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生物融合器治疗非融合高风险患者单节段腰椎退行性疾病的疗效:一项至少随访2年的前瞻性对照研究

Efficacy of Biocage in treating single-segment lumbar degenerative disease in patients with high risk of non-fusion: a prospective controlled study with at least 2 years' follow-up.

作者信息

Li Yang, Yu Yang, Hou Tian-Yong, Zhang Ze-Hua, Xing Jun-Chao, Lu Hong-Wei, Zhou Rui, Cheng Peng, Xu Jian-Zhong, Wu Wen-Jie, Luo Fei

机构信息

National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.

Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.

出版信息

J Int Med Res. 2020 Sep;48(9):300060520945500. doi: 10.1177/0300060520945500.

Abstract

OBJECTIVE

To evaluate the clinical efficacy of an allogeneic bone cage (Biocage; Beijing Datsing Bio-Tech Co., Ltd., Beijing, China) for treatment of single-segment lumbar degenerative disease in patients with a high risk of non-fusion.

METHODS

From January 2013 to December 2016, 67 patients who underwent lumbar fusion were divided into the Biocage group (n = 33) and polyether ether ketone (PEEK) group (n = 34). The patients were followed up for 24 to 48 months. The mean intervertebral height of the fusion level, fusion rate, height of the intervertebral foramen, visual analog scale score, and Oswestry disability index were compared.

RESULTS

The PEEK group had a lower fusion rate than the Biocage group (88.24% vs. 90.91%), although the difference was not statistically significant. During follow-up, the height of the intervertebral space was similar between the Biocage and PEEK groups (12.88 ± 0.45 and 12.84 ± 1.01 mm, respectively). The height of the intervertebral foramen was larger in the Biocage than PEEK group (20.67 ± 1.34 vs. 20.00 ± 2.05 mm). Good clinical efficacy was achieved in both groups.

CONCLUSION

The Biocage is efficient and safe for treatment of single-segment lumbar degenerative disease in patients with a high risk of non-fusion.

摘要

目的

评估同种异体骨笼(生物骨笼;北京大津生物科技有限公司,中国北京)治疗非融合高风险患者单节段腰椎退行性疾病的临床疗效。

方法

2013年1月至2016年12月,67例行腰椎融合术的患者被分为生物骨笼组(n = 33)和聚醚醚酮(PEEK)组(n = 34)。对患者进行24至48个月的随访。比较融合节段的平均椎间隙高度、融合率、椎间孔高度、视觉模拟评分和Oswestry功能障碍指数。

结果

PEEK组的融合率低于生物骨笼组(88.24%对90.91%),尽管差异无统计学意义。随访期间,生物骨笼组和PEEK组的椎间隙高度相似(分别为12.88±0.45和12.84±1.01mm)。生物骨笼组的椎间孔高度大于PEEK组(20.67±1.34对20.00±2.05mm)。两组均取得了良好的临床疗效。

结论

生物骨笼治疗非融合高风险患者单节段腰椎退行性疾病有效且安全。

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