精神分裂症急性激越症状治疗和一年维持治疗的研究
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摘要
目的
比较利培酮口服液合并氯硝安定口服与氟哌啶醇肌注治疗精神分裂症急性激越症状的疗效和安全性,探讨不同给药方式对治疗急性激越症状的作用。观察从肌注换为口服给药对急性治疗期(6周)疗效的影响。方法
采用随机多中心对照开放研究方法,189例伴有急性激越症状的精神分裂患者随机分为利培酮口服液+氯硝安定口服组(n＝98)和氟哌啶醇肌注组(n=91)。研究分为两个阶段。第一阶段:病人随机给予利培酮口服液+氯硝安定口服和氟哌啶醇肌注治疗并评定,研究期为5天。第二阶段:观察氟哌啶醇肌注换为利培酮口服和撤用氯硝安定对急性期(6周)治疗疗效的影响,从治疗第六天始至研究结束。以PANSS-EC和PANSS评定量表分别作为第一和第二阶段的主要疗效评价指标。安全性采用Simpson-Angus Scale(ASA)、Barnes Akathisia Scale(BAS)、不良事件报告和实验室检查评定。结果
(1)利培酮口服液合并氯硝安定口服与氟哌啶醇肌注对急性激越症状都有明显的治疗作用(P<0.01),两组间疗效差异无显著性(P>0.05),但利培酮组合作程度好于氟哌啶醇组(P<0.05),且总体不良反应尤其是锥体外系不良反应低于氟哌啶醇组,差异有显著性(P<0.05)。
(2)换(撤)药期间两组PANSS-EC和PANSS均分仍继续改善(P<0.01),两组间差异无显著(P>0.05),且治疗6周末两组间疗效相当(P>0.05)。两组总体不良事件发生率无显著性差异(P>0.05),但锥体外系不良反应氟哌啶醇组仍高于利培酮组,差异有显著性(P<0.05)。结论
利培酮口服液合并氯硝安定口服治疗精神分裂症急性激越症状与氟哌啶醇疗效相当,但利培酮组合作程度好,总体不良事件,尤其是锥体外系不良反应发生率低。换(撤)药期间症状稳定,治疗6周后两组间疗效相似,但利培酮组锥体外系不良反应少于氟哌啶醇组。
目的
比较氯丙嗪、舒必利、氯氮平、利培酮、奥氮平、喹硫平、阿立哌唑7种抗精神病药对精神分裂症患者1年维持治疗的有效性和安全性以及其对认知功能、生命质量和社会功能的影响。
方法
对服用7种药物之一、病程≤5年稳定期的1227例精神分裂症患者给予1年的维持治疗,以治疗中断率、中断前治疗时间结合临床疗效评价抗精神病药的总体有效性,采用不良事件和实验室检查评价安全性,每间隔3个月评估1次。以威斯康星卡片分类测验、数字符号测验、视觉再生测验、数字广度分测验、连续作业测验、连线测验评估患者的认知功能,每间隔6个月评估1次。以健康状况问卷(SF-36)评定患者的生命质量,每间隔6个月评定1次;以大体功能评定量表(GAS)、日常生活能力量表(ADL)、就业率评定患者的社会功能,GAS、就业率每间隔3个月评定1次,ADL每间隔6个月评定1次。
结果
(1)随访1年,1227例中44.1%(541例)的患者中断治疗,治疗中断率及中断前治疗时间在7种药物间的差异均无统计学意义(P>0.05);40.3%(495例)的患者完成1年随访并达到临床痊愈标准,临床痊愈率在7种药物间的差异无统计学意义(P>0.05)。随访1年末,奥氮平组PANSS总分低于其他各组(P<0.05),差异具有显著性;1年末PANSS总分与基线差值,阿立哌唑、奥氮平、利培酮与喹硫平和氯丙嗪之间存在差异(P<0.05)。7种药物总的不良反应发生率差异无统计学意义(P>0.05),但镇静作用、锥体外系不良反应、月经紊乱及体质量增加等不良反应在不同药物间的差别存在统计学意义(P<0.01和0.05)。
(2)801例患者完成基线与6月末认知功能评定。维持治疗6月前后认知功能变化值较小(-0.04～0.11),7组认知功能综合z分和各领域z分间比较差异无显著性(P>0.05);综合z分和各领域z分与基线相比的变化值7组间亦无显著性差异(P>0.05)。
(3)437例患者完成基线与12月末认知功能评定。维持治疗12月前后认知功能变化值较小(-0.19～0.30),7组认知功能综合z分和各领域z分间比较差异无显著性(P>0.05);综合z分和各领域z分与基线相比的变化值7组间亦无显著性差异(P>0.05)。
(4)848例患者完成基线与12月末SF-36评定。维持治疗12月后,7组SF-36总分比较差异无显著性(P>0.05),但生理职能、精力、情感职能、精神健康因子分7组间存在差异(P<0.05);与基线相比,SF-36总分提高了6.2～10.6分,7组间变化值差异无显著性(P>0.05),但躯体疼痛、精力、精神健康因子分的差异7组间差异具有显著性(P<0.05)。
(5)777例患者完成基线与12月末社会功能评定。维持治疗12月后,7组GAS分比较差异有显著性(P<0.05),奥氮平、利培酮的大体社会功能较好;与基线相比的变化值7组间亦有显著性差异(P<0.05),奥氮平、喹硫平、阿立哌唑的改善程度较大;7组维持治疗12月后ADL总分、ADL与基线的变化值、就业率间比较差异无显著性(P>0.05)。
结论
1.7种抗精神病药治疗精神分裂症患者的1年临床疗效相当,但药物的不良反应各异。
2.稳定期精神分裂症患者认知功能相对稳定,7种抗精神病药维持治疗1年对认知功能的改善作用较小,并且7种抗精神病药对认知功能的影响无明显差别。
3.7种抗精神病药维持治疗1年对精神分裂症患者生命质量有明显改善,7种药物疗效相当,但对不同因子的影响有所差别。稳定期精神分裂症患者日常生活能力无明显受损;奥氮平、利培酮组的患者的社会功能相对较好;7组就业率都较低,但不同药物间无明显差别。
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 and schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of acute 6 weeks treatment from switching IM injection to oral.
Method
In a randomized,parallel-group,open study conducted at 6 sites in china,189 patients exhibiting agitation associated with active psychosis were randomly assigned to reveive either oral treatment with risperidone oral solution puls clonazepam(n=98) or intramuscular treatment with haloperidol (n=91).Eligible subjects will be entered 5 days treatment sessionⅠto compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation,then will be followed by 6 additional weeks treatment sessionⅡfor exploring the effect of medicine switching from IM injection to oral.The primary efficacy outcome measure will be the change in scores based on PANSS-EC,composed of 5 items(excitement,hostility, uncooperativeness,hallucinatory,and poor impulse control) from the Positive and Negative Syndrome Scale(PANSS) in sessionⅠ,and the response rate based on the PANSS in sessionⅡ.Safety was evaluated using Simpson-Angus Scale(ASA),Barnes Akathisia Scale(BAS),adverst events and lab test.
Result
(1) Mean acute-agitation score improvement were significant after 5 days 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 risperdone oral solution groups than that in haloperidol group(p＜0.05).
(2) Mean PANSS-EC and PANSS scores remained stable after switching from IM to oral.The efficacy was no significant difference in both groups after 6 weeks 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 haloperidol group than that in risperidone group(p＜0.05).
Conclusion
The results showed that risperidone oral solution combination clonazepam oral has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation,but risperdone oral solution has better cooperation and tolerability.Mean PANSS-EC and PANSS scores remained stable after switching from IM to oral.The efficacy were similar in both groups after 6 weeks treatment.
PartⅡComparative one-year follow-up outcomes of seven antipsychotic drugs in patients with schizophrenia
Objective
To compare the maintenance treatment effectiveness,the cognitive function effectiveness,the quality of life and social function effectiveness of seven antipsychotic agents including chlorpromazine,sulpiride,clozapine, risperidone,olanzapine,quetiapine,and aripiprazole to schizophrenia for 12 months.
Methods
A total of 1227 patients suffering from schizophrenia no more than 5 years who took one of the seven study medications as maintenance treatment were recruited at 10 china sites for following up to 12 months.Study measures were administered at baseline and the end of each 3 month assessment period.The outcomes were evaluated using discontinuation of treatment and time to treatment discontinuation combined with clinical efficacy outcome.The adverse events were reported and lab tests were administered to evaluate side effects.Cognitive function was assessed at baseline and the end of each 6 month assessment period using Wisconsion card sorting test(WCST),Digit symbol test,Digit span test,Visual reproduction,Coutinuous performance test(CPT),Trail making test(TMT). SF-36 was used to evaluate quality of life of patients at baseline and the end of each 6 month assessment period.The social function of patients were assessed using GAS,which was admisitered at baseline and the end of each 3 month assessment period,ADL,admisitered at baseline and the end of each 6 month assessment period and employment rate.
Results
(1) Almost 44.1 percent patients discontinued their assigned treatment before 12 months.The rate of discontinuation and the time to the discontinuation of treatment for any cause had no significant difference among the seven groups.40.3 percent patients completed the one year follow-up and attained the clinical remission.At the end of 12 months,the total PANSS score was lower in olanzapine group than other groups and the difference was significant.Patients receiving risperidone,olanzapine,and aripiprazole showed greater improvement from baseline compared with patients receiving chlorpromazine and quetiapine.There was no significant difference on the total side effects while sedation,extrapyramidal symptoms, weight gain and menstrual irregularities were obvious difference among the seven antipsychotic drugs.
(2) 804 patients completed the assessment of cognitive function both at baseline and the end of 6 months.After month 6,the improvement was small(-0.04～0.11).There was no significant overall difference between treatment(p＞0.05).
(3) 437 patients completed the assessment of cognitive function both at baseline and the end of 12 months.After month 12,The improvement was small(-0.19～0.30).There was no significant overall difference between treatment(p＞0.05).
(4) 848 patients completed the assessment of SF-36 both at baseline and the end of 12 months.After the maintain treatment of 12 month,there was no significant difference among the total score of SF-36 for senen group (p＞0.05),but there were difference among the factor scores of role-physical, vitality,role-emotional and mental health for seven group(p＜0.05).The total score of SF-36 incresed by 6.0-10.6,but there was no signinicant difference amont the variance value for seven groups(p＞0.05).However,variance value differemce among bodily pain,vitality,and mental health was significant(p＜0.05).
(5) 777 patients completed the assessment of GAS and ADL both at baseline and the end of 12 months.After the maintain treatment of 12 month, the difference of GAS for seven group was signifant,the score of GAS of patients assigned olanzapine and risperidone were higher than that of other groups(p＜0.05).And there was also sifnificant difference amont the variation values compared with baseline for seven groups,which was obvious for patients assigned loanzapine,quetiapine and arisperizole (p＜0.05).There was no significant difference in the total social of ADL,the variation value compred with baseline and employment rates at the end of 12 months for seven groups(p＞0.05).
Conclusions
1.Clinical outcomes were similar among 7 antipsychotic drugs.The slight difference in side effects were useful guides in matching the individual sensitivities of patients to the side effect profiles of treatment.
2.The cognitive function impairment of schizophrenic patients in stable stage was relative stable.The improvemt was small after 6 and 12 months treatment and there was no significant difference between seven antipsychotic drugs.
3.The quality of life of schizophrenia patients can be improved and the effectivenss of seven antipsychtoc drugs were similar,while the influences for different factors were differenct.Activity of daily living of schizophrenia patients in stable phase was not obviously damaged.Social function of patientsd assigned for olanzapine and risperdone were better than other groups.Employment rates were low in each group,but there was no significant difference among seven groups.
比较利培酮口服液合并氯硝安定口服与氟哌啶醇肌注治疗精神分裂症急性激越症状的疗效和安全性,探讨不同给药方式对治疗急性激越症状的作用。观察从肌注换为口服给药对急性治疗期(6周)疗效的影响。方法
采用随机多中心对照开放研究方法,189例伴有急性激越症状的精神分裂患者随机分为利培酮口服液+氯硝安定口服组(n＝98)和氟哌啶醇肌注组(n=91)。研究分为两个阶段。第一阶段:病人随机给予利培酮口服液+氯硝安定口服和氟哌啶醇肌注治疗并评定,研究期为5天。第二阶段:观察氟哌啶醇肌注换为利培酮口服和撤用氯硝安定对急性期(6周)治疗疗效的影响,从治疗第六天始至研究结束。以PANSS-EC和PANSS评定量表分别作为第一和第二阶段的主要疗效评价指标。安全性采用Simpson-Angus Scale(ASA)、Barnes Akathisia Scale(BAS)、不良事件报告和实验室检查评定。结果
(1)利培酮口服液合并氯硝安定口服与氟哌啶醇肌注对急性激越症状都有明显的治疗作用(P<0.01),两组间疗效差异无显著性(P>0.05),但利培酮组合作程度好于氟哌啶醇组(P<0.05),且总体不良反应尤其是锥体外系不良反应低于氟哌啶醇组,差异有显著性(P<0.05)。
(2)换(撤)药期间两组PANSS-EC和PANSS均分仍继续改善(P<0.01),两组间差异无显著(P>0.05),且治疗6周末两组间疗效相当(P>0.05)。两组总体不良事件发生率无显著性差异(P>0.05),但锥体外系不良反应氟哌啶醇组仍高于利培酮组,差异有显著性(P<0.05)。结论
利培酮口服液合并氯硝安定口服治疗精神分裂症急性激越症状与氟哌啶醇疗效相当,但利培酮组合作程度好,总体不良事件,尤其是锥体外系不良反应发生率低。换(撤)药期间症状稳定,治疗6周后两组间疗效相似,但利培酮组锥体外系不良反应少于氟哌啶醇组。
目的
比较氯丙嗪、舒必利、氯氮平、利培酮、奥氮平、喹硫平、阿立哌唑7种抗精神病药对精神分裂症患者1年维持治疗的有效性和安全性以及其对认知功能、生命质量和社会功能的影响。
方法
对服用7种药物之一、病程≤5年稳定期的1227例精神分裂症患者给予1年的维持治疗,以治疗中断率、中断前治疗时间结合临床疗效评价抗精神病药的总体有效性,采用不良事件和实验室检查评价安全性,每间隔3个月评估1次。以威斯康星卡片分类测验、数字符号测验、视觉再生测验、数字广度分测验、连续作业测验、连线测验评估患者的认知功能,每间隔6个月评估1次。以健康状况问卷(SF-36)评定患者的生命质量,每间隔6个月评定1次;以大体功能评定量表(GAS)、日常生活能力量表(ADL)、就业率评定患者的社会功能,GAS、就业率每间隔3个月评定1次,ADL每间隔6个月评定1次。
结果
(1)随访1年,1227例中44.1%(541例)的患者中断治疗,治疗中断率及中断前治疗时间在7种药物间的差异均无统计学意义(P>0.05);40.3%(495例)的患者完成1年随访并达到临床痊愈标准,临床痊愈率在7种药物间的差异无统计学意义(P>0.05)。随访1年末,奥氮平组PANSS总分低于其他各组(P<0.05),差异具有显著性;1年末PANSS总分与基线差值,阿立哌唑、奥氮平、利培酮与喹硫平和氯丙嗪之间存在差异(P<0.05)。7种药物总的不良反应发生率差异无统计学意义(P>0.05),但镇静作用、锥体外系不良反应、月经紊乱及体质量增加等不良反应在不同药物间的差别存在统计学意义(P<0.01和0.05)。
(2)801例患者完成基线与6月末认知功能评定。维持治疗6月前后认知功能变化值较小(-0.04～0.11),7组认知功能综合z分和各领域z分间比较差异无显著性(P>0.05);综合z分和各领域z分与基线相比的变化值7组间亦无显著性差异(P>0.05)。
(3)437例患者完成基线与12月末认知功能评定。维持治疗12月前后认知功能变化值较小(-0.19～0.30),7组认知功能综合z分和各领域z分间比较差异无显著性(P>0.05);综合z分和各领域z分与基线相比的变化值7组间亦无显著性差异(P>0.05)。
(4)848例患者完成基线与12月末SF-36评定。维持治疗12月后,7组SF-36总分比较差异无显著性(P>0.05),但生理职能、精力、情感职能、精神健康因子分7组间存在差异(P<0.05);与基线相比,SF-36总分提高了6.2～10.6分,7组间变化值差异无显著性(P>0.05),但躯体疼痛、精力、精神健康因子分的差异7组间差异具有显著性(P<0.05)。
(5)777例患者完成基线与12月末社会功能评定。维持治疗12月后,7组GAS分比较差异有显著性(P<0.05),奥氮平、利培酮的大体社会功能较好;与基线相比的变化值7组间亦有显著性差异(P<0.05),奥氮平、喹硫平、阿立哌唑的改善程度较大;7组维持治疗12月后ADL总分、ADL与基线的变化值、就业率间比较差异无显著性(P>0.05)。
结论
1.7种抗精神病药治疗精神分裂症患者的1年临床疗效相当,但药物的不良反应各异。
2.稳定期精神分裂症患者认知功能相对稳定,7种抗精神病药维持治疗1年对认知功能的改善作用较小,并且7种抗精神病药对认知功能的影响无明显差别。
3.7种抗精神病药维持治疗1年对精神分裂症患者生命质量有明显改善,7种药物疗效相当,但对不同因子的影响有所差别。稳定期精神分裂症患者日常生活能力无明显受损;奥氮平、利培酮组的患者的社会功能相对较好;7组就业率都较低,但不同药物间无明显差别。
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 and schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of acute 6 weeks treatment from switching IM injection to oral.
Method
In a randomized,parallel-group,open study conducted at 6 sites in china,189 patients exhibiting agitation associated with active psychosis were randomly assigned to reveive either oral treatment with risperidone oral solution puls clonazepam(n=98) or intramuscular treatment with haloperidol (n=91).Eligible subjects will be entered 5 days treatment sessionⅠto compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation,then will be followed by 6 additional weeks treatment sessionⅡfor exploring the effect of medicine switching from IM injection to oral.The primary efficacy outcome measure will be the change in scores based on PANSS-EC,composed of 5 items(excitement,hostility, uncooperativeness,hallucinatory,and poor impulse control) from the Positive and Negative Syndrome Scale(PANSS) in sessionⅠ,and the response rate based on the PANSS in sessionⅡ.Safety was evaluated using Simpson-Angus Scale(ASA),Barnes Akathisia Scale(BAS),adverst events and lab test.
Result
(1) Mean acute-agitation score improvement were significant after 5 days 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 risperdone oral solution groups than that in haloperidol group(p＜0.05).
(2) Mean PANSS-EC and PANSS scores remained stable after switching from IM to oral.The efficacy was no significant difference in both groups after 6 weeks 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 haloperidol group than that in risperidone group(p＜0.05).
Conclusion
The results showed that risperidone oral solution combination clonazepam oral has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation,but risperdone oral solution has better cooperation and tolerability.Mean PANSS-EC and PANSS scores remained stable after switching from IM to oral.The efficacy were similar in both groups after 6 weeks treatment.
PartⅡComparative one-year follow-up outcomes of seven antipsychotic drugs in patients with schizophrenia
Objective
To compare the maintenance treatment effectiveness,the cognitive function effectiveness,the quality of life and social function effectiveness of seven antipsychotic agents including chlorpromazine,sulpiride,clozapine, risperidone,olanzapine,quetiapine,and aripiprazole to schizophrenia for 12 months.
Methods
A total of 1227 patients suffering from schizophrenia no more than 5 years who took one of the seven study medications as maintenance treatment were recruited at 10 china sites for following up to 12 months.Study measures were administered at baseline and the end of each 3 month assessment period.The outcomes were evaluated using discontinuation of treatment and time to treatment discontinuation combined with clinical efficacy outcome.The adverse events were reported and lab tests were administered to evaluate side effects.Cognitive function was assessed at baseline and the end of each 6 month assessment period using Wisconsion card sorting test(WCST),Digit symbol test,Digit span test,Visual reproduction,Coutinuous performance test(CPT),Trail making test(TMT). SF-36 was used to evaluate quality of life of patients at baseline and the end of each 6 month assessment period.The social function of patients were assessed using GAS,which was admisitered at baseline and the end of each 3 month assessment period,ADL,admisitered at baseline and the end of each 6 month assessment period and employment rate.
Results
(1) Almost 44.1 percent patients discontinued their assigned treatment before 12 months.The rate of discontinuation and the time to the discontinuation of treatment for any cause had no significant difference among the seven groups.40.3 percent patients completed the one year follow-up and attained the clinical remission.At the end of 12 months,the total PANSS score was lower in olanzapine group than other groups and the difference was significant.Patients receiving risperidone,olanzapine,and aripiprazole showed greater improvement from baseline compared with patients receiving chlorpromazine and quetiapine.There was no significant difference on the total side effects while sedation,extrapyramidal symptoms, weight gain and menstrual irregularities were obvious difference among the seven antipsychotic drugs.
(2) 804 patients completed the assessment of cognitive function both at baseline and the end of 6 months.After month 6,the improvement was small(-0.04～0.11).There was no significant overall difference between treatment(p＞0.05).
(3) 437 patients completed the assessment of cognitive function both at baseline and the end of 12 months.After month 12,The improvement was small(-0.19～0.30).There was no significant overall difference between treatment(p＞0.05).
(4) 848 patients completed the assessment of SF-36 both at baseline and the end of 12 months.After the maintain treatment of 12 month,there was no significant difference among the total score of SF-36 for senen group (p＞0.05),but there were difference among the factor scores of role-physical, vitality,role-emotional and mental health for seven group(p＜0.05).The total score of SF-36 incresed by 6.0-10.6,but there was no signinicant difference amont the variance value for seven groups(p＞0.05).However,variance value differemce among bodily pain,vitality,and mental health was significant(p＜0.05).
(5) 777 patients completed the assessment of GAS and ADL both at baseline and the end of 12 months.After the maintain treatment of 12 month, the difference of GAS for seven group was signifant,the score of GAS of patients assigned olanzapine and risperidone were higher than that of other groups(p＜0.05).And there was also sifnificant difference amont the variation values compared with baseline for seven groups,which was obvious for patients assigned loanzapine,quetiapine and arisperizole (p＜0.05).There was no significant difference in the total social of ADL,the variation value compred with baseline and employment rates at the end of 12 months for seven groups(p＞0.05).
Conclusions
1.Clinical outcomes were similar among 7 antipsychotic drugs.The slight difference in side effects were useful guides in matching the individual sensitivities of patients to the side effect profiles of treatment.
2.The cognitive function impairment of schizophrenic patients in stable stage was relative stable.The improvemt was small after 6 and 12 months treatment and there was no significant difference between seven antipsychotic drugs.
3.The quality of life of schizophrenia patients can be improved and the effectivenss of seven antipsychtoc drugs were similar,while the influences for different factors were differenct.Activity of daily living of schizophrenia patients in stable phase was not obviously damaged.Social function of patientsd assigned for olanzapine and risperdone were better than other groups.Employment rates were low in each group,but there was no significant difference among seven groups.
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