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

Xu YANG; Huaxin WANG; Qian ZHANG; Guoqiang ZHANG; Kaiying CUI; Guoyan LIU

doi:10.13422/j.cnki.syfjx.20221494

您当前的位置：

首页 >

文章列表页 >

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

更新时间：2022-09-01

- Clinical Efficacy of Liuwei Dihuangwan Combined with Aclasta on Osteoporosis and Effect on Quality of Life
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 28, Issue 14, Pages: 115-120(2022)
- 作者机构：
  
  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
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20221494
  CLC： R22;R242;R2-031;R969.4;R274
- Published：20 July 2022，
  
  Published Online：23 March 2022，
  
  Received：06 December 2021，
- 稿件说明：
扫描看全文
杨旭,王花欣,张倩等.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[J].中国实验方剂学杂志,2022,28(14):115-120.

YANG Xu,WANG Huaxin,ZHANG Qian,et al.Clinical Efficacy of Liuwei Dihuangwan Combined with Aclasta on Osteoporosis and Effect on Quality of Life[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(14):115-120.
杨旭,王花欣,张倩等.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[J].中国实验方剂学杂志,2022,28(14):115-120. DOI： 10.13422/j.cnki.syfjx.20221494.

YANG Xu,WANG Huaxin,ZHANG Qian,et al.Clinical Efficacy of Liuwei Dihuangwan Combined with Aclasta on Osteoporosis and Effect on Quality of Life[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(14):115-120. DOI： 10.13422/j.cnki.syfjx.20221494.

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D

（VITD-T）、骨钙素（OC）、血清碱性磷酸酶（ALP）、甲状旁腺素（PTH）、

-胶原特殊序列（

-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（

0.01），JOA评分显著升高（

0.01）；腰椎、髋关节BMD、Ca、VITD-T、OC、ALP、PTH水平均明显升高（

0.05，

0.01），

-CTX显著下降（

0.01），观察组患者T-P1NP水平显著下降（

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（

=4.047，

0.05）；观察组BMD、Ca、VITD-T、OC、PTH水平均明显升高（

0.05），T-P1NP均明显降低（

0.05）；观察组VAS评分显著降低（

0.01）；JOA评分明显升高（

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。

Abstract

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 double-blind method. The observation group consisted of 60 patients （26 males and 34 females） with the age of 59-85 years old ［mean：（72.0 ± 6.5） years old］. The control group was composed of 66 patients （31 males and 35 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 D

（VITD-T）， osteocalcin （OC）， serum alkaline phosphatase （ALP）， parathyroid hormone （PTH），

-collagen special sequence （

-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 （

0.01）， increase in JOA score （

0.01）， BMD of lumbar spine and hip joint， elevation of Ca， VITD-T， OC， ALP， and PTH （

0.05，

0.01）， and decrease of

-CTX （

0.01） as compared with before treatment. The level of T-P1NP dropped in the observation group after treatment （

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 （

=4.047，

0.05）. Moreover， after treatment， the observation group demonstrated higher levels of BMD， Ca， VITD-T， OC， and PTH （

0.05）， lower levels of T-P1NP （

0.05）， lower VAS score （

0.01）， and higher JOA score （

0.05） than the control group， but the ODI score was insignificantly different from that in the control group.

Conclusion

Aclasta combined with Liuwei Dihuangwan is effective on osteoporosis， without increasing the incidence of adverse reactions. In addition， the combination can alleviate pain and improve the quality of life of osteoporosis patients.

关键词

密固达六味地黄丸骨质疏松症骨密度

Keywords

AclastaLiuwei Dihuangwanosteoporosisbone mineral density

references

马远征，王以朋，刘强，等. 中国老年骨质疏松症诊疗指南（2018）［J］. 中国骨质疏松杂志，2018，24（12）：1541-1567.

COUGHLAN T，DOCKERY F. Osteoporosis and fracture risk in older people［J］.Clin Med（Lond），2014，14（2）：187-191.

HERNLUND E，SVEDBOM A，IVERGÅRD M，et al. Osteoporosis in the European Union：Medical management，epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation （IOF） and the European Federation of Pharmaceutical Industry Associations （EFPIA）［J］. Arch Osteoporos，2013，8（1）：136.

KANIS J A，COOPER C，RIZZOLI R，et，al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women［J］. Osteoporos Int，2019，30（1）：3-44.

夏维波，章振林，林华，等.原发性骨质疏松症诊疗指南（2017）［J］.中华骨质疏松和骨矿盐疾病杂志，2017，10（5）：413-444.

SMIT D L，ZILLIKENS M C，DE JONGH R T. Zoledronic acid；Useful in osteopenia？［J］. Ned Tijdschr Geneeskd，2019，163：D3626.

葛继荣，王和鸣，郑洪新，等. 中医药防治原发性骨质疏松症专家共识（2020）［J］.中国骨质疏松杂志，2020，26（12）：1717-1725.

赵博旭，王世东，赵能江，等. 六味地黄丸（汤）相关研究可视化分析［J］.中医学报，2021，36（10）：2246-2254.

LIU M M，DONG R，HUA Z，et al. Therapeutic potential of Liuwei Dihuang pill against KDM7A and Wnt/β-catenin signaling pathway in diabetic nephropathy-related osteoporosis［J］. Biosci Rep，2020，40（9）：BSR20201778.

侯伟，杜斌.中医药治疗骨质疏松症的研究进展［J］.世界中西医结合杂志，2021，16（10）：1956-1960.

张文静.骨质疏松治疗的相关研究进展［J］.中国老年保健医学，2020，18（4）：101-102.

兰挨元，王中元，刘彦平.六味地黄丸改善绝经后骨质疏松症的临床观察［J］.中国民间疗法，2021，29（21）：56-58.

郑筱萸.中药新药临床研究指导原则（试行）［M］北京：中国中医药科技出版社，2002：356-360

SHAFSHAK T S， ELNEMR R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain［J］. J Clin Rheumatol，2021，27（7）：282-285.

ISHIBASHI Y，ADACHI N，KOGA H，et al. Japanese Orthopaedic Association （JOA） clinical practice guidelines on the management of anterior cruciate ligament injury - secondary publication［J］. Orthop Sci，2020 ，25（1）：6-45.

BINAYA K，KAJAL T，RANJEETA A S，et al. Responsiveness of Nepali version of Oswestry Disability Index （ODI） on individuals with non-specific low back pain［J］. Patient Rep Outcomes， 2021，5（1）：67.

ZHAO F，GUO L，WANG X，et al. Correlation of oxidative stress-related biomarkers with postmenopausal osteoporosis：A systematic review and Meta-analysis［J］. Arch Osteoporos，2021，16（1）：4-13.

ARMAS L A，RECKER R R. Pathophysiology of osteoporosis：New mechanistic insights［J］. Endocrinol Metab Clin North Am，2012，41（3）：475-486.

LI J，HO W T P，LIU C，et al. The role of gut microbiota in bone homeostasis［J］. Bone Joint Res，2021，10（1）：51-59.

LI B，LIU M，WANG Y，et al. Puerarin improves the bone micro-environment to inhibit OVX-induced osteoporosis via modulating SCFAs released by the gut microbiota and repairing intestinal mucosal integrity［J］. Biomed Pharmacother，2020，132：110923.

于雪冰，马建强，汪栋等. 六味地黄丸治疗绝经后骨质疏松症肾阴虚证对骨钙素、骨密度及JAK/STAT信号通路的影响［J］. 中药材，2020，43（3）：734-737.

杨锋，孙玉华，刘佃滨，等骨质疏松患者骨碱性磷酸酶、钙、磷代谢变化及与牙槽骨骨密度的相关性［J］. 中国骨质疏松杂志，2017，23（9）：1160-1166

WATTS N B，CAMACHO P M，LEWIECKI E M，et al. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update［J］. Endocr Pract，2021，27（4）：379-380.

JOSEPH B，JAVALI M A，KHADER M A，et al. Salivary osteocalcin as potential diagnostic marker of periodontal bone destruction among smokers［J］. Biomolecules，2020 ，10（3）：380.

LIU Z，CHEN R，JIANG Y，et al. A Meta-analysis of serum osteocalcin level in postmenopausal osteoporotic women compared to controls［J］. BMC Musculoskelet Disord，2019，20（1）：532.

王健，廖燚，袁锋. 骨代谢标志物在骨质疏松中的应用进展［J］. 河北医药，2021，43（20）：3164-3170.

RACHNER T D，HOFBAUER L C，GÖBEL A，et al. Novel therapies in osteoporosis：PTH-related peptide analogs and inhibitors of sclerostin［J］. J Mol Endocrinol，2019，62（2）：R145-R154.

范海博. 血清β-CTX、CatheK、OPG检测诊断绝经后骨质疏松的临床价值［J］.中国现代医生，2021，59（20）：123-126，193.

WU X，XU X，LIU Q，et al. Unilateral cervical spinal cord injury induces bone loss and metabolic changes in non-human primates（Macaca fascicularis）［J］. J Orthop Translat，2021，29：113-122.

温明韬，梁学振，李嘉程，等. 基于网络药理学与分子对接技术探讨六味地黄丸抗骨质疏松症的机制研究［J］.中国骨质疏松杂志，2021，27（8）：1129-1134，1153.

冯万立，王新刚，卫建民，等. 强筋健骨胶囊联合鲑鱼降钙素治疗绝经后骨质疏松症短期疗效临床研究［J］.中国骨质疏松杂志，2018，24（12）：1620-1623.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Clinical Efficacy and Mechanism of Modified Erxian Decoction in Treating Osteoporosis with Yang Deficiency

Effect of Bushen Guben Decoction on Bone Mineral Density, Bone Mineral Content and Calcitonin Level in Ovariectomized Rat Model of Osteoporosis

Establishment of Quantitative Analysis Method and Evaluation System for Liuwei Dihuangwan

Corylin in Treatment of Metabolic Bone Diseases： A Review

Mechanism of miRNA Intervention in Osteoporosis and Intervention Effect of Traditional Chinese Medicine： A Review

Related Author

Shi-zhou CHEN

Guo-qing MAO

Yu-ming SUN

Lu-mei CAO

Long-xiu QIN

Yao YAO

Jian-feng GE

HUANG Ji-feng

Related Institution

Affiliated Hospital of Nanjing University of Chinese Medicine

Suzhou Drug Inspection and Testing Research Center

The First Affiliated Hospital of University of South China

Affiliated Hospital of Gansu University of Chinese Medicine

Gansu University of Chinese Medicine

Postal code：100700
Tel：010-84076882 Email：syfjx_2010@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备11006657号-10 京公网安备11010802024621
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰