地仲强骨胶囊治疗肾虚兼气血不足型骨质疏松症的疗效及对骨代谢、骨转化的影响

目的:观察地仲强骨胶囊治疗肾虚兼气血不足型骨质疏松症的临床疗效和生活质量,探讨其对骨代谢、骨转化指标的影响。方法:将120例符合肾虚兼气血不足型骨质疏松症患者随机分为对照组和观察组,每组各60例,两组均给予常规基础治疗,对照组患者在基础治疗上给予阿仑膦酸钠片,观察组在基础治疗上给予地仲强骨胶囊,治疗6个月。检测两组患者治疗前后的骨密度、骨代谢指标、骨转化指标、疗效、目测模拟疼痛(visual analogue scale,VAS)指数,健康状态评分,并记录不良反应情况。结果:与本组治疗前相比,观察组和对照组患者腰椎L2-4,股骨颈(Neck),三角(Ward)三处骨密度指标均明显增加(P0.05),骨代谢指标血清骨碱性磷酸酶(bone alkaline phosphatase,BALP),雌二醇(estradiol,E2)和降钙素(calcitonin,CT)均明显提高(P0.05),骨转化指标骨钙素(bone gla protein,BGP)上升,Ⅰ型胶原交联C-末端肽(typeⅠcollagen Ctelopeptide,CTX-1)下降(P0.05),VAS疼痛指数下降、健康状态也很大改善(P0.05);治疗后与对照组相比,观察组可以明显增加腰椎L2-4骨密度,提高BALP,CT,E2指标水平,促使骨转化指标BGP水平上升,CTX-1水平下降,减少VAS疼痛指数,这些指标均具有统计学差异(P0.05),且临床总有效率也明显高于对照组,不良反应相对较少。结论:地仲强骨胶囊治疗骨质疏松症的疗效明显,能有效增加患者的骨密度,改善骨代谢及骨转换状态,其机制与该复方多成分、多靶向直接或间接作用于成骨细胞与破骨细胞,而降低骨转化和抑制骨吸收起作用有关。

Efficacy of Dizhong Qianggu Capsule in Treatment of Kidney and Blood Deficiency Type Postmenopausal Osteoporosis and Its Effect on Markers of Bone Metabolism and Bone Turnover

Objective: To observe the clinical efficacy of Dizhong Qianggu capsule in the treatment of kidney and blood deficiency type postmenopausal osteoporosis and on the living quality, in order to explore its effect on the markers of bone metabolism and bone turnover. Method: Totally 120 patients in line with the diagnostic criteria for the kidney and blood deficiency type postmenopausal osteoporosis were randomly divided into two groups. The two groups were given the conventional basic therapy. The control group received alendronate sodium tablets in addition to the conventional basic therapy, while the observation group received Dizhong Qianggu capsule and alendronate sodium tablets in addition to the conventional basic therapy. After 6 months, bone mineral density (BMD), bone metabolism indexes, bone transformation index, clinical efficacy, visual analogue scale (VAS) pain index and health status were scores. And the adverse reactions were recorded. Result: Compared with before treatment, L_2-4, neck and Ward BMD indexes significantly increased (P<0.05), index of bone transformation significantly elevated (P<0.05), bone transformation index bone gla protein (BGP) increased, whereas type I collagen C-telopeptide (CTX-1) decreased (P<0.05), VAS pain index descended, health status improved greatly in the control group and the observation group, with significant differences between them (P<0.05). Compared with control group, the observation group showed the increase in bone density of lumbar L_2-4, bone metabolism indexes bone alkaline phosphatase (BALP), calcitonin (CT), estradiol (E₂), bone metabolism BALP, CT, E₂ index level and bone transformation index BGP level, and the reduction in CTX-1 level and VAS pain index, with significant differences in these indicators (P<0.05). The total effective rate of the observation group was also significantly higher than that of control group. And there were a few adverse reactions. Conclusion: Dizhong Qianggu capsule has a significant efficacy in the treatment of osteoporosis, and can effectively increase BMD of the patients, and improve bone metabolism and bone turnover status. Its possible anti-osteoporosis mechanism may be correlated with the decrease of bone turnover and the inhibition of bone resorption by directly or indirectly acting on osteoblasts and osteoclasts in a multicomponent and multi-target manner.