密骨胶囊对原发性骨质疏松症患者中医证候疗效的随机对照研究

Random controlled clinical trial on effect of Migu Capsule in improving TCM syndrome of osteoporotic patients

目的:初步评价密骨胶囊治疗原发性骨质疏松症的中医证候疗效。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,3粒/次、3次/d,对照组口服仙灵骨葆胶囊,3粒/次、2次/d,以及仙灵骨葆胶囊模拟剂,3粒/次、1次/d,疗程6个月;以肝肾不足证侯总积分和单项症状积分为疗效指标,分别评价积分值的变化和疗效。结果:密骨胶囊组中医证候总积分逐渐下降,第1个月末证候总积分与治疗前的差异具统计学意义(P<0.05)。仙灵骨葆组从第2个月末开始与治疗前比较差异具统计学意义(P<0.05)。密骨胶囊组中医证候积分总有效率为89.57%、控显率为42.61%,仙灵骨葆组分别为92.04%、40.71%,两组差异无统计学意义。治疗终点第6个月末时,两组缓解各单项症状的有效率无统计学差异。结论:密骨胶囊可明显缓解原发性骨质疏松症肝肾不足证的临床证候。

Objective： To evaluate the effect of Chinese herbal medicine, Migu Capsule （MGC）, in improving the scale of kidney deficiency syndrome of osteoporotic patients. Methods： A multicenter, random, positive-controlled and double-blinded clinical study was conducted, osteoporotic patients with the deficiency of kidney and liver syndrome were enrolled in this study. The positive-controlled drug was Xianling Gubao Capsule （XLGBC）. Each patient was given three capsules every time with three times every day. After six months treatment, the changes of the total scale of the syndrome and the scale of each symptom were evaluated. Results： During six months treatment, the scale of the MGC group slowly decreased, and there were significant differences of the total scale as well as the symptom of strength, especially after one month treatment（P〈0.05）. However, the scale change of XLGBC group was observed after two months treatment. The effective average percentages of MGC and positive- controlled group were 89.57% and 92.04% respectively, and the curative rate of MGC and XLGB group was 42.61% and 40.71%. There was no significant difference between the two groups（P〉0.05）. Conclusion： The Chinese herbal medicine MGC could improve the symptom of the osteoporotic patients especially in increasing muscle strength, relieving body pain and dizziness.