Comparison of Treatment Effect of Resperidone on First-Episode Schizophrenia Patients at Different Ages and its Influencing Factor Analysis

Objectives To explore the treatment effect of risperidone on patients with firstepisode schizophrenia at different ages and analyze its influencing factors.Methods fifty cases of adult patients with the first-episode schizophrenia(adult group)and forty cases of juvenile patients with the firstepisode schizophrenia(juvenile group)treated in our hospital from March 2013 to March 2015 were selected for oral administration of risperidone.The clinical efficacy,adverse effect,brief psychiatric rating scale(BPRS)score before and after the therapy,brain-derived neurotrophic factor(BDNF)and blood lipid level were compared between the two groups after eight weeks’treatment with risperidone,and meanwhile,the multivariable linear regression analysis was performed to the related factors possibly influencing the efficacy of risperidone.Results The difference of total effective rate between the adult group(86%)and the juvenile group(82.5%)was not significant(P0.05).The total score of BPRS,TC,TG,and LDL-C levels in the two groups after the treatment were significantly decreased compared with that before the treatment,while BDNF was significantly increased.The difference of inter-group comparison was significant before and after the treatment(P0.05).However,the comparison difference between two groups was not significant before and after the treatment(P0.05).The multivariable linear regression equation was used to analyze the longer duration of untreated psychosis(DUP),BPRS total score before treatment and BDNF levels that influence the efficacy of risperidone on patients with schizophrenia.Conclusion the treatment efficacy of risperidone on adult patients and juvenile patients with first-episode schizophrenia was similar and it was safe and effective.The DUP,BPRS total score before treatment and BDNF levels were associated with the efficacy of risperidone.     

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

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 or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral.Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam ( n = 104) or intramuscular injection treatment with haloperidol ( n = 101 ).The primary efficacy outcome measure was the change in scores based on PANSS-EC in session Ⅰ ( the first five days), and the response rate based on the PANSS score in session Ⅱ ( the following 6 weeks).Safety was evaluated using the Simpson-Angus Scale (ASA), Barnes Akathisia Scale (BAS), adverse events and lab test.Result Mean acute-agitation score improvement was significant after 5 day 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 risperidone oral solution groups than that in haloperidol IM injection group(P ＜0.05).The mean PANSS-EC and PANSS scores remained stable after switching from IM injection to oral.The efficacy was not differenct in both groups after 6 week 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 switching drug group than that in oral group ( P ＜ 0.05 ).Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability.The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment.     

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

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 or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral.Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam ( n = 104) or intramuscular injection treatment with haloperidol ( n = 101 ).The primary efficacy outcome measure was the change in scores based on PANSS-EC in session Ⅰ ( the first five days), and the response rate based on the PANSS score in session Ⅱ ( the following 6 weeks).Safety was evaluated using the Simpson-Angus Scale (ASA), Barnes Akathisia Scale (BAS), adverse events and lab test.Result Mean acute-agitation score improvement was significant after 5 day 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 risperidone oral solution groups than that in haloperidol IM injection group(P ＜0.05).The mean PANSS-EC and PANSS scores remained stable after switching from IM injection to oral.The efficacy was not differenct in both groups after 6 week 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 switching drug group than that in oral group ( P ＜ 0.05 ).Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability.The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment.     

文拉法辛联合治疗方案对难治性抑郁症疗效的随机对照研究

Objective To compare the efficacy of venlafaxine combination of cognitive behavior therapy or lithium or olanzapine for treatment-resistant depression. Method A prospective stratified randomized controlled clinical trial were adopted to the patients with treatment-resistant depression. 69 cases were divided into three groups with random number table, each group including 23 cases. One group was with venlafaxine combination of cognitive behavior therapy, others with combination of lithium, or olanzapine, for 6 weeks to observe the efficacy. The major indexes for therapeutic effects was Hamilton Depression Scale (HAMD) reducing score rate. Results The differences were significant in HAMD reducing score rate between the group with combination of cognitive behavior therapy[(61±5) %] and the group with combination of lithium [( 54 ± 7 ) %] ( t = 8.90, P < 0. 05 ), or olanzapine [( 47 ± 6 ) %] ( t =3.46,P < 0.05 ), with no significant difference is between the group with combination of lithium and the group with combination of olanzapine. Conclusion The total efficacy of venlafaxine combination of cognitive behavior therapy is superior to venlafaxine combination of lithium or olanzapine for treatmet-resistant depression.     

唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients.Methods An open, perspective, fixed-dose, multicentre and selfcontrolled clinical trial was conducted.Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg.The primary efficacy measurement was the change of Pittsburg Sleep Quality Index(PSQI) score after 1 week treatment in comparison with the baseline.The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) and self-reported sleeping parameters ( latency of falling asleep, total sleeping time and sleeping quality) after 3 week treatment.Results The mean reduction score 17 items of PSQI were 2.8 after 1 week treatment and 3.2 at the end of 3 week ( P ＜ 0.01 ).The selfreported sleeping parameters were much improved from the baseline (P ＜0.01 ).The total scores of HAMD and HAMA were reduced significantly ( P ＜ 0.01 ) after 3 week treatment.The overall incidence of adverse events was 19.1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate.Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.     

唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients.Methods An open, perspective, fixed-dose, multicentre and selfcontrolled clinical trial was conducted.Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg.The primary efficacy measurement was the change of Pittsburg Sleep Quality Index(PSQI) score after 1 week treatment in comparison with the baseline.The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) and self-reported sleeping parameters ( latency of falling asleep, total sleeping time and sleeping quality) after 3 week treatment.Results The mean reduction score 17 items of PSQI were 2.8 after 1 week treatment and 3.2 at the end of 3 week ( P ＜ 0.01 ).The selfreported sleeping parameters were much improved from the baseline (P ＜0.01 ).The total scores of HAMD and HAMA were reduced significantly ( P ＜ 0.01 ) after 3 week treatment.The overall incidence of adverse events was 19.1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate.Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.     

Gamma knife treatment for refractory epilepsy in seizure focus localized by positron emission tomography/CT

A total of 80 patients with refractory epilepsy were recruited from the Inner Mongolia Medical College Affiliated Hospital. The foci of 60% of the patients could be positioned using a combined positron emission tomography/CT imaging modality. Hyper- and hypometabolism foci were examined as part of this study. Patients who had abnormal metabolism in positron emission tomography/CT imaging were divided into intermittent-phase group and the seizure-phase group. The intermittent-phase group was further divided into a single-focus group and a multiple-foci group according to the number of seizure foci detected by imaging. Following gamma knife treatment, seizure frequency was significantly lower in the intermittent-phase group and the seizure-phase group. Wieser’s classification reached Grade Ⅰ or Ⅱ in nearly 40% of patients. Seizure frequency was significantly lower following treatment, but Wieser’s classification score was significantly higher in the seizure-phase group compared with the intermittent-phase group. Seizure frequency was significantly lower following treatment in the single-focus group, but Wieser’s classification score was significantly higher in the single-focus group as compared with the multiple-foci group.     

Effect of antidepressant treatment on water load test and cortlsol changes in patients with functional dyspepsia

BACKGROUND: It has been demonstrated that patients with functional dyspepsia have experiences social life stress events, and accompanied by psychological disorders, mainly manifested as depression and anxiety. Mental factors can lead to excessive gastrointestinal consensual reaction, and result in different brain-gut axis disturbance, and then cause the gastrointestinal sensorimotor abnormality and endocrine changes. OBJECTIVE: To observe the effect of antidepressant treatment on the changes of water load and serum cortisol in patients with functional dyspepsia, and analyze the therapeutic mechanism. DESIGN: A comparative observation. SETTING: The First Affiliated Hospital o Zhengzhou University. PARTICIPANTS: Forty-five patients with functional dyspepsia accompanied by depression were selected from the Department of Gastroenterology, the First Affiliated Hospital of Zhengzhou University from July 2004 to July 2006, and they were 25–65 years of age, and their disease courses ranged 1–10 years. They were all accorded with the diagnostic standards for RomeⅡfunctional dyspepsia functional dyspepsia. As the patients' will, they were divided into treatment group (n =30, 12 males and 18 females) and control group (n =15, 6 males and 9 females), and there were no significant differences in the data between the two groups (P > 0.05). The programs were discussed and agreed by the committee of medical ethics of the First Affiliated Hospital of Zhengzhou University. Informed contents were obtained from all the patients. METHODS: In the treatment group, the patients were treated with venlafaxine sustained release capsule (75 mg per day), and those with sleep disorder were added by benzodiazepines (alprazolam). In the control group, the patients were given routine treatments of antacid, prokinetics, etc. Before and after 8-week treatment, the following examinations were performed: ① The gastrointestinal symptoms were assessed according to the symptoms; ② The severity of depression was evaluated with Hamilton depression scale (HAMD); ③The relaxation of proximal stomach was observed using water load test; ④ The serum level of cortisol was detected. MAIN OUTCOME MEASURES: ① Symptom score; ② HAMD score; ③ Water load amount; ④ Serum level of cortisol. RESULTS: All the 45 patients were involved in the analysis of results. ① Symptom score: The scores of gastrointestinal symptoms were decreased as compared with those before treatment in both the treatment group and control group (P < 0.05). ② HAMD scores: The scores of HAMD were decreased as compared with those before treatment in both the treatment group and control group (P < 0.05). ③ Water load amount: The total effective rate was significantly higher in the treatment group than the control group (P < 0.05). ④ The serum levels of cortisol after treatment were significantly lower than those before treatment in the patients with severe gastrointestinal symptoms in the treatment group and control group (P < 0.05). CONCLUSION: Antidepressants can normalize the cortisol level of patients with functional dyspepsia, and then decrease gastric sensitivity and ameliorates the receptive relaxation of proximal stomach, also increase the water load amount correspondingly, and finally control the gastrointestinal symptoms of functional dyspepsia.     

疏血通注射液治疗急性脑梗死患者的临床观察及其对血清C反应蛋白的影响

Objective To observe the curative effects of Shuxuetong in treating patients with acute cerebral infarction and its effects on the level of serum C-reactive protein (CRP).Methods One hundred and twenty patients with acute cerebral infarction who had the onset within 48 h were equally randomized into treatment group and control group.Six ml Shuxuetong and Troxerutin for intravenous drip daily were given to the treatment group and the control group,respectively,for a consecutive 14 d.The concentrations of serum CRP in the 2 groups were measured by immunonephelometry before treatment and on the 5th,10th and 14th d of treatment.The scores of neurological functional deficit scale were compared before treatment and on the 14th d of treatment in the 2 groups.Results The concentration of serum CRP in the treatment group on the 5th,10th and 14th d of treatment was significantly lower than that in the control group (P<0.05).The scores of neurological functional deficit scale in the treatment group (14.57±7.88) were significantly lower than those in the control group (19.08±8.11) (P<0.05).The clinical efficacy between the 2 groups was obviously different (P<0.05).Conclusion Shuxuetoug can decrease the concentration of serum CRP and improve the nervous function in patients with acute cerebral infarction.     

A Study on the Effect of Risperidone on PPI and P50 Deficit in First-Episode and Chronic Patients with Schizophrenia

Objective To investigate the effect of atypical antipsychotics risperidone on prepulse inhibition of the startle reflex(PPI) and P50 deficit in first-episode and chronic patients with schizophrenia. Methods PPI and P50 were tested and compared in 81 first-episode acute schizophrenia patients and 92 chronic schizophrenia patients before and after the risperidone. Results There was no significant difference in PPI and P50 indices between the two groups before treatment(P>0. 05); 2) there was no significant correlation between PPI & P50 inhibition indices and PANSS score, onset frequency and disease course(P>0.05); 3) Except the significant group main effect for S2 amplitude in P50(P=0. 02), there was no significant change for main effect and interaction of the other P50 and PPI inhibition ratio indices after treatment(P>0. 05). The effect of risperidone on PPI and P50 measurement index had nothing to do with the curative effect. Conclusion There exists a deficit in sensory gating inhibition in both first-episode schizophrenia and chronic schizophrenia, which is relatively independent from disease course. The risperidone is not effective in improving PPI and P50 inhibition deficit.     

Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial

BACKGROUND: Paliperidone extended-release tablet (paliperidone ER) is an investigational oral psychotropic developed for schizophrenia treatment. It utilizes OROS technology to provide a unique pharmacokinetic profile, eliminating the need for titration and potentially leading to improved tolerability. Furthermore, paliperidone undergoes limited hepatic metabolism. METHODS: The efficacy and safety of once-daily paliperidone ER (6 mg, 9 mg and 12 mg) were assessed versus placebo in 628 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. RESULTS: All doses of paliperidone ER demonstrated significant improvement in PANSS score, all PANSS Marder factor scores (p<0.001) and personal and social functioning versus placebo (p<0.001). The PANSS total score also improved significantly in the olanzapine treatment arm. Significantly higher percentages of paliperidone ER patients demonstrated a > or =30% reduction in PANSS total score versus placebo (p<0.001). The incidence of movement disorder-related AEs and rating scales measurements were similar to placebo for the paliperidone ER 6 mg group and higher in the 9 mg and 12 mg groups. In the paliperidone ER groups there were no reports of glucose-related AEs or clinically relevant changes in plasma lipid levels and changes in mean bodyweight<1 kg. CONCLUSION: In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. Paliperidone ER offers a distinctive treatment profile and may provide a valuable new treatment option for patients with schizophrenia.     

Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study

BACKGROUND: Paliperidone extended-release tablet (paliperidone ER) is an oral psychotropic agent developed for schizophrenia treatment. Paliperidone (9-OH-risperidone, metabolite of risperidone), when used with OROS technology has a unique pharmacokinetic profile undergoing limited hepatic metabolism. METHODS: The efficacy and safety of once-daily paliperidone ER (3 mg, 9 mg and 15 mg) were compared with placebo in 618 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. An assay sensitivity group with known efficacy was included to confirm trial validity (olanzapine 10 mg). RESULTS: All doses of paliperidone ER demonstrated significant improvements in PANSS total and PANSS factors scores (p<0.05) and in personal and social functioning (p<0.001) compared with placebo. Symptom improvement has been observed at the first observation assessment (Day 4) (p<0.001) compared with placebo, suggesting a rapid onset of action for paliperidone ER. Paliperidone ER was associated with a low incidence of treatment-emergent adverse events. The incidence of movement disorder-related adverse events and rating scale scores were similar in the paliperidone ER 3 mg and placebo groups and increased with dose. Increases in prolactin plasma levels and dose-related increases in body weight (<2 kg) were observed; there were no significant changes in serum lipid or glucose levels. CONCLUSION: In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. As such, paliperidone ER may provide a valuable new treatment option for patients with schizophrenia.     

奥氮平与利培酮治疗难治性精神分裂症的对照研究

目的 比较奥氮平与利培酮对难治性精神分裂症的疗效及安全性.方法 68例难治性精神分裂症患者按照排列表法随机分为奥氮平组[34例,(24.1±5.4)mg/d]和利培酮组[34例,(7.9±1.8)mg/d],疗程均为12周.采用阳性和阴性症状量表(PANSS)、临床总体印象量表(CGI)及治疗中需处理的不良反应症状量表(TESS),在治疗前及治疗第1,2,4,8,12周末分别评定疗效和不良反应.结果 (1)奥氮平组PANSS总分、阳性症状分、阴性症状分及一般病理分均从治疗第2周末起较治疗前下降(P<0.05～0.01);利培酮组PANSS总分、阳性症状分、一般病理分从治疗第2周末起,阴性症状分从第4周末起,较治疗前下降(P<0.05～0.01);奥氮平组从治疗第2周末起各时点PANSS总分、阴性症状分均低于利培酮组(P<0.05～0.01).(2)治疗第2周末起,2组临床总体印象量表-严重程度和改善程度(CGI-SI)总分均较治疗前下降(P<0.05～0.01);2组间各时点CGI-SI分的差异无统计学意义(P>0.05).(3)治疗第12周末,奥氮平组、利培酮组临床总有效率分别为65%、41%,差异有统计学意义(P<0.05).(4)奥氮平组、利培酮组不良反应发生率分别为53%(18/34)和59%(20/34),差异无统计学意义(P>0.05);奥氮平组体质量增加发生率高于利培酮组(P<0.05);利培酮组静坐不能、异常泌乳和(或)闭经、肌张力增高的发生率高于奥氮平组(P<0.05).结论 奥氮平对难治性精神分裂症有良好疗效,不良反应轻微.     

阿立哌唑与利培酮治疗精神分裂症的疗效及安全性对照研究

目的 探讨阿立哌唑治疗急性精神分裂症的疗效及安全性.方法 人组首次发病或症状急性恶化的精神分裂症患者200例,随机分为阿立哌唑组和利培酮组各100例,观察时间为6周.于基线及治疗第1,2,4,6周末,采用阳性和阴性症状量表(PANSS)评定疗效,采用治疗中需处理的不良反应症状量表、血生化指标和心电图的改变评价治疗的安全性.最终纳入分析197例(阿立哌唑组98例,利培酮组99例).结果 (1)阿立哌唑组自治疗第1周末(除阴性症状分外)、利培酮组自治疗第4周末,PANSS阳性、阴性症状分、精神病理症状分和总分均明显下降(P＜0.05或P＜0.01).治疗第6周末,阿立哌唑组PANSS阳性症状分(12.5 ±6.3)分,阴性症状分(14.8±7.6)分,精神病理症状分(27.4±9.9)分,总分(54.7±21.3)分,与基线分[分别为(22.1±6.9)分,(21.8±8.6)分,(41.1±10.1)分,(85.1±18.6)分]的差异均有统计学意义(P均＜0.01),且疗效优于利培酮组(P＜0.01).(2)治疗第6周末,阿立哌唑组治愈35例(36%),显著好转31例(32%),好转14例(14%),症状无显著变化15例(15%),恶化3例(3%);治愈率为36%,显效率为67%;有效率为82%,高于利培酮组(74%).(3)6周的观察期中,未发现阿立哌唑导致的体质量明显增加及心电图明显改变.结论 阿立哌唑对急性精神分裂症有良好的疗效,而且起效较迅速,安全性较好.     

奥氮平与氯氮平治疗难治性精神分裂症对照研究

目的评价奥氮平治疗难治性精神分裂症的疗效及安全性。方法将64例难治性精神分裂症患者随机分为研究组和对照组,分别予以奥氮平和氯氮平治疗8周,采用PANSS量表和TESS量表评定疗效和不良反应。结果奥氮平组治疗前后PANSS减分率为39.3%,有效率为72.8%;氯氮平组治疗前后PANSS减分率为36.6%,有效率为59.4%。奥氮平组未见严重的不良反应。结论奥氮平与氯氮平治疗难治性精神分裂症均有良好疗效,奥氮平的副作用小,病人依从性好。     

Neurological soft signs and positive treatment response to olanzapine in chronic schizophrenia

The goal of this study is to examine if Neurological Soft Signs (NSS) scores may improve on an 8-week olanzapine treatment in 10 patients with chronic schizophrenia. The patients were rated every 2 weeks on the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression Scale (CGI). Baseline and endpoint NSS scores were evaluated by the Neurological Evaluation Scale (NES). The results demonstrated that baseline total PANSS and subscale scores of positive and general symptomatology, and baseline CGI scores were significantly reduced at the end of olanzapine treatment. There were no significant differences between baseline and endpoint subscale scores of negative symptomatology. We have also found no significant differences between baseline and endpoint total and subscale scores of NES. Baseline total scores of NES were significantly correlated only with negative schizophrenic symptoms at baseline. Our findings indicate that NSS may not improve in schizophrenic patients with olanzapine treatment.     

Effectiveness of the selective D4 antagonist sonepiprazole in schizophrenia: a placebo-controlled trial.

BACKGROUND: Selective localization of dopamine D(4) receptors in the prefrontal cortex and preferential affinity of clozapine for the dopamine D(4) receptor over the D(2) receptor led to the hypothesis that the superior efficacy of clozapine may be mediated via blockade of the D(4) receptor. This hypothesis was tested by evaluating sonepiprazole, a selective D(4) dopamine antagonist, in schizophrenia patients. METHODS: We treated 467 hospitalized schizophrenia patients with scores of > or = 60 on the Positive and Negative Syndrome Scale (PANSS) with sonepiprazole, olanzapine, or placebo once daily for 6 weeks. The primary efficacy end point was the mean change from baseline in the PANSS total score at 6 weeks. Secondary efficacy end points were the mean change from baseline in the PANSS factor scores, the Brief Psychiatric Rating Scale score, the Clinical Global Impressions Severity of Illness score, and the Calgary Depression Scale score. RESULTS: No statistically significant differences were observed between placebo and any sonepiprazole dose on the primary or any secondary end point after 6 weeks of treatment. Statistically significant differences, favoring olanzapine over placebo, were observed on all efficacy end points but the Calgary Depression Scale. CONCLUSIONS: Sonepiprazole was ineffective for the treatment of patients with schizophrenia.     

Paliperidone extended-release tablets in patients with recently diagnosed schizophrenia

Aim: Effective early and persistent antipsychotic treatment in recently diagnosed schizophrenia may positively impact long-term outcomes. Paliperidone extended-release (ER) was assessed in this population. Methods: Post hoc analysis of pooled data from three 6-week, double-blind (DB), placebo-controlled, and three 1-year open-label (OL) studies of paliperidone ER in schizophrenia patients. Data stratified by time since diagnosis (≤3 vs. >3 years). Results: At DB (n = 1193) and OL baselines (n = 744), 259 (21.9%) and 188 (25.3%) patients were diagnosed ≤3 years. At DB end point, both populations improved with paliperidone ER versus placebo on Positive and Negative Syndrome Scale (PANSS) total, Clinical Global Impressions–Severity and Personal and Social Performance (PSP) scale scores (all P < 0.05). At OL end point, there were significant improvements from DB baseline in both populations on these scales (P < 0.0001), with greater improvement in the ≤3-year population on PANSS total (P < 0.001) and PSP (P < 0.001) scores. During DB treatment, only the ≤3-year population reported adverse events (AEs) in ≥5% (placebo-adjusted rate) of subjects receiving paliperidone ER: akathisia, extrapyramidal disorder not otherwise specified and somnolence. During OL treatment, akathisia and somnolence occurred more frequently (≥5%) in the ≤3- versus >3-year population. OL study completion rates were 51.1% in ≤3-year, and 48.2% in >3-year subjects. Conclusions: Paliperidone ER significantly improved symptoms and functioning in schizophrenia patients, regardless of time since diagnosis. Recently diagnosed patients who continued treatment exhibited greater symptom reduction and functional benefit over the long term. Results also suggest that these patients may be more susceptible to certain AEs.     

喹硫平与奥氮平对精神分裂症患者生活质量影响的对照研究

目的 比较喹硫平与奥氮平对精神分裂症患者的疗效及生活质量的影响.方法 对60例精神分裂症患者,随机分为喹硫平组(30例)与奥氮平组(30例)治疗,疗程12周.分别于治疗前、4周、8周、12周末,采用阳性与阴性症状量表( PANSS)评定疗效,治疗中出现的症状量表(TESS)评定不良反应,于治疗前和12周末采用生活质量综...     

Double-blind, randomized comparison of olanzapine versus fluphenazine in the long-term treatment of schizophrenia

This study was undertaken to evaluate the efficacy and safety of olanzapine compared with fluphenazine in the treatment of patients who met the Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnostic criteria for schizophrenia or schizoaffective disorder. This was a long-term (22-week), randomized, double-blind, parallel clinical trial. Sixty patients (mean age, 35.4 years) were randomly assigned to either olanzapine (n=30) or fluphenazine (n=30). They received treatment at three centers in Croatia during a 22-week study period and were assessed weekly for the first 6 weeks and monthly thereafter. Efficacy was measured using the Brief Psychiatric Rating Scale (BPRS), the Positive and Negative Syndrome Rating Scale (PANSS) and the Clinical Global Impression (CGI) Severity and Improvement scores. The Hillside Akathisia Scale (HAS), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), vital signs, laboratory tests, and treatment-emergent adverse events were assessed to evaluate safety. The olanzapine group showed significantly greater mean decreases from baseline to endpoint for BPRS total (-25.8 vs. -16.5, P=.035), PANSS total (-45.7 vs. -29.5, P=.037), PANSS positive (-13.0 vs. -7.9, P=.034), and CGI Severity (-2.2 vs. -1.3, P=.031) scores. The olanzapine group showed greater mean decreases on all measures of extrapyramidal symptoms, significantly so for the SAS (-2.1 vs. 1.9, P=.004) and HAS (-3.4 vs. 2.6, P=.028). Patients in the fluphenazine group experienced a higher incidence of treatment-emergent adverse events (76.7% vs. 50.0%, P=.032). Weight gain was the most frequently reported adverse event in the olanzapine group (16.7% vs. 0.0%, P=.020). Akathisia (30.0% vs. 10.0%, P=.053) and insomnia (20.0% vs. 0.0%, P=.010) appeared most frequent in the fluphenazine group. Daily use of anticholinergics and benzodiazepines were both significantly greater for the fluphenazine group (P=.003 and.04, respectively). No significant changes were observed in vital signs, ECG, or clinical chemistry. The study indicates that olanzapine has advantages in both efficacy and safety compared to fluphenazine; however, the small sample size limits our ability to draw definitive conclusions.