熄风止动片治疗小儿多发性抽动症肝风内动挟痰证的临床研究

Clinical research of Xifeng Zhidong Tablet in treating Multiple tics with Liver Wind and sputum stirring internally

目的初步评价熄风止动片治疗小儿多发性抽动症肝风内动挟痰证的有效性和安全性。方法采用区组随机、双盲、平行对照试验方法。将入选216例患儿分成2组,试验组108例,对照组108例,2组剔除或脱落病例各2、3例。结果熄风止动片与对照药硫必利片对小儿多发性抽动症的总有效率分别为81.48%、83.81%。对于中医症状综合疗效,熄风止动片与硫必利片的总有效率分别为83.02%、83.81%,组间差异均无统计学意义。非劣效检验结果显示,试验组疗效不劣于对照组。两组的中医单项证候及舌脉治疗前后组内比较,差异均有统计学意义。试验组与对照组分别有2、4例不良反应,不良反应发生率为分别为1.85%、3.70%。结论熄风止动片对小儿多发性抽动症肝风内动挟痰证的疗效不劣于对照药疏必利片,并具有良好安全性。

Objective To evaluate the efficacy and safety of Xifeng Zhidong Tablet in the treatment of Multiple tics with syndrome of Liver Wind and sputum stirring internally. Methods The random, double blind, parallel controlled method was applied to this study. Results The total effective rate of Multiple tics treatment in treatment group and control group was 81.48% and 83.81% respectively. To total effective rate of improving TCM symptoms was 83.02% and 83.81% respectively. There was no significant difference between the two groups （P〉0.05）. The results of non-inferiority test indicated that the efficiency of treatment group was no worse than that of control group. In this clinical research, 6 subjects showed adverse reactions （2 from treat group, 4 from control group）. The incidence rate of adverse reaction in the two groups was 1.85% and 3.7% respectively. Conclusion Xifeng Zhidong Tablet has high safety and good therapeutic effects for the treatment of Multiple tics with syndrome of Liver Wind and sputum stirring internally.