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人脐带间充质干细胞关节腔内注射治疗退行性膝关节骨关节炎的疗效

[CURATIVE EFFECT OF HUMAN UMBILICAL CORD MESENCHYMAL STEM CELLS BY INTRA-ARTICULAR INJECTION FOR DEGENERATIVE KNEE OSTEOARTHRITIS].

作者信息

Wang Yali, Jin Wenxiao, Liu Haiyan, Cui Yuhua, Mao Qingcong, Fei Zhongying, Xiang Chunsheng

机构信息

Medicine School of Zhejiang University, Hangzhou Zhejiang, 310058, P. R. China.

Biological Therapy Center of Zhejiang Armed Police Corps Jiaxing Hospital.

出版信息

Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2016 Dec 8;30(12):1472-1477. doi: 10.7507/1002-1892.20160305.

DOI:10.7507/1002-1892.20160305
PMID:29786336
Abstract

OBJECTIVE

To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells (MSCs) by intra-articular injection for degenerative knee osteoarthritis.

METHODS

Between January 2015 and January 2016, 36 patients with moderate or severe degenerative knee osteoarthritis were randomly devided into 2 groups (=18). Intra-articular injection of 2.5-3.0 mL human umbilical cord MSCs suspension containing (2-3)×10 cells was performed once a month for 2 times as a course of treatment in the cell treatment group; sodium hyaluronate by intra-articular injection was used once a week for 5 times as a course of treatment in the control group. There was no significant difference in gender, age, body mass index, side, stage of osteoarthritis, course of disease, and preoperative Lysholm score of the knee joint, the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and SF-36 scale score between 2 groups (>0.05). The clinical efficacy was evaluated by SF-36 scale score, Lysholm score, and WOMAC score.

RESULTS

All patients of 2 groups received a course of treatment. The patients were followed up for 6 months. After injection, the incidences of pain and swelling in the cell treatment group were significantly higher than those in the control group (=16.200, =0.000; =11.688, =0.000), but no significant difference was found in the incidence of effusion (=2.118, =0.146). In the cell treatment group, Lysholm score at 1-6 months after treatment, WOMAC score and SF-36 scale score at 2-6 months after treatment were significantly better when compared with scores before treatment (<0.05), and no recurrence of knee pain was observed during follow-up. In the control group, there was no significant difference in Lysholm score and SF-36 scale score between pre- and post-treatment (>0.05); there were significant differences in WOMAC score between pre-treatment and at 1, 2, 3 months after treatment (<0.05); at 3 months after treatment, 11 patients had joint pain symptoms again. No significant difference was found in the knee joint function score and SF-36 scale score at 1 and 2 months after treatment between 2 groups (>0.05), but the scores of the cell treatment group were significantly better than those of the control group at 3 and 6 months (<0.05).

CONCLUSIONS

It can significantly improve the joint function and quality of life to use intra-articular injection of human umbilical cord MSCs for treating degenerative knee osteoarthritis. It takes effect after 1 month and the treatment effect can be sustained for 6 months.

摘要

目的

探讨关节腔内注射人脐带间充质干细胞(MSCs)治疗退行性膝关节骨关节炎的安全性和有效性。

方法

2015年1月至2016年1月,将36例中重度退行性膝关节骨关节炎患者随机分为2组(每组 = 18例)。细胞治疗组每月进行1次关节腔内注射2.5 - 3.0 mL含(2 - 3)×10⁶个细胞的人脐带MSCs悬液,共注射2次作为1个疗程;对照组每周进行1次关节腔内注射透明质酸钠,共注射5次作为1个疗程。两组患者在性别、年龄、体重指数、患侧、骨关节炎分期、病程以及术前膝关节Lysholm评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)、SF - 36量表评分方面差异均无统计学意义(P > 0.05)。采用SF - 36量表评分、Lysholm评分及WOMAC评分评估临床疗效。

结果

两组患者均接受1个疗程治疗。随访6个月。注射后,细胞治疗组疼痛和肿胀的发生率显著高于对照组(χ² = 16.200,P = 0.000;χ² = 11.688,P = 0.000),但积液发生率差异无统计学意义(χ² = 2.118,P = 0.146)。细胞治疗组治疗后1 - 6个月的Lysholm评分、治疗后2 - 6个月的WOMAC评分及SF - 36量表评分与治疗前比较差异有统计学意义(P < 0.05),随访期间未观察到膝关节疼痛复发。对照组治疗前后Lysholm评分及SF - 36量表评分差异无统计学意义(P > 0.05);治疗前与治疗后1、2、3个月的WOMAC评分差异有统计学意义(P < 0.05);治疗后3个月,11例患者再次出现关节疼痛症状。两组治疗后1、2个月膝关节功能评分及SF - 36量表评分差异无统计学意义(P > 0.05),但细胞治疗组治疗后3、6个月的评分显著优于对照组(P <  0.05)。

结论

关节腔内注射人脐带MSCs治疗退行性膝关节骨关节炎可显著改善关节功能和生活质量。治疗1个月后起效,治疗效果可持续6个月。

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