A Multicenter Randomized Controlled Trial of <italic style="font-style: italic">Qubi Yangxi Formula </italic>（祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome

ZHANG Shuming; XU Jinhai; FANG Yabei; JIANG Yuwen; GUO Yanmin; QIAO Jiaojiao; YE Jie; MO Wen; SHI Qi

doi:10.13288/j.11-2166/r.2023.06.009

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A Multicenter Randomized Controlled Trial of Qubi Yangxi Formula （祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome

更新时间：2023-03-13

- A Multicenter Randomized Controlled Trial of Qubi Yangxi Formula （祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome
  增强出版
- Journal of Traditional Chinese Medicine Vol. 64, Issue 6, Pages: 587-592(2023)
- 作者机构：
  
  1.上海中医药大学附属龙华医院，上海市徐汇区宛平南路725号，200032
  2.上海市静安区彭浦新村街道社区卫生服务中心
  3.上海市徐汇区凌云街道社区卫生服务中心
  4.上海市浦东新区陆家嘴社区卫生服务中心
  5.上海中医药研究院脊柱病研究所
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2023.06.009
  CLC：
- Received：23 September 2022，
  
  Revised：2022-12-18，
  
  Published：17 March 2023
- 稿件说明：
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张书铭,许金海,方娅贝等.祛痹养膝方结合整膝三步九法治疗早中期膝骨关节炎肝肾不足、痰瘀交阻证的多中心随机对照研究[J].中医杂志,2023,64(06):587-592.

ZHANG Shuming,XU Jinhai,FANG Yabei,et al.A Multicenter Randomized Controlled Trial of Qubi Yangxi Formula （祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome[J].Journal of Traditional Chinese Medicine,2023,64(06):587-592.
张书铭,许金海,方娅贝等.祛痹养膝方结合整膝三步九法治疗早中期膝骨关节炎肝肾不足、痰瘀交阻证的多中心随机对照研究[J].中医杂志,2023,64(06):587-592. DOI： 10.13288/j.11-2166/r.2023.06.009.

ZHANG Shuming,XU Jinhai,FANG Yabei,et al.A Multicenter Randomized Controlled Trial of Qubi Yangxi Formula （祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome[J].Journal of Traditional Chinese Medicine,2023,64(06):587-592. DOI： 10.13288/j.11-2166/r.2023.06.009.

摘要

目的

观察祛痹养膝方结合整膝三步九法手法治疗早中期膝骨关节炎（KOA）肝肾不足、痰瘀交阻证的临床疗效及安全性。

方法

共收集137例KOA肝肾不足、痰瘀交阻证患者，按照分中心完全随机分组法分为治疗组70例与对照组67例。治疗组予祛痹养膝方配方颗粒口服，每日1剂，分2次服，配合整膝三步九法手法治疗每次15 min，每周3次，共治疗4周。对照组给予塞来昔布口服，每次0.2 g，每日1次，服用1周后停药；同时给予氨基葡萄糖胶囊口服，每次0.24 g，每日3次，服用4周；结合低频理疗仪治疗每次15 min，每周3次，共治疗4周。于治疗前、治疗2周、治疗4周及第12周随访时记录视觉模拟（VAS）评分、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、健康调查简表（SF-36）评分［包括躯体健康（PCS）评分及心理健康（MCS）评分］、步态评估量表（Tinetti）评分，并评价临床疗效及安全性。

结果

共134例患者完成本次试验的治疗和随访，两组各67例。治疗组临床控制0例，显效19例，有效45例，无效3例，总有效率95.52%；对照组临床控制0例、显效3例、有效32例、无效32例，总有效率52.24%；治疗组临床疗效优于对照组（

＜0.05）。与本组治疗前比较，两组患者治疗后不同时间WOMAC评分、VAS评分均降低，PCS评分、MCS评分和Tinetti评分均升高（

＜0.05），且随治疗时间的延长各指标改善更明显（

＜0.05）。治疗4周、随访时，治疗组患者WOMAC评分、VAS评分、Tinetti评分均优于同时间对照组（

＜0.05）。两组均未发生严重不良事件，安全性较好。

结论

祛痹养膝方结合整膝三步九法手法治疗早中期KOA肝肾不足、痰瘀交阻证，能显著缓解膝关节疼痛症状，提升膝关节功能，改善患者的生活质量，其疗效不劣于氨基葡萄糖、塞来昔布口服结合理疗的治疗方法，且安全性较好。

Abstract

Objective

To observe the clinical efficacy and safety of

Qubi Yangxi Formula

（祛痹养膝方） combined with three-step nine-manipulation methods for adjusting knee in the treatment of early and middle knee osteoarthritis （KOA） with liver-kidney insufficiency and phlegm-stasis obstruction syndrome

Methods

A total of 137 KOA cases with liver-kidney insufficiency and phlegm-stasis obstruction syndrome were included and divided into treatment group （70 cases） and control group （67 cases） according to cluster randomization method. The treatment group was given

Qubi Yangxi Formula

granules， 1 dose by two times per day， and three-step nine-manipulation method for adjusting knee， 15 minutes each time， 3 times a week， for a total of 4 weeks. The control group orally took celecoxib， 0.2 g per time， once a day for one week， and glucosamine capsules， 0.24 g each time， 3 times a day for 4 weeks， and received the low-frequency physiotherapy 15 minutes each time， 3 times a week for 4 weeks. The visual analog scale （VAS）score， Western Ontario and McMaster University Osteoarthritis Index （WOMAC）score， health survey summary form （SF-36）score including physical component score （PCS） and mental component score （MCS）， and gait assessment scale （Tinetti） score were recorded before treatment， after 2- and 4-week treatment， and 12-week follow-up， and the clinical efficacy and safety were evaluated.

Results

A total of 134 cases completed the treatment and follow-up，with 67 cases in each group. The total effective rate of the treatment group was 95.52% （clinical control： 0； markedly effective： 19 cases； effective： 45 cases； ineffective： 3 cases）， significantly higher than 52.24% （clinical control： 0； markedly effective： 3 cases； effective： 32 cases； ineffective： 32 cases） of the control group （

＜0.05）. Compared to those before treatment， the WOMAC and VAS scores of both groups decreased at all timepoints， while the PCS score， MCS score and Tinetti score increased（

＜0.05）， and more changes were found with the time （

＜0.05）. After 4-week treatment and at 12-week follow-up， the WOMAC， VAS scores and Tinetti scores of the treatment group were superior to those of the control group measured at the same timepoints （

＜0.05）. None of the two groups had serious adverse events.

Conclusion

Qubi Yangxi Formula

combined with the three-step nine-manipulatioon method for adjusting knee， not inferior to oral glucosamine and celecoxib plus physiotherapy， can significantly relieve knee pain， improve knee function， improve the quality of life and is safe in the treatment of early and middle KOA with liver-kidney insufficiency and phlegm-stasis obstruction syndrome.

关键词

Keywords

references

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A Multicenter Randomized Controlled Trial of Qubi Yangxi Formula （祛痹养膝方） Combined with Three-step Nine-manipulation Method for Adjusting Knee in the Treatment of Early and Middle Knee Osteoarthritis with Liver-kidney Insufficiency and Phlegm-stasis Obstruction Syndrome

DOI：10.13288/j.11-2166/r.2023.06.009

摘要

Abstract

关键词

Keywords

references