目的 探讨健腰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，试验组给予健腰密骨颗粒，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）；25OHD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 健腰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 Jianyao 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 Jianyao 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 6th,12th month 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 Jianyao 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.