脐带间充质干细胞治疗严重膝骨关节炎的对照研究  

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

作　　者：杨孝兵[1] 蒋峰[1] 张帆[1] 施星芬[1] 刘丽敏[1] 徐志国 

机构地区：[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

出　　处：《中国临床药理学与治疗学》2017年第3期305-311,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：浙江省湖州市生物医药重大专项计划(2011ZD2007)

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,h UC-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h UC-MSCs注射组;C组13例,4次h UC-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:h UC-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。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.

关 键 词：骨关节炎 脐带间充质干细胞 透明质酸钠 

分 类 号：R684.3[医药卫生—骨科学]