骨萎汤配方颗粒治疗绝经后骨质疏松症(肾阳虚证)的临床观察  

Clinical observation on treating postmenopausal osteoporosis(the Shenyangxu syndrome)with the Guwei decoction granule

作　　者：张冰彬 董克芳[2] Zhang Bingbin

机构地区：[1]湖南中医药大学,湖南长沙410208 [2]湖南中医药大学第二附属医院,湖南长沙410005

出　　处：《中医临床研究》2020年第13期5-12,共8页Clinical Journal Of Chinese Medicine

基　　金：湖南省自然科学基金:科卫联合项目(2018JJ6113)。

摘　　要：目的:观察骨萎汤配方颗粒治疗绝经后骨质疏松症(Postmenopausal Osteoporosis,PMOP)肾阳虚证患者的临床疗效。方法:选取2017年12月-2018年12月湖南中医药大学第二附属医院符合纳入标准的PMOP患者60例,将其随机分为治疗组和对照组,每组30例。对照组服用仙灵骨葆胶囊,治疗组服用骨萎汤配方颗粒。临床观察3个月,疗程结束后对骨密度(Bone Mineral Density,BMD)、骨钙素(Bone Glaprotein,BGP),尿脱氧吡啶啉(U-DPD),疼痛视觉模拟评分(Visual Analogue Scale,VAS)及中医证候积分和临床疗效进行统计分析比较。结果:治疗后,两组三大常规,肝、肾功能和心电图等安全性指标与治疗前在每个疗程后比较无明显变化。两组间治疗前后股骨颈BMD比较无显著差异(P>0.05);组内治疗前后比较股骨颈BMD比较无显著差异(P>0.05)。两组间治疗前后BGP比较有显著差异(P<0.05),治疗组优于对照组;U-DPD比较无显著差异(P>0.05);治疗组组内治疗前后BGP及U-DPD比较差异有统计学意义(P<0.05),对照组组内治疗前后U-DPD比较差异有统计学意义(P<0.05),BGP比较无显著差异(P>0.05)。两组间治疗后及组内治疗前后VAS和中医证候评分比较有显著差异(P<0.05),治疗组优于对照组。两组间治疗后疗效比较有显著差异(P<0.05),治疗组优于对照组。结论:骨萎汤配方颗粒临床应用无明显不良反应,安全性高。骨萎汤配方颗粒对改善肾阳虚型PMOP患者疼痛、腰背酸软乏力、畏寒喜暖、及小便频多等症状有较好的治疗效果。骨萎汤配方颗粒可改善PMOP患者异常的骨代谢指标变化,有待进一步临床实验证明。Objective:To observe the clinical study of the Guwei decoction granule(骨萎汤颗粒)on postmenopausal osteoporosis with the Shenyangxu syndrome(肾阳虚证).Methods:60 patients were divided into the treatment group and control group,30 patients in each group.The control group was given the Xianling Gubao capsule(仙灵骨葆胶囊).The treatment group was treated with the Guwei decoction granules.Results:After treatment,there was no significant changes in liver,renal function,electrocardiogram and other safety indicators between the two groups after each course of treatment.The two groups of treatment is safe and reliable to human body,without obvious toxic and side effects.There was no difference in femoral neck BMD in two groups between before and after treatment(P﹥0.05).There was no difference in femoral neck BMD between two groups(P﹥0.05).There were significant differences in BGP before and after treatment between the two groups(P﹤0.05),but no differences in U-DPD(P﹥0.05).BGP and U-DPD were significantly different between before and after treatment in the treatment group(P﹤0.05),and U-DPD and BGP were significantly different in the control group between before and after treatment(P﹤0.05).There were significant differences in VAS and TCM syndrome scores between and two groups and before and after treatment(P﹤0.05).There were significant differences between the two groups after treatment(P﹤0.05).Conclusion:The Guwei decoction granules shows no obvious toxic and side effects,and the safety is high.The Guwei decoction granule shows a good therapeutic effect on the symptoms of postmenopausal osteoporosis with Shenyangxu syndrome.The Guwei decoction granule can improve abnormal changes of bone metabolism indexes,it may inhibit bone destruction and osteoclast activity,and further clinical trials are needed.

关 键 词：配方颗粒 绝经后骨质疏松症 骨密度 骨钙素 尿脱氧吡啶啉 

分 类 号：R322.71[医药卫生—人体解剖和组织胚胎学]