目的:对近年来涤痰汤加减治疗癫痫的随机对照试验(randomized controlled trial,RCT)文献进行收集,基于Meta分析方法,利用客观数据证明涤痰汤加减治疗癫痫的疗效及安全性。

方法:使用计算机检索中国知网、维普、万方等中文及英文数据库中关于涤痰汤治疗癫痫的RCT研究,严格筛选后借助Cochrane评价工具评估质量,用RevMan5.4软件进行Meta分析,并得出结论。

结果:初步检索到文献115篇,最终纳入16篇文献,统计的癫痫患者共1510例。Meta分析结果显示,涤痰汤联合抗癫痫药物(anti-epileptic drugs,AEDs)治疗癫痫的临床总有效率为RR=1.23,95%CI:1.16~1.31,Z=7.10,P<0.000 01;发作频率为SMD= -2.07 ,95%CI:-2.87~-1.27,Z=5.10,P<0.000 01;生活质量为SMD=1.00,95%CI:0.75 ~ 1.26,Z=7.66, P<0.000 01;白细胞介索-6水平为SMD=-2.28,95%CI:-2.66~-1.91,Z= 11.92,P<0.00001;hs-CRP水平为MD=-0.94,95%CI:- 1.29~-0.59,Z=5.32,P<0.00001; MDA水平为MD=-1.71,95%CI; -2.59~-0.83,Z=3.80,P=0.0001;SOD水平为MD= 23.72 , 95%CI: 22.86~24.57,Z= 54.32,P<0.00001;用药后的不良反应为RR=0.45, 95%CI:0.30~0.68,Z= 3.87,P=0.0001。研究组上述各指标均要优于对照组,且差异有统计学意义。

结论:涤痰汤加减联合AEDS治疗癫痫优于常规AEDS治疗,且不良反应少,安全性高。但由于所纳入RCT在质量及数量上存在一定局限性,相关结论仅作为癫痫临床诊疗的参考,仍然 需要更多高质量的研究进一步证实其疗效。

Objective: To collect randomized controlled trial (RCT) literature on the treatment of epilepsy with Ditan Decoction with modifications in recent years, and to use Meta-analysis method based on objective data to demonstrate the fficacy and safety of the treatment.

Methods: Chinese and English databases such as CNKI, VIP, Wanfang data were searched for randomized clinical trials on the treatment of epilepsy with Ditan Decoction. After strict screening the quality was evaluated using the Cochrane evaluation tool, Meta-analysis was conducted using RevMan 5.4 software, and conclusions were drawn.

Results: A preliminary search yielded 115 articles, of which 16 were finally included, totaling 1510 patients with epilepsy enrolled. Meta-analysis results showed that the overall clinical ficacy of Ditan Decoction combined with anti-epileptic drugs [AEDs) in the treatment of epilepsy: RR = 1.23,95% CI; 116-131,Z=7.10,P<0.000 01; seizure frequency: SMD=-2.07,95%CI:- 2.87~- 1.27,Z=5.10,P<0.000 01; quality of life: SMD=1.00, 95%CI; 0.75-1.26,Z=7.66, P<0.00001; lL-6:SMD=-2.28, 95%CI:-2.66~-1.91,Z=11.92,P< 0.000 01; hs-CRP: MD= -0.94,95%CI: -1.29~-0.59,Z= 5.32,P<000 01; MDA: MD= -1.71, 95%CI:-2.59~-0.83,Z= 3.80,P=0.000 1; SOD: MD=23.72,95% Cl:22.86-24.57,Z = 54.32, P<0.000 01; adverse reactions after medication: RR= 0.45, 95%CI 0.30-0.68,Z- 3.87,P= 0.000 1. The above indicators of the research group were superior to those of the control group, and the differences were statistically significant.

Conclusion: Ditan Decoction with modifications combined with AEDs is superior t conventional AEDs treatment for epilepsy, with fewer adverse reactions and high safety. However, due to limitations in the quality and quantity of the included RCT, the relevant conclusions serve only as a reference for the clinical diagnosis and treatment of epilepsy, and more high-quality research is needed to further confirm its efficacy.