利培酮与氟哌啶醇治疗双相Ⅰ型障碍急性躁狂发作的多中心双盲对照研究

目的评价利培酮和氟哌啶醇治疗双相Ⅰ型障碍躁狂发作的疗效及安全性。方法采用随机双盲多中心对照研究方法，对173例双相Ⅰ型障碍躁狂发作患者分别进行利培酮（利培酮组）和氟哌啶醇（氟哌啶醇组）治疗，其中利培酮组85例，平均剂量为4．6mg／d；氟哌啶醇组88例，平均剂量为8．0mg／d；观察疗程均为4周。以Young躁狂评定量表作为主要疗效评价指标。根据人用药品注册技术规定国际协调会议统计指导原则规定，由PP人群统计分析判断是否非劣效。结果利培酮组患者的有效率为79％，氟哌啶醇组的有效率为76％。PP人群统计学分析，利培酮治疗急性躁狂的疗效不劣于氟哌啶醇。利培酮组与研究药物有关的不良事件发生率为60％，氟哌啶醇组为73％，差异无统计学意义（P〉0．05）。利培酮组锥体外系不良反应的发生率（44％）明显低于氟哌啶醇组（58％），差异有统计学意义（P=0．028）。结论利培酮治疗双相Ⅰ型障碍躁狂发作的疗效与氟哌啶醇相当，锥体外系不良反应少于氟哌啶醇。     

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

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.     

氯硝西泮治疗急性躁狂发作的辅助作用

目的:研究氯硝西泮与碳酸锂合用治疗急性躁狂发作的疗效及不良反应。方法:对72例急性躁狂发作患者随机分为氯硝西泮合并碳酸锂组和氟哌啶醇合并碳酸锂组治疗,在治疗前及治疗第1、2、3、4周末分别用Bech-Rafaelsen躁狂量表(BRMS),副反应量表(TESS)评定疗效和不良反应。结果:氯硝西泮组与氟哌啶醇组疗效相仿。氟哌啶醇组锥体外系反应发生率高于氯硝西泮组。结论:氯硝西泮合并碳酸锂可有效治疗急性躁狂的兴奋患者,疗效与氟哌啶醇相仿,安全性优于氟哌啶醇。     

利培酮与氟哌啶醇治疗儿童抽动障碍的对照研究

目的:比较利培酮与氟哌啶醇治疗儿童抽动障碍的疗效和安全性。方法:将52例6~14岁抽动障碍患儿随机分为利培酮组和氟哌啶醇组;分别予以相应的药物治疗8周;于治疗前及治疗2、4、8周末采用耶鲁综合抽动严重程度量表(YGTSS)、治疗中出现的症状量表(TESS)评估疗效和安全性。结果:共有46例患者完成8周的治疗;治疗第2周末利培酮组(24例)YGTSS总分明显高于氟哌啶醇组(22例)[(57.71±15.45)分vs.(47.34±18.13)分],有效率明显低于氟哌啶醇组(29.17%vs.59.09%)(P均0.05);治疗第4、8周末两组间YGTSS总分和有效率差异无统计学意义;治疗第2、4、8周末利培酮组TESS分明显低于氟哌啶醇组(P均0.01)。结论:利培酮治疗儿童抽动障碍的疗效与氟哌啶醇相当;虽然起效较慢,但不良反应小,适合儿童治疗。     

奥氮平与利培酮口服液治疗精神分裂症兴奋激越的临床观察

目的观察奥氮平与利培酮口服液治疗精神分裂症急性期兴奋激越的临床疗效及不良反应。方法将170例精神分裂症急性中度兴奋患者,随机分入奥氮平组56例,利培酮口服液组54例,氟哌啶醇组60例,共治疗7天;治疗前及治疗1周末评估阳性与阴性症状量表兴奋因子（PANSS-EC）,采用TESS评定不良反应。结果奥氮平组、利培酮口服液组与氟哌啶醇组比较,均获得明显改善,差异均无显著性（P均〉0.05）,氟哌啶醇组锥体外系反应发生率高于奥氮平组与利培酮口服液组（P〈0.01）,且奥氮平组几乎无锥体外系反应发生。结论奥氮平与利培酮口服液治疗精神分裂症急性中度兴奋患者与氟哌啶醇的疗效相当,且不良反应较小,安全性良好。     

利培酮治疗老年精神分裂症患者对照研究

目的 :评价利培酮和氟哌啶醇治疗老年精神分裂症患者的疗效和安全性。　方法 :对 10 5例老年精神分裂症患者分别给予利培酮、氟哌啶醇治疗 ,其中利培酮组 5 4例 ,氟哌啶醇组 5 1例。疗程12周。以简明精神病评定量表 (BPRS)评定临床疗效 ,以副反应量表 (TESS)和实验室检测评价安全性。　结果 :治疗结束时 ,两组BPRS总分较治疗前显著降低 (P <0 0 1) ,两组间差异无显著性 ,两组临床疗效 ,利培酮组有效率 87 0 % ,显效率 5 7 4 %。氟哌啶醇组有效率 84 3% ,显效率 5 4 9% ,两组差异无显著性。利培酮组不良反应总发生率较氟哌啶醇组少 (P <0 0 5 )。　结论 :利培酮治疗老年精神分裂症患者的疗效与氟哌啶醇相似 ,不良反应较氟哌啶醇轻而少。     

利培酮治疗老年期精神分裂症双盲对照研究

目的：探讨利培酮治疗老年期精神分裂症的有效性及安全性。方法：分别用利培酮和氟哌啶醇对62例老年期精神分裂症患者进行8周治疗。疗效评定采用阳性与阴性症状量表(PANSS)，不良反应评定用副反应量表(TESS)和Sampson锥体外系反应量表。结果：两组治疗前后比较PANSS总分和各因子分均具有显著差异、两组在治疗第1、2、4、6、8周PANSS总分及各因子分比较差异均无显著性，但利培酮组较氟哌啶醇组在治疗阴性症状方面起效早2周。不良反应震颤、肌强直、活动减退发生率利培酮组显著低于氟哌啶醇组。结论：利培酮和氟哌啶醇均为治疗老年期精神分裂症有效、安全的药物。利培酮治疗阴性症状起效较早，氟哌啶醇锥体外系反应较显著。     

利培酮合并氯硝西泮治疗精神分裂症急性兴奋的研究

目的 与氯氮平和氟哌啶醇相对照,观察利培酮合并氯硝西泮治疗精神分裂症急性兴奋的疗效及不良反应特点。方法 254例精神分裂症急性期中度兴奋患者,随机分为口服利培酮合并肌内注射氯硝西泮组(88例,以下简称利培酮组)、口服氯氮平组(84例,氯氮平组)和肌内注射氟哌啶醇组(82例,氟哌啶醇组)治疗,疗程均为7 d。治疗期间每日评估阳性和阴性症状量表(PANSS)兴奋因子(PANSS-EC)和治疗中需处理的不良反应量表。结果 利培酮组的疗效与氯氮平组、氟哌啶醇组比较,经重复测量分析显示PANSS-EC分,差异无显著性(F=1.65,P=0.194)。3组精神分裂症患者的急性兴奋症状均获明显改善(各组组内治疗前后比较,F=415.35,P<0.01)。氟哌啶醇组锥体外系副反应发生率高于利培酮组和氯氮平组(P<0.01);氯氮平组嗜睡、便秘、流涎和心动过速的发生率高于利培酮组和氟哌啶醇组(P<0.05-0.01)。结论 利培酮合并氯硝西泮可有效治疗精神分裂症急性期中度兴奋患者,疗效与氯氮平和氟哌啶醇的疗效相当;安全性优于氯氮平和氟哌啶醇。     

利培酮、氯氮平和氟哌啶醇治疗精神分裂症的疗效比较结果

目的　比较利培酮、氯氮平和氟哌啶醇的疗效和不良反应。方法　将符合CCMD - 2 -R诊断标准的精神分裂症患者 ,根据入院顺序分别进入利培酮组、氯氮平组和氟哌啶醇组 ,并观察 8周。以PANSS和TESS量表评定药物的疗效和不良反应。结果　利培酮组、氯氮平组和氟哌啶醇组的PANSS量表总分、阴性分量表、一般精神病理学分量表评分均下降 ;利培酮组和氯氮平组减分较氟哌啶醇组明显 (分别P <0 0 1,P <0 0 5 ) ,TESS量表的评分也与氟哌啶醇组有显著性差异 (分别P <0 0 1,P <0 0 5 ) ;利培酮组、氯氮平组和氟哌啶醇组肝功能、心电图检查结果 ,组间差异有非常显著意义 (P <0 0 1) ;利培酮组不良反应少于氯氮平组和氟哌啶醇组。结论　利培酮、氯氮平和氟哌啶醇均具有较强的抗精神病作用 ,利培酮的安全性相对较好。     

利培酮口服液治疗老年期精神分裂症临床观察

目的:研究利培酮口服液治疗老年期精神分裂症的疗效和不良反应.方法:将51例老年期精神分裂症住院患者随机分为两组,分别给予利培酮口服液和氟哌啶醇治疗6周.以阳性与阴性症状量表(PANSS)评定疗效,用副反应量表(TESS)评定不良反应.结果:利培酮口服液与氟哌啶醇的疗效无显著差异.利培酮口服液的不良反应主要为失眠、恶心等,程度轻微,氟哌啶醇的锥体外系反应较严重.结论:利培酮口服液对老年期精神分裂症有效,不良反应轻微.     

Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind,placebo-controlled comparison of efficacy and safety

OBJECTIVE: The study assessed the efficacy and safety of risperidone as an adjunctive agent to mood stabilizers in the treatment of acute mania. METHOD: This 3-week randomized, double-blind, placebo-controlled study included 156 bipolar disorder patients with a current manic or mixed episode who received a mood stabilizer (lithium or divalproex) and placebo, risperidone, or haloperidol. The primary efficacy measure was the Young Mania Rating Scale. Other assessments used the Brief Psychiatric Rating Scale, the Clinical Global Impression scale, and safety measures. RESULTS: The trial was discontinued by 25 (49%) of the 51 placebo group patients, 18 (35%) of the 52 risperidone group patients, and 28 (53%) of the 53 haloperidol group patients. Mean modal doses were 3.8 mg/day (SD=1.8) of risperidone and 6.2 mg/day (SD=2.9) of haloperidol. Significantly greater reductions in Young Mania Rating Scale scores at endpoint and over time were seen in the risperidone group and in the haloperidol group, compared with the placebo group. Young Mania Rating Scale total scores improved with risperidone and with haloperidol both in patients with psychotic features and in those without psychotic features at baseline. Extrapyramidal Symptom Rating Scale total scores at endpoint were significantly higher in the haloperidol patients than in the placebo patients. Antiparkinsonian medications were received by 8%, 17%, and 38% of patients in the placebo, risperidone, and haloperidol groups, respectively. CONCLUSIONS: Risperidone plus a mood stabilizer was more efficacious than a mood stabilizer alone, and as efficacious as haloperidol plus a mood stabilizer, for the rapid control of manic symptoms and was well tolerated.     

Risperidone versus haloperidol in psychotic patients with disturbing neuroleptic-induced extrapyramidal symptoms: a double-blind, multi-center trial

BACKGROUND: A randomized, double-blind, multi-center trial was started to compare the severity of extrapyramidal symptoms (EPS) during risperidone and haloperidol treatment in schizophrenic patients who had disturbing EPS during their previous neuroleptic treatment. Additional objectives of this trial were comparing the antipsychotic effectiveness of the two treatments and the use of antiparkinsonian medication. METHODS: Effects of flexible doses of risperidone and haloperidol were compared in 77 psychotic patients (83% with chronic schizophrenia) with disturbing neuroleptic-induced EPS (risperidone 40 patients, haloperidol 37). The trial was completed by 47 patients: 25 in the risperidone group (12 women, 13 men), and 22 in the haloperidol group (10 women, 12 men). RESULTS: An adequate antipsychotic effect was obtained in most patients by both treatments. The primary aim of this trial was comparing parkinsonism measured with the extrapyramidal syndrome rating scale (ESRS) during treatment with risperidone and haloperidol. Two primary parameters were selected: the change from baseline to the worst score during treatment of ESRS II (parkinsonism) and ESRS VI (clinical global impression of severity of parkinsonism). The CGI of severity of parkinsonism was better with risperidone (P=0.025), while the parkinsonism total score tended to be better with risperidone (P<0. 10). Before the double-blind treatment, 34 (of the 77) had used antiparkinson medication (risperidone 18, haloperidol 16). During the double-blind treatment phase, 21 patients had used antiparkinson medication (risperidone 11, haloperidol 10). The larger reduction of parkinsonism in the risperidone group was not due to a difference in the use of anti-parkinsonian medication. CONCLUSIONS: In this group of schizophrenic patients with disturbing EPS during previous neuroleptic treatment, a stronger reduction of parkinsonism was observed with risperidone than with haloperidol.     

Effectiveness of antipsychotic therapy in a naturalistic setting: a comparison between risperidone, perphenazine, and haloperidol

BACKGROUND: Therapeutic ineffectiveness and noncompliance with antipsychotic agents are major contributors to rehospitalization in patients with psychotic disorders. It is unknown whether risperidone's favorable side effect profile compared with that of the conventional antipsychotics results in improved compliance and reduced hospitalizations in a naturalistic setting. The purpose of this study was to test the hypothesis that treatment with risperidone reduces readmission rates and associated costs when compared with treatment with perphenazine or haloperidol. METHOD: Inpatients prescribed either risperidone, perphenazine, or haloperidol between January 1, 1995, and December 31, 1995, as a single oral antipsychotic at discharge were retrospectively identified. Data were collected for that index hospitalization and for a 1-year follow-up period. Primary outcome measures included re-admission rates, changes in antipsychotic therapy, anticholinergic drug use, and costs. RESULTS: There were 202 evaluable patients (81 treated with risperidone, 78 with perphenazine, and 43 with haloperidol). Baseline demographics were similar between groups except that more patients in the risperidone group had a primary diagnosis of psychotic disorder or had been hospitalized in the year prior to study. The percentage of patients readmitted during the 1-year follow-up period was similar among drug groups (41% risperidone, 26% perphenazine, and 35% haloperidol) when controlled for baseline differences in diagnosis and hospitalization history (p = .32). Anticholinergic drug use was more common in the haloperidol group (p = .004). Mean yearly cost (drug + hospitalization) in the risperidone group was $20,317, nearly double that in the other treatment groups (p < .001). CONCLUSION: The results from this naturalistic study indicate that the high cost of risperidone is not offset by a reduction in readmission rates when compared with conventional antipsychotics.     

利培酮对精神分裂症患者生活质量的影响

目的：比较利培酮与氟哌啶醇对精神分裂症患者生活质量的影响。方法：对门诊72例服用氟哌啶醇及74例服用利培酮的精神分裂症患者用生活质量综合评定问卷（GQOLI）、阳性与阴性症状量表（PANSS）、副反应量表（TESS）进行评定。结果：利培酮组患者治疗后生活质量有所提高,而氟哌啶醇组患者生活质量有所下降。结论：利培酮治疗有利于患者提高生活质量。     

利培酮治疗Tourette综合征对照研究

目的:进一步验证利培酮治疗Tourette综合征的疗效和不良反应. 方法:60例Tourette综合征患者分为两组,每组30例,分别给予利培酮和氟哌啶醇治疗.疗程6周.治疗前和治疗6周分别进行耶鲁综合抽动严重性量表(YGTSS)和副反应量表(TESS)评定疗效和不良反应. 结果:两组治疗后YGTSS总分和各维度评分均显著低于治疗前,利培酮组显著高于氟哌啶醇组,利培酮组显效率为67.9%明显低于氟哌啶醇组96.7%;利培酮组不良反应明显小于氟哌啶醇组. 结论:利培酮和氟哌啶醇均能有效治疗Tourette综合征,但利培酮疗效不及氟哌啶醇,利培酮不良反应少而轻.     

Weight gain associated with olanzapine and risperidone in adolescent patients: a comparative prospective study

OBJECTIVE: To evaluate weight gain associated with olanzapine, risperidone, and haloperidol treatment and its clinical risk factors in adolescent patients. METHOD: The study was conducted at three adolescent psychiatric departments in two mental health centers in the Tel Aviv area. All patients were Jewish Israelis. Weight and body mass index (BMI) of hospitalized adolescents treated with olanzapine (n = 21), risperidone (n = 21), or haloperidol (n = 8) were prospectively monitored on a weekly basis for the first 12 weeks of treatment. Various clinical risk factors were tested for association with weight gain. RESULTS: The olanzapine and risperidone groups experienced significant weight gain between baseline and endpoint (p < .01), whereas the average weight of the haloperidol group did not change. Average weight gain was significantly higher for the olanzapine group (7.2 +/- 6.3 kg, 11.1% +/- 7.8%) than for the risperidone (3.9 +/- 4.8 kg, 6.6% +/- 8.6%) and haloperidol (1.1 +/- 3.3 kg, 1.5% +/- 6.0%) groups. Extreme weight gain (>7%) was recorded in 19 patients (90.5%), 9 patients (42.9%), and 1 (12.5%) patient, respectively Gender (males), low concern about gaining weight (females), low baseline BMI, and paternal BMI were positively correlated with weight gain, whereas previous neuroleptic history, neuroleptic dosage, response to treatment, and illness duration were not. CONCLUSIONS: Olanzapine and risperidone are associated with extreme weight gain in adolescents, much higher than that reported in adults. This side effect should be taken into consideration before prescribing these medications, especially in patients at high risk.     

拉莫三嗪治疗双相心境障碍对照研究

目的：探讨拉莫三嗪治疗双相情感障碍的疗效与安全性。方法：双相心境障碍患者135例,其中双相抑郁78例,躁狂57例。将患者随机分为3组,每组抑郁相26例,躁狂相19例。疗程32周。前8周为急性期治疗阶段,对照组抑郁相只服选择性5-羟色胺回收抑制剂（SSRI）类抗抑郁剂,躁狂相只服利培酮;拉莫三嗪组在对照组用药的基础上加服拉莫三嗪;碳酸锂组在对照组用药的基础上加服碳酸锂。后24周为巩固治疗阶段,所有患者随机分为两组,只服拉莫三嗪或碳酸锂。采用汉密尔顿抑郁量表（HAMD）、Young躁狂评定量表（YMRS）、治疗中出现的症状量表（TESS）评定疗效及安全性。结果：急性期治疗结束后,无论躁狂相还是抑郁相,拉莫三嗪组和碳酸锂组的临床疗效显著高于对照组（P〈0．01或〈0．05）。巩固治疗阶段两组相比,拉莫三嗪的抗抑郁作用较好,碳酸锂的抗躁狂作用较强。不良反应发生率,碳酸锂组40％,拉莫三嗪组22％。巩固治疗阶段病情复发率,拉莫三嗪组8％,碳酸锂组11％,两组差异无显著性（P〉0．05）。结论：拉莫三嗪作为心境稳定剂治疗双相情感障碍疗效可靠,不良反应小,与碳酸锂相比,抗抑郁作用更强。     

奥氮平快速镇静疗法与氟哌啶醇肌注治疗急性躁狂发作的对照研究

目的比较奥氮平快速镇静疗法和氟哌啶醇肌注对急性躁狂发作的疗效和安全性。方法52例伴有激越行为的急性躁狂患者,随机分成两组,奥氮平组26例、氟哌啶醇组26例,分别在治疗前、治疗后12h、72h、1周及2周末采用阳性症状与阴性症状量表(PANSS)的兴奋因子分评定疗效,治疗时出现的症状量表(TESS)评定不良反应。结果两组治疗后12h、72h、1周及2周末的PANSS兴奋因子分均较前明显下降,两组对兴奋激越症状均能快速起效,两组疗效相当,各时点两组间比较无显著性差异,但氟哌啶醇组在各时点TESS总分显著高于奥氮平组。结论奥氮平快速镇静疗法和氟哌啶醇肌注治疗对急性躁狂发作患者的兴奋激越症状均有很好疗效,两组疗效大致相当,但前者在安全性方面更有优势。     

Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy

BACKGROUND: The purpose of this analysis was to assess rates of symptomatic remission in patients with bipolar mania receiving risperidone in a double-blind, parallel-group, multicenter, placebo-controlled trial conducted in India. METHOD: Two hundred ninety-one adult patients who met DSM-IV criteria for bipolar I disorder manic or mixed episode were randomly assigned to flexible doses of risperidone (1-6 mg/day, N = 146) or placebo (N = 145) for up to 3 weeks. An entry Young Mania Rating Scale (YMRS) score of >or= 20 was required at trial screening and baseline. Remission was defined as achieving and maintaining a YMRS score 相似文献