天藤熄风方联合盐酸硫必利片治疗小儿抽动障碍临床观察

Clinical Observation of Tianten capsule Combined with Tiapride hydrochloride tablets in Treatment of Pediatric tic disorder

目的:探讨天藤熄风方联合盐酸硫必利片治疗小儿抽动障碍的临床疗效及安全性。方法:197例小儿抽动障碍患者采用数字随机法分为对照组和观察组。对照组给予口服盐酸硫必利片,4~7岁,50mg/次,2次/d;7+~10岁,75mg/次,2次/d;10+~14岁,100mg/次,2次/d,连用6周。观察组在对照组基础上口服天藤熄风方,4~7岁,30m L/次,2次/d;7+~10岁,50m L/次,2次/d;10+~14岁,100m L/次,2次/d,连用6周。观察两组患儿治疗前后YGTSS积分及临床症状消失情况,并检测血清DA、5-HT和SP表达水平,记录不良反应发生情况。结果:治疗后,观察组控显率80.39%、总有效率95.10%,对照组控显率45.26%、总有效率85.26%。两组控显率和总有效率比较差异有统计学意义(P<0.01)。观察组临床症状运动性抽动、发声性抽动、烦躁易怒、眩晕、多梦、胸闷呕恶的消失率均高于对照组(P<0.01);两组血清DA和SP表达水平均显著低于同组治疗前,且观察组显著低于对照组(P<0.01)。而血清5-HT表达水平均显著高于同组治疗前,且观察组显著高于对照组(P<0.01)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:天藤熄风方联合盐酸硫必利片治疗小儿抽动障碍疗效和安全性均好。可降低血清DA和SP表达水平,提高5-HT表达,有效抑制多巴胺系统。

Objective： To investigate the clinical efficacy and safety of Tianten capsule combined with tiapride hydrochloride tablets in treatment of pediatric tic disorder. Methods： 197 patients with pediatric tic disorder were randomly divided into control group and observation group. Control group was treated with tiapride hydrochloride tablets age four to seven years old 50mg / time, 2times/day. Age above seven years old to ten years old ,70mg / time, 2times/day. Age above ten years to fourteen years old 100mg / time, 2times / day for external use. Observation group was treated with Tianten capsule age four to seven years old , 30mL / time, 2times/day. Age above eight years old to ten years old , 5OraL / time, 2times/day. Age above eleven years to fourteen years old lOOmL g/time, 2 times /day, based on the treatment of control group. Courses of treatment in two groups were both 6 weeks. Scores of yale global tic severity scale （YGTSS） was graded and the symptoms disappearance was observed before and after treatment. Serum dopamine （DA）,5- hydroxytryptaphane （5-HT）,substance p （SP） and were compared in 2 groups before and after treatment, and clinical efficacy and the occurrence of ADR were observed. Results： After treatment, The observation group＇s the accused of penetrance rate and the total effective rate were80.39% ,and 95.10%, Significantly higher than 45.26%and 85.26% in control group （P〈0.01） . The symptoms of motor tics, vocal tics, irritability, vertigo, dreaminess and chest distress disappearance rate in observation group was more than that in control group （P〈0.01）. The contents of serum DA, SP levels in two groups were significantly lower than those before and observation group＇s was lower than those of the control group （P〈0.01） . The contents of serum 5-HT levels in two groups were significantly higher than those before and observation t group＇s was higher than those of the control group （/）〈0.05） . There was no statistical significance in the incidence of ADR between 2 groups （P〉0.05） . Conclusions： Tianten capsule combined with tiapride hydrochloride tablets has good clinical efficacy and safety in the treatment of pediatric tic disorder ,it can reduce the expression levels of serum DA,SP in pediatric tic disorder and increase the expression levels of serum 5-HT, restraining dopamine inhibitory system.