补肾壮骨汤联合阿托伐他汀治疗糖尿病性骨质疏松症临床研究

Clinical Study on Bushen Zhuanggu Decoction Combined with Atorvastatin in Treatment of Diabetic Osteoporosis

目的:观察补肾壮骨汤联合阿托伐他汀治疗糖尿病性骨质疏松症的临床疗效。方法:180例糖尿病性骨质疏松症患者按抽签方式随机平均分为对照组和观察组。对照组给予阿托伐他汀治疗,观察组在对照组治疗基础上给予补肾壮骨汤。比较治疗前后两组的骨密度、中医证候积分、Ⅰ型原胶原N端前肽(procollagen I N-terminal peptide,PINP)、胰岛素样生长因子(insulin like growth factor,IGF-1)、视觉模拟评分(visual analogue scale,VAS)法评分、简化Mc Gill疼痛问卷(SFMPQ)评分、血清钙、血清磷、血清碱性磷酸酶(alkaline phosphatase,ALP)的变化情况及临床疗效。结果:与治疗前比较,治疗后两组的中医证候积分、PINP水平、VAS、SF-MPQ评分、ALP水平均明显下降,而骨密度水平、IGF-1水平均明显上升,差异具有统计学意义(P<0.05);治疗后,观察组的中医证候积分、PINP水平、VAS、SF-MPQ评分、ALP水平均明显低于对照组,而骨密度水平、IGF-1水平均明显高于对照组,差异具有统计学意义(P<0.05);治疗前后,两组患者血清钙、血清磷水平均处于正常水平,组间、组内相比,差异无统计学意义(P>0.05);观察组的临床疗效明显优于对照组,差异具有统计学意义(P<0.05)。结论:补肾壮骨汤联合阿托伐他汀治疗糖尿病性骨质疏松症临床疗效显著,可提高骨密度,缓解临床症状,减轻疼痛感。

Objective To investigate the clinical efficacy of Bushen Zhuanggu decoction combined with atorvastatin in treatment of diabetic osteoporosis（ DOP）. Methods 180 cases were randomly divided into atorvastatin group（ n = 90） and decoction association group（ n = 90） by drawing lots. Atorvastatin group was given atorvastatin and decoction association group was given Bushen Zhuanggu decoction combined with atorvastatin. The changes of BMD,TCM score,PINP,IGF-1,VAS score,SF-MPQ score,S-Ca,S-P,ALP and clinical efficacy in the two groups before and after treatment were compared. Results Compared with pre-treatment,TCM score,SF-MPQ score,levels of PINP and ALP of two groups after treatment significantly decreased,while levels of BMD and IGF-1 significantly increased（ P〈0. 05）; After treatment,the scores of TCM,VAS,SF-MPQ and the levels PINP and ALP in decoction association group were significantly lower than those in atorvastatin group,while the levels of BMD and IGF-1 were signifi-cantly higher than atorvastatin group（ P〈0. 05）; Before and after treatment,the levels of S-Ca and S-P of two groups remained at a normal level. There was no statistical difference between groups and within the group（ P〉0. 05）; Clinical efficacy of decoction association group was significantly better than that of atorvastatin group（ P〈0. 05）. Conclusion Bushen Zhuanggu decoction combined with atorvastatin treatment of DOP patients can significantly improve bone mineral density,relieve clinical symptoms and reduce pain,which has clear clinical advantages and is worthy of generalization.