAS, SF-36 were recorded. Tests for changes in Bone Mass Density(BMD), bone metabolism indicators, blood routine test, liver and kidney function were carried out on the 6 th,12 thmonth into intervention. Results ①There was no change in lumbar spine BMD before and after treatment in the 2 groups. The hip BMD in the treatment group was higher than that in the control group at 12 months after treatment(P < 0.05). ② PTH, beta-CTX, BGP and S-Ca in the 2 groups increased in 6 months and 12 months after treatment(P < 0.05), but there was no significant difference between the 2 groups at different time points(P > 0.05);25-hydroxyvitamin D decreased in 6 months and 12 months after treatment(P < 0.05);PINP in the treatment group was not significantly changed, while that in the control group was significantly decreased in 6 months and 12 months after treatment(P < 0.05);ALP in the 2 groups had no change before and after treatment(P > 0.05);S-P in the treatment group increased in 12 months after treatment(P < 0.05), while that in the control group had no significant change(P > 0.05). ③The VAS scores of lumbar back pain in the 2 groups decreased after treatment in 6, 9 and 12 months(P < 0.05), but there was no significant difference between the 2 groups at different time points(P >0.05). SF-36 PCS and MCS in the treatment group were higher than those in the control group after 9 and 12 months treatment(P < 0.05). ④No serious adverse reactions occurred in the 2 groups. Conclusion Migu Granule can prevent the loss of bone mass in patients with osteopenia, improve physical pain and improve the quality of life, and has better safety.