心肝同治法治疗小儿抽动障碍的Meta分析

A Meta-analysis of simultaneous treatment of heart and liver in treating tic disorder in children

目的:系统评价心肝同治法治疗小儿抽动障碍的疗效及安全性。方法:计算机检索中国知网、万方、维普及PubMed数据库中有关心肝同治法治疗小儿抽动障碍的临床随机对照试验,检索时间设定为自建库起至2022年8月31日。由2位研究员对文献进行独立筛选及资料提取,采用Jadad量表及Cochrane偏倚风险评估工具对纳入文献进行质量评估,并采用RevMan 5.4软件对提取的数据进行Meta分析。结果:最终纳入9项随机对照试验,共790例患者。纳入的9项研究中有3项属于高质量研究(Jadad量表评分为3分),其余6项均为低质量研究(包括评分为2分的4篇、评分为1分的2篇)。试验组采用口服心肝同治类中药复方制剂治疗,对照组采用口服常规西药治疗。Meta分析结果显示,与单纯西药治疗相比,心肝同治法能提高抽动障碍患儿的总有效率[比值比(OR)=2.43,95%置信区间(CI)(1.58,3.76),P <0.000 1],减少不良反应[OR=0.12,95%CI(0.06,0.24),P <0.000 01]及随访复发率[相对危险度(RR)=0.39,95%CI(0.20,0.75),P <0.005];且在远期疗效、耶鲁综合抽动严重程度量表(Yale Global Tic Severity Scale,YGTSS)评分、中医证候有效率、中医证候积分方面,试验组均优于对照组。结论:运用中医辨证,使用心肝同治法治疗小儿抽动障碍有较好的临床疗效,且安全性较好,但仍需开展更多高质量、大样本的研究进一步验证结论。

Objective:To systematically evaluate the efficacy and safety of heart-liver simultaneous treatment for children with tic disorder.Methods:CNKI,Wanfang,VIP and PubMed database were searched for clinical randomized controlled trial studies on the treatment of pediatric tic disorder by heart-liver simultaneous treatment.The retrieval time was set from the establishment of the database to August 31,2022.The literature was screened and extracted independently by two researchers.The quality of the included literature was evaluated by Jadad scale and Cochrane bias risk assessment tool,and the extracted data was analyzed by RevMan 5.4 software.Results:A total of 790 patients were included in 9 studies of randomized controlled trials.Among the 9 studies included,3 were high-quality studies(Jadad score was 3),and the other six were low-quality studies(including 4 with 2 scores and 2 with 1 score).The experimental group was treated with oral traditional Chinese medicine compound preparation for heart and liver,while the control group was treated with oral routine Western medicine.The results of Meta-analysis showed that,compared with Western medicine alone,the method of simultaneous treatment of heart and liver could improve the total effective rate[OR=2.43,95%CI(1.58,3.76),P<0.0001]and reduce adverse reactions[OR=0.12,95%CI(0.06,0.24),P<0.00001]and follow-up recurrence rate[RR=0.39,95%CI(0.20,0.75),P<0.005].In addition,the experimental group was superior to the control group in terms of long-term efficacy,YGTSS score,effective rate of TCM syndrome and TCM syndrome score.Conclusion:TCM syndrome differentiation and simultaneous treatment of heart and liver have good clinical efficacy in the treatment of tic disorder in children,and the security is good,but more high-quality and large-sample studies are still needed to further verify the conclusion.