Real-World Study on the Clinical Efficacy of Different Medication Regimens of <italic style="font-style: italic">Wangbi Tablet </italic>（尪痹片） in the Treatment of Knee Osteoarthritis

ZHANG Kuayue; LI Chao; WU Zhuoyun; DONG Yawei; ZHENG Zelu; LIU Yuzhi; ZHOU Jun; LIN Jiaming; CHEN Yuefeng; MI Baohong; CHEN Weiheng

doi:10.13288/j.11-2166/r.2024.22.007

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Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet （尪痹片） in the Treatment of Knee Osteoarthritis

更新时间：2024-11-12

- Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet （尪痹片） in the Treatment of Knee Osteoarthritis
- Journal of Traditional Chinese Medicine Vol. 65, Issue 22, Pages: 2316-2325(2024)
- 作者机构：
  
  1.北京中医药大学第三附属医院，北京市朝阳区安外小关街51号，100029
  2.北京中医药大学中医骨伤治疗与运动康复智能化教育部工程研究中心
  3.北京中医药大学骨伤科研究所
  4.国家奥林匹克体育中心
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.22.007
  CLC：
- Received：18 April 2024，
  
  Revised：2024-09-17，
  
  Published：17 November 2024
- 稿件说明：
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张跨越,李超,吴卓耘等.尪痹片不同用药方式治疗膝骨关节炎临床疗效的真实世界研究[J].中医杂志,2024,65(22):2316-2325.

ZHANG Kuayue,LI Chao,WU Zhuoyun,et al.Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet （尪痹片） in the Treatment of Knee Osteoarthritis[J].Journal of Traditional Chinese Medicine,2024,65(22):2316-2325.
张跨越,李超,吴卓耘等.尪痹片不同用药方式治疗膝骨关节炎临床疗效的真实世界研究[J].中医杂志,2024,65(22):2316-2325. DOI： 10.13288/j.11-2166/r.2024.22.007.

ZHANG Kuayue,LI Chao,WU Zhuoyun,et al.Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet （尪痹片） in the Treatment of Knee Osteoarthritis[J].Journal of Traditional Chinese Medicine,2024,65(22):2316-2325. DOI： 10.13288/j.11-2166/r.2024.22.007.

摘要

目的

研究真实世界中尪痹片不同用药方式对膝骨关节炎的临床疗效差异，为尪痹片的临床合理用药提供依据。

方法

采用前瞻性病例注册登记研究方法，观察2019年1月26日至2021年12月17日在全国30家医院注册登记的KOA患者共2999例，根据观察周期内尪痹片的使用情况，将患者分为单用组1507例和联用组1492例，联用组分为尪痹片+中药、尪痹片+西药、尪痹片+中药+西药3个亚组。比较单用组和联用组患者基线资料，包括年龄、性别、体质量、用药时间、临床分期、凯格伦-劳伦斯膝骨关节炎影像分级（K-L分级）等情况；疗效指标包括视觉模拟量表（VAS）评分、西安大略与麦克马斯特大学骨关节炎指数（WOMAC）总分、欧洲五维健康指数量表（EQ-5D）效应值，分别于治疗前及治疗4、8、12周后评价1次，并于治疗4、8、12周后计算治疗前后差值，并将所有患者以上各项指标的基线与治疗12周后差值作为因变量，以性别、年龄、体重指数（BMI）、病程、K-L分级、临床分期等作为自变量，采用多重线性回归探讨疗效的影响因素。同时统计主要症状（包括晨僵、关节肿胀、腰膝酸软、畏风、畏寒）发生情况，并分别于治疗4、8、12周后统计各时间点症状消失情况。

结果

基线时单用组与联用组的性别、年龄分布差异无统计学意义（

＞0.05）；单用组中发作期与康复期患者占比高于联用组，而缓解期的占比低于联用组

（

＜0.05）；单用组VAS评分高于联用组，EQ-5D效应值低于联用组（

＜0.01），WOMAC总分差异无统计学意义（

＞0.05）。与本组治疗前及上一时间点比较，两组患者治疗后各时间点VAS评分、WOMAC总分均明显下降，EQ-5D效应值均明显上升（

＜0.05）；治疗12周后单用组VAS评分治疗前后差值高于联用组，治疗4、8、12周后联用组WOMAC总分、EQ-5D效应值治疗前后差值均高于单用组（

＜0.05）。多重线性回归分析结果显示，治疗前VAS评分对疼痛改善的影响最大（

＜0.01），尪痹片+西药、尪痹片+中药对疼痛的改善作用优于单用尪痹片（

＜0.05），尪痹片疗程＞28天的疗效更好（

＜0.01）；尪痹片+西药对膝关节整体功能的改善作用优于单用尪痹片（

＜0.01），尪痹片疗程＞28天的疗效更好（

＜0.05）；发作期和缓解期患者生活质量的提升较康复期更明显（

＜0.01），尪痹片+西药、尪痹片+中药对生活质量的提升作用优于单用尪痹片（

＜0.05）。治疗前单用组中晨僵、腰膝酸软、畏风、畏寒患者的占比均高于联用组（

＜0.01），两组患者在治疗4、8、12周后主要症状占比均低于本组治疗前（

＜0.05），治疗4周后联用组各主要症状消失率均优于单用组，治疗12周后单用组畏风消失率高于联用组，关节肿胀、腰膝酸软消失率低于联用组（

＜0.05）。

结论

单独使用尪痹片及联合其他药物对KOA全病程均有效，用于发作期和缓解期在提高关节功能和生活质量方面的获益大于康复期；联合用药起效更快，但在8周后疗效与单用逐渐趋近一致，联合西药疗效最好，联合其他中药次之。

Abstract

Objective

To investigate the differences in clinical efficacy of different medication regimens of

Wangbi Tablets

（尪痹片） for knee osteoarthritis （KOA） in a real-world setting， providing a basis for rational clinical use of

Wangbi Tablets

Methods

A prospective registry study was conducted， involving 2，999 KOA patients registered in 30 hospitals nationwide from January 26th， 2019， to December 17th， 2021. Based on the use of

Wangbi Tablets

during the observation period， patients were divided into a monotherapy group （1，507 cases） and a combination therapy group （1，492 cases）， and the combination group can be further divided into

Wangbi Tablets

plus Chinese medicine （CM），

Wangbi Tablets

plus western medicine （WM）， and

Wangbi Tablets

plus Chinese and western medicine （CM+WM） subgroups. The baseline data of patients in the monother

apy group and the combination group were compared， including age， gender， body weight， medication time， clinical stage， K-L grade， and others. Efficacy indicators included the Visual Analog Scale （VAS） score， Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） score， and EuroQol five-dimensional （EQ-5D） health index， which were evaluated before and after 4-， 8- and 12-week treatment， and the difference before and after treatment was calculated after 4， 8 and 12 weeks of treatment. The difference between the baseline and 12 weeks of treatment of all the above indicators was used as the dependent variables， and gender， age， body mass index （BMI）， course of disease， K-L grade， and clinical stage were used as independent variables， when multiple linear regression was taken to explore the influencing factors of the efficacy. At the same time， the occurrence of major symptoms （including morning stiffness， joint swelling， soreness of waist and knees， fear of wind， and fear of cold） was counted， and the disappearance of symptoms at each time point was counted after 4， 8， and 12 weeks of treatment.

Results

At baseline， there were no statistically significant differences in gender and age distribution between the monotherapy and combination therapy groups （

＞0.05）； the proportion of patients in the acute stage and recovery stage was higher in the monotherapy group than in the combination therapy group， while the proportion in the remission stage was lower （

＜0.05）； the VAS score was higher in the monotherapy group， and the EQ-5D index was lower （

＜0.01）， with no statistically significant difference in total WOMAC score between the two groups （

＞0.05）. Compared to those measured before treatment and at previous timepoint， the VAS score and WOMAC total score significantly decreased in both groups， while EQ-5D value increased （

＜0.05）. The difference in VAS score between baseline and after 12-

week treatment was higher in the monotherapy group than the combination group， while the differences in WOMAC total score and EQ-5D value between baseline and after 4-， 8- and 12-week treatment were higher in the combination group （

＜0.05）. Multiple linear regression showed that VAS score before treatment had greatest impact on pain improvement （

＜0.01）， and compared to

Wangbi Tablets

monotherapy， the combination of

Wangbi tablets

with WM or CM had larger associations with pain improvement （

＜0.05）； and

Wangbi Tablets

had better efficacy when the course of treatment was ＞28 days （

＜0.01）.

Wangbi Tablets

plus WM had a better effect on improving the overall function of the knee joint than

Wangbi Tablets

alone （

＜0.01）； and the efficacy of

Wangbi Tablets

with a course of treatment ＞28 days was better （

＜0.05）. The improvement of quality of life of patients in the attack and remission stages was more obvious than that in the recovery stage （

＜0.01）；

Wangbi Tablets

plus WM or CM had a better effect on improving quality of life than

Wangbi Tablets

alone （

＜0.05）. Before treatment， the proportion of patients with morning stiffness， soreness of waist and knees， fear of wind and chills in the monotherapy group was higher than that in the combination group （

＜0.01）. The proportion of main symptoms in both groups decreased after 4， 8 and 12 weeks of treatment （

＜0.05）. After 4 weeks of treatment， the disappearance rate of each main symptom in the combination group was higher than that in the monotherapy group， and after 12 weeks of treatment， the disappearance rate of fear of wind in the monotherapy group was higher than that in the combination group， while the disappearance rate of joint swelling and soreness of waist and

knees was lower （

＜0.05）.

Conclusion

Wangbi Tablets

， whether used alone or in combination with other medications， is effective throughout the course of KOA， with greater benefits in improving joint function and quality of life during the acute and remission stages compared to the recovery stage. Combination therapy had a faster onset of effect， but began to converge with monotherapy after 8 weeks. The best efficacy was observed with the combination of

Wangbi Tablets

with WM， followed by combination with CM.

关键词

Keywords

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Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet （尪痹片） in the Treatment of Knee Osteoarthritis

DOI：10.13288/j.11-2166/r.2024.22.007

摘要

Abstract

关键词

Keywords

references