硬膜外注射与不注射类固醇治疗腰椎间盘突出症的临床疗效比较:系统评价和荟萃分析。
Comparison of Clinical Efficacy of Epidural Injection With or Without Steroid in Lumbosacral Disc Herniation: A Systematic Review and Meta-analysis.
机构信息
Department of Physical Medicine and Rehabilitation, Wooridul Spine Hospital, Seoul.
Department of Physical and Rehabilitation Medicine, College of Medicine, Kyung Hee University Hospital, Seoul, South Korea.
出版信息
Pain Physician. 2018 Sep;21(5):449-468.
BACKGROUND
Epidural injection is performed for treatment of back and radicular pain in patients with lumbosacral disc herniation (LDH). Steroids are usually administered to effectively remove inflammatory mediators, and local anesthetics or saline also contribute to pain reduction by washing out chemical mediators or blocking the nociceptor activity. Controversy exists regarding whether steroids produce superior clinical effects compared with local anesthetics or saline.
OBJECTIVES
This study investigated whether epidural injection of steroids produces better clinical effects than local anesthetics or saline in the treatment of LDH.
STUDY DESIGN
A literature search was performed in MEDLINE, EMBASE, Cochrane review, and KoreaMed for studies published from January 1996 until July 2017. From among the studies fulfilling the search criteria, those that compared the clinical efficacy of steroids and control agents, such as local anesthetics or saline, in terms of pain control and functional improvement were included in this study. Exclusion criteria included a previous history of lumbosacral surgery, non-specific low back pain, severe spinal stenosis, and severe disc degeneration.
SETTING
A systematic review and meta-analysis using a random effects model on randomized controlled studies (RCTs).
METHODS
After reviewing titles, abstracts, and full texts of 6,711 studies that were chosen following removal of duplicates after the initial database search, 15 randomized controlled studies were included in our qualitative synthesis. Data including pain score, functional score, and follow-up period were extracted from 14 studies and analyzed using a random effects model to calculate the effect size and its corresponding statistical significance. Quality and level of evidence were established in accordance with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
RESULTS
Steroids and local anesthetics were shown to be effective. Steroid showed significantly better pain control than control agents at 1 month, 3 months, and 6 months. The superiority of steroid in pain control was more prominent at one month, but diminished from 3 months to 1 year, showing no significant superiority in terms of mean difference, With respect to functional score, no significant difference was observed between steroids and control agents. The subgroup analysis showed that steroid revealed significant superiority in pain and functional score at 1 month to saline rather than local anesthetics. Generally, the quality of included studies was evaluated as high-grade, but the evidence level was determined to be moderate, due to inconsistencies.
LIMITATION
Analyses of safety or adverse effects could not be performed due to a lack of available data from the included studies.
CONCLUSIONS
Steroid is recommended over local anesthetics or saline for pain control in patients with LDH, with a weak strength of recommendation. The superiority of steroids was remarkable, especially at relatively short-term follow-ups, and maintained until the 1 year follow-up. The clinical benefits of steroids at 1 month were more prominent when compared with saline, than when compared with local anesthetics.
KEY WORDS
Steroid, local anesthetics, saline, epidural injection, pain, function, meta-analysis, systemic review.
背景
硬膜外注射用于治疗腰骶椎间盘突出症(LDH)患者的背痛和神经根痛。通常给予类固醇以有效去除炎症介质,局部麻醉剂或生理盐水通过冲洗化学介质或阻断伤害感受器活动也有助于减轻疼痛。关于类固醇是否比局部麻醉剂或生理盐水产生更好的临床效果存在争议。
目的
本研究旨在探讨硬膜外注射类固醇是否比局部麻醉剂或生理盐水在治疗 LDH 方面具有更好的临床效果。
研究设计
在 MEDLINE、EMBASE、Cochrane 综述和 KoreaMed 中进行了文献检索,以检索 1996 年 1 月至 2017 年 7 月发表的研究。从符合搜索标准的研究中,纳入了比较类固醇和对照剂(如局部麻醉剂或生理盐水)在疼痛控制和功能改善方面的临床疗效的研究。排除标准包括既往腰骶部手术史、非特异性腰痛、严重椎管狭窄和严重椎间盘退变。
设置
使用随机效应模型对随机对照研究(RCT)进行系统评价和荟萃分析。
方法
在对初次数据库搜索后去除重复项后选择的 6711 项研究的标题、摘要和全文进行审查后,15 项随机对照研究被纳入我们的定性综合分析。从 14 项研究中提取包括疼痛评分、功能评分和随访期在内的数据,并使用随机效应模型进行分析,以计算效应大小及其相应的统计学意义。根据推荐评估、制定和评估(GRADE)方法学确定质量和证据水平。
结果
类固醇和局部麻醉剂均有效。类固醇在 1 个月、3 个月和 6 个月时的疼痛控制明显优于对照组。类固醇在疼痛控制方面的优势在 1 个月时更为明显,但从 3 个月到 1 年时减弱,在平均差异方面没有显著优势。关于功能评分,类固醇与对照组之间没有观察到差异。亚组分析显示,类固醇在 1 个月时对盐水的疼痛和功能评分显示出显著优势,而不是局部麻醉剂。一般来说,由于不一致性,纳入研究的质量被评估为高级别,但证据水平被确定为中级。
局限性
由于纳入研究缺乏可用数据,因此无法进行安全性或不良反应分析。
结论
对于 LDH 患者,建议使用类固醇代替局部麻醉剂或生理盐水进行疼痛控制,推荐强度较弱。类固醇的优势明显,特别是在相对短期的随访中,并且一直持续到 1 年的随访。类固醇在 1 个月时与盐水相比,与局部麻醉剂相比,其临床获益更为显著。
关键词
类固醇、局部麻醉剂、生理盐水、硬膜外注射、疼痛、功能、荟萃分析、系统评价。