中国组织工程研究

中国组织工程研究 ›› 2019, Vol. 23 ›› Issue (10): 1540-1545.doi: 10.3969/j.issn.2095-4344.1597

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复方芙蓉叶凝胶膏剂工艺优化及临床疗效与安全性的验证

颜 威1，2，3，罗仕华1，贾友冀1，奚小冰1，2，3，李中伟3   

  1. 1上海交通大学医学院附属瑞金医院，上海市 200025；2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；3上海市伤骨科研究所，上海市 200025
  • 收稿日期:2018-11-05 出版日期:2019-04-08 发布日期:2019-04-08
  • 通讯作者: 李中伟，副主任医师，上海市伤骨科研究所，上海市 200025
  • 作者简介:颜威，男，1992年生，江苏省人，汉族，上海交通大学医学院在读硕士，主要从事骨与关节损伤的研究。
  • 基金资助:

    上海市进一步加快中医药事业发展三年行动计划(ZY3-JSFC-2-2009)，项目负责人：李中伟；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事业发展三年行动计划(2018年-2020年)(ZY-(2018-2020)-CCCX-1011)，项目负责人：奚小冰

Process optimization of compound cotton rose hibiscus leaf ointment and its clinical efficacy and safety verification

Yan Wei1, 2, 3, Luo Shihua1, Jia Youji1, Xi Xiaobing1, 2, 3, Li Zhongwei3   

  1. 1Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; 2Shanghai Key Laboratory of Prevention and Treatment of Bone and Joint Diseases, Shanghai 200025, China; 3Shanghai Institute of Traumatology and Orthopedics, Shanghai 200025, China
  • Received:2018-11-05 Online:2019-04-08 Published:2019-04-08
  • Contact: Li Zhongwei, Associate chief physician, Shanghai Institute of Traumatology and Orthopedics, Shanghai 200025, China
  • About author:Yan Wei, Master candidate, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; Shanghai Key Laboratory of Prevention and Treatment of Bone and Joint Diseases, Shanghai 200025, China; Shanghai Key Laboratory of Prevention and Treatment of Bone and Joint Diseases, Shanghai 200025, China; Shanghai Institute of Traumatology and Orthopedics, Shanghai 200025, China
  • Supported by:

    Shanghai’s Three-Year Action Plan for Further Accelerating the Development of Traditional Chinese Medicine, No. ZY3-JSFC-2-2009 (to LZW); the Chinese Medicine Research Project of Shanghai Municipal Health and Family Planning Commission, No. 2018LP025 (to LZW); Shanghai’s Three-Year Action Plan for Further Accelerating the Development of Traditional Chinese Medicine (2018-2020), No. ZY-(2018-2020)-CCCX-1011 (to XXB)

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摘要：

文章快速阅读：

 

文题释义：
复方芙蓉叶凝胶膏剂：是在上海交通大学医学院附属瑞金医院使用40余年的传统伤科名方“消肿散”基础上，通过对贴膏黏着剂和骨架材料不断优化发展而来一种新型外用贴膏，这种优化改良可以在不改变疗效的前提下，使传统膏药的应用更加广泛。通过复方芙蓉叶凝胶膏剂与复方紫荆消伤巴布膏在治疗急性软组织损伤的对比研究中，发现复方芙蓉叶凝胶膏剂和复方紫荆消伤巴布膏都具有良好的疗效并且复方芙蓉叶凝胶膏剂稍优于复方紫荆消伤巴布膏，证实了复方芙蓉叶凝胶膏剂具有良好的临床疗效与安全性。
 
 
背景：复方芙蓉叶凝胶膏剂是在传统伤科名方“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。“消肿散”在上海交通大学医学院附属瑞金医院使用已超过40年，具有良好的临床疗效。
目的：通过对制作工艺优化后的复方芙蓉叶凝胶膏剂的临床研究，验证其临床疗效与安全性，为其治疗急性软组织损伤的应用奠定基础。
方法：将112例急性软组织损伤患者按随机数字表法分为试验组55例和对照组57例，试验组选用复方芙蓉叶凝胶膏剂，对照组选用复方紫荆消伤巴布膏。

结果与结论：①2组在治疗前、治疗第3天、治疗第7天以及治疗后的疼痛、压痛、肿胀、功能障碍等主要指标以及瘀斑、失眠、口干、便秘、舌苔、脉象等次要指标方面差异无显著性意义(P > 0.05)；②2组在治疗急性软组织损伤方面都具有明显的疗效，但2组临床疗效差异无显著性意义(P > 0.05)；③2组在血尿便常规以及肝肾功能方面都未见明显异常，④在并发症方面仅有5例轻微皮肤过敏，其中试验组2例，对照组3例；⑤结果说明复方芙蓉叶凝胶膏剂具有良好的临床疗效与安全性，值得临床推广应用。

ORCID: 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: 急性, 软组织, 损伤, 复方芙蓉叶, 凝胶膏剂, 工艺优化, 临床研究, 安全性, 生物材料

Abstract:

BACKGROUND: Compound cotton rose hibiscus leaf ointment is developed from the continuous optimization of the preparation process of traditional famous prescription “Xiaozhong San”. Xiaozhong San has been used in Ruijin Hospital Affiliated to School of Medicine of Shanghai Jiaotong University for over 40 years and has achieved good clinical outcomes.

OBJECTIVE: To verify the clinical efficacy and safety of compound cotton rose hibiscus leaf ointment, laying a foundation for its popularization and application in the treatment of acute soft tissue injury.
METHODS: 112 cases of acute soft tissue injury were divided into trial group (n=55) and control group (n=57) according to the random number table method. The experimental group selected the compound cotton rose hibiscus leaf ointment, and the control group selected the compound Zijing ointment.
RESULTS AND CONCLUSION: (1) There were no statistical differences in the primary outcomes, such as pain, tenderness, swelling, dysfunction and in the secondary outcomes, such as ecchymosis, insomnia, dry mouth, constipation, tongue coating and pulse condition, between the two groups before treatment, at 3 and 7 days of treatment and after treatment termination (P > 0.05). (2) The two groups achieved obvious clinical outcomes in the treatment of acute soft tissue injury, but there was no difference in the clinical efficacy between the two groups (P > 0.05). (3) The two groups had no obvious abnormalities in the routine of hematuria and stool and the function of the liver and kidney. (4) There were only five cases of mild skin allergy, including two cases in the trial group and three cases in the control group. To conclude, the compound cotton rose hibiscus leaf ointment has good clinical efficacy and safety, which is worthy of clinical application.

Key words: Soft Tissue Injuries, Ointments, Tissue Engineering

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