火针治疗神经性皮炎的Meta分析及GRADE证据质量评价

Meta-analysis and GRADE Evidence Quality Evaluation of Fire Acupuncture in the Treatment of Neurodermatitis

目的:运用Meta分析系统评价火针治疗神经性皮炎的临床疗效。方法:计算机检索中国期刊全文数据库(CNKI)、重庆维普(VIP)、万方数据库(WanFang)、中国生物医学文献数据库(CBM)及Pubmed、Cochrane library等中英文数据库,时限设定为建库-2023年2月28日,检索火针治疗神经性皮炎的随机对照试验(Randomized controlled,RCT)相关文献。运用Cochrane风险偏倚评估工具对纳入研究的文献质量评估,再运用Revman5.4软件进行Meta分析,运用TSA0.9.5.10软件进行试验序贯分析,使用GRADE软件对主要结局指标的证据进行证据质量评级。结果:①共纳入18篇研究,1 662例患者,火针组840例,对照组822例;②Meta分析结果显示:火针组的临床有效率[OR=3.99,95%CI(2.81,5.68),Z=7.71,P<0.00 001]、复发率[OR=0.27,95%CI(0.11,0.68),Z=2.79,P=0.005)]均优于对照组;症状积分[MD=-1.49,95%CI(-2.25,-0.73),Z=3.85,P=0.0 001]、TNF-α水平[MD=-4.26,95%CI(-7.01,-1.51),Z=3.03,P=0.002]、IL-6水平[MD=-7.39,95%CI(-14.36,-0.42),Z=2.08,P=0.04]、IL-4水平[MD=-1.50,95%CI(-1.94,-1.06),Z=6.69,P<0.00 001]方面火针组均低于对照组;③火针组不良反应率整体低于对照组;④试验序贯分析显示:累计Z值穿过了传统界值和TSA界值,表示虽然累计的信息量未达到期望值,但不需要更多的试验,提前得到肯定的结论,结果较为可靠。结论:火针治疗神经性皮炎的具有明确的疗效,在症状积分和TNF-α、IL-6、IL-4水平表达等方面效果均优于对照组,安全性也较高,可为中医外治法治疗神经性皮炎的有效性提供相关证据。但因GRADE证据质量评级显示证据质量不理想,建议后续医务工作者可减少开展火针治疗神经性皮炎相关低质量试验,开展一些多中心、高质量的研究对结果加以佐证,从而避免科研和医疗资源的浪费。

Objective To evaluate the clinical efficacy of fire acupuncture in the treatment of neurodermatitis using Meta-analysis system.Methods Chinese and English databases including CNKI,VIP,WanFang,CBM,Pubmed,and Cochrane Library were searched from their inception to February 28,2023,for randomized controlled trials(RCTs)related to fire needling in the treatment of neurodermatitis.The Cochrane risk of bias assessment tool was used to assess the quality of the included studies.Meta-analysis was performed using Revman 5.4 software,and trial sequential analysis(TSA)was conducted using TSA 0.9.5.10 software.The evidence quality of the primary outcome measures was assessed using GRADE software.Results①A total of 18 studies involving 1662 patients,with 840 in the fire needling group and 822 in the control group,were included.②The results of the meta-analysis showed that the clinical effective rate[OR=3.99,95%CI(2.81,5.68),Z=7.71,P<0.00001]and recurrence rate[OR=0.27,95%CI(0.11,0.68),Z=2.79,P=0.005in the fire needling group were superior to those in the control group.In terms of symptom score[MD=-1.49,95%CI(-2.25,-0.73),Z=3.85,P=0.0001],TNF-αlevel[MD=-4.26,95%CI(-7.01,-1.51),Z=3.03,P=0.002],IL-6 level[MD=-7.39,95%CI(-14.36,-0.42),Z=2.08,P=0.04],and IL-4 level[MD=-1.50,95%CI(-1.94,-1.06),Z=6.69,P<0.000001],the fire needling group was lower than the control group.③The overall rate of adverse reactions in the fire needling group was lower than that in the control group.④The trial sequential analysis showed that the cumulative Z-curve crossed the conventional and TSA boundaries,indicating that although the cumulative information did not reach the required sample size,further trials were not necessary,and a definitive conclusion could be made with reliable results.Conclusion Fire needling has clear therapeutic effects in the treatment of neurodermatitis,with superior effects in symptom score,TNF-αlevel,IL-6 level,and IL-4 level compared to the control group.It also exhibits a higher safety profile,providing relevant evidence for the effectiveness of traditional Chinese external therapy in the treatment of neurodermatitis.However,the evidence quality assessed by GRADE was not ideal.It is recommended that future researchers reduce the number of low-quality trials on fire needling in the treatment of neurodermatitis and conduct multicenter,high-quality studies to further validate the results,thereby avoiding the waste of research and medical resources.