六味地黄丸联合密固达对骨质疏松症的临床疗效及生活质量的影响  

Clinical Efficacy of Liuwei Dihuangwan Combined with Aclasta on Osteoporosis and Effect on Quality of Life

作　　者：杨旭[1] 王花欣[1] 张倩[1] 张国强[1] 崔凯莹 刘国岩[1,2] YANG Xu;WANG Huaxin;ZHANG Qian;ZHANG Guoqiang;CUI Kaiying;LIU Guoyan(Shandong University of Traditional Chinese Medicine(TCM),Jinan 250355,China;The Affiliated Hospital of Shandong University of TCM,Jinan 250000,China)

机构地区：[1]山东中医药大学,济南250355 [2]山东中医药大学附属医院,济南250000

出　　处：《中国实验方剂学杂志》2022年第14期115-120,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金青年科学基金项目(82004087);山东中医药大学青年创新团队项目(2020-54-19)。

摘　　要：目的:探索六味地黄丸联合密固达治疗骨质疏松症的疗效及对患者生活质量评分的影响。方法:选择山东中医药大学附属医院2019年9月至2020年9月收治的126例骨质疏松症患者作为研究对象,依照随机双盲法分为观察组和对照组,观察组60例,男性26例,女性34例,年龄59~85岁,平均(72.0±6.5)岁;对照组66例,男性31例,女性35例,年龄62~82岁,平均(73.0±8.2)岁。对照组给予密固达治疗,观察组给予密固达联合六味地黄丸治疗,用药后对所有患者进行有效率评价。在用药前后测定两组患者的骨密度(BMD),同时检测血清学指标钙(Ca)、总25(OH)维生素D3(VITD-T)、骨钙素(OC)、血清碱性磷酸酶(ALP)、甲状旁腺素(PTH)、β-胶原特殊序列(β-CTX)和总Ⅰ型胶原氨基延长肽(T-P1NP),并进行视觉模拟评分(VAS)、日本骨科学会评分(JOA)、Oswestry功能障碍评分(ODI),比较两组用药效果。结果:用药前两组患者各指标差异无统计学意义,经6个月治疗后,与本组治疗前比较,两组患者VAS评分、ODI评分显著降低(P<0.01),JOA评分显著升高(P<0.01);腰椎、髋关节BMD、Ca、VITD-T、OC、ALP、PTH水平均明显升高(P<0.05,P<0.01),β-CTX显著下降(P<0.01),观察组患者T-P1NP水平显著下降(P<0.01)。与对照组治疗后比较,观察组的总有效率为88.3%(53/60),明显高于对照组的74.2%(49/66),差异具有统计学意义(χ^(2)=4.047,P<0.05);观察组BMD、Ca、VITD-T、OC、PTH水平均明显升高(P<0.05),T-P1NP均明显降低(P<0.05);观察组VAS评分显著降低(P<0.01);JOA评分明显升高(P<0.05);ODI评分差异无统计学意义。结论:密固达联合六味地黄丸治疗骨质疏松症疗效较为突出,并且未增加不良反应的发生率,同时能减轻患者疼痛,提高生活质量。Objective: To study the efficacy of Aclasta combined with Liuwei Dihuangwan on osteoporosis and the effect on quality of life. Method:A total of 126 patients with osteoporosis who were treated in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2019 to September 2020 were classified into the observation group and the control group with the randomized doubleblind method. The observation group consisted of 60 patients(26 males and 34 females)with the age of 59-85years old [mean:(72.0 ± 6.5)years old]. The control group was composed of 66 patients(31 males and35 females),with the age of 62-82 years old[mean:(73.0±8.2)years old]. The control group was treated with Aclasta,and the observation group Aclasta combined with Liuwei Dihuangwan. After treatment,the effective rate of each group was calculated. Bone mineral density(BMD)was measured in both groups before and after treatment,and serological parameters calcium(Ca),total 25(OH)vitamin D3(VITD-T),osteocalcin(OC),serum alkaline phosphatase(ALP),parathyroid hormone(PTH),β-collagen special sequence(β-CTX),and total procollagen 1 N-terminal propeptide(T-P1NP)were also measured. Visual Analogue Scale(VAS)score,Japanese Orthopaedic Association(JOA)score,and Oswestry Disability Index(ODI)score were evaluated. On this basis,the effect was compared between the two groups. Result: The indexes were insignificantly different between the two groups before treatment. After 6 months of treatment,the two groups showed decrease in VAS score and ODI score(P<0.01),increase in JOA score(P<0.01),BMD of lumbar spine and hip joint,elevation of Ca,VITD-T,OC,ALP,and PTH(P<0.05,P<0.01),and decrease of β-CTX(P<0.01)as compared with before treatment. The level of T-P1NP dropped in the observation group after treatment(P<0.01). After treatment,the total effective rate of the observation group was 88.3%(53/60),as compared with the 74.2%(49/66) in the control group (χ^(2)=4.047, P<0.05). Moreover, after treatment, the observation group demonstra

关 键 词：密固达 六味地黄丸 骨质疏松症 骨密度 

分 类 号：R22[医药卫生—中医基础理论] R242[医药卫生—中医学] R2-031R969.4R274