中华精神科杂志
中華精神科雜誌
중화정신과잡지
CHINESE JOURNA OF PSYCHIATRY
2012年
1期
20-24
,共5页
张鸿燕%郝晓楠%王雪芹%刘琦%李玲芝%董继承%张晋碚%李洁%许秀峰%舒良
張鴻燕%郝曉楠%王雪芹%劉琦%李玲芝%董繼承%張晉碚%李潔%許秀峰%舒良
장홍연%학효남%왕설근%류기%리령지%동계승%장진배%리길%허수봉%서량
抗精神病药%精神分裂症%治疗结果%安全%帕利哌酮
抗精神病藥%精神分裂癥%治療結果%安全%帕利哌酮
항정신병약%정신분렬증%치료결과%안전%파리고동
Antipsychotic agents%Schizophrenia%Treatment outcome%Safety%Paliperidone
目的 评价可变剂量帕利哌酮缓释片治疗既往口服抗精神病药缺乏疗效或无法耐受而需换药的非急性期精神分裂症患者的疗效及安全性.方法 本研究为非随机、单组、为期12周的多中心的开放性临床研究,共纳入405例患者.主要疗效指标为治疗第12周末阳性和阴性症状量表( PANSS)评分较基线的变化.次要疗效指标包括:临床总体印象-严重度量表(CGI-S)、个人和社会功能量表(PSP).安全性评价包括不良反应记录、锥体外系症状评定量表(ESRS)、实验室及生命体征监测等.结果 PANSS总分由基线的(70.1±19.3)分下降至治疗终点的(48.1±15.7)分(P＜0.01),CGI-S由基线的(4.1±1.2)分下降至治疗终点的(2.5±1.1)分(P＜0.01),PSP总分由基线的(58.6±14.9)分提高至治疗终点的(74.5±13.4)分(P＜0.01).发生率＞5％的不良反应有:锥体外系反应(39.0％)、失眠(6.5％)和过度镇静(5.5％),ESRS总分由基线的(13.0±2.1)分下降至治疗终点的(12.6±1.6)分(P＜0.01).平均体质量治疗终点较基线增加(0.2±3.5)kg (P ＜0.05).结论 换用可变剂量帕利哌酮缓释片对既往抗精神病药疗效不佳或耐受性不佳的非急性期精神分裂症患者疗效肯定,并具有较好安全性和耐受性.
目的 評價可變劑量帕利哌酮緩釋片治療既往口服抗精神病藥缺乏療效或無法耐受而需換藥的非急性期精神分裂癥患者的療效及安全性.方法 本研究為非隨機、單組、為期12週的多中心的開放性臨床研究,共納入405例患者.主要療效指標為治療第12週末暘性和陰性癥狀量錶( PANSS)評分較基線的變化.次要療效指標包括:臨床總體印象-嚴重度量錶(CGI-S)、箇人和社會功能量錶(PSP).安全性評價包括不良反應記錄、錐體外繫癥狀評定量錶(ESRS)、實驗室及生命體徵鑑測等.結果 PANSS總分由基線的(70.1±19.3)分下降至治療終點的(48.1±15.7)分(P＜0.01),CGI-S由基線的(4.1±1.2)分下降至治療終點的(2.5±1.1)分(P＜0.01),PSP總分由基線的(58.6±14.9)分提高至治療終點的(74.5±13.4)分(P＜0.01).髮生率＞5％的不良反應有:錐體外繫反應(39.0％)、失眠(6.5％)和過度鎮靜(5.5％),ESRS總分由基線的(13.0±2.1)分下降至治療終點的(12.6±1.6)分(P＜0.01).平均體質量治療終點較基線增加(0.2±3.5)kg (P ＜0.05).結論 換用可變劑量帕利哌酮緩釋片對既往抗精神病藥療效不佳或耐受性不佳的非急性期精神分裂癥患者療效肯定,併具有較好安全性和耐受性.
목적 평개가변제량파리고동완석편치료기왕구복항정신병약결핍료효혹무법내수이수환약적비급성기정신분렬증환자적료효급안전성.방법 본연구위비수궤、단조、위기12주적다중심적개방성림상연구,공납입405례환자.주요료효지표위치료제12주말양성화음성증상량표( PANSS)평분교기선적변화.차요료효지표포괄:림상총체인상-엄중도량표(CGI-S)、개인화사회공능량표(PSP).안전성평개포괄불량반응기록、추체외계증상평정량표(ESRS)、실험실급생명체정감측등.결과 PANSS총분유기선적(70.1±19.3)분하강지치료종점적(48.1±15.7)분(P＜0.01),CGI-S유기선적(4.1±1.2)분하강지치료종점적(2.5±1.1)분(P＜0.01),PSP총분유기선적(58.6±14.9)분제고지치료종점적(74.5±13.4)분(P＜0.01).발생솔＞5％적불량반응유:추체외계반응(39.0％)、실면(6.5％)화과도진정(5.5％),ESRS총분유기선적(13.0±2.1)분하강지치료종점적(12.6±1.6)분(P＜0.01).평균체질량치료종점교기선증가(0.2±3.5)kg (P ＜0.05).결론 환용가변제량파리고동완석편대기왕항정신병약료효불가혹내수성불가적비급성기정신분렬증환자료효긍정,병구유교호안전성화내수성.
Objective To explore the tolerability, safety and efficacy in adult non-acute schizophrenic patients after switching to flexibly doses of paliperidone extended-release ( paliperidone ER),for lack of efficacy,safety or tolerability with their previous oral antipsychotic.Methods In this nonrandomized,single arm,multi-center,12-week and open-label study,the primary efficacy measure was the total score changes of the Positive and Negative Syndrome Scale (PANSS),and the Clinical Global Impression-Severity Scale (CGI-S),Personal and Social Performance Scale (PSP) were adopted as secondary efficacy measures. The safety evaluation included monitoring adverse events,Extrapyramidal Symptom Rating Scale ( ESRS),clinical laboratory testing and vital sign measurements.Results For all patients,the mean total PANSS score change was from (70.1 ± 19.3) at baseline to (48.1 ± 15.7) at endpoint(P ＜0.01).The mean total CGI-S score decrease was from (4.1 ±1.2) at baseline to (2.5 ± 1.1 ) at endpoint ( P ＜ 0.01 ).Mean total PSP score increased from (58.6 ± 14.9) at baseline to (74.5 ± 13.4) at endpoint (P ＜ 0.01).Adverse events (AEs) with the incidence rate of ≥5％ included extrapyramidal disorder (39.0％),insomnia (6.5％ ),somnolence (5.5％).The mean total ESRS score decreased from ( 13.0 ± 2.1 ) at baseline to ( 12.6 ± 1.6 ) at endpoint ( P ＜ 0.01 ).The mean weight change from baseline to endpoint was (0.2 ± 3.5 ) kg ( P ＜ 0.05 ).Conclusion It indicates that flexibly dosed of oral paliperidone ER is safe,well tolerated and effective in adult non-acute schizophrenic patients after switching to paliperidone ER for lack of efficacy,safety or tolerability with their previous oral antipsychotic.
