观察IntraSPINE椎板间动态稳定系统治疗腰椎退行性疾病的近期疗效及适应证探讨

Observation of the short-term efficacy of IntraSPINE interlaminar dynamic stabilization system in the treatment of lumbar degenerative diseases and discussion of its indications

目的 观察IntraSPINE椎板间动态稳定系统治疗腰椎退行性疾病的近期疗效,探讨其适应证。方法 分析2017年2月~2018年3月28例采用IntraSPINE椎板间动态稳定系统治疗腰椎退行性疾病的手术疗效及近期随访结果(术后1周、3个月、6个月、12个月),采用疼痛视觉模拟评分(VAS)、日常生活能力评分(ODI)、Odom’s评分及患者满意度评价近期手术疗效,测量分析术前、术后手术节段椎间隙高度比及活动度,对比术前与术后腰椎整体活动度变化。结果 术后随访15~27个月,所有患者术后症状均得到不同程度缓解。术后各时间段VAS评分、ODI评分与术前比显著改善,差异有统计学意义(P<0.01)。末次随访Odom’s评分优24例,良3例,可1例,优良率为96.4%。手术节段活动度(range of motion,ROM)术前,术后1周、3个月、6个月、12个月分别为6.6°±2.4°、6.3°±2.4°、6.9°±2.1°、7.1°±1.8°、7.0°±1.6°,术前与术后手术节段活动度差异无统计学意义(P>0.05);术前与术后12个月腰椎整体活动度分别为31.5°±4.7°、32.7°±4.8°,差异无统计学意义(P>0.05)。术后1周椎间隙高度比明显增加,与术前相比差异有统计学意义(P<0.05),3个月后椎间隙高度比逐渐减小至平稳水平,但仍然大于术前。本组患者未出现严重并发症,总体满意度为96.4%。结论 IntraSPINE椎板间动态稳定系统操作简便,手术时间短,出血量少,无棘突骨折等植入物相关并发症,近期疗效确切,中长期临床疗效还需大样本、多中心观察评价。

Objective To observe the short-term efficacy of Intra SPINE interlaminar dynamic stabilization system in the treatment of lumbar degenerative diseases and discuss its indications.Methods Analyzing the operative efficacy and recent follow-up results(1 week,3 months,6 months and 12 months after surgery)of 28 cases of lumbar degenerative diseases treated by Intra SPINE interlaminar dynamic stabilization system from February 2017 to March 2018.The shortterm efficacy of surgery was evaluated by visual analogue score(VAS),the Oswestry disability index(ODI),Odom’s score and patients’satisfaction,the height ratio of intervertebral space and the range of motion(ROM)of Intra SPINE implanted segments were measured and analyzed before and after the operation,and the changes of the overall ROM of the lumbar spine were compared before and after the treatment.Results Postoperative follow-up was 15 to 27 months,all patients postoperative symptoms were relieved to varying degrees.VAS and ODI were significantly improved in different periods after operation,and the difference was statistically significant(P<0.01).There were 24 cases of excellent Odom’s score,3 cases of good,and 1 case of general,with an excellent and good rate of 96.4%.ROM of operative level was 6.6°±2.4°before surgery and 6.3°±2.4°,6.9°±2.1°,7.1°±1.8°and 7.0°±1.6°after 1 week,3 months,6 months,12 months of surgery,with no difference of ROM change(P>0.05).The overall ROM of lumbar spine was 31.5°±4.7°and 32.6°±4.8°,before and 12 months after surgery respectively,with no statistically significant differences(P>0.05).Intervertebral disc height increased significantly 1 week after surgery,difference was statistically significant(P<0.05)compared with the preoperative,and gradually reduced to a steady level after 3 months,greater than that of the preoperative as well.No serious complications occurred in all patients during perioperative,and the overall satisfaction rate was96.4%.Conclusion Intra SPINE interlaminar dynamic stabilization system is simple to operate,with short operative time,low blood loss and no implant-related complications such as spinous process fracture.The short-term efficacy is definite,but the long-term clinical efficacy needs large sample and multi-center observation and evaluation.