利培酮口服液合用氯硝西泮与氟哌啶醇针剂肌内注射治疗精神分裂症急性激越症状疗效和安全性的研究
리배동구복액합용록초서반여불고정순침제기내주사치료정신분렬증급성격월증상료효화안전성적연구
Efficacy and safety of risperidone oral solution combination clonazepam oral versus haloperidol intramuscular injection for treatment of acute psychotic agitation in schizophrenia
  • 万方数据
    中华精神科杂志 중화정신과잡지
    CHINESE JOURNA OF PSYCHIATRY
    2010年 2期 83-87 ,共5页

    房茂胜%赵靖平%李乐华%陈红辉%李毅%刘连忠%叶萌%黄继忠%诸索宇%王刚%张庆娥%郑洪波%张璐璐%汪波%周建初

    방무성%조정평%리악화%진홍휘%리의%류련충%협맹%황계충%제색우%왕강%장경아%정홍파%장로로%왕파%주건초

    精神分裂症%利哌立酮%氟哌啶醇%治疗结果%安全 精神分裂癥%利哌立酮%氟哌啶醇%治療結果%安全
    정신분렬증%리고립동%불고정순%치료결과%안전
    Schizophrenia%Risperidone%Haloperidol%Treatment outcome%Safety
    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5 d)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5 d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.
    목적 비교리배동구복액합용록초서반여불고정순침제기내주사(이하간칭기주)대정신분렬증급성격월증상적료효화안전성,이급유불고정순기주환리배동구복(이하간칭환약조)대급성기료효적영향.방법 205례반유급성격월증상적정신분렬증환자안수궤수자표방법분위리배동구복액조(104례)화불고정순기주조(101례).연구분위급성격월증상료효평개(치료전5 d)화환약후급성기료효평고(치료6주)2개계단.이양성화음성증상량표흥강인자(PANSS-EC)급양성화음성증상량표(PANSS)총분작위주요료효평개지표.안전성평고채용추체외계부반응량표(Simpson-Angus Rating Scale,SAS)화정좌불능평정량표(Barnes Akathisia Scale,BAS)평정추체외계증상、기록불량사건화실험실검사.결과 치료전5 d리배동구복액조화불고정순기주조적급성격월증상도유명현개선(P＜0.01),2조간료효차이무통계학의의(P＞0.05);리배동구복액조합작정도호우불고정순기주조(P＜0.05),추체외계불량반응저우불고정순기주조(P＜0.05).유불고정순기주환리배동구복후,치료6주말구복조화환약조료효급총체불량사건발생솔비교차이균무통계학의의(P균＞0.05),단추체외계불량반응환약조고우구복조,차이유통계학의의(P＜0.05).결론 리배동구복액합용록초서반구복치료정신분렬증급성격월증상여불고정순기주료효상당,단리배동구복액합작정도호,추체외계불량반응발생솔저.유불고정순기주환리배동구복대급성기료효무명현영향.
    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 injection to 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.
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