奎硫平与利培酮治疗女性首发精神分裂症疗效比较

目的比较利培酮与奎硫平治疗女性首发精神分裂症的疗效和不良反应。方法将80例符合CCMD一3诊断标准的精神分裂症按数字表法随机分为两组（奎硫平组和利培酮组各40例）,分别给予奎硫平（300—750mg／d）和利培酮（2～5mg／d）治疗8周。用阳性与阴性症状量表评定疗效,并观察两组不良反应发生情况。结果两组治疗2、4、8周阳性与阴性症状量表评分比较差异均无统计学意义（均P〉0．05）,奎硫平组和利培酮组治疗临床有效率分别为90．O％和87．5％,差异无统计学意义（P〉0．05）,利培酮组发生震颤、肌强直、静坐不能、月经改变及泌乳等不良反应发生率显著高于奎硫平组（均P〈0．05）。结论奎硫平与利培酮治疗女性首发精神分裂症的临床疗效相当,但奎硫平不良反应小。     

奎硫平与利培酮治疗精神分裂症患者对照研究

目的探讨奎硫平治疗精神分裂症的疗效以及不良反应。方法80例精神分裂症患者随机分为2组,分别给予奎硫平与利培酮治疗8周。采用阳性与阴性症状量表（PANSS）、副反应量表（TESS）评定疗效及不良反应。结果奎硫平组显效率92.5％,利培酮组显效率95.0％。利培酮组的锥体外系不良反应稍高于奎硫平组。结论奎硫平与利培酮治疗精神分裂症的疗效相当。     

奎硫平与利培酮治疗精神分裂症的对照研究

目的探讨奎硫平治疗精神分裂症的效果与不良反应。方法将90例精神分裂症患者随机分为奎硫平治疗组和利培酮治疗组,各45例。于治疗前及治疗第1、2、4、8周末采用阳性与阴性症状量表（PANSS）评价临床疗效,副反应量表（TESS）评价不良反应。结果奎硫平组治疗有效率为75.6%高于利培酮组的73.3%,差异无统计学意义（P〉0.05）。奎硫平组锥体外系不良反应明显少于利培酮组（P〈0.05）,其他不良反应2组比较差异均无统计学意义（P〉0.05）。结论奎硫平治疗精神分裂症疗效肯定,不良反应少,依从性好。     

喹硫平与利培酮治疗精神分裂症的效果分析

目的 探讨喹硫平与利培酮治疗精神分裂症的效果.方法 选择82例患有精神分裂症的患者,随机分为对照组和治疗组,每组各41例,对照组患者给予利培酮治疗,治疗组患者给予喹硫平治疗.结果 治疗组患者的总有效率为90.2％,显著优于对照组的68.3％,差异有统计学意义（P＜0.05）;治疗组的精神分裂症状控制时间及接受治疗平均时间均明显少于对照组,差异有统计学意义（P＜0.05）;治疗组的不良反应发生率显著低于对照组,差异有统计学意义（P＜0.05）.结论 喹硫平治疗精神分裂症的效果良好,不良反应发生率低,值得临床推广应用.     

Changes in cognitive functioning with risperidone and olanzapine treatment: a large-scale,double-blind,randomized study

Objective The effects of risperidone and olanzapine on cognitive functioning in patients with schizophrenia were compared in a randomized, double-blind trial. Method Three hundred and seventy-seven patients were randomly assigned to receive 2–6 mg/day of risperidone or 5–20 mg/day of olanzapine for 8 weeks. Cognitive function was assessed with a focused cognitive assessment battery; in addition, extrapyramidal symptoms were assessed using the extrapyramidal symptom rating scale (ESRS), and the positive and negative syndrome scale (PANSS) was rated for all patients. Results Treatment with these two atypical antipsychotic medications was associated with improved performance on the Wisconsin card sorting test, the trail-making test, the California verbal learning test, the continuous performance test, and some aspects of verbal fluency and spatial working memory. No differences in the effects of the drugs on any of the cognitive tests were noted. Correcting for the effects of anticholinergic treatment did not alter the magnitude of cognitive effects. Conclusions Atypical antipsychotic treatment is associated with wide-ranging benefits on cognitive functioning. Previous reports of greater benefits of olanzapine over risperidone in a small-sample pilot study were not substantiated. These results are not due in general to changes in clinical symptoms or movement disorders, suggesting a direct effect of atypical antipsychotic medications on cognitive deficits in schizophrenia.     

Switching treatment-resistant patients with schizophrenia or schizoaffective disorder to olanzapine: a one-year open-label study with five-year follow-up

Objective: To determine whether patients with treatment-resistant schizophrenia or schizoaffective disorder would respond when switched to olanzapine and whether they could maintain their response on this atypical anti psychotic.

Research design and methods: In this single-center, observational, 1-year open-label study, a cohort of patients was switched to olanzapine due to failure on previous treatment. The patients were followed up (retrospectively) for an additional 5 years. Patients had schizophrenia or schizoaffective disorder and all but one were treatment-resistant. The starting dose was 10?mg/day, with dosage adjustments based on physician judgment.

Main outcome measures: The CGI-S and CGI-I scales were the primary outcome measures. During the observation period, positive and negative symptoms, hospital readmission rates and duration of hospitalization were measured, and treatment-emergent adverse events recorded.

Results: Mean age of patients (n?=?25) was 39.7 years; 19 were male, and all were Caucasian. The mean number of antipsychotics used prior to olanzapine was 4.6 with risperidone (76%) being the most common. The mean duration of olanzapine therapy was 8.6 months. The average number of hospital admissions per patient dropped from 1.32 during the year prior to olanzapine therapy to 0.39 after starting olanzapine. Total number of hospital days was 1042 the year before and 258 the year after olanzapine treatment. The mean CGI-S score improved from markedly ill at baseline to borderline/mildly ill at study end. The mean CGI-I score was rated much improved at study end. Few adverse events occurred during the study. Twelve patients remained on olanzapine monotherapy after 5 years of treatment (mean duration of 62 months).

Conclusions: Olanzapine may be a treatment option for patients who fail to respond to treatment with other antipsychotics. Importantly, this is one of the first reports showing that patients with schizophrenia can be maintained on atypical antipsychotic monotherapy for at least 5 years.     

喹硫平与利培酮治疗精神分裂症对照研究

目的探讨喹硫平治疗精神分裂症的疗效及安全性。方法将110例精神分裂症患者随机分为两组各55例,研究组给予喹硫平治疗,对照组给予利培酮治疗,疗程8周。采用潘氏量表及付反应量表评定临床疗效和不良反应。结果研究组总有效率67．2％,对照组87．3％,两组比较有显著性差异（P〈0．05）。治疗2周末两组潘氏量表评分均较治疗前有显著性下降（P〈0．05）,4周末均有极显著下降（P〈0．01）,同期组间潘氏量表评分有显著或极显著性差异（P〈0．05或0．01）。两组不良反应评分无显著性差异（P〉0．05）但不良反应表现存有异同。结论喹硫平治疗精神分裂症疗效显著、安全,疗效虽然稍逊于利培酮,但对临床选药有一定的借鉴作用。     

Comparison of quetiapine and risperidone in Chinese Han patients with schizophrenia: results of a single-blind,randomized study

Abstract

Objective:

To evaluate the efficacy and safety of 750?mg/day quetiapine fumarate (Seroquel) in the treatment of Chinese Han patients with schizophrenia.     

Randomized,controlled, double-blind,multicenter comparison of the cognitive effects of ziprasidone versus olanzapine in acutely ill inpatients with schizophrenia or schizoaffective disorder

Background Newer antipsychotic medications have been reported to enhance cognitive functioning in schizophrenia. Head to head studies with double-blind methods are still relatively few in number.Objectives To compare the relative cognitive enhancing effects of ziprasidone and olanzapine in the treatment of acutely ill inpatients with schizophrenia or schizoaffective disorder.Procedures In this 6-week, multicenter, double-blind, parallel-designed trial, patients were randomized to ziprasidone or olanzapine. No patient who had ever received a complete treatment trial with either of these medications previously was entered into the study. Cognitive testing measuring attention, motor speed, memory, executive functioning, and verbal skills were performed on all patients at baseline and endpoint.Results Treatment with either ziprasidone or olanzapine was associated with statistically significant improvements from baseline in attention, memory, working memory, motor speed, and executive functions. Treatment with olanzapine was also associated with a statistically significant improvement in verbal fluency. No statistically significant differences between these medications were found in the magnitude of improvement from baseline on any of the cognitive measures (other than verbal fluency in an exploratory analysis). Observed changes were not associated with changes in clinical symptoms measured using the PANSS or changes in movement disorders.Conclusions During 6 weeks of treatment, ziprasidone and olanzapine demonstrated substantial and comparable cognitive-enhancing effects relative to previous treatment. These effects were noted in all aspects of cognitive functioning previously proven to predict functional outcome in schizophrenia. No overall differences were detected between the medications in terms of the extent of cognitive enhancement.     

奎硫平与利培酮治疗精神分裂症的比较分析

目的：以利培酮为对照，探讨奎硫平治疗精神分裂症的疗效和不良反应。方法：将60例符合CCMD-3诊断标准的精神分裂症病人随机分为两组．分别用奎硫平和利培酮治疗8周，采用阳性症状和阴性症状量表（PANSS）评定临床疗效。用不良反应量表（TESS）评定不良反应。结果：两组治疗8周后的疗效差异无统计学意义（P〉0．05）；奎硫平组和利培酮组的显效率差异无统计学意义（P〉0．05）。结论：奎硫平和利培酮对精神分裂症的疗效相当，不良反应小。     

Pharmacy cost evaluation of risperidone,olanzapine, and quetiapine for the treatment of schizophrenia in acute care inpatient settings

SUMMARY

Objective: This study examines total pharmacy cost and usage patterns of schizophrenic patients in acute mental health inpatient settings for three atypical antipsychotics – risperidone, olanzapine, and quetiapine. Despite the readily available unit cost information for drugs, actual pharmacy costs may deviate significantly from ‘labeled costs’. Recent research findings indicate the need for more robust evaluation of such pharmacy costs.

Research design and methods: This study used data from non-randomized inpatient retrospective charts from three acute care inpatient mental health facilities. The final pooled sample included 327 patients, of which 120 received risperidone, 153 received olanzapine, and 54 received quetiapine. Medication cost was defined as the average wholesale price (AWP) as listed in the 2001 ‘Red Book’. Propensity scoring methodology and multinomial regression were employed to reduce treatment selection bias.

Results: The observed mean daily antipsychotic drug doses were 4.45?mg (SD 2.44) for risperidone, 14.04?mg (SD 5.55) for olanzapine, and 350.33?mg (SD 228.24) for quetiapine. The corresponding mean daily drug costs were $7.66(SD $4.20) for risperidone, $8.11 (SD $5.29) for quetiapine and, $12.10 (SD $4.79) for olanzepine. Numbers adjusted for treatment selection bias show that the average daily total pharmacy cost of risperidone was $4.35 lower than olanzapine (?p < 0.001) and $1.41 lower than quetiapine (?p = 0.38). The adjusted average daily pharmacy cost of olanzapine was $4.02 higher than quetiapine (?p < 0.001). After statistical adjustment there were no significant differences between study drugs in terms of length of stay or patient functioning.

Conclusion: This study provides the first US comparison of medication utilization patterns and pharmacy costs for olanzapine, risperidone, and quetiapine administered in acute mental health care inpatient settings. While this study did not estimate the full economic value of the three antipsychotics in these inpatient settings, it demonstrated that the mean daily costs for risperidone were lower than the mean daily costs for olanzapine (?p < 0.001) and quetiapine although the later difference was not statistically significant (?p = 0.38).     

Subjective well-being in schizophrenia: A randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER)

This randomised 12-month open study analysed the effectiveness of quetiapine XR (400–800 mg) versus risperidone (2–6 mg) on subjective well-being in schizophrenia (NCT00600756). Primary objective was to demonstrate non-inferiority of quetiapine XR to risperidone in 6-month responder rate using the Subjective Well-Being under Neuroleptics scale (SWN-K) (per-protocol at Month 6 [PP 6] population). Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) greater than ?9.7% for the adjusted difference between quetiapine XR and risperidone. Secondary objectives included non-inferiority of quetiapine XR versus risperidone (lower limit of 95% CI greater than ?7.5 points) for SWN-K change from baseline to Month 12 (PP 12). 798 patients were randomised (quetiapine XR, n=395; risperidone, n=403); at Month 12, 212 (54%) and 227 (56%) patients, respectively, completed the study. At Month 6, SWN-K responder rate in the PP 6 population was 65% (136/210) with quetiapine XR and 68% (158/232) with risperidone (adjusted treatment difference: ?5.7%; 95% CI: ?15.1, 3.7); thus, non-inferiority could not be established. SWN-K change from baseline to Month 12 was 23.2 points for quetiapine XR and 21.1 points for the risperidone group; treatment difference was 2.1 (95% CI: ?0.8; 5.0); non-inferiority was established (PP 12). Conclusion: SWN-K response at 6 months was comparable between the two antipsychotics. However, with a lower than expected responder rate and a lower than expected number of evaluable patients in the PP 6 population, non-inferiority was not demonstrated. A secondary objective (SWN-K total score) established non-inferiority of quetiapine XR to risperidone at Month 12.     

Switching from risperidone to olanzapine in a one-year,randomized, open-label effectiveness study of schizophrenia

ABSTRACT

Objective: Switching medications is common in the treatment of schizophrenia. This study examines the effectiveness of olanzapine therapy following a clinically warranted switch from risperidone during treatment of patients with schizophrenia.

Research design and methods: This post-hoc analysis used data from the risperidone arm of a randomized, open-label, 1-year study of patients with schizophrenia. Study protocol permitted antipsychotic switching when clinically warranted, and outcomes were assessed with standard psychiatric measures. Statistical analyses assessed changes from pre- to post-medication switch and endpoint comparisons between patients switched from risperidone to olanzapine and patients continued on risperidone.

Results: Most patients who switched from risperidone switched to olanzapine (43/60; 71.7%). Average duration of risperidone treatment prior to switching was 86 days (mean modal dose 4.0?mg/day). Most switchers (86%) completed the 1-year study on olanzapine (average duration 241 days; mean modal dose 12.0?mg/day). Following switch to olanzapine, patients experienced significant improvements on clinical (Brief Psychiatric Rating Scale) and social (Quality of Life Inventory) parameters, with similar proportions of patients achieving remission status at endpoint compared with risperidone patients not requiring medication switch (41.9 vs. 35.5%). Mean weight gain for switchers was approximately 0.4?kg while on risperidone (average treatment duration <?3 months) and 2.4?kg on olanzapine (average treatment duration approximately 8 months).

Conclusions: This study suggests that olanzapine is an effective treatment option for schizophrenia patients requiring a switch from risperidone. Given the small sample size and lack of a comparative group, one cannot determine if other medication options would have been as effective as the switch to olanzapine. Thus, further research is warranted.     

喹硫平与舒必利改善精神分裂症患者认知功能的比较研究

目的：观察喹硫平与舒必利对精神分裂症患者认知功能的改善情况。方法：将50例初诊或经典抗精神病药物治疗疗效不显著或无法耐受不良反应的精神分裂症患者分为喹硫平（n=25）与舒必利（n=25）两组,进行为期3个月的治疗。治疗前后应用PANSS、MMES分别评定精神症状与认知功能。结果：共39例患者完成3个月的治疗（喹硫平=19,舒必利=20）。与基线比较,喹硫平与舒必利都能明显改善精神分裂症患者的精神症状与认知功能,但两组间精神症状与认知功能改善程度并无差异。结论：喹硫平与舒必利都能明显改善精神分裂症患者的认知障碍,疗效无差异。     

Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo-controlled trial

A double-blind, placebo-controlled, multicenter study, was performed to evaluate the efficacy and safety of ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder. Patients were randomized to receive ziprasidone 40 mg/day, 120 mg/day or placebo for 28 days. Ziprasidone 120 mg/day was significantly more effective than placebo in improving the BPRS total, CGI-S, BPRS depression cluster and BPRS anergia cluster scores (all P < 0.05). Similarly, the percentages of patients classified as responders on the BPRS (≥30% reduction) and the CGI improvement (score ≤2) were significantly greater with ziprasidone 120 mg/day compared with placebo (P < 0.05). The number of patients who experienced an adverse event was similar in all three treatment groups, and discontinuation due to adverse events was rare (five of 91 ziprasidone-treated patients). The most frequently reported adverse events, that were more common in either ziprasidone group than in the placebo group, were dyspepsia, constipation, nausea and abdominal pain. There was a notably low incidence extrapyramidal side-effects (including akathisia) and postural hypotension and no pattern of laboratory abnormalities or apparent weight gain. Ziprasidone-treated patients were not clinically different from placebo-treated patients on the Simpson-Angus Rating scale, Barnes Akathisia scale and AIMS assessments. These results indicate that ziprasidone 120 mg/day is effective in the treatment of the positive, negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden. Received: 5 November 1997/Final version: 16 March 1998     

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。     

Standard and higher dose of olanzapine in patients with schizophrenia or schizoaffective disorder: a randomized, double-blind, fixed-dose study

The objective of this study was to assess the dose-response relationship of standard and higher doses of olanzapine in a randomized, double-blind, 8-week, fixed-dose study comparing olanzapine 10 (n = 199), 20 (n = 200), and 40 mg/d (n = 200) for patients with schizophrenia or schizoaffective disorder and suboptimal response to current treatment. Patients meeting criteria for antipsychotic treatment resistance were excluded. Dose-response relationship was assessed by linear regression analysis with log-transformed dose (independent variable) and Positive and Negative Syndrome Scale (PANSS) total score (dependent variable). There were no significant dose group differences in patients completing the study (overall, 67.8%). All dose groups showed statistically significant improvement in PANSS total scores from baseline to end point without significant dose-response relationship (P = 0.295). Post hoc analysis of response showed significant interaction between baseline PANSS and dose (P = 0.023), indicating better response at higher doses for patients with higher baseline PANSS. There was a significant dose response for mean change in weight (P = 0.003) with significant difference between the 10- and 40-mg-dose groups (P = 0.002; 1.9 [10 mg/d], 2.3 [20 mg/d], and 3.0 kg [40 mg/d]). There was a significant dose response for change in prolactin (P < 0.001) with a significant difference between each group (-10.5 [10 mg/d], -1.7 [20 mg/d], and 4.9 ng/mL [40 mg/d]; P < or = 0.018). Over 8 weeks, non-treatment-resistant patients with schizophrenia or schizoaffective disorder responded to all 3 doses of olanzapine, without a statistically significant dose-response relationship, suggesting that for many patients with schizophrenia or schizoaffective disorder, particularly those who are mildly or moderately ill, 10 mg/d should be the initial dose of choice.     

Prolactin levels in male schizophrenic patients treated with risperidone and haloperidol: a double-blind and randomized study

Rationale There are few data from systematic, double-blind clinical trials that have compared the effect of the typical and the atypical antipsychotics on serum prolactin (PRL) levels in patients with schizophrenia.Objectives The goal of this study was to compare the effect of risperidone and haloperidol on serum PRL and investigate the relationship between serum PRL levels and clinical response in patients with schizophrenia.Methods Seventy-eight inpatients with a diagnosis of schizophrenia (according to DSM-III-R) were randomly assigned to 12 weeks of treatment with 6 mg/day of risperidone or 20 mg/day of haloperidol after a 2-week washout period, using a randomized, double-blind design. Clinical efficacy was determined using the positive and negative syndrome scale (PANSS). Their serum PRL was assayed by means of radioimmunometric assay (RIA) between pre-treatment and post-treatment, and compared with 30 sex-matched and age-matched normal subjects.Results Both risperidone and haloperidol treatment significantly increased serum PRL levels in drug-free chronic schizophrenia patients (both P<0.001). Hyperprolactinemia induced by risperidone 6 mg/kg was comparable to levels produced by haloperidol 20 mg/day. Considering dose-adjusted serum PRL levels, risperidone treatment induced a significant elevation of PRL levels compared with haloperidol treatment at the haloperidol equivalent (P<0.001). Change in PRL levels at pre-treatment and post-treatment were related to positive symptom improvement seen in the risperidone group (r=0.51, P=0.016), but not in the haloperidol group (P>0.05). Female patients showed both a higher baseline and post-treatment PRL level and a greater increase in PRL than men (all P<0.05).Conclusions Risperidone is associated with a robust effect on prolactin secretion in contrast to the conventional antipsychotic haloperidol. Prolactin monitoring during risperidone treatment should be performed.     

阿立哌唑和利培酮对首发分裂症患者疗效及安全性的对照研究

目的：比较阿立哌唑与利培酮对首发精神分裂症患者的疗效和安全性。方法：100例首发分裂症患者随机分为两组,分别进行为期12周的阿立哌唑治疗和利培酮治疗,评定工具包括阳性与阴性症状量表（PANSS,在治疗前及治疗后2、4、6、8、12周末评定）及治疗副反应量表（TESS,治疗后2、4、6、8、12周末评定）,使用PANSS减分率评定疗效。结果：与基线相比,两组患者的PANSS评分在治疗后各观察点均显著降低（P均〈0.05）,治疗后各观察点的PANSS总分及减分率在两组间,差异无统计学意义（P均〉0.05）;两组在治疗终点的总体疗效差异无统计学意义（χ2=0.723,P=0.728）;两组总体副反应发生率差异无统计学意义（χ2=1.288,P=0.256）,但治疗后4、6、8、12周末,利培酮组的TESS评分显著高于阿立哌唑组（P均〈0.05）。结论：阿立哌唑对首发精神分裂症的疗效与利培酮相当,但其副作用严重程度和持续时间要轻于利培酮。