密骨胶囊延缓原发性骨质疏松症病人骨量丢失的随机对照研究

Randomized controlled clinical trial for effect of Migu capsule on bone mineral density of primary osteoporotic patients

目的初步评价密骨胶囊对原发性骨质疏松症病人骨密度的影响。方法采用随机、阳性药物平行对照、双盲单模拟、多中心的试验设计,以符合原发性骨质疏松症和肝肾不足证诊断标准者为研究对象。试验组口服密骨胶囊,每次3粒,tid,对照组口服仙灵骨葆胶囊,每次3粒,bid及仙灵骨葆胶囊模拟剂,每次3粒,qd,疗程均为6mo。观察L2～L4、股骨颈、大粗隆和Ward三角部位骨密度值的变化。结果共纳入病人235例,完成225例,其中试验组113例,对照组112例。治疗后,4个部位骨密度试验组均未见降低,对照组与治疗前比较差异亦无显著变化,皆有维持骨量的效果,2组比较无显著差异(P>0.05)。试验组总有效率为97.4%,对照组为98.2%,2组疗效无显著差异(P>0.05)。结论密骨胶囊治疗原发性骨质疏松症,在维持骨密度方面是有效的。

AIM To evaluate the preliminary effect of Chinese herbal medicine, Migu capsule （MGC）,on bone mineral density （BMD） for primary osteoporosis. controlled and double-blinded clinical study was conducted based on the following criteria： （i） the T score was lower METHODS A muhicenter, random, positivein 238 patients enrolled from five clinical centers than -2.0 SD with at least one of the four lumbar vertebraes （L2_L4） , femoral neck, Ward＇s triangle and greater trochanter involved; （ii） with evidently functional deficiencies of kidney and liver. The positive-controlled drug was Xianlinggubao capsule （XLGBC）. Each patient was given 3 capsules tid, with a course of six months. And the criteria for the assessment of treatment were set as： （i） significant, when BMD increment was 2% or more, and （ii） effective, when BMD increment was between 0% and 2%. RESULTS Two hundred and twenty-eight patients out of the original enrolled 235 patients had passed and completed the trial, including 113 patients in trial （MGC） group and 112 patients in control （XLGBC） group. After six months course of treatment in trial group, the BMD of the four interested regions did not significantly decrease and there was no significant difference in BMD before and after the treatment of the four interested regions of control group. The effective average percentages of trial and control group were 97.4% and 98.2%, with no statistically significant difference between the two groups （P 〉 0.05）.CONCLUSION For treatment of primary osteoporosis, the Chinese herbal medicine MGC could effectively maintain BMD.