Evaluation of the efficacy and safety evaluation of the epidural adhesion closure and release device in the treatment of FBSS
丁学琛 1任格 1展利东 2路玲玲 2赵晓东 2吴照凤 2满飒 2王理康2
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作者信息
1. 山西中医药大学,山西 晋中 030619
2. 解放军总医院第三医学中心 康复医学科,北京 100039
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摘要
目的 观察计算机断层扫描(computed tomography,CT)引导下硬膜外粘连闭合松解器治疗腰椎手术失败综合征(failed back surgery syndrome,FBSS)的临床疗效及安全性.方法 选取解放军总医院第三医学中心骨科和康复医学科就诊的FBSS患者80例,根据随机数字表法分为治疗组和对照组,各40例.治疗组采用硬膜外粘连闭合松解器治疗,1次/周,第2次治疗在第1次治疗2周后进行,共治疗2次;对照组予低频治疗,每次30 min,3次/周,共治疗2周,治疗结束后对比两组疗效.治疗前和治疗后1个月、3个月、6个月采用视觉模拟评分法(visual analogue scale,VAS)、改良Oswestry功能障碍指数(Oswestry disability index,ODI)和健康调查简表(the MOS item short from health survey,SF-36)进行评定,同时填写不良事件表进行安全性研究.结果 治疗6个月后,两组患者VAS评分及ODI评分均较治疗前降低(P<0.01),且治疗组显著优于对照组(P<0.01);对于SF-36评分,治疗6个月后,除对照组情感职能维度外,两组各维度均较治疗前显著改善(P<0.01),且在生理功能维度治疗组改善优于对照组(P<0.05),其余各维度治疗组改善显著优于对照组(P<0.01).研究过程中仅治疗组发生晕针1例,两组均无严重不良反应发生(P>0.05).结论 CT引导下硬膜外粘连闭合松解器治疗FB-SS疗效确切,不良事件发生率低,可显著减轻FBSS患者疼痛程度,改善功能障碍.
Abstract
Objective To observe the clinical efficacy and safety of CT-guided epidural adhesion closure release device in the treatment of failed back surgery syndrome(FBSS).Methods A total of 80 patients with FBSS from the Department of Orthopedics and Rehabilitation Medicine(Pain)of the Third Medical Center of PLA General Hospital were randomly divided into treatment group and control group,with 40 cases in each group.The treatment group was treated with an epidural adhesion closure release device 1 time/week,and the second treatment was carried out two weeks after the first treatment,with a total of 2 treatments;The control group was conducted with low frequency treatment for 30 min each time,3 times/week,for a total of 2 weeks.After treatment,the efficacy of the two groups was compared.Before treatment and at 1,3 months and 6 months after treatment,VAS score,modified ODI scale and SF-36 scale were used for assessment,and adverse event tables were filled in for safety studies.Results After 6 months of treatment,VAS scores and ODI scores of patients in both groups were lower than before treatment(P<0.01),and the treatment group was significantly better than the control group(P<0.01);for SF-36 scores,after 6 months of treatment,except for the control group's affective functioning dimension,all dimensions were significantly improved in both groups compared with the pre-treatment period(P<0.01),and in the physiological functioning dimension,the improvement in the treatment group was better than that of the In the physiological function dimension,the treatment group improved better than the control group(P<0.05),and in the remaining dimensions,the treatment group improved significantly better than the control group(P<0.01).Only one case of needle-sickness occurred in the treatment group during the study,and no serious adverse reactions occurred in both groups(P>0.05).Conclusions CT-guided epidural closure release device has a definite efficacy in the treatment of FBSS,and the incidence of adverse events is low,which can significantly reduce rhe degree of pain and improve dysfunction in FBSS patients.
关键词
松解器/腰椎手术失败综合征/计算机断层扫描引导
Key words
Release device/Failed back surgery syndrome/Computed tomography-guided
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