奎硫平合并丙戊酸镁缓释片治疗精神分裂症兴奋激越研究

目的：比较奎硫平合并丙戊酸镁缓释片与氟哌啶醇治疗精神分裂症患者伴有兴奋、激越症状的疗效及不良反应.方法：对精神分裂症住院患者采用随机对照、开放性研究治疗2周.以阳性与阴性症状量表（PANSS）及临床疗效总评量表（CGI）评估疗效,以治疗中出现的症状量表（TESS）评估不良反应.结果：合用组与对照组的总体疗效相当,兴奋、激越症状的控制前者优于后者（P＜0.05）;不良反应方面,氟哌啶醇引起的锥体外系不良反应较奎硫平合并丙戊酸镁缓释片高.结论：奎硫平合并丙戊酸镁缓释片对精神分裂症兴奋、激越症状的疗效优于氟哌啶醇,且不良反应较小.     

喹硫平联合氯硝西泮治疗精神分裂症急性兴奋疗效观察

目的比较喹硫平联合氯硝西泮与典型抗精神病药氟哌啶醇治疗精神分裂症患者伴有兴奋激越的疗效与不良反应。方法将符合CCMD-3诊断标；住的精神分裂症住院患者，随机进入喹硫平联合氯硝西沣组和氟哌啶醇组．观察28天。以阳性与阴性症状量表评估疗效，以副反应量表评估不良反应。结果合用组和氟哌啶醇组在治疗后7天、14天的PANSS和兴奋因子评分与治疗前比较均P〈0．05，28天时P〈0．01差异显著；而合用组与氟哌啶醇组间评分比较，P〉0.05无统计学差异。合用组静坐不能、肌强直、震颤、扭特性运动等的发生率显著低于氟哌啶醇组，且差异具有显著性（P〈0．01）。结论喹硫平合并氯硝西泮可有效活疗精神分裂症急性期中度兴奋患者，其疗效与氟哌啶醇的疗效相当，但不良反应少，安全性优于氟哌啶馨。     

奎硫平治疗女性精神分裂症患者的疗效

目的探讨奎硫平与传统抗精神病药物氯丙嗪对女性精神分裂症患者疗效及不良反应的差异。方法上海市精神卫生中心的女性精神分裂症住院患者105例,采用随机对照、开放性研究。奎硫平组48例,氯丙嗪组57例,治疗8周。以阳性与阴性症状量表(PANSS)评估疗效,以治疗中出现不良症状量表(TESS)评估不良反应。同时检测血糖、催乳素等生化指标。结果1.以PANSS量表作为评估指标,奎硫平与氯丙嗪的总体疗效相当(P>0.05)。2.不良反应方面:TESS量表评估显示氯丙嗪较奎硫平引起肌强直、震颤、扭转痉挛、静坐不能等椎体外系副反应发生率高,引起胆碱能系统不良反应:口干、视物模糊、便秘、鼻塞发生率高(P<0.05);奎硫平对血清催乳素水平无明显影响;奎硫平对血糖、体重影响较氯丙嗪小(P<0.05)。结论奎硫平对女性精神分裂症疗效与传统抗精神病药物氯丙嗪相当,不良反应较小。     

氟哌啶醇治疗精神分裂症的增效作用

目的:评价奎硫平合并氟哌啶醇治疗精神分裂症的疗效与不良反应。方法:对110例单纯口服奎硫平的精神分裂症患者疗效不佳者合并氟哌啶醇治疗12周。用阳性症状和阴性症状量表(PANSS)评定疗效,用UKU不良反应评定量表评定不良反应。结果:治疗12周末PANSS量表总分及各分量表评分较治疗前均有显著下降(P<0.05或P<0.01);有效率达71.82%;不良反应无明显增加(P>0.05)。结论:奎硫平合并氟哌啶醇治疗精神分裂症疗效肯定,不良反应较轻。     

富马酸奎硫平与氟哌啶醇对精神分裂症抑郁症状影响的对照研究

目的:对照比较富马酸奎硫平与氟哌啶醇对精神分裂症患者抑郁症状的作用。方法:70例精神分裂症偏执型患者随机分为两组,分别予以富马酸奎硫平及氟哌啶醇治疗4周,于入组前、用药第1、14天及第28天以中文版卡尔加里精神分裂症抑郁量表(CDSS-C)、阳性和阴性症状量表(PANSS)及治疗中出现的症状量表(TESS)进行评定,并体格检查及实验室检查,记录不良事件的发生,以量表分值的变化来判断治疗效果及药物不良反应。结果:①70例患者中有21例患者CDSS-C评分≥6分,抑郁发生率为30%;②富马酸奎硫平组与氟哌啶醇组患者在抑郁症状疗效上差异有统计学意义(有效率分别为90.9%和37.5%,P=0.000),在精神病性症状改善方面无统计学差异(有效率分别为44.4%和54.9%,P=0.481);③氟哌啶醇组药物不良反应严重程度及不良反应所引起的痛苦均要明显高于奎硫平组,且对血泌乳素水平影响较大,多个研究时点TESS评分两组差异均有统计学意义(P=0.000～0.002)。结论:富马酸奎硫平相对于氟哌啶醇对精神分裂症的抑郁症状有较好的疗效和较小的不良反应。     

奎硫平和氟哌啶醇对精神分裂症患者生活质量影响的对照研究

目的　探讨奎硫平与氟哌啶醇治疗对精神分裂症患者生活质量的影响。方法　对 16 8例精神分裂症患者分别给予奎硫平、氟哌啶醇治疗 ,其中奎硫平组 85例 ,剂量为 5 0 2 .4 7± 75 .5 3mg/d ;氟哌啶醇组 83例 ,剂量为 30± 5 .6mg/d ;疗程 12周。用阳性与阴性症状量表 (PANSS)、生活质量综合评定问卷 (GQOLI)分别评估患者的疗效及生活质量。结果　两组PANSS分值治疗前后差异均有显著性 ,而两组之间相互比较 ,差异无显著性。奎硫平组的躯体健康维度、心理健康维度、社会功能维度得分分别高于氟哌啶醇组 ,均有显著性差异 (P <0 .0 1) .结论　奎硫平组和氟哌啶醇组对精神分裂症的疗效相当 ,但奎硫平组的生活质量优于氟哌啶醇组。     

奎硫平与氟哌啶醇治疗脑血管病所致精神障碍患者对照研究

目的:探讨奎硫平与氟哌啶治疗脑血管病所致精神障碍的临床疗效与不良反应. 方法:脑血管病所致精神障碍患者各30例,分别以奎硫平与氟哌啶醇治疗4周.采用简明精神病评定量表(BPRS)评定疗效,简明智能状况检查表(MMSE)评定认知状况,治疗中出现的症状量表(TESS)评定不良反应. 结果:治疗结束时两组BPRS评分较入组时显著减低(P＜0.01);奎硫平组有效率86.7％,氟哌啶醇有效率80.0％,两组疗效差异无统计学意义(P＞0.05),奎硫平组MMSE减分率显著低于氟哌啶醇组,奎硫平组无明显锥外系反应. 结论:奎硫平治疗脑血管病所致精神障碍患者疗效与氟哌啶醇相似,但奎硫平不良反应较氟哌啶醇轻而少.     

氯普噻吨注射液与氟哌啶醇注射液治疗急性期精神分裂症的对照研究

目的 比较氯普噻吨注射液与氟哌啶醇注射液治疗急性期精神分裂症的疗效和副作用。方法 71例患者随机分为氯普噻吨组（n=33）及氟哌啶醇组（n=38）进行治疗，分别在治疗前及治疗后采用阳性与阴性症状量表（PANSS），临床总体印象量表（CGI）及不良反应量表（TESS）评定其疗效及药物不良反应。结果 氯普噻吨注射液对控制急性精神分裂症的兴奋、躁动疗效与氟哌啶醇注射液相当，统计学无显著意义（P〉0．05），但锥体外系不良反应较氟哌啶醇注射液少。结论 氯普噻吨注射液与氟哌啶醇注射液治疗急性精神分裂症的疗效相当而不良反应较少。     

奥氮平合用氯硝西泮治疗精神分裂症急性精神运动性兴奋的研究

目的：观察奥氮平合并氯硝西泮治疗精神分裂症急性精神运动性兴奋的疗效与不良反应。方法：65例精神分裂症急性期兴奋患者,随机分为口服奥氮平合并肌内注射氯硝西泮组（奥氮平组）34例和肌内注射氟哌啶醇组（氟哌啶醇组）31例治疗,疗程7 d。以阳性与阴性症状量表兴奋激越项目（PANSS-EC）和治疗中出现的症状量表（TESS）评定疗效和不良反应。结果：奥氮平组与氟哌啶醇组疗效相当,差异无显著性（P〉0.05）。两组急性兴奋症状均获明显改善,氟哌啶醇组不良反应发生率高于奥氮平组（P〈0.05）。结论：奥氮平合并氯硝西泮可有效治疗精神分裂症患者急性期精神运动性兴奋,疗效与氟哌啶醇相当,不良反应明显少于氟哌啶醇。     

奎硫平与氯丙嗪治疗精神分裂症的对照研究

目的评价奎硫平与氯丙嗪治疗精神分裂症的疗效及不良反应。方法将60例精神分裂症患者随机分为两组,每组各30例,研究组给予奎硫平治疗,对照组给予氯丙嗪治疗,疗程12周。采用PANSS量表及副反应量表（TESS）评定临床疗效和不良反应。结果奎硫平组与氯丙嗪组治疗前PANSS量表阴性症状分、阳性症状分、总分差异无显著性（P〉0.05）。各组治疗后PANSS量表评分与治疗前比较差异有显著性（P〈0.05或P〈0.01）。奎硫平的不良反应较氯丙嗪轻。结论奎硫平治疗精神分裂症疗效显著、安全、经济,疗效虽然与氯丙嗪相当,而前者不良反应相对较轻,安全性更好,对临床选择用药具有一定的借鉴作用。     

Long-term maintenance therapy with quetiapine versus haloperidol decanoate in patients with schizophrenia or schizoaffective disorder

OBJECTIVE: To compare the long-term efficacy and tolerability of oral quetiapine with those of intramuscular haloperidol. METHOD: Patients with DSM-IV-diagnosed schizophrenia or schizoaffective disorder requiring long-term antipsychotic treatment were randomly assigned to open-label oral quetiapine or intramuscular haloperidol decanoate for 48 weeks. Clinicians were instructed to target dosing at 500 mg/day of quetiapine or 200 mg of haloperidol decanoate every 4 weeks. The Positive and Negative Syndrome Scale was used to assess efficacy; the Simpson-Angus Scale and the Barnes Akathisia Scale were used to assess safety and tolerability. For statistical analyses, a general linear mixed-model repeated-measures analysis of covariance was used, with change scores for dependent variables computed with the baseline score as covariate. Data were collected from 1998 to 2001. RESULTS: Thirty-five patients were enrolled, but 6 did not participate after being informed of their treatment assignment; 4 of the 6 withdrawals were assigned to haloperidol decanoate. Mean doses at week 48 were 493 mg/day of quetiapine (N = 16) and 170 mg/28 days of haloperidol decanoate (N = 9). Survival analysis showed no between-group differences in estimates of the number of patients remaining exacerbation-free over time. Both drugs were efficacious, but quetiapine was significantly better than haloperidol decanoate in controlling negative symptoms (p < .05). The incidence of extrapyramidal symptoms was low in both groups; patients receiving quetiapine showed significantly greater improvement in rigidity and akathisia (p < .05). CONCLUSION: Oral quetiapine was as efficacious as intramuscular haloperidol in preventing symptom exacerbation over 48 weeks in patients with schizophrenia or schizoaffective disorder, with fewer extrapyramidal symptoms, especially rigidity and akathisia. Quetiapine was more efficacious than haloperidol decanoate in treating negative symptoms.     

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.     

The utility of intramuscular ziprasidone in the management of acute psychotic agitation.

Many psychiatric illnesses, including chronic schizophrenia, bipolar disorder, and dementia, are characterized by episodes of acute agitation, making administration of oral agents difficult or impossible. Ziprasidone, the first atypical antipsychotic available in both intramuscular (IM) and oral formulations, has demonstrated significant control of acute agitation within 15 minutes, as seen in two 24-hour studies in patients with schizophrenia. Improvement was maintained for > or = 4 hours, and a low incidence of extrapyramidal symptoms, akathisia, and dystonia as well as no excessive sedation were observed Also, two 7-day studies (n = 132 and n = 306) and one 6-week study (n = 567) of sequential IM/oral ziprasidone versus IM/oral haloperidol in patients with psychotic disorders found IM ziprasidone more effective than IM haloperidol within 3 days of IM treatment; both drugs produced further comparable improvements in efficacy parameters after transition to oral therapy. IM ziprasidone was associated with a lower incidence of movement disorders than was haloperidol in all of these studies. Overall, discontinuations were similar for IM ziprasidone and haloperidol in the comparative trials, including the sequential IM/oral studies. However, in the 6-week sequential IM/oral trial, the rate of discontinuation due to adverse events was twice as high among haloperidol vs ziprasidone patients. This report focuses on the pharmacology, clinical efficacy, and tolerability of IM ziprasidone, and provides an overview of the utility of other commonly used antipsychotics in the management of acute psychotic agitation.     

Adverse effects of risperidone and haloperidol treatment in schizophrenia

PURPOSE: Side effects of pharmacological treatment in schizophrenia continue to be a major issue in spite of the development of new antipsychotics. The aim of this study is to explore the adverse effects of conventional and atypical antipsychotic drugs and their associated factors. METHODS: Over 3 months, 41 patients with schizophrenia were randomized to treatment with risperidone 1-12 mg (n=21) or haloperidol 2-20 mg (n=20) daily. Efficacy was assessed by improvement of psychotic symptoms, measured on the Positive and Negative Syndrome Scale (PANSS). The safety and tolerability were assessed with the Extrapyramidal Symptom Rating Scale, the UKU Side-Effect Rating Scale and clinical laboratory assessments. RESULTS: Each treatment reduced psychotic symptoms. PANSS total scores, positive scores, and general psychopathology scores declined as trial went on without significant differences between the two groups. While PANSS negative scores improved better in the risperidone group than in the haloperidol group. The tolerability of antipsychotics was statistical significantly better in the risperidone than in the haloperidol-treated patients. The most frequent adverse effects for both groups were tremor and rigidity. Antipsychotics, their doses, and hyperprolactinemia predict short-term extrapyramidal side effects. Serum prolactin levels could predict parkinsonism and dyskinesia severity. However, dyskinesia was best predicted by the doses of neuroleptics. The predictive factor of dystonia was the antipsychotic drug itself. After adjusting drug doses and concomitant medications, side effects could be markedly improved. CONCLUSIONS: This study suggested that risperidone was superior to haloperidol in improving negative symptoms and better tolerated during the 12 weeks' treatment of schizophrenia. Serum prolactin levels could predict the severity of parkinsonism and dyskinesia.     

Olanzapine optimal dose: results of an open-label multicenter study in schizophrenic patients. Olanzapine Late-Phase II Study Group

This open-label clinical study was conducted for patients with schizophrenia in order to investigate the efficacy, safety and optimal dose of olanzapine. One hundred and fifty-six of the 159 enrolled patients were included in the analysis set. For the primary efficacy measure, the Final Global Improvement Rating (FGIR) score, 15.4% of patients had remarkable improvement, 58.3% of patients had moderate improvement or more, 79.5% of patients had slight improvement or more, and 10.3% of patients had increase in disease symptomatology (worsening). Results from the Brief Psychiatric Rating Scale (BPRS) in all individual items were improved from baseline. Olanzapine was effective not only against positive psychotic symptoms but also against negative symptoms. This was consistent with results from the Positive and Negative Syndrome Scale (PANSS). For the majority of patients, a dose range of 7.5-10.0mg/day, as a lower bound on the minimally effective dose, was suggested by the results of the dose to first response based on improvement in Global Improvement Rating (GIR) analyses. The ratio of olanzapine dose to equivalent haloperidol dose was estimated at 1.2 :1. The most commonly reported treatment-emergent signs and symptoms (TESS) occurring at a frequency of 10% or more were insomnia, weight increase, excitement, sleepiness, anxiety, malaise and dull headaches. There was a low incidence of extrapyramidal treatment-emergent signs and symptoms; the most commonly reported were akathisia (6.4%), tremor (5.8%) and muscle rigidity (2.6%).     

Quetiapine treatment of psychosis associated with dementia: a double-blind, randomized, placebo-controlled clinical trial.

OBJECTIVES: The objectives of this study were to evaluate the efficacy, safety, and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning. METHOD: The authors conducted a multicenter, double-blind, placebo-controlled, randomized trial of flexibly dosed quetiapine and haloperidol. Primary outcomes were change in total Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impressions-Severity of Illness (CGI-S) scores at week 10. Secondary outcomes included BPRS factors, Neuropsychiatric Inventory (NPI), Multidimensional Observation Scale for Elderly Subjects (MOSES), and Physical Self-Maintenance Scale (PSMS). RESULTS: Two hundred eighty-four participants (mean age: 83.2 years) were randomized; 63.4% completed; and mean Mini-Mental State Examination score was 12.8. Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol. No differential benefit was seen on any psychosis measure. BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol. BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo. No NPI factors showed change, including the agitation factor. MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine. Somnolence occurred in 25.3%, 36.2%, and 4.1% of the quetiapine, haloperidol, and placebo groups, respectively; parkinsonism was most prevalent in the haloperidol group; other safety and tolerability measures differed little among groups. CONCLUSION: All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed. Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation. Tolerability was better with quetiapine compared with haloperidol.     

利培酮口服液合并氯硝西泮片治疗精神分裂症急性激越的对照研究

目的:比较利培酮口服液合并氯硝西泮片与氟哌啶醇肌内注射治疗精神分裂症急性激越症状的疗效及不良反应。方法:60例精神分裂症急性激越症状患者,按1:1比例随机分入利培酮口服液(2～6mg/d)合并氯硝西泮片(2～8mg/d)组(利培酮组)或氟哌啶醇肌注(5～20mg/d)组(氟哌啶醇组)治疗,疗程7d。采用阳性和阴性症状量表(PANSS)、阳性和阴性症状量表兴奋因子(PANSS-EC)、病人合作程度评定表、修改版外显攻击行为量表(MOAS)、临床疗效总体评定量表(CGI)评定疗效,采用治疗中出现的症状量表(TESS)、静坐不能评定量表(BAS)、锥体外系副反应量表(SAS),不良事件和实验室检查评定安全性。结果:在治疗7d后,利培酮组和氟哌啶醇组PANSS-EC评分分别为(11.1,3.6)分和(12.9,5.2)分,较治疗前均明显进步(P<0.01),两组间PANSS-EC和PANSS总分差异无统计学意义(P>0.05);利培酮组在阳性因子分、MOAS、合作程度改善方面均优于氟哌啶醇组(P<0.05);肌强直、静坐不能的发生率显著低于氟哌啶醇肌注组(P<0.01)。结论:利培酮口服液合并氯硝西泮片治疗精神分裂症急性激越症状与氟哌啶醇肌内注射疗效相当,在某些方面优于氟哌啶醇肌内注射。     

Comparative efficacy of olanzapine and haloperidol for patients with treatment-resistant schizophrenia.

BACKGROUND: There is relatively little information regarding the efficacy of newer atypical antipsychotic drugs for patients with schizophrenia who are treatment-resistant to neuroleptic agents. Several lines of evidence suggest that a clinical trial of olanzapine in this population is warranted. METHODS: A subpopulation of patients (n = 526) meeting treatment-resistant criteria selected from a large, prospective, double-blind, 6-week study assessing the efficacy and safety of olanzapine and haloperidol were examined. Both last-observation-carried-forward (LOCF) and completers (observed cases) analyses were conducted. RESULTS: Olanzapine demonstrated significantly greater mean improvement from baseline in Positive and Negative Syndrome Scale (PANSS) negative symptoms, comorbid depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale, akathisia as measured by Barnes Akathisia Scale, and extrapyramidal symptoms as measured by Simpson-Angus Extrapyramidal Rating Scale with both LOCF and completers analyses. In addition, olanzapine was significantly superior to haloperidol for Brief Psychiatric Rating Scale total (p = .006), PANSS total (p = .005), and PANSS positive symptoms (p = .017) in completers of the 6-week study. Significantly greater response rates were observed in olanzapine-treated (47%) than haloperidol-treated (35%) patients in the LOCF analysis (p = .008), but significance was not reached in the completers analysis (p = .093). Mean doses (+/- SD) of olanzapine and haloperidol were 11.1 +/- 3.4 mg/day and 10.0 +/- 3.6 mg/day, respectively. CONCLUSIONS: Olanzapine was superior to haloperidol for key symptom domains and parkinsonian side effects. Implications of these data for the therapeutics of this severely ill subgroup are discussed.