学龄期儿童多发性抽动症的中医诊疗方案验证

Study on School-age Children Tourette Syndrome in TCM Diagnosis and Treatment Scheme

目的:初步观察学龄期儿童多发性抽动症中医诊疗方案的临床疗效和安全性。方法:采用随机、对照、多中心的方法进行学龄期儿童多发性抽动症中医诊疗方案的临床研究。收集符合西医诊断标准的病例240例,用SAS随机分组,分为治疗组和对照组。治疗组根据中医诊疗方案予中药协定处方口服,对照组采用泰必利口服,总疗程8周。对比两组患者治疗后耶鲁综合抽动严重程度量表(YGTSS)积分改善情况及疾病疗效和中医证候疗效,利用SPSS 19.0软件对资料进行数据统计,分析中医诊疗方案的有效性及安全性。结果:240例患者中因失访共脱落14例(治疗组6例,对照组8例),完成观察226例(治疗组114例,对照组112例)。疾病疗效评价,在4周时对照组显著优于治疗组(P<0.01),8周时两组无明显差异(P>0.05)。组内YGTSS积分比较,P值均小于0.05,结果提示两组在改善YGTSS积分方面均有疗效。组间YGTSS积分比较,4周时对照组显著优于治疗组(P<0.01),8周时两组无明显差异(P>0.05)。中医证候疗效,在4周及8周治疗组痊愈率均显著优于对照组,差异有统计学意义((P<0.01)。出现不良反应者共16例,治疗组5例,对照组11例,两组不良反应发生率差异无统计学意义(P>0.05)。结论:学龄期儿童多发性抽动症的中医诊疗方案有效,无严重不良反应事件,依从性良好,值得进一步临床推广应用。

Objective:To observe the safety and effects of traditional Chinese medicine(TCM)diagnosis and treatment scheme in tourette syndrome of school-age children.Methods:Random,contrast,multicenter trial was designed for TCM diagnosis and treatment scheme in tourette syndrome of school-age children.A total of 240 school-age children were pilled who met the diagnosis criterion of tourette syndrome.The patients were divided into the treatment group and control group by the SAS randomized method.The treatment group was given the agreement prescription of TCM while the control group was treated by tiapridal tablet.YGTSS and the TCM syndrome score were compared to evaluate the efficiency and safety.SPSS 19.0 soft ware was used to analysize the data.Results:There were 14 patients dropped out due to the loss of contact(treatment group 6 cases,control group 8 cases).A total of 114 cases in the treatment group and 112 cases in the control group were included in this study.The YGTSS integral before and after therapy in each group had significant difference(P<0.05).The control group was more effective than treatment group in the YGTSS integral at 4 th week(P<0.01).And there was no difference between two groups at 8 th week(P>0.05).The control group was better than the treatment group in the effect of YGTSS at 4 th week(P<0.01).And no difference was found at 8 th week(P>0.05).The treatment group was more remarkable than the control group in the TCM syndrome score at4 th and 8 th week(P<0.01).Neither of the cases were found unsafe index.Sixteen patients had side effects in clinical observation.In the treatment group,there were 5 cases and 11 cases in the control group.There was no appreciable difference in the adverse reactions between the two groups(P>0.05).Conclusion:The TCM diagnosis and treatment scheme was effective and safe.