利培酮合并短期肌注氟哌啶醇治疗精神分裂症急性期激越行为疗效的随机对照研究

Randomized controlled trial of effectiveness of Risperidone combining short-term intramuscular Haloperidol in the treatment of the agitated behavior of psychotic patients

目的对比氟哌啶醇或氯硝西泮短期肌注合并利培酮与氟哌啶醇肌内注射对急性期精神分裂症患者兴奋激越行为的疗效。方法将符合CCMD-3诊断标准的150例新入院伴有兴奋冲动行为的精神分裂症患者,随机分为利培酮合并氟哌啶醇组(A组)、利培酮合并氯硝西泮组(B组)和氟哌啶醇组(C组),观察2周。采用阳性及阴性评定量表(PANSS)兴奋激越因子评定精神症状(激越行为),采用副作用量表(TESS)评定不良反应。结果治疗后,与入院测评基线比较,各组患者PANSS兴奋因子分均显著下降,差异有高度统计学意义(P<0.01),治疗1周后各组组间兴奋因子得分比较差异有高度统计学意义(P<0.01),LSD两两比较,A、B两组差异有高度统计学意义(P<0.01),B、C两组差异有高度统计学意义(P<0.01);A、C两组差异无统计学意义(P>0.05)。但以PANSS-兴奋激越项目减分率分级标准计算疗效的比较却没有发现显著差异。TESS量表不良反应发生率比较,三组患者在肌强直、震颤、扭转性运动及静坐不能等锥体外系症状(EPS)方面差异有统计学意义(P<0.05);A组肌强直、震颤及静坐不能等EPS的发生率显著高于B组,C组肌强直、震颤、扭转性运动等EPS的发生率显著高于B组,而A、C两组间差异无统计学意义。结论利培酮合并氟哌啶醇短期肌注提高了患者的耐受性,能迅速有效地控制急性期精神分裂症的兴奋激越行为,可作为临床处理精神分裂症急性期兴奋激越手段之一。

Objective To compare the efficacy and adverse events of Risperidone combining short-term intramuscular Haloperidol or clonazepam and intramuscular Haloperidol in the treatment of the agitated behavior of patients in the acute phase of schizophrenia.Methods 150 patients associated with impulsive behavior who met the diagnostic criteria of CCMD-3 for schizophrenia were randomly divided into three groups.Group A was treated with Risperidone combining short-term intramuscular Haloperidol,group B with Risperidone combining short-term intramuscular donazepam and group C with only Haolperidol for 2 weeks.The efficacy and adverse events were evaluated by PANSS and TESS.Results After treatment,factor-scores of excitement of PANSS in each group were reduced compared to baseline,and there were significant differences among them（P 0.01）.After one week treatment,there were significant differences between group A and B（P 0.01）,group B and C（P 0.01） on the score of the factor-scores of excitement of PANSS,but the difference between A and C was not statistically significant（P 0.05）.Meanwhile,no significant difference was found among the three groups taking the reduce rate of factor-scores of excitement of PANSS as the standard of efficacy level.There was a significant difference among three groups on the incidence rate of adverse drug reactions（ADR）（P 0.05）.The incidence of EPS（muscle rigidity,tremor and akathisia） of group A was significantly higher than that in group B,and group B was a significantly lower than that in group C on muscle rigidity,tremor and the torsion movement of EPS,while there were no signifcant differences between group A and group C.Conclusion Risperidone combined with short-term Haloperidol intramuscular can greatly improve patient＇s tolerability and control agitated behavior of patients in the acute phase of schizophrenia quickly and efficiently.It can be a good means for them.