身痛逐瘀汤治疗腰椎间盘突出症疗效和安全性的系统评价和Meta分析

评价身痛逐瘀汤治疗腰椎间盘突出症(lumbar disc herniation,LDH)的临床有效性和安全性,为其临床应用提供循证依据。系统检索PubMed,Cochrane Library,EMbase,CNKI,WanFang,VIP,CBM,Clinical Trials.gov数据库,2位评价者独立检索、筛选文献、提取数据,纳入符合该研究的身痛逐瘀汤治疗LDH的随机对照试验。文献质量评估采用Cochrane Handbook中的偏倚风险工具,最后采用RevMan 5.3进行整合分析。检索共获得604篇文献,通过筛选最终纳入9项研究824例患者,疗程1个月左右,所有研究均在国内开展完成。Meta分析结果显示身痛逐瘀汤加减(RR=1.19,95%CI1.12,1.26],P<0.00001)治疗腰椎间盘突出症有效率明显优于对照组,包括对比腰痛宁胶囊(RR=1.10,95%CI1.02,1.19],P=0.01)和双氯芬酸钠缓释片(RR=1.26,95%CI1.11,1.44],P=0.0004);在改善疼痛VAS评分方面,身痛逐瘀汤加减对比对照组具有明显优势(MD=-3.70,95%CI-6.31,-1.09],P=0.005)。此外,身痛逐瘀汤加减治疗发生的不良事件例数较对照组更少。身痛逐瘀汤加减能够有效缓解腰椎间盘突出症患者的不适症状,具有明显的临床疗效,且不良事件发生较少,但受纳入研究质量及方法学的限制,仍需要开展前瞻性、多中心、大样本的随机对照试验进一步提升临床证据。

Efficacy and safety of Shentong Zhuyu Decoction for lumbar disc herniation:systematic review and Meta-analysis

To evaluate the clinical efficacy and safety of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation,in order to provide evidence for its clinical application.PubMed,Cochrane Library,EMbase,CNKI,WanFang,VIP,CBM and Clinical Trials.gov databases were sysmatically retrieved.Two researchers independently searched,screened and extracted data.Randomized controlled trials in line with the inclusion criteria were included in the study.The article quality was assessed with the bias risk tool in the Cochrane Handbook.Meta-analysis was performed using RevMan 5.3.A total of 604 articles were obtained from the retrieval,and 824 patients in 9 studies were finally selected through screening.The course of treatment was about 1 month,and all of the studies were completed in China.Meta-analysis showed that the efficacy of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation was better than that of the control group(RR=1.19,95%CI1.12,1.26],P<0.00001),including the comparison with Yaotongning Capsules(RR=1.10,95%CI1.02,1.19],P=0.01)and diclofenac sodium tablets(RR=1.26,95%CI1.11,1.44],P=0.0004).In VAS pain score,Shentong Zhuyu Decoction had also obvious advantages(MD=-3.70,95%CI-6.31,-1.09],P=0.005).In addition,the number of adverse events in the Shentong Zhuyu Decoction group was lower than that in the control group.Shentong Zhuyu Decoction can effectively alleviate discomfort symptoms of patients with LDH.It has an obvious clinical efficacy and less adverse reactions.However,restricted by the quality of the included literatures,prospective,multi-center,large-sample-size randomized controlled trials are still needed to further improve the clinical evidence of the effect of Shentong Zhuyu Decoction in the treatment of LDH.