Real-world Study of Medication Characteristics and Clinical Efficacy of Tenghuang Jiangu Tablets in Treatment of Knee Osteoarthritis in Remission Stage

FU Zhihong; LI Shuwen; LI Ruihan; JIA Yan; ZHU Ruizheng; LI Xiangyu; LIANG Zhi; GAO Shuai; WU Zhuoyun; CHEN Lin; CHEN Weiheng

doi:10.13422/j.cnki.syfjx.20222340

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Real-world Study of Medication Characteristics and Clinical Efficacy of Tenghuang Jiangu Tablets in Treatment of Knee Osteoarthritis in Remission Stage

更新时间：2023-02-15

- Real-world Study of Medication Characteristics and Clinical Efficacy of Tenghuang Jiangu Tablets in Treatment of Knee Osteoarthritis in Remission Stage
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 29, Issue 6, Pages: 120-127(2023)
- 作者机构：
  
  1.北京中医药大学第三附属医院，北京 100029
  2.中国中药协会，北京 100061
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20222340
  CLC： R2-0;R33;R684.3
- Published：20 March 2023，
  
  Published Online：24 October 2022，
  
  Received：31 July 2022，
- 稿件说明：
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符智虹,李述文,李瑞涵等.真实世界藤黄健骨片治疗膝骨关节炎缓解期人群用药特征及临床疗效分析[J].中国实验方剂学杂志,2023,29(06):120-127.

FU Zhihong,LI Shuwen,LI Ruihan,et al.Real-world Study of Medication Characteristics and Clinical Efficacy of Tenghuang Jiangu Tablets in Treatment of Knee Osteoarthritis in Remission Stage[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(06):120-127.
符智虹,李述文,李瑞涵等.真实世界藤黄健骨片治疗膝骨关节炎缓解期人群用药特征及临床疗效分析[J].中国实验方剂学杂志,2023,29(06):120-127. DOI： 10.13422/j.cnki.syfjx.20222340.

FU Zhihong,LI Shuwen,LI Ruihan,et al.Real-world Study of Medication Characteristics and Clinical Efficacy of Tenghuang Jiangu Tablets in Treatment of Knee Osteoarthritis in Remission Stage[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(06):120-127. DOI： 10.13422/j.cnki.syfjx.20222340.

摘要

目的

探究真实世界藤黄健骨片治疗膝骨关节炎（KOA）缓解期人群的用药特征和临床疗效，为藤黄健骨片的临床合理用药提供依据。

方法

基于“藤黄健骨片治疗膝骨关节炎病例注册登记系统”资料，应用SPSS 25.0和IBM SPSS Modeler 18.0软件及Apriori算法对应用过藤黄健骨片的2 439例膝骨关节炎缓解期病例数据进行分析：缓解期患者年龄、体质量指数（BMI）、疗程采用

http://html.publish.founderss.cn/rc-pub/api/common/picture?pictureId=39921081&type=

http://html.publish.founderss.cn/rc-pub/api/common/picture?pictureId=39921078&type=

7.78933382

2.62466669

的形式描述；性别、K-L分级、单日用药剂量、用药频次等信息采用频数分析描述；单用藤黄健骨片治疗组和联合用药治疗组（以下简称单用组和联用组）例数、疗程、单日用药剂量、用药频次采用频数分析，联合药物采用频数分析以及Apriori算法进行关联分析；VAS、WOMAC、疼痛、僵硬、关节活动功能评分采用Mann-Whitney U检验进行组间比较。

结果

临床用药结果显示，使用藤黄健骨片治疗膝骨关节炎缓解期患者共2 439例，其中单用组1 432例（58.71%），多于联用组1 007例（41.29%），日均使用藤黄健骨片（3.90±1.44）g，K-L分级主要为Ⅱ级（54.47%），单用组日均使用藤黄健骨片（3.64±1.35）g，低于联用组（4.26±1.48）g（

0.05）；联合用药中，使用频次前三的西药是氨基葡萄糖（270次，14.68%）、玻璃酸钠（126次，6.85%）、艾瑞昔布（116次，6.31%），使用频次前三的中药是活血止痛胶囊/片/膏（31次，1.69%）、痹祺胶囊（25次，1.36%）、迈之灵（23次，1.25%）。总体临床疗效评价显示，VAS评分治疗前（5.13±0.93）分，治疗后（2.22±1.18）分，明显降低（

0.01），平均下降（2.91±1.14）分，其中单用组平均下降（2.76±1.43）分，低于联用组（3.12±1.36）分（

0.01）；WOMAC评分治疗前（31.05±11.84）分，治疗后（13.55±9.91）分（

0.05），平均下降（17.50±11.79）分，其中单用组平均下降（16.39±11.14）分，低于联用组（19.08±12.50）分（

0.05）；单用组K-L分级Ⅱ级以上患者占91.34%（1 308/1 432），略低于联用组93.55%（942/1 007）（

=80.026，

0.05），单用组合并疾病患者占43.37%（621/1 432），低于联用组54.92%（553/1 432）（

=20.087，

0.01）。

结论

临床中超过一半的KOA缓解期患者单独使用藤黄健骨片治疗，联合用药多因病情较重或合并其他疾病，在缓解膝关节疼痛，改善关节僵硬和关节功能方面，单独用药和联合用药均有明显疗效，而在病情较重或合并其他疾病的情况下，联合用药的治疗方案更适合。

Abstract

Objective

To explore the medication characteristics and clinical efficacy of the Tenghuang Jiangu tablets in the treatment of knee osteoarthritis （KOA） in the remission stage in the real world，providing references for rational clinical use of this prescription.

Method

Based on the "registration system of KOA treated with Tenghuang Jiangu tablets"，2 439 KOA cases in the remission stage were analyzed by SPSS 25.0，IBM SPSS Modeler18.0，and Apriori algorithm. To be specific，the age，body mass index （BMI），and course of treatment were described in the form of

x̄

. The information on gender，K-L grade，daily dose，and frequency of drug use was described by frequency analysis. The number of cases，course of treatment，daily dose，and drug use frequency of the single-use group and the combined-use group were described by frequency analysis，and the combination of drugs was described by frequency analysis and Apriori algorithm. Mann-Whitney U test was employed to compare the scores of Visual Analogue Scale （VAS），Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC），pain，stiffness，and joint function between the single-use group and the combined-use group.

Result

The results of clinical treatment showed that 2 439 patients with KOA in the remission stage were treated with Tenghuang Jiangu tablets，with 1 432 （58.71%） in the single-use group and 1 007 （41.29%） in the combined-use group. The average daily dose of Tenghuang Jiangu tablets was （3.90±1.44） g，and the majority of the patients were at grade Ⅱ （54.47%）. The daily average daily dose of Tenghuang Jiangu tablets in the single-use group was （3.64±1.35） g，which was lower than that in the combined-use group ［（4.26±1.48） g，

0.05］. In the combined use，the top three western medicines were glucosamine （270 times，14.68%），sodium hyaluronate （126 times，6.85%），and imrecoxib （116 times，6.31%），and the top three Chinese medicines were Huoxuezhitong capsules/tablets/ointments （31 times，1.69%），Biqi capsules （25 times，1.36%），and Maizhiling （23 times，1.25%）. As for the overall clinical efficacy，the VAS score was （5.13±0.93） score before treatment and （2.22±1.18） score after treatment （

0.05），with an overall average decrease of （2.91±1.14） score， and the average decrease in the single-use group was （2.76±1.43） score， which was lower than that in the combined-use group ［（3.12±1.36） score，（

0.01）］. The WOMAC score was （31.05±11.84） score before treatment and （13.55±9.91） score after treatment （

0.05）. The overall average decrease was （17.50±11.79） score， and the average decrease in the single-use group and combined-use group was （16.39±11.14） score and （19.08±12.50） score，respectively （

0.01）. The patients with KOA

grade Ⅱ accounted for 91.34%（1 308/1 432） and 93.55%（942/1 007） in the single-use group and combined-use group，respectively （

=80.026，

0.05）. A total of 43.37%（621/1 432） of the patients in the single-use group had other complications，lower than that in the combined-use group ［54.92%（553/1 432），（

=20.087，

0.01）］.

Conclusion

More than half of the patients with KOA in the remission stage are treated with Tenghuang Jiangu tablets alone，and the combination therapy is mainly applied in patients with severe conditions or other complications. In relieving knee joint pain and improving joint stiffness and joint function，both the Tenghuang Jiangu tablets alone and the combination therapy are effective.

关键词

藤黄健骨片膝骨关节炎缓解期真实世界研究用药特征

Keywords

Tenghuang Jiangu tabletsknee osteoarthritisremissionreal-world studymedication characteristics

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