天麻钩藤饮加减治疗阿立哌唑所致锥体外系不良反应的临床研究

Clinical Study on Modified Tianma Gouteng Decoction(天麻钩藤饮)in the Treatment of Extrapyramidal Reaction Induced by Aripiprazole

目的:探讨天麻钩藤饮加减治疗阿立哌唑所致锥体外系不良反应的疗效、安全性及对阿立哌唑浓度的影响。方法:将71例使用阿立哌唑治疗后出现锥体外系不良反应的精神分裂症患者随机分为治疗组(35例)和对照组(36例),治疗组患者予天麻钩藤饮加减合并苯海索安慰剂,对照组患者予天麻钩藤饮安慰剂合并苯海索片,治疗8周,分别于基线、治疗4周末、治疗8周末评估锥体外系副反应(RSESE)、不自主运动(AIMS)、副反应量表(TESS)。结果:时间因素和分组因素对RSESE的影响不存在交互效应(F=1.270,P=0.284);两组患者RSESE总体比较,差异无统计学意义(F=0.688,P=0.410),即不存在分组效应;治疗后不同时间点RSESE的差异有统计学意义(F=28.317,P<0.001),即存在时间效应。时间因素和分组因素对AIMS的影响不存在交互效应(F=0.653,P=0.522);两组患者AIMS总体比较,差异无统计学意义(F=2.740,P=0.102),即不存在分组效应;治疗后不同时间点AIMS的差异有统计学意义(F=23.649,P<0.001),即存在时间效应。两组患者在基线水平、第4周末、第8周末的阿立哌唑剂量比较,差异均无统计学意义(P>0.05);血清阿立哌唑浓度的时间因素、不同干预措施的主效应及交互效应均不显著(P>0.05)。两组均有震颤、静坐不能、活动减退、便秘、流涎、口干、失眠、心电图异常等不良反应发生,其中治疗组患者口干、便秘、视物模糊的发生率低于对照组(P<0.05),其他不良反应的发生率两组间的差异无统计学意义(P>0.05)。结论:天麻钩藤饮加减可以替代苯海索片达到治疗锥体外系不良反应的作用,同时副作用更少,值得临床推广。

Objective:To explore the effect and safety of modified Tianma Gouteng Decoction in the treatment of aripiprazole induced extrapyramidal reaction and its effect on the concentration of aripiprazole.Methods:Totally 71 patients of schizophrenic with extrapyramidal reaction after taking aripiprazole were randomly divided into treatment group(35 cases)and control group(36 cases).Patients were treated with modified Tianma Gouteng Decoction combined with benhaisuo tableplacebo in treatment group and modified Tianma Gouteng Decoction placebo combined with benhaisuo tablet in control group,for eight weeks.Extrapyramidal side effects(RSESE),involuntary movement(AIMS)and side effects scale(TESS)were evaluated at baseline and four weeks and eight weeks after treatment.Results:There was no interaction effect of time factors and grouping factors on RSESE(F=1.270,P=0.284);There was no statistically significant difference in RSESE between the two groups(F=0.688,P=0.410),and there was no grouping effect;The difference of RSESE at different time points after treatment was statistically significant(F=28.317,P<0.001),and there was time effect.There was no interaction effect of the time factor and grouping factor on AIMS(F=0.653,P=0.522);There was no significant difference in aims between the two groups(F=2.740,P=0.102),and there was no grouping effect;There was significant difference in AIMS at different time points after treatment(F=2.740,P=0.102),and there was time effect.There was no statistical difference on aripiprazole of the two groups at baseline,at the end of the 4 thand 8 thweek.There was no time effect,group effece and interaction effect on serum aripiprazole concentration(P>0.05).There were adverse reactions,including tremor,akathisia,hypokinesia,constipation,salivation,dry mouth,insomnia,ECG abnormalities and so on.The treatment group showed lower incidence rate of dry mouth,constipation and blurred vision,than control group(P<0.05);There was no significant difference on incidence rate of other adverse reactions between the two groups(P>0.05).Conclusion:Modified Tianma Gouteng Decoction can replace benhaisuo tablet to treat extrapyramidal side effects,and the side effects are less,which is worthy of clinical promotion.