摘要
目的比较利培酮口服液合用氯硝西泮与氟哌啶醇针剂肌内注射（以下简称肌注）对精神分裂症急性激越症状的疗效和安全性，以及由氟哌啶醇肌注换利培酮口服（以下简称换药组）对急性期疗效的影响。方法205例伴有急性激越症状的精神分裂症患者按随机数字表方法分为利培酮口服液组（104例）和氟哌啶醇肌注组（101例）。研究分为急性激越症状疗效评价（治疗前5d）和换药后急性期疗效评估（治疗6周）2个阶段。以阳性和阴性症状量表兴奋因子（PANSS-EC）及阳性和阴性症状量表（PANSS）总分作为主要疗效评价指标。安全性评估采用锥体外系副反应量表（Simpson-Angus Rating Scale，SAS）和静坐不能评定量表（Barnes Akathisia Scale，BAS）评定锥体外系症状、记录不良事件和实验室检查。结果治疗前5d利培酮口服液组和氟哌啶醇肌注组的急性激越症状都有明显改善（P〈0．01），2组间疗效差异无统计学意义（P〉0．05）；利培酮口服液组合作程度好于氟哌啶醇肌注组（P〈0．05），锥体外系不良反应低于氟哌啶醇肌注组（P〈0．05）。由氟哌啶醇肌注换利培酮口服后，治疗6周末口服组和换药组疗效及总体不良事件发生率比较差异均无统计学意义（P均〉0．05），但锥体外系不良反应换药组高于口服组，差异有统计学意义（P〈0．05）。结论利培酮口服液合用氯硝西泮口服治疗精神分裂症急性激越症状与氟哌啶醇肌注疗效相当，但利培酮口服液合作程度好，锥体外系不良反应发生率低。由氟哌啶醇肌注换利培酮口服对急性期疗效无明显影响。
Objective To compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral. Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam （n = 104） or intramuscular injection treatment with haloperidol （n = 101 ）. The primary efficacy outcome measure was the change in scores based on PANSS-EC in session I （the first five days）, and the response rate based on the PANSS score in session Ⅱ （the following 6 weeks）. Safety was evaluated using the Simpson-Angus Scale （ASA）, Barnes Akathisia Scale （BAS）, adverse events and lab test. Result Mean acute-agitation score improvement was significant after 5 day treatment in both groups （P 〈0.01 ） and were similar in both groups （ P 〉 0. 05 ）. While the cooperation was better and the advert events, especially extrapyramidal symptoms was lower in risperidone oral solution groups than that in haloperidol IM injection group （P 〈 0. 05 ）. The mean PANSS-EC and PANSS scores remained stable after switching from IM injectionto oral. The efficacy was not differenct in both groups after 6 week treatment （ P 〉 0.05 ）. There was no significant difference at the rate of total advert events （ P 〉 0. 05 ） while there were yet significantly higher rates of extrapyramidal symptoms in switching drug group than that in oral group （ P 〈 0. 05 ）. Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability. The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment.
出处
《中华精神科杂志》
CAS
CSCD
北大核心
2010年第2期83-87,共5页
Chinese Journal of Psychiatry
