注射用利培酮微球治疗精神分裂症的疗效和安全性研究
주사용리배동미구치료정신분렬증적료효화안전성연구
The efficacy and safety of risperidone long-acting injectable for the treatment of schizophrenia
  • 万方数据
    中华精神科杂志 중화정신과잡지
    CHINESE JOURNA OF PSYCHIATRY
    2010年 1期 14-18 ,共5页

    罗炯%马辛%母生梅%聂长杰%房萌%谭云龙%曹毅%祁富生%何卫宁%陈红辉%王晓萍%薛志敏%张敬悬%高安民%袁国桢%晏云兴%张少平%杨汉清%况利%唐伟%林崇光%钱惠忠%冯斌%王刚

    라형%마신%모생매%섭장걸%방맹%담운룡%조의%기부생%하위저%진홍휘%왕효평%설지민%장경현%고안민%원국정%안운흥%장소평%양한청%황리%당위%림숭광%전혜충%풍빈%왕강

    精神分裂症%迟效制剂%利哌立酮%治疗结果%安全 精神分裂癥%遲效製劑%利哌立酮%治療結果%安全
    정신분렬증%지효제제%리고립동%치료결과%안전
    Schizophrenia%Delayed-action preparation%Risperidone%Treatment outcome%Safety
    目的 评估注射用利培酮微球(LAIR)对中国人群治疗精神分裂症的疗效和安全性.方法 采用前瞻性、开放、多中心研究方法,对251例符合美国精神障碍诊断与统计手册第4版诊断标准的精神分裂症患者进行LAIR治疗,每2周注射1次,观察期为12周.分别在基线和治疗第4,6,8,12周末进行阳性和阴性症状量表(PANSS)评分、临床总体印象量表评分等,并记录治疗中的不良事件.结果 治疗4周后,PANSS评分均较治疗前持续下降(P<0.01);而病程≤2年患者的PANSS总分[(28.01±24.74)分]降低程度显著优于病程>2年者[(22.34±20.46)分];P<0.01.治疗第4周末,临床总体印象量表-严重程度(CGI-S)评分较基线显著降低(P<0.01).总体不良事件发生率为12.4%,多为轻、中度不良事件.结论 LAIR治疗精神分裂症安全、有效,对病程较短者疗效更好.
    목적 평고주사용리배동미구(LAIR)대중국인군치료정신분렬증적료효화안전성.방법 채용전첨성、개방、다중심연구방법,대251례부합미국정신장애진단여통계수책제4판진단표준적정신분렬증환자진행LAIR치료,매2주주사1차,관찰기위12주.분별재기선화치료제4,6,8,12주말진행양성화음성증상량표(PANSS)평분、림상총체인상량표평분등,병기록치료중적불량사건.결과 치료4주후,PANSS평분균교치료전지속하강(P<0.01);이병정≤2년환자적PANSS총분[(28.01±24.74)분]강저정도현저우우병정>2년자[(22.34±20.46)분];P<0.01.치료제4주말,림상총체인상량표-엄중정도(CGI-S)평분교기선현저강저(P<0.01).총체불량사건발생솔위12.4%,다위경、중도불량사건.결론 LAIR치료정신분렬증안전、유효,대병정교단자료효경호.
    Objective To evaluate the efficacy and safety of risperidone long-acting injectable (LAIR) for the treatment of schizophrenia in a large sample size in Chinese population.Methods This was an open-label, multi-center and prospective study in naturalistic treatment.Patients suffering from schizophrenia and schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders-IV diagnostic criteria were treated with LAIR for 12 weeks, every two weeks a time.The PANSS total score, positive and negative symptom scores, Clinical Global Impressions-Severity and Clinical Global Impressions-Improvement were evaluated at baseline, and the 4th, 6th, 8th, 12th week treatment respectively.The adverse events were recorded.Results Altogether 251 patients from 17 hospitals across China were enrolled in the study.From the end of 4th week to the end of 12th week, the PANSS total score,positive and negative symptom scores, general psychopathology score significantly decreased compared with the baseline score (P<0.01).The effective rate, improvement rate and the percentage of patients who met the criteria of clinical relief were 57.4%, 79.9% and 76.6%, respectively.At the end of 4th week, the better decline level on PANSS score were in patients with illness duration of 2 years or shorter than that in ones with duration of longer than 2 year, and this trend persisted into the end of treatment.The total adverse events rate was 12.4%, and most were mild and moderate.Conclusions LAIR is effective and safe for treatment of schizophrenia and schizoaffective disorder, with better effect in patients with shorter illness duration.
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