针刀治疗腰椎间盘突出症的系统评价

目的运用循证医学方法系统评价针刀治疗腰椎间盘突出症的有效性及安全性。方法采用Cochrane系统评价方法 ,电子检索MEDLINE、EMBASE、Cochrane图书馆临床对照试验资料库、中国生物医学文献数据库、中国期刊全文数据库、重庆维普数据库、万方数据库等,手工检索相关中医学术期刊,有关学术会议已发表与未发表的相关文献。纳入治疗组采用针刀治疗、对照组采用非针刀疗法的随机对照试验。由2名评价者独立选择试验、提取资料、交叉核对和进行方法学质量评估。统计分析采用RevMan4.2软件进行。结果共13个针刀治疗腰椎间盘突出症的临床随机对照试验符合纳入标准,仅有2篇高质量研究文献。针刀治疗腰椎间盘突出症近期疗效汇总:OR=3.17(95%CI:2.58～3.90),Z=10.93,P0.00001。远期疗效汇总:OR=6.48(95%CI:4.64～9.06),Z=10.95,P0.00001。复发率汇总:OR=0.56(95%CI:0.31～1.01),Z=1.91,P=0.06。结论目前有限的纳入研究初步显示针刀治疗腰椎间盘突出症安全,在改善症状、提高整体功能等方面均较对照组有效,但因本系统评价纳入研究的方法学质量较低,例数较少,且诊断标准、随访时间、结果测量指标和判效标准等均不一致,因此需要开展设计合理、执行严格的大样本、多中心和方法科学、规范的高质量随机对照试验进一步验证其疗效及安全性。

Systematic Review of Needle-knife Therapy for Lumbar Intervertebral Disc Protrusion

Objective To evaluate the efficacy and safety of needle-knife therapy for lumbar intervertebral disc protrusion. Methods MEDLINE, EMBASE, The Cochrane Library, PubMed, VIP, CNKI and CBM were retrieved to identify randomized controlled trials of needle-knife therapy versus control for lumbar intervertebral disc protrusion. The quality of included studies was critically assessed and data analysis were performed with Cochrane Collaboration’s RevMan4.2. Results Thirteen studies of needle-knife treatment for lumbar disc herniation were included. Only two studies were high quality. Meta-analyses showed that the short-term effect OR=3.17, 95%CI 2.58～3.90, Z=10.93, P〈0.000 01, long-term effect OR=6.48, 95%CI 4.64～9.06. Z=10.95, P〈0.000 01, and relapse rate OR=0.56, 95%CI 0.31～1.01. Z=1.91, P=0.06. Conclusion Needle-knife therapy is effective in the treatment of lumbar intervertebral disc protrusion, but its superiority over control is not demonstrated due to the poor quality and small sample of the included trials. More large-scale, multi-center, well-designed, scientific method to standardize the quality of randomized controlled trials are needed.