氨磺必利对不同亚型精神分裂症的治疗效应

目的探讨氨磺必利对不同亚型精神分裂症治疗效应的差异。方法将150例符合《中国精神障碍分类与诊断标准(第3版)》(CCMD-3)诊断标准的首发住院精神分裂症患者按临床亚型和阳、阴性症状分型(分别为I型和II型)进行分组,全部根据临床用药原则结合病情给予氨磺必利治疗,第一天200mg/d,第二天300mg/d,第三、四天300~400mg/d,第五天起,根据病情及用药后的感受调整剂量至400~1000mg/d,分2次服用,观察8周。于治疗前及治疗第1、4、8周末采用阳性与阴性症状量表(PANSS)评定各时点的病情,按四级临床疗效标准评定治疗第8周末的疗效,比较不同亚型之间PANSS总分减分率、剂量、疗效的差异。结果 4周末和8周末不同亚型患者的PANSS总评分均低于治疗前(P<0.01),治疗1周末偏执型、未定型、青春型和I型患者的PANSS总评分低于治疗前(P<0.05或0.01);治疗第1、4、8周末PANSS减分率偏执型组高于紧张型组、I型组高于II型组,差异均有统计学意义(P<0.01)。不同亚型之间8周末的疗效和显效率差异无统计学意义(P>0.05),但氨磺必利的平均等效用量以偏执型和I型较高,差异均有统计学意义(P<0.01)。结论氨磺必利对各亚型精神分裂症患者均有较好的效果,需根据患者的亚型特点调整个体化的治疗剂量。     

氨磺必利与喹硫平治疗以阴性症状为主的精神分裂症对照观察

目的比较小剂量氨磺必利与喹硫平对以阴性症状为主的精神分裂症的疗效和安全性。方法采用数字随机法将112例以阴性症状为主的精神分裂症患者分为两组各50例,分别给予氨磺必利与喹硫平治疗,疗程8周,采用阳性与阴性症状量表(PANSS)、阴性症状评定量表(SANS)评定疗效,以副反应量表(TESS)评定不良反应。结果治疗8周氨磺必利组显效率为55.40%,两组PANSS阳性症状、阴性症状评分差异有统计学意义(P<0.01);两组SANS各因子分及总分差异有统计学意义(P<0.01)。结论小剂量氨磺必利对以阴性症状为主的精神分裂症有较好的疗效和安全性。     

氨磺必利与奥氮平治疗精神分裂症首次发病患者的对照研究

目的:比较氨磺必利和奥氮平治疗精神分裂症的临床疗效和安全性。方法:将62例精神分裂症首次发病患者随机分为氨磺必利组和奥氮平组治疗8周。采用阳性与阴性症状量表(PANSS)于治疗前后评定疗效,并观察不良反应。结果:治疗8周两组PANSS总分减分及一般病理学减分比较差异无统计学意义;氨磺必利组PANSS阴性症状减分明显高于奥氮平组,奥氮平组PANSS阳性症状减分显著高于氨磺必利组(P均0.05)。氨磺必利组和奥氮平组总有效率分别为93.5%和96.8%,差异无统计学意义(P0.05)。奥氮平组体质量增加、镇静嗜睡和血糖升高发生率明显高于氨磺必利组(P0.05或P0.01)。结论:氨磺必利治疗精神分裂症的疗效与奥氮平相当,但不良反应相对较少。     

氨磺必利治疗精神分裂症阴性症状的对照研究

目的探讨氨磺必利治疗精神分裂症阴性症状的效果。方法采用随机数字表法将符合《中国精神障碍分类与诊断标准第3版》(CCMD-3)精神分裂症诊断标准的72例精神分裂症患者分为氨磺必利组(研究组)和利培酮组(对照组)各36例,观察8周。采用阳性与阴性症状量表(PANSS)评定疗效,副反应量表(TESS)评定不良反应。结果经8周治疗,两组PANSS总分均较治疗前低(P均0.01)。氨磺必利组与利培酮组有效率分别为88.9%和86.1%,差异无统计学意义(P0.05)。但氨磺必利组阴性症状评分减分与利培酮组比较,差异有统计学意义(P0.05)。治疗结束时两组TESS评分差异无统计学意义(P0.05)。结论氨磺必利对精神分裂症阳性症状的疗效与利培酮相当,而对精神分裂症的阴性症状的疗效优于利培酮。     

氨磺必利与利培酮治疗精神分裂症首次发病患者的临床对照研究

目的比较氨磺必利和利培酮对精神分裂症的疗效和安全性。方法采用数字随机法将68例精神分裂症首次发病患者分为氨磺必利治疗组(n=34)和利培酮治疗组(n=34)。疗程12周,采用阳性和阴性症状量表(PANSS)、副反应量表(TESS)和锥体外系副反应量表(RSESE)分别评定疗效和不良反应。结果治疗后4、8、12周末两组PANSS总分及各因子分均较治疗前低(P﹤0.05)。氨磺必利组体重增加小于利培酮组(P﹤0.05)。结论两种药物治疗精神分裂症患者首次发病疗效相当,但氨磺必利对体重的影响优于利培酮。     

氨磺必利与阿立哌唑口崩片治疗以阴性症状为主的精神分裂症的临床对照研究

目的比较氨磺必利和阿立哌唑口崩片治疗以阴性症状为主的精神分裂症的临床疗效和安全性。方法采用随机对照研究,将64例符合《中国精神障碍分类与诊断标准(第3版)》(CCMD-3)诊断标准的以阴性症状为主的精神分裂症患者按照入组先后顺序分为氨磺必利组(研究组)和阿立哌唑口崩片组(对照组)各32例,疗程8周,采用阳性和阴性症状量表(PANSS)评定疗效,采用副反应量表(TESS)评定不良反应。结果治疗8周后,两组PANSS评分均下降(P0.05),氨磺必利组和阿立哌唑口崩片组有效率分别为90.63%,87.5%,差异无统计学意义(P0.05)。两组TESS评分分别为(3.98±1.03)分、(4.07±1.89)分,差异无统计学意义(P0.05)。结论氨磺必利与阿立哌唑口崩片治疗以阴性症状为主的精神分裂症疗效相当,不良反应轻。     

氨磺必利与利培酮治疗老年精神分裂症的效果和安全性

目的比较氨磺必利和利培酮治疗老年精神分裂症的效果和安全性,为临床医生用药提供参考。方法按照《国际疾病分类(第10版)》诊断标准,在山东省泰安市复员退伍军人精神病院收集63例老年精神分裂症住院患者,将入组患者进行编号,采用随机数字表法将患者分为两组,分别给予氨磺必利(氨磺必利组,n=31)和利培酮(利培酮组,n=32)治疗,氨磺必利起始剂量50~100 mg/d,第7~10天逐步增至100~600 mg/d,利培酮起始剂量0.5~1 mg/d,第7~10天逐步增至1~4 mg/d。两组均有28例完成研究。分别于基线期和治疗1、2、4、6周后进行血压、脉搏、体重、血常规、心电图检测,于基线期和治疗6周后进行肝、肾功能、空腹血葡萄糖检测,使用阳性和阴性症状量表(PANSS)评定临床疗效,采用Simpson锥体外系副反应评定量表(SEPS)评定锥体外系副反应。结果氨磺必利组脱落率为9.7%,利培酮组脱落率为12.5%,两组脱落率比较差异无统计学意义(χ~2=0.287,P0.05)。治疗6周后,氨磺必利组和利培酮组有效率(92.9%vs.89.3%,χ~2=0.186,P0.05)及显效率(67.9%vs.67.9%,χ~2=0.179,P0.05)差异均无统计学意义。治疗第1周末,氨磺必利组PANSS总评分与基线期比较,差异有统计学意义(P0.05),治疗第2周末,利培酮组PANSS总评分与基线期比较,差异有统计学意义(P0.05)。氨磺必利组和利培酮组不良反应发生率比较差异无统计学意义(50.0%vs.57.1%,χ~2=0.462,P0.05)。结论氨磺必利与利培酮对老年精神分裂症总体疗效和安全性相当,但氨磺必利比利培酮起效更快。     

氨磺必利与奥氮平治疗首发精神分裂症疗效对比观察

目的评价氨磺必利与奥氮平治疗首发精神分裂症的临床疗效及安全性。方法将68例首发精神分裂症患者随机分为氨磺必利组和奥氮平组,分别治疗8周,采用阳性和阴性综合征量表（PANSS）、治疗中需处理的不良反应症状量表（TESS）评定疗效及不良反应。结果氨磺必利组显效率（70.6%）、有效率（76.5%）与奥氮平组显效率（91.2%）、有效率（94.1%）差异无统计学意义（P＆gt;0.05）。两组患者治疗后各时点PANSS总分及各因子分与治疗前比较均降低（P〈0.05,P〈0.01）。震颤方面氨磺必利组发生率高于奥氮平组（P〈0.05）;嗜睡、肝功异常、体质量增加等方面氨磺必利组发生率均低于奥氮平组（P〈0.01）。结论氨磺必利治疗精神分裂症与奥氮平疗效相当,不良反应轻,依从性好,值得临床推广。     

氨磺必利联合重复经颅磁刺激治疗首发精神分裂症的随机对照研究

目的探讨氨磺必利合并重复经颅磁刺激(r TMS)治疗精神分裂症的效果。方法采用随机数字表法将符合《国际疾病分类(第10版)》(ICD-10)精神分裂症诊断标准的88例首发精神分裂症患者分为研究组和对照组各44例,研究组采用氨磺必利联合重复经颅磁刺激(rTMS)治疗,对照组单用氨磺必利治疗,采用阳性与阴性症状量表(PANSS)于治疗前及治疗后第2、4、6、8周评定疗效,采用副反应量表(TESS)评定不良反应。结果经8周治疗,两组PANSS总评分均较治疗前低(P均0.01)。研究组与对照组有效率分别为88.6%和81.8%,差异无统计学意义(P0.05)。但研究组阴性症状评分减分与对照组比较,差异有统计学意义(P0.05)。治疗结束时两组TESS评分差异无统计学意义(P0.05)。结论氨磺必利合并r TMS对首发精神分裂症阳性症状的疗效与单用氨磺必利相当,而对首发精神分裂症的阴性症状的疗效优于单用氨磺必利,两组不良反应相当。     

氨磺必利与奥氮平治疗精神分裂症的随机对照研究

目的 比较氨磺必利与奥氮平治疗精神分裂症的疗效与安全性.方法 将80例精神分裂症患者,随机分为氨磺必利组和奥氮平组,各40例,疗程8周.采用阳性与阴性症状量表(PANSS)、临床疗效总评量表(CG1)及治疗中出现的症状量表(TESS)分别评定疗效和不良反应.结果 经过8周治疗,氨磺必利组和奥氮平组显效率分别为65.8％和71.8％,两组疗效差异无统计学意义(P＞0.05).治疗后第8周末氨磺必利组阴性症状分较奥氮平组减少更显著(P＜0.05).安全性方面,氨磺必利组、奥氮平组不良反应总发生率分别为44.7％(17/38)和53.8％(21/39),差异无统计学意义(P＞0.05).氨磺必利组泌乳或月经紊乱发生率高于奥氯平组(P＜0.05),奥氮平组便秘和体重增加发生率高于氨磺必利组(P＜0.05).其他不良反应发生率差异无统计学意义(P均＞0.05).结论 氨磺必利和奥氮平对精神分裂症的疗效相当,不良反应轻,值得临床应用.     

Amisulpride has a superior benefit/risk profile to haloperidol in schizophrenia: results of a multicentre, double-blind study (the Amisulpride Study Group).

In a multicentre, double-blind, flexible-dose study, 199 patients with paranoid schizophrenia or schizophreniform disorders received haloperidol (10-30 mg/d) or amisulpride (400-1200 mg/d) for four months. More patients in the haloperidol group withdrew prematurely (44% vs 26%; P = 0.0077) due to a higher incidence of adverse events. Amisulpride was at least as effective as haloperidol in reducing the Brief Psychiatric Rating Scale (BPRS) total score (-27.3 vs -21.9) (non-inferiority test; P < 0.001). The PANSS positive score improved to a similar extent in both groups whilst improvement in the PANSS negative score was significantly greater with amisulpride (-10.5 vs -7.2; P = 0.01). The percentage of responders on the Clinical Global Impression scale was also significantly greater with amisulpride (71% vs 47%; P < 0.001). Both the Quality of Life Scale (QLS) and the Functional Status Questionnaire (FSQ) improved to a significantly greater extent under amisulpride. Haloperidol was associated with a greater incidence in extrapyramidal symptoms and with a greater increase in the Simpson-Angus score than was seen with amisulpride (0.32 vs 0.02; P < 0.001). In conclusion, amisulpride is globally superior to haloperidol in the treatment of acute exacerbations of schizophrenia and significantly improves patients' quality of life and social adjustment.     

Amisulpride,an atypical antipsychotic,in the treatment of acute episodes of schizophrenia: a dose-ranging study vs. haloperidol

This 4-week, double-blind, randomized study was undertaken to determine the dose-response relationship of amisulpride in 319 patients with acute exacerbation of schizophrenia. Fixed doses of amisulpride (400, 800 and 1200 mg/day) and haloperidol (16 mg/day) were compared to amisulpride, 100 mg/day, as a potentially subtherapeutic dose. Efficacy data (BPRS total score and PANSS positive subscale) in the amisulpride groups generated a bell-shaped dose-response curve, with 400 mg/day and 800 mg/day being the most effective treatments for positive symptoms. Parkinsonism did not increase significantly between baseline and endpoint with amisulpride 400, 800 and 1200 mg/day compared to the amisulpride 100 mg/day group, whereas the difference was significant for haloperidol (P<0.05). It is concluded that amisulpride 400 mg and 800 mg/day is highly effective in treating the positive symptoms of schizophrenia, with less extrapyramidal side-effects than haloperidol 16 mg/day.     

氨磺必利与利培酮治疗首发精神分裂症的对照研究

目的比较氨磺必利与利培酮治疗首发精神分裂症的疗效和安全性。方法按就诊先后顺序将首发精神分裂症患者分为研究组和对照组,分别给予氨磺必利和利培酮治疗8周。于治疗前及治疗后第4、8周末采用阳性与阴性综合征量表（PANSS）评定患者的疗效,以治疗中需处理的不良反应症状量表（TESS）评定患者的不良反应。结果治疗后第4、8周末,两组PANSS量表总分及分量表评分较治疗前均有显著降低（P〈0．05,P〈0．01）;研究组有效率93．8％,显效率71．9％;对照组有效率为90．6％,显效率68．8％,两组比较无显著性差异（P〉0．05）。研究组和对照组药物不良反应均较少。结论氨磺必利是一种安全有效的抗精神病药物,对治疗首发精神分裂症疗效与利培酮相当。     

Amisulpride versus moclobemide in treatment of clozapine-induced hypersalivation

Abstract

Objectives. Previous publications demonstrated substitute benzamides as effective agents in treatment of clozapine-induced sialorrhea (CIS). The aim of this study was to compare efficacy of amisulpride and moclobemide (both from the substitute benzamide group) in controlling, or at least minimizing, CIS. Methods. The study was designed as a 6-week, two-center, fixed-dose, comparison study of 400 mg/day of amisulpride versus 300 mg/day of moclobemide as an adjunctive treatment in 53 schizophrenia and schizoaffective disorder patients (diagnosed according to DSM-IV) suffering from CIS. The patients were treated with each medication during 2 weeks, followed by a washout period of 2 weeks. Primary outcome measures included the reduction in the five-point Nocturnal Hypersalivation Rating Scale (NHRS). Secondary outcomes included the Positive and Negative Syndrome Scale (PANSS), Manic State Assessment Scale, and Extrapyramidal Symptom Rating Scale (ESRS). Results. Both amisulpride and moclobemide were very effective in reducing CIS. Almost 74% of patients treated with amisulpride and 83% of patients treated with moclobemide showed some level of improvement on NHRS. Only in one patient treated with amisulpride, CIS worsened. Conclusions. Both medications were safe and effective as treatment of CIS. Although moclobemide exceeded amisulpride in antisalivation activity, treatment of CIS with amisulpride leads to improvement in psychotic symptoms.     

A pilot study of the safety and efficacy of amisulpride and risperidone in elderly psychotic patients

ObjectiveThe primary objective of this randomised, active–controlled, parallel group, double-blind study was to evaluate the tolerability of treatment with either amisulpride or risperidone in elderly patients with schizophrenia aged over 65 years; evaluation of efficacy was a secondary objective.MethodsThe study included patients of either sex aged 65 years or older fulfilling DSM IV-diagnostic criteria for psychotic disorders and who presented psychotic symptoms severe enough to require antipsychotic medication. Subjects were randomly allocated to a flexible dose of either amisulpride (100–400 mg/day) or risperidone (1–4 mg/day) for six weeks following a three- to six-day placebo wash-out period. Safety assessment involved adverse event reporting, physical examination, blood pressure, heart rate and ECG monitoring, and laboratory tests. Extrapyramidal symptoms were evaluated with the Simpson–Angus Scale, Barnes Akathisia Scale and the AIMS. Efficacy parameters were changes in score on the PANSS, BPRS, CDS and MMSE scores.ResultsThirty-eight patients were randomised, 25 to amisulpride and 13 to risperidone. A total of 26 adverse events were experienced by 10 patients in the amisulpride group and five patients in the risperidone group. One patient in each group discontinued the study due to the emergence of a movement disorder. Changes in scores on the three measures of extrapyramidal symptoms were similar in the two groups. The PANSS total score decreased by 27.8% in the amisulpride group and by 29% in the risperidone group between inclusion and study end.ConclusionAmisulpride and risperidone are generally well tolerated in elderly patients with schizophrenia. Both drugs appeared to be efficacious in this study population, with no differences in efficacy being observed. However, the sample size was too low to reveal potential inter-group differences. Both these atypical antipsychotics thus appear to be suitable for the treatment of schizophrenia in the elderly.     

Amisulpride vs. risperidone in the treatment of acute exacerbations of schizophrenia. Amisulpride study group

Amisulpride, a substituted benzamide with high selectivity for dopamine D3 and D2 receptors, was compared with the antipsychotic risperidone in patients with acute exacerbations of schizophrenia. The study was double-blind and involved 228 patients allocated, after a 3-6-day wash-out period, to amisulpride 800 mg (n = 115) or risperidone 8 mg (n = 113) for 8 weeks. Both treatments produced a marked improvement in schizophrenic symptomatology. Decreases in mean BPRS total score were 17.7 +/- 14.9 for amisulpride and 15.2 +/- 13.9 for risperidone, and all of the individual factors on the BPRS showed a numerically greater improvement in the amisulpride than in the risperidone patients. Both treatments were equally effective against positive symptoms on the PANSS positive syndrome subscale; however, there was a trend in favor of greater improvement in negative symptoms assessed on the PANSS negative subscale in patients receiving amisulpride with a decrease of 6.9 +/- 7.5 vs. 5.3 +/- 6.6 for risperidone (P = 0.09). Both drugs demonstrated good safety profiles, and scores on neurological scales (SAS, AIMS, and BAS) did not increase during treatment. A comparable proportion of patients received antiparkinsonian medication, 30 and 23% in the amisulpride and risperidone groups, respectively (P = 0.21). Patients receiving risperidone experienced an increase in body weight, which was significantly greater than for amisulpride (P = 0.026).     

Amisulpride versus risperidone in the treatment of depression in patients with schizophrenia: a randomized, open-label, controlled trial

OBJECTIVE: To determine the effectiveness of amisulpride on depression in patients with schizophrenia, in comparison to risperidone. METHOD: In this open-label, 12-week study, patients with stable schizophrenia and a comorbid major or minor depressive episode (DSM-IV) taking risperidone were randomized into a risperidone-continuation group (N = 45) or an amisulpride-switch group (N = 42). The main outcome measures were changes from baseline on the Calgary Depression Scale for Schizophrenia (CDSS) and the Beck Depression Inventory (BDI). Secondary efficacy measures included the Positive and Negative Syndrome Scale (PANSS), and the Global Assessment of Functioning. Safety measures included treatment-emergent adverse events and extrapyramidal symptoms. RESULTS: The mean dose at endpoint was 4.2 mg/day for risperidone and 458.3 mg/day for amisulpride. Improvements in the CDSS and BDI scores were significantly greater in the amisulpride-switch group than in the risperidone-continuation group at weeks 8 and 12, and at the endpoint. The amisulpride-switch group also showed a significantly greater reduction in the score for the PANSS depression/anxiety factor, and the total score from baseline to endpoint. No significant difference was observed between the two groups for treatment-emergent adverse events or change from baseline for extrapyramidal symptoms. CONCLUSION: Switching from risperidone to amisulpride in patients with stable schizophrenia with comorbid depression improved depressive symptoms significantly compared to continuing with risperidone.     

氨磺必利与利培酮治疗青少年精神分裂症的对照研究

目的 探讨氨磺必利治疗青少年精神分裂症的疗效和安全性.方法 68例青少年精神分裂症患者随机分为氨磺必利治疗组（研究组）和利培酮治疗组（对照组）,于治疗前和治疗后第8周末,采用阳性和阴性综合征量表（PANSS）、卡尔加里精神分裂症抑郁量表（CDSS）评定临床疗效,治疗中需处理的不良反应症状量表（TESS）评定药物的不良反应.结果 治疗8周后两组有效率分别为87.5％和78.8％,差异无统计学意义（x^2=0.858,P＞0.05）;研究组PANSS阴性症状量表减分和CDSS量表减分明显高于对照组（P＜0.05）;研究组在静坐不能、心血管不良反应、体质量增加、血清泌乳素升高方面不良反应的发生率明显低于对照组（P＜0.05）.结论 氨磺必利与利培酮治疗青少年精神分裂症总体疗效相当,但在改善阴性症状及抑郁症状方面优于利培酮.