中国组织工程研究

中国组织工程研究 ›› 2024, Vol. 28 ›› Issue (10): 1580-1585.doi: 10.12307/2024.367

• 水凝胶材料Hydrogel materials • 上一篇    下一篇

“消肿散”剂型优化的复方芙蓉叶凝胶治疗膝关节滑膜炎

颜  威1，孔  博2，奚小冰1，3，4，许  勇3，贾友冀1，阮贝特1，4，张家慧1，3，4，马泓泓1，3，4，李中伟4   

  1. 1上海交通大学医学院附属瑞金医院，上海市  200025；2上海交通大学医学院附属瑞金医院无锡分院，江苏省无锡市  214100；3上海市中西医结合防治骨与关节病损重点实验室，上海市  200025；4上海市伤骨科研究所，上海市  200025
  • 收稿日期:2023-03-11 接受日期:2023-05-27 出版日期:2024-04-08 发布日期:2023-08-19
  • 通讯作者: 李中伟，主任医师，上海市伤骨科研究所，上海市 200025
  • 作者简介:颜威，男，1992年生，江苏省连云港市人，汉族，硕士，医师，主要从事骨与关节损伤的外固定研究。
  • 基金资助:

    上海市卫生和计划生育委员会中医药科研课题(2018LP025)，项目负责人：李中伟；上海市进一步加快中医药传承创新发展三年行动计划项目(2021-2023年)[ZY(2021-2023)-0208]，项目负责人：奚小冰；上海市进一步加快中医药传承创新发展三年行动计划项目(2021-2023年)[ZY(2021-2023)-0209-03]，项目负责人：奚小冰；上海市青年科技英才扬帆计划项目(20YF1427400)，项目负责人：颜威；上海市临床重点专科建设项目(SHSLCZDZK04802)，项目负责人：奚小冰；上海交通大学“交大之星”计划医工交叉重点项目(YG2019ZDA16)，项目负责人：奚小冰；上海市中西医结合旗舰医院建设项目[ZY(2021-2023)-0205-01]，项目参与者：奚小冰、颜威；海派中医流派传承创新团队建设项目(2021LPTD-003)，项目负责人：奚小冰

Compound cottonrose hibiscus leaf gel plaster of optimal “Xiaozhongsan” formulation for knee synovitis

Yan Wei1, Kong Bo2, Xi Xiaobing1, 3, 4, Xu Yong3, Jia Youji1, Ruan Beite1, 4, Zhang Jiahui1, 3, 4, Ma Honghong1, 3, 4, Li Zhongwei4   

  1. 1Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; 2Wuxi Branch of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Wuxi 214100, Jiangsu Province, China; 3Shanghai Key Laboratory of Prevention and Treatment of Bone and Joint Diseases, Shanghai 200025, China; 4Shanghai Institute of Traumatology and Orthopedics, Shanghai 200025, China
  • Received:2023-03-11 Accepted:2023-05-27 Online:2024-04-08 Published:2023-08-19
  • Contact: Li Zhongwei, Chief physician, Shanghai Institute of Traumatology and Orthopedics, Shanghai 200025, China
  • About author:Yan Wei, Master, Physician, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
  • Supported by:
    Scientific Research Project of Traditional Chinese Medicine of Shanghai Municipal Commission of Health and Family Planning, No. 2018LP025 (to LZW); Three-Year Action Plan Project for Further Accelerating the Inheritance, Innovation and Development of Traditional Chinese Medicine in Shanghai (2021-2023), No. ZY(2021-2023)-0208 (XXB); Three-Year Action Plan Project for Further Accelerating the Inheritance, Innovation and Development of Traditional Chinese Medicine in Shanghai (2021-2023), No. ZY(2021-2023)-0209-03 (to XXB); Shanghai Young Scientific and Technological Talents Sailing Plan Project, No. 20YF1427400 (to YW); Shanghai Key Clinical Specialty Construction Project, No. SHSLCZDZK04802 (to XXB); “Jiao Tong University Star” Planned Key Medical Engineering Project of Shanghai Jiao Tong University, No. YG2019ZDA16 (to XXB); Shanghai Flagship Hospital Construction Project of Integrated Traditional Chinese and Western Medicine, No. ZY(2021-2023)-0205-01 (to XXB, YW); Shanghai Style TCM School Inheritance and Innovation Team Construction Project, No. 2021LPTD-003 (to XXB)

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摘要：

文题释义：

膏药剂型优化：是指对膏药制剂进行改良或改进，以提高其药效、安全性、透皮吸收性、稳定性、舒适性等方面的性能。优化包括改变膏药的配方、贴剂的材料和结构及调整药物释放速率等，可以使膏药更好地满足治疗需求，并提高患者的治疗体验和依从性。
复方芙蓉叶凝胶膏剂：在国家级非物质文化遗产项目——魏氏伤科正骨疗法的名方“消肿散”基础上，通过对贴膏基质制作工艺的不断优化发展而来，临床上主要用于关节肿胀、疼痛的治疗，目前在上海交通大学医学院附属瑞金医院有几十年临床应用历史。


背景：前期研究证实，新型复方芙蓉叶凝胶膏剂治疗急性软组织肿胀具有良好的效果。

目的：观察复方芙蓉叶凝胶膏剂治疗膝关节滑膜炎的临床疗效。
方法：选择2019年12月至2021年5月上海交通大学医学院附属瑞金医院诊治的膝关节滑膜炎患者72例，采用随机数字表法分为试验组与对照组，每组36例。试验组患者病患处进行复方芙蓉叶凝胶膏剂贴敷治疗，1次/d，12 h/次；对照组患者病患处进行双氯芬酸二乙胺乳胶剂涂抹治疗，2次/d。治疗28 d后，对比两组患者目测类比评分、WOMAC骨关节炎指数评分、SF-36生活质量评分、膝关节滑膜厚度及综合疗效。

结果与结论：①两组患者治疗后的目测类比评分均低于治疗前(P < 0.05)，试验组患者治疗7，14，28 d后的目测类比评分均低于对照组(P < 0.05)；②两组患者治疗后的WOMAC骨关节炎指数评分均低于治疗前(P < 0.05)，试验组患者治疗7，14，28 d后的WOMAC骨关节炎指数评分均低于对照组(P < 0.05)；③两组患者治疗28 d后的SF-36生活质量评分均高于治疗前(P < 0.05)，试验组治疗28 d后的SF-36生活质量评分高于对照组(P < 0.05)；④试验组治疗28 d后的膝关节滑膜厚度小于对照组(P < 0.05)，治疗有效率高于对照组(P < 0.05)；⑤结果表明，与采用双氯芬酸二乙胺乳胶剂相比，新型复方芙蓉叶凝胶膏剂可以更好地缓解膝关节疼痛、改善膝关节功能、减少滑膜增生、提高患者整体生活质量。

https://orcid.org/0000-0002-4353-7970(颜威)

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料；口腔生物材料；纳米材料；缓释材料；材料相容性；组织工程

关键词: 膝关节滑膜炎, 膝关节骨关节炎, 复方芙蓉叶凝胶膏剂, 外治, 膏药, 药物治疗

Abstract: BACKGROUND: Previous studies have confirmed that the new compound cottonrose hibiscus leaf gel plaster has a good effect in the treatment of acute soft tissue swelling.
OBJECTIVE: To observe the clinical efficacy of compound cottonrose hibiscus leaf gel plaster in the treatment of synovitis of the knee joint. 
METHODS: Seventy-two patients with knee synovitis were selected from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from December 2019 to May 2021. These patients were randomly divided into a trial group and a control group, with 36 cases in each group. The trial group was treated with compound cottonrose hibiscus leaf gel plaster, once a day, 12 hours each time, while the control group was treated with Diclofenac Diethylamine Emulgel, twice a day. After 28 days of treatment, visual analog scale score, WOMAC Osteoarthritis Index score, quality of life score (SF-36), thickness of knee synovium and comprehensive curative effect were compared between the two groups. 
RESULTS AND CONCLUSION: (1) Visual analog scale scores after treatment were lower than those before treatment (P < 0.05). Visual analog scale scores in the trial group after 7, 14 and 28 days of treatment were lower than those in the control group (P < 0.05). The WOMAC Osteoarthritis Index scores of the two groups after treatment were lower than those before treatment (P < 0.05), and the WOMAC Osteoarthritis Index scores in the trial group after 7, 14 and 28 days of treatment were lower than those in the control group (P < 0.05). (3) The SF-36 quality of life score in the two groups after 28 days of treatment was higher than that before treatment (P < 0.05). SF-36 quality of life score in the trial group after 28 days of treatment was higher than that in the control group (P < 0.05). (4) After 28 days of treatment, the thickness of knee synovium in the trial group was less than that in the control group (P < 0.05), and the effective rate in the trial group was higher than that in the control group (P < 0.05). (5) These findings indicate that compared with Diclofenac Diethylamine Emulgel, the compound cottonrose hibiscus leaf gel plaster can better relieve knee pain, enhance knee joint function, reduce synovial hyperplasia, and elevate the overall quality of life of patients. 

Key words: knee synovitis, knee osteoarthritis, compound cottonrose hibiscus leaf gel plaster, external treatment, plaster, medicinal treatment

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