金天格胶囊治疗绝经后骨质疏松的临床效果及作用机制

Effect of zoledronic acid combined with Jintiange capsule on treatment of postmenopausal osteoporosis

目的探究金天格胶囊治疗绝经后骨质疏松的临床效果及作用机制。方法收集2011年10月至2015年8月在杭州师范大学附属医院骨科治疗且符合标准的133例绝经后骨质疏松（postmenopausalosteoporosis, PMOP ） 患者的临床资料，采用随机数列法将患者分为治疗组、对照组，对照组给口服钙剂和阿仑膦酸钠，治疗组在对照组基础上口服金天格胶囊，3次，d，3粒／次，连续治疗6个月。记录2组治疗前后腰椎、股骨颈、大转子及Ward三角骨密度（bone density, BMD）、膝关节及腰背部视觉模拟评分（visual analoguescore, VAS）、血清骨钙素（bone glaprotein, BGP）、骨源性碱性磷酸酶（alkaline phosphatase, ALP）、β胶原降解产物（β-C-terminal telopeptide of type I collagen, β-CTX）、I型原胶原N端前肽（ N-terminal propeptide of type Iprocollagen, PINP）水平及治疗过程中的并发症。结果治疗组治疗后腰椎、股骨颈、大转子及Ward三角BMD均优于治疗前和对照组（P〈0．05），治疗后腰背部和髋膝关节VAS评分均显著低于对照组患者（P〈0．05）。治疗组治疗后血清BGP、ALP、β—CTX、PINP水平显著低于治疗前和对照组（P〈0．05），2组治疗前后血钙及血磷水平差异无统计学意义（P〉0．05），2组治疗过程中不良反应率差异无统计学意义（P〈0．05）。结论金天格胶囊可降低PMOP患者骨转换水平，提高骨密度，减少骨质丢失，缓解腰背部及关节疼痛，同时并未增加不良反应发生率，值得临床推广。

Objective To explore the effect of Jintiange capsule on treatment of postmenopausal osteo- porosis （PMOP） and its mechanism. Method 133 patients diagnosed as PMOP and meeting the standard were collected from Oct. 2011 to Aug. 2015 in our hospital They were randomly divided into two groups： treatment group and the control group. The control group received calcium and alendronate, while the treatment group re- ceived 3 Jintiange capsules 3 times daily on the basis of the control group. The lumbar bone densit （BMD）, greater trochanter BMD, femoral neck BMD, Ward triangle BMD, visual analogue score （VAS） of knee and back, the serum levels of bone glaprotein（BGP）, alkaline phosphatase （ALP）, β-C-terminal telopeptide of type I colla- gen（β-CTX）, N-terminal propeptide of type I procollagen （PINP） and adverse reactions were recorded before and after treatment. Results The lumbar BMD, greater trochanter BMD, femoral neck BMD, ward triangle BMD of treatment group after treatment were higher than those before treatment and those of the control group （P〈0.05）. VAS score of knee and back of treatment group were lower than those of the control group （P〈0.05）. The serum levels of BGP, ALP, β-CTX, PINP of treatment group were lower than those of the control group （P〈0.05）. The adverse reactions rate of two groups had no significant difference （P〉0.05）. Conclusion Jintiange capsule can significantly reduce bone metabolism level increasing BMD, reducing bone loss, relieving knee and back pain of PMOP, without increasing complication rates, which is worthy to be promoted due to high safety and efficacy.