脐带间充质干细胞治疗严重膝骨关节炎的对照研究

中国临床药理学与治疗学 ›› 2017, Vol. 22 ›› Issue (3): 305-311.

脐带间充质干细胞治疗严重膝骨关节炎的对照研究

杨孝兵¹，蒋峰¹，张帆1，施星芬¹，刘丽敏¹，徐志国²

¹浙江湖州市第三人民医院风湿免疫科，²协和华东干细胞基因工程有限公司，湖州 313000，浙江

收稿日期:2015-11-26 修回日期:2017-02-13 出版日期:2017-03-26 发布日期:2017-03-29
作者简介:杨孝兵，男，硕士，主治医师，研究方向: 风湿免疫病干细胞治疗。 Tel：15088354361 E-mail：yxb0516@126.com
基金资助:
浙江省湖州市生物医药重大专项计划（2011ZD2007）

Therapeutic effect of human umbilical cord-derived mesenchymal stem cells for severe knee osteoarthritis

YANG Xiaobing ¹, JIANG Feng ¹, ZHANG Fan¹, SHI Xingfen ¹, LIU Limin ¹, XU Zhiguo ²

¹Department of Rheumatology and Immunology, Huzhou Third Municipal Hospital, Huzhou 313000, Zhejiang, China;² Eastern Union Stem Cell and Gene Engineering Co., Ltd. Huzhou 313000, Zhejiang, China

Received:2015-11-26 Revised:2017-02-13 Online:2017-03-26 Published:2017-03-29

摘要/Abstract

摘要：

目的:对照透明质酸钠（sodium hyaluronate or hyaluronic acid,HA）与人源脐带间充质干细胞（human umbilical cord derived mesenchymal stem cells,hUC-MSCs）膝关节腔两种注射方法治疗中重度膝骨关节炎(osteoarthritis，OA)，观察关节疼痛、功能的疗效、放射学变化以及安全性。方法:采用随机半盲平行对照的研究方法，将44例中重度膝骨关节炎的患者分为3组：A组16例，5次透明质酸钠注射组；B组15例，2次hUC-MSCs注射组；C组13例，4次hUC-MSCs注射组。观察指标：静止VAP评分，美国膝关节协会 (AKS)的膝骨关节炎关节性和功能性评分，Kellgren-Lawrence（K-L）放射学评估。随访期12个月，治疗前和治疗后3、6、12个月进行随访记录临床体检、观察指标结果及安全性评估；治疗前和治疗后6、12个月进行实验室检查和膝关节X片检查。结果: 3组治疗前比较，静止VAP评分、AKS关节性评分、AKS功能评分、K-L放射学评估均无统计学差异（P＞0.05）。治疗后3、6、12个月时，3组间静止VAP评分、AKS关节性评分、AKS功能评分比较均有统计学差异（P＜0.05，P＜0.01）；K-L放射学评估各时段各组间比较差异均无统计学意义（P＞0.05）。结论:hUC-MSCs移植治疗严重OA较透明质酸钠能更快速、更显著、更持久地减轻关节疼痛、改善关节功能，4次注射疗效优于2次注射。

关键词: 骨关节炎, 脐带间充质干细胞, 透明质酸钠

Abstract:

AIM: To explore the therapeutic effect of two methods of knee joint cavity injection in treating sodium hyaluronate and human umbilical cord-derived mesenchymal stem cells for severe knee osteoarthritis by evaluating pain degree, clinical effect, radiological change, and safety. METHODS: In this semi-blind parallelling study, 44 severe knee osteoarthritis patients were randomly divided into 3 groups. 16 patients in group A were injected with sodium hyaluronate 5 times individually. 15 patients in group B were injected with human umbilical cord-derived mesenchymal stem cells twice. 13 patients in group C were injected with human umbilical cord-derived mesenchymal stem cells 4 times. VAP scores, American Knee Society Knee scores, and Kellgren-Lawrence radiographic evaluation were evaluated. Follow-up were conducted 3, 6 and 12 months after treatment for recording clinical examination, evaluating observed indicators and safety assessment. Laboratory tests and X-ray examination of the knee were checked 6 and 12 months after treatment independently. RESULTS: VAP scores: significant difference were found in three groups before and 3, 6, 12 months after treatment; results showed that there were significant difference in group A 12 months after treatment comparing with group B and group C. AKS scores: significant difference were found in group B and group C before and 3, 6, 12 months after treatment; AKS Function: significant difference were found in group B and group C before and 3, 6, 12 months after treatment; Kellgren-Lawrence radiographic evaluation: no significant difference were found during the study. CONCLUSION: Comparing with sodium hyaluronate injection, the therapeutic effect of human umbilical cord-derived mesenchymal stem cells for severe knee osteoarthritis was more effective in relieving pain and improving joint function. Four times injections are better than two times injection.

Key words: osteoarthritis, human umbilical cord derived mesenchymal stem cells, sodium hyaluronate

中图分类号:

R684.3

杨孝兵，蒋峰，张帆，施星芬，刘丽敏，徐志国. 脐带间充质干细胞治疗严重膝骨关节炎的对照研究[J]. 中国临床药理学与治疗学, 2017, 22(3): 305-311.

YANG Xiaobing, JIANG Feng, ZHANG Fan, SHI Xingfen, LIU Limin, XU Zhiguo. Therapeutic effect of human umbilical cord-derived mesenchymal stem cells for severe knee osteoarthritis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(3): 305-311.

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