骨健口服液治疗原发性骨质疏松症的临床疗效分析  

Analysis of clinical efficacy of Gujian Oral Liquid in treatment of primary osteoporosis

作　　者：汪小健 王瑞 顾勇 王彭禾 应俊 金红婷[3] 吕帅洁[3] 童培建[3] WANG Xiao-jian;WANG Rui;GU Yong;WANG Peng-he;YING Jun;JIN Hong-ting;LU Shuai-jie;TONG Pei-jian(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China;Zhejiang Chinese Medical University,Hangzhou,310053,China;First Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310006,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]浙江中医药大学,浙江杭州310053 [3]浙江中医药大学附属第一医院,浙江杭州310006

出　　处：《时珍国医国药》2022年第10期2424-2427,共4页Lishizhen Medicine and Materia Medica Research

基　　金：国家自然科学基金(81873324,81873325);浙江省中管局科技项目(2021ZZ014)。

摘　　要：目的观察骨健口服液治疗原发性骨质疏松症的临床疗效及安全性,探讨其应用前景。方法纳入2018年1月至2020年12月在我院治疗且符合标准的120例原发性骨质疏松症患者,采用随机数列法将其分为观察组和对照组,每组各60例。观察组给予口服骨健口服液和阿仑膦酸钠片及碳酸钙D3片治疗,对照组给予口服金天格胶囊和阿仑膦酸钠片及碳酸钙D3片治疗,连续服用6个月后观察并分析各组临床症状、骨密度(bone mineral density,BMD)、骨代谢生化指标、视觉模拟评分(Visual Analogue Score,VAS)及Oswestry功能障碍指数(Oswestry Disability Index,ODI)的改善情况与治疗过程中出现的不良反应。结果共纳入115例患者,其中观察组57例,对照组58例。①观察组总有效率为89.4%,与对照组(86.2%)相比,差异无统计学意义(P>0.05);②两种治疗方法均能有效提升患者腰椎、股骨颈、大转子及Ward三角等部位的BMD,但观察组的效果更佳;两组BMD差异具有统计学意义(P<0.05);③2组治疗后骨转换指标均较治疗前有所改善(P<0.05);且观察组治疗后骨形成标志物——Ⅰ型原胶原N端前肽和骨吸收标志物——胶原特殊序列,两指标水平与对照组相比,差异均具有统计学意义(P<0.05);④治疗后VAS及ODI均较前明显好转,两组差异无统计学意义(P>0.05);⑤2组治疗过程中不良反应率差异无统计学意义(P>0.05)。结论骨健口服液和金天格胶囊联合基础西药均可提升患者BMD值,降低骨转换水平,缓解疼痛,减轻功能障碍;但前者效果更佳,且未增加不良反应率。Objective To observe the clinical efficacy and safety of Gujian Oral Liquid in treatment of primary osteoporosis,and to explore its application prospects.Methods A total of 120 patients with primary osteoporosis who were treated in our hospital from January 2018 to December 2020 and met the criteria were enrolled.Random numbers were used to divide them into observation group and control group,with 60 cases in each group.The observation group was given oral Gujian Oral Liquid and alendronate sodium tablets and calcium carbonate D3 tablets,and the control group was given oral Jintiange Capsules,alendronate sodium tablets and calcium carbonate D3 tablets.After 6 months of continuous application,it was recorded and analyzed that the improvement of clinical symptoms,bone mineral density(BMD),bone metabolism biochemical indicators,Visual Analogue Score(VAS)and Oswestry Disability Index(ODI)in each group,and adverse reactions that occurred during the treatment.Results A total of 115 patients were enrolled,including 57 cases in the observation group and 58 cases in the control group.①The total effective rate of the observation group was 89.4%.Compared with the control group(86.2%),the difference was not statistically significant(P>0.05).②Both treatment methods can effectively improve the BMD of lumbar spine,femoral neck,the greater trochanter and Ward’s triangle,but the observation group had better results.However,the difference in BMD between the two groups was statistically significant(P<0.05).③The bone turnover indexes of the two groups after treatment were improved compared with before treatment(P<0.05).In addition,compared with the control group,the bone formation markers type Ⅰ procollagen-N-terminal propeptide and bone resorption markers--heterogeneous C-terminal peptide levels had statistically significant(P<0.05).④VAS and ODI improved significantly after treatment,and the difference between the two groups was not statistically significant(P>0.05).⑤There was no significant difference in the adverse

关 键 词：骨质疏松症 骨健口服液 骨密度 临床观察 

分 类 号：R589.5[医药卫生—内分泌]