阿立哌唑与利培酮治疗精神分裂症的双盲双模拟多中心研究

目的:研究阿立哌唑与利培酮治疗精神分裂症的疗效与安全性。方法:采用CCMD-3精神分裂症的诊断标准,223例精神分裂症患者随机分为阿立哌唑组(109例)和利培酮组(114例),治疗6周。治疗前后用阳性症状和阴性症状量表(PANSS)、临床疗效总评量表(CGI)和副反应量表(TESS)、锥体外系副反应量表(ESRS)评定疗效和安全性。结果:经6周治疗,223例患者完成研究。阿立哌唑组治愈率31.8%,有效率83.3%;利培酮组治愈率39.1%,有效率87.5%(P>0.05)。两组治疗前后PANSS总分、阳性症状、阴性症状、一般精神病理症状评分比较有显著差异(P<0.01)。阿立哌唑组阴性症状分治疗6周末下降较利培酮组明显,有显著差异(P<0.05)。治疗4周末、6周末阿立哌唑组反应缺乏分下降,和利培酮组比较有显著差异(P<0.05)。治疗4,6周末TESS评定阿立哌唑不良反应发生率低于利培酮(P<0.05)。阿立哌唑组主要不良反应是锥体外系副反应、失眠、头昏等。结论:阿立哌唑对精神分裂症患者安全有效。     

阿立哌唑与奋乃静治疗精神分裂症的临床疗效与安全性比较

目的比较阿立哌唑与奋乃静治疗精神分裂症的临床疗效及安全性。方法 94例精神分裂症患者随机分为阿立哌唑组和奋乃静组各47例,分别口服阿立哌唑10～30mg·d~(-1)或奋乃静20～40mg·d~(-1)治疗,疗程为8wk。于基线及服药wk 2、4、6、8末,采用阳性和阴性症状量表(PANSS)评定疗效,副反应量表(TESS)评定不良反应。结果 2组治疗wk 2末起PANSS总分均较治疗前有显著下降(P<0.01),阿立哌唑组PANSS阳性症状、阴性症状和一般病理症状因子分与治疗前比较均有非常显著下降(P<0.01),奋乃静组阴性症状因子分与治疗前比较无显著差异(P>0.05)。治疗wk 8末阿立哌唑组PANSS总分减分率为(68±11)%,奋乃静组为(67±12)%;阿立哌唑组显效率为70%,奋乃静组为68%,2组疗效无显著差异(P>0.05)。阿立哌唑组不良反应发生率较奋乃静组少(26%vs.89%,P<0.01)。结论阿立哌唑治疗精神分裂症疗效与奋乃静相当,不良反应较奋乃静少,能更有效改善阴性症状。     

阿立哌唑与利培酮治疗女性精神分裂症患者的临床对照研究

目的比较阿立哌唑与利培酮治疗女性精神分裂症患者的疗效和安全性。方法采用随机、单盲对照的方法,将80例女性精神分裂症患者分为2组,分别使用阿立哌唑与利培酮对照治疗8周。采用阳性症状与阴性症状量表(PANSS)评定疗效,副反应量表%(TESS)评定副反应。结果治疗8周后阿立哌唑组显效率87.5%;利培酮组显效率为82.5%,两组差异无显著性(P>0.05),阿立哌唑组总不良反应发生率为40%,利培酮组总不良反应发生率为45%,两组差异无显著性(P>0.05)。结论阿立哌唑适用女性精神分裂症患者的临床治疗,疗效好、安全性高、依从性好、不良反应轻(且有同有异)、锥体外系反应少、对体重和月经影响小,无溢乳的抗精神病药。     

舒肝解郁胶囊合并抗精神病药物治疗精神分裂症阴性症状的疗效

目的比较舒肝解郁胶囊合并抗精神病药物(阿立哌唑)与单用抗精神病药物(阿立哌唑)治疗精神分裂症的疗效和安全性。方法50例精神分裂症,25例入治疗组,25例入对照组。治疗组用舒肝解郁胶囊4片/日,阿立哌唑20～30mg/d,对照组单用阿立哌唑20～30mg/d。两组病例均采用阳性与阴性症状量表(PANSS)疗效评定,副反应量表(TESS)评定不良反应,于治疗前及治疗4、8、12周各评定一次。结果根据PANSS评定,治疗组显效率为64%,对照组显效率为40%,从治疗4周起,治疗组PANSS总分及阴性症状分均显著低于对照组。结论以阴性症状为主的精神分裂症患者,抗精神病药物(阿立哌唑)同时合用舒肝解郁胶囊,可改善阴性症状,两组不良反应无明显差异。     

阿立哌唑与氟哌啶醇治疗首发精神分裂症随机对照研究

目的:评价阿立哌唑治疗首发精神分裂症的临床疗效及安全性。方法:87例首次住院的精神分裂症患者随机分为2组,分别给予阿立哌唑、氟哌啶醇治疗,疗程8周。治疗前及治疗2,4,8周末采用阳性与阴性综合征量表(PANSS)评定疗效,副反应量表(TESS)评定不良反应。结果:治疗8周末,阿立哌唑组有效率为91.11%;氟哌啶醇组有效率为88.10%;两组差异无统计学意义(P>0.05)。治疗2周末两组评分均较治疗前下降差异显著(P<0.01),随治疗时间的延长两组疗效差距逐渐缩小。结论:阿立哌唑治疗精神分裂症起效时间短于氟哌啶醇,远期疗效优于氟哌啶醇;且安全性高,依从性好。     

阿立哌唑治疗精神分裂症阴性症状的临床观察

目的评价阿立哌唑治疗精神分裂症阴性症状的临床疗效及安全性。方法将60例精神分裂症患者随机分为阿立哌唑组和奥氮平组各30例,2组均用药8周。采用阳性和阴性症状量表(PANSS)评定临床疗效,并采用不良反应量表(TESS)评定药物不良反应,分别于治疗前及治疗第2、4、8周末评定1次。结果 2组治疗第2、4、8周末PANSS评分均低于治疗前,且阿立哌唑组治疗第8周末阴性症状评分低于奥氮平组,差异均有统计学意义(P<0.05)。阿立哌唑组不良反应发生率为63.3%,奥氮平组为60.0%,2组比较差异无统计学意义(P>0.05)。结论阿立哌唑治疗精神分裂症阴性症状有效,且不良反应轻微。     

阿立哌唑治疗老年期精神分裂症的研究

目的:探讨阿立哌唑与利培酮对老年期精神分裂症的疗效和安全性。方法:将86例老年期精神分裂症患者随机分为2组,分别选用阿立哌唑或利培酮治疗,疗程12周,疗效评定采用阳性与阴性症状量表(PANSS)及不良反应量表(TESS)评定疗效和不良反应。结果:治疗12周后2组PANSS评分较治疗前均显著下降。阿立哌唑组有效率69.76%,显效率88.37%;利培酮组有效率72.09%,显效率90.70%,2组间差异无显著性(P>0.05)。结论:阿立哌唑与利培酮治疗老年期精神分裂症均有肯定疗效,不良反应均比较轻,安全性好。     

帕利哌酮与阿立哌唑治疗青少年首发精神分裂症的临床对照研究

目的比较帕利哌酮与阿立哌唑治疗青少年首发精神分裂症的临床疗效及安全性。方法 68例青少年首发精神分裂症患者随机分为帕利哌酮组和阿立哌唑组,每组34例。帕利哌酮组起始剂量3 mg·d~(-1),剂量范围3～12 mg·d~(-1);阿立哌唑组起始剂量2.5 mg·d~(-1),剂量范围2.5～20 mg·d~(-1),治疗12周。于基线及2、4、8、12周末,采用阳性与阴性症状量表(PANSS)、个人和社会功能量表(PSP)评定疗效,采用副反应量表(TESS)评价不良反应。结果最终有63例纳入分析,其中帕利哌酮组32例,阿立哌唑组31例。帕利哌酮组治疗总显效率为72%,阿立哌唑组为68%,疗效无显著差异(P>0.05)。治疗12周末时两组PANSS总分、阳性症状分、阴性症状分和一般精神病理症状分均较治疗前有显著下降(P<0.05或P<0.01),组间比较无显著差异(P>0.05)。两组PANSS减分在治疗2周末比较有显著差异(P<0.01),其余时间点比较无显著差异(P>0.05)。两组PSP值均比治疗前显著增高(P<0.01),帕利哌酮组增高更明显,组间比较有显著差异(P<0.05)。两组不良反应发生率无显著差异(72%vs.70%,P>0.05)。结论帕利哌酮治疗青少年首发精神分裂症疗效与阿立哌唑相当,且起效快,安全性高。     

阿立哌唑合并氟哌啶醇治疗难治性精神分裂症的临床观察

目的探讨阿立哌唑合并氟哌啶醇治疗难治性精神分裂症的疗效与安全性。方法用阿立哌唑合并氟哌啶醇治疗难治性精神分裂症38例。以阳性与阴性症状量表(PANSS)以及副反应量表(TESS)对患者的疗效及其安全性进行评定疗程8周。结果阿立哌唑合并氟哌啶醇治疗难治性精神分裂症有效率为86%显效率为75%。无严重不良反应。结论阿立哌唑合并氟哌啶醇对难治性精神分裂症有很好的疗效,且无明显不良反应。     

阿立哌唑治疗精神分裂症阴性症状临床观察

目的探讨阿立哌唑治疗精神分裂症阴性症状的疗效和安全性。方法随机分配27例和25例患者进入利培酮和阿立哌唑治疗组,以阳性和阴性症状量表(PANSS),锥体外系副反应量表(SAS)评估疗效和安全性。结果经6周治疗,阿立哌唑和利培酮对精神分裂症阴性症状的疗效和安全性差异无统计学意义。结论阿立哌唑短期治疗精神分裂症阴性症状可能是利培酮外的另一种安全有效的选择。     

阿立哌唑治疗老年期精神分裂症的研究

目的：探讨阿立哌唑与氟哌啶醇对老年期精神分裂症的疗效和安全性。方法：将86例老年期精神分裂症患者随机分为两组,分别选用阿立哌唑和氟哌啶醇治疗,疗程12周,疗效评定采用阳性与阴性症状量表（PANSS）及副反应量表（TESS）评定疗效和不良反应。结果：治疗12周后,两组PANSS评分较治疗前均显著下降。阿立哌唑组有效率69．76％,显效率88．37％,氟哌啶醇组有效率65．12％,显效率86．05％,两组间比较,差异无统计学意义（P〉0．05）,阿立哌唑组不良反应少而轻。结论：阿立哌唑与氟哌啶醇治疗老年期精神分裂症均有肯定疗效．阿立哌唑不良反应轻,安全性好。     

阿立哌唑与利培酮治疗精神分裂症的对照研究

目的观察阿立哌唑治疗精神分裂症的临床疗效和安全性。方法将65例精神分裂症患者随机分为阿立哌唑组32例和利培酮组33例。分别采用阿立哌唑和利培酮治疗,疗程8周。采用阳性与阴性症状量表（PANSS）和治疗中出现的症状量表（TESS）于治疗前后评定临床疗效和不良反应。结果两组治疗后的PANSS评分均较治疗前显著降低（P〈0．01）。阿立哌唑组和利培酮组的显效率分别为75．0％和69．7％,总有效率分别为93．8％和90．9％,两组比较无显著性差异（P均〉0．05）。两组TESS均分也无显著性差异（P〉0．05）。结论阿立哌唑治疗精神分裂症疗效肯定,不良反应少。     

氯氮平与阿立哌唑治疗精神分裂症临床疗效的对照研究

目的评价阿立哌唑与氯氮平治疗精神分裂症的疗效与不良反应。方法将78例精神分裂症患者随机分为2组,分别予以氯氮平及阿立哌唑治疗,疗程8周。采用潘氏量表、副反应量表评定临床疗效和不良反应。结果两组临床疗效比较无显著性差异(P>0.05)。两组PANSS评分分析,治疗前后比较有显著性差异(P<0.05),两组间比较无显著性差异(P>0.05)。结论阿立哌唑与氯氮平治疗精神分裂症均有效,前者不良反应少,安全性高。     

两种药物对改善精神分裂症患者生活质量的观察

目的观察阿立哌唑口腔崩解片与奋乃静片对改善精神分裂症患者生活质量的影响。方法对精神分裂症患者分组分别口服阿立哌唑口腔崩解片和奋乃静片,治疗6个月,观察药物对患者的精神症状、生活质量和效果指数的影响。结果阿立哌唑口腔崩解片组患者的生活质量,除精神支柱和生理领域外,其余均有明显提高;奋乃静组仅明显改善心理领域,生活质量总评有所降低。阿立哌唑口腔崩解片组的生活质量总评,心理领域,生理领域,社会关系领域,独立性领域,环境领域,阳性症状与阴性症状的改善明显优越于奋乃静组。前者的效果指数亦优于后者。结论阿立哌唑口腔崩解片比奋乃静片更有利于改善精神分裂症患者的生活质量,有利于患者重返社会。     

阿立哌唑与利培酮治疗首发精神分裂症对照研究

目的:评估阿立哌唑治疗首发精神分裂症的疗效和不良反应。方法:将60例门诊首发精神分裂症患者随机分为两组,分别给予阿立哌唑和利培酮治疗6周,采用简明精神病量表(BPRS)和不良反应量表(TESS)评定疗效与不良反应。结果:两组疗效和不良反应发生率比较差异无显著性,但阿立哌唑的锥体外系反应和内分泌改变发生率显著低于利培酮。结论:阿立哌唑治疗首发精神分裂症安全有效。     

阿立哌唑对舒必利所致高催乳素血症的影响

目的 探讨阿立哌唑对舒必利所致高催乳素血症的影响及安全性.方法 对61例服用舒必利6周后的精神分裂症患者,随机分为治疗组31例,对照组30例.治疗组在服用原药的基础上,每天加用阿立哌唑10 mg,对照组维持以前的药物治疗.服用舒必利治疗第6周及第9周末分别测定患者血清催乳素水平,并进行比较.同时用不良反应量表（TESS）评定不良反应.结果 经阿立哌唑治疗后,治疗组患者血清催乳素水平明显下降（P<0.01）,对照组血清催乳素水平无明显变化.两组TESS评分差异无显著性（P>0.05）.结论 阿立哌唑对舒必利所致高催乳素血症有一定的治疗作用,并且相对安全.     

阿立哌唑对精神分裂症患者血清催乳素的影响

目的探讨阿立哌唑对精神分裂症患者血清催乳素的影响。方法选取60例精神分裂症患者,随机分为阿立哌唑组和利培酮组,分别给予阿立哌唑和利培酮治疗8周,在治疗前及治疗后2、4、8周末采用阳性与阴性症状量表（PANSS）对两组进行评定,并于治疗前、治疗后4周末、8周末采用放射免疫法测查PRL水平。结果两组PANSS量表评分治疗8周末均比治疗前极显著减少（P〈0.01）,但两组间相比差异无统计学意义（P〉0.05）;治疗前后阿立哌唑组PRL水平比较差异无统计学意义（P〉0.05）,利培酮组治疗8周末PRL水平明显升高（P〈0.05）;出现月经紊乱或泌乳阿立哌唑组较利培酮组明显为少（P〈0.05）。结论阿立哌唑对精神分裂症患者有较好的疗效,对PRL的影响较小,是一种有效而安全的新型抗精神病药物。     

阿立哌唑与利培酮治疗精神分裂症对照研究

目的:探讨阿立哌唑与利培酮治疗精神分裂症的疗效和不良反应。方法:应用阿立哌唑与利培酮分别治疗精神分裂症各34例,疗程8周。用阳性与阴性症状量表(PANSS)评定疗效,用治疗中出现的症状量表(TESS)评定药物不良反应。结果:两组PNSS总评分治疗前后差异有显著性。阿立哌唑组总有效率82.3%,利培酮组为82.3%,两者相同(P>0.05)。不良反应发生率:阿立哌唑组为19.82%,利培酮组为25.32%,阿立哌唑组低于利培酮组,差异有显著性(P<0.05)。结论:阿立哌唑与利培酮对精神分裂症有疗效好,且疗效相同。但不良反应少,是一种安全、有效的抗精神药。     

阿立哌唑与奋乃静治疗老年期精神分裂症对照研究

目的比较阿立哌唑和奋乃静治疗老年期精神分裂症的疗效和安全性。方法将67例老年期精神分裂症患者随机分为两组,分别给予阿立哌唑与奋乃静治疗8周,并在治疗前及治疗后1,2,4,8周末采用简明精神病评定量表（BPRS）、副反应量表（TESS）分别评定疗效和不良反应。结果阿立哌唑、奋乃静治疗老年期精神分裂症的疗效差异无显著性（P〉0.05）,但阿立哌唑不良反应较奋乃静少而轻微。结论阿立哌唑治疗老年期精神分裂症疗效好、起效快、不良反应少。     

Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder

Aripiprazole, a quinolinone derivative, is an atypical antipsychotic drug indicated for the treatment of adult patients with schizophrenia. Aripiprazole 10 or 15 mg once daily is effective and well tolerated in patients with schizophrenia or schizoaffective disorder. Although aripiprazole has only been directly compared with haloperidol and olanzapine in treatment-responsive patients to date, current data generally indicate that aripiprazole has a beneficial profile in terms of a low potential for bodyweight gain. Dosage titration is not necessary and the drug is effective in the first few weeks of treatment. Head-to-head comparative trials with atypical antipsychotic agents are required, as are long-term (> or =1 year) studies, to fully define the position of aripiprazole in relation to other antipsychotic drugs. Aripiprazole is a valuable new therapeutic option in the management of patients with schizophrenia. PHARMACOLOGICAL PROPERTIES: Aripiprazole is a quinolinone derivative with a high affinity for dopamine D2 and D3 receptors, and serotonin 5-HT1A, 5-HT2A and 5-HT2B receptors. The mechanism of action of aripiprazole is not yet known, but evidence suggests that its efficacy in the treatment of the positive and negative symptoms of schizophrenia and its lower propensity for extrapyramidal symptoms (EPS) may be attributable to aripiprazole's partial agonist activity at dopamine D2 receptors. At serotonin 5-HT1A receptors, in vitro studies have shown that aripiprazole acts as a partial agonist whereas at serotonin 5-HT2A receptors aripiprazole is an antagonist. The main active metabolite, dehydro-aripiprazole, has affinity for dopamine D2 receptors and thus has some pharmacological activity similar to that of the parent compound. Aripiprazole is rapidly absorbed after oral administration. The mean time to peak plasma concentration is 3 hours following multiple-dose administration of aripiprazole 10 or 15 mg and the absolute oral bioavailability of the drug is 87%. Steady-state plasma drug concentrations are achieved by 14 days; however, the drug appears to accumulate over this period, since mean peak plasma concentration and mean area under the plasma concentration-time curve values of aripiprazole 10 or 15 mg/day are 4-fold greater on day 14 than on day 1. This accumulation may be expected, since the mean elimination half-life of a single dose of aripiprazole is about 75 hours. Aripiprazole has extensive extravascular distribution and more than 99% of aripiprazole and dehydro-aripiprazole (the main active metabolite of aripiprazole) is bound to plasma protein. Elimination of the drug is primarily hepatic; the cytochrome P450 (CYP) 3A4 and CYP2D6 enzyme systems transform aripiprazole to dehydro-aripiprazole, with the latter enzyme system subject to genetic polymorphism. Thus, dosage adjustment of aripiprazole is necessary when it is coadministered with CYP3A4 and CYP2D6 inhibitors (since aripiprazole concentration is increased) and with inducers of CYP3A4 (since aripiprazole concentration is decreased). THERAPEUTIC EFFICACY: The efficacy of aripiprazole has been demonstrated in patients with schizophrenia or schizoaffective disorder. In general, significant reductions from baseline in mean Positive and Negative Syndrome Scale total, positive and negative symptom scores, and Clinical Global Impression Severity of Illness scores were observed in patients with acute relapse of chronic schizophrenia or schizoaffective disorder receiving recommended (10 or 15 mg/day) or higher-than-recommended (20 or 30 mg/day) dosages of aripiprazole versus those receiving placebo in three well controlled, short-term trials. No additional therapeutic benefit was observed at the higher-than-recommended dosages. The drug is effective as early as the first or second week of treatment. The efficacy of aripiprazole was maintained for up to 52 weeks. The drug was significantly more effective than placebo in preventing relapse in patients with stable chronic schizophrenia in a 26-week, randomised trial. In a 52-week trial in patients with acute relapse of schizophrenia, the percentage of responders maintaining a response at study end was 77% of aripiprazole versus 73% of haloperidol recipients. Aripiprazole may improve cognitive function. In a nonblind, 26-week trial, patients with chronic schizophrenia receiving aripiprazole 30 mg/day experienced similar (general cognitive function) or better (verbal learning) changes from baseline in the neurocognitive parameters evaluated compared with recipients of olanzapine 10-15 mg/day. TOLERABILITY: Aripiprazole 10-30 mg/day was generally well tolerated. The tolerability profile of aripiprazole was broadly similar to that observed with placebo in a meta-analysis of short-term trials in patients with acute relapse of schizophrenia or schizoaffective disorder and in a 26-week trial in patients with chronic stable schizophrenia. The most frequent treatment-emergent adverse events included insomnia and anxiety, and additionally, headache and agitation (in short-term trials) or akathisia and psychosis (in a 52-week trial). In general, the drug was associated with a placebo-level incidence of EPS and EPS-related adverse events. Significantly fewer aripiprazole recipients experienced EPS-related adverse events than haloperidol recipients in a 52-week trial. Changes in severity of EPS were minimal and usually no different from those observed with placebo. Moreover, there was less severe EPS in the aripiprazole group than the haloperidol group in a long-term trial. Treatment-emergent tardive dyskinesia was reported in only 0.2% of patients receiving aripiprazole (short-term trials), an incidence similar to that seen in placebo recipients (0.2%). Aripiprazole has a low propensity to cause clinically significant bodyweight gain, hyperprolactinaemia or corrected QT interval prolongation in patients with schizophrenia or schizoaffective disorder. In addition, there were no clinically relevant differences in mean changes from baseline in measures of diabetes and dyslipidaemia between the aripiprazole or placebo groups in a 26-week, placebo-controlled trial.