阿立哌唑与利培酮治疗精神分裂症随机双盲对照研究

目的：评价阿立哌唑治疗精神分裂症的有效性和安全性。方法：将52例精神分裂症患者,随机分配到阿立哌唑组26例和利培酮组26例,进行为期6周的随机双盲对照研究。采用阳性和阴性症状量表（PANSS）、临床疗效总评量表（CGI）、治疗中出现的症状量表（TESS）及有关实验室检查评定疗效和安全性。结果：治疗6周两组PANSS评分较治疗前均显著降低（P均〈0．05）,各时点PANSS评分两组间减分差异无统计学意义。治疗6周末,阿立哌唑组有效率58．3％,利培酮有效率75％,两组比较差异无统计学意义（χ^2=1．50,P=0．221）。两组均未发生严重相关不良事件。阿立哌唑组对血清催乳素的影响较利培酮组小。结论：阿立哌唑治疗精神分裂症的疗效与利培酮相当,对催乳素无影响,是一种安全而有效的抗精神病药物。     

阿立哌唑与利培酮对血清催乳素水平的影响

目的:比较阿立哌唑与利培酮对精神分裂症患者血清催乳素(PRL)的影响及其与临床疗效的关系。方法:选取70例精神分裂症患者,随机分为阿立哌唑组36例,利培酮组34例,分别给予阿立哌唑和利培酮治疗8周,在治疗前及治疗1、2、4、6、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、中、后采用放射免疫法测查PRL水平。结果:两组PANSS减分率分别为阿立哌唑组(44.9±15.0)%、利培酮组(51.3±14.3)%,临床有效率分别为89.7%、92.1%,治疗前后阿立哌唑组PRL水平比较差异无显著性(P>0.05),利培酮组PRL明显增高(P<0.05)。阿立哌唑组治疗前后PRL水平的差值与PANSS减分率经相关分析差异有显著性(r=0.50,P<0.05),而利培酮组差异则无显著性(r=0.20,P>0.05)。出现月经紊乱或泌乳阿立哌唑组(1/14,7.1%)较利培酮组(7/18,38.9%)明显为少(χ2=4.23,P<0.05)。结论:2药对精神分裂症均有较好疗效,阿立哌唑与利培酮对PRL影响不同,与疗效关系不明显。     

阿立哌唑与利培酮治疗精神分裂症对照研究

目的:探讨阿立哌唑治疗精神分裂症的疗效和安全性,并与利培酮对照.方法:将64例符合中国精神障碍分类与诊断标准第3版诊断标准的精神分裂症患者随机分为两组,分别给予阿立哌唑及利培酮治疗8周,采用阳性与阴性症状量表(PANSS)评定临床疗效,治疗中出现的症状量表(TESS)评定不良反应.结果:两组治疗后PANSS总分及各因子分减分率差异无显著性(P》0.05),阿立哌唑组显效率93.9%,利培酮组显效率96.8%,阿立哌唑与利培酮治疗精神分裂症均有较好的疗效,对治疗精神分裂症的阳性及阴性症状均有良好的效果,阿立哌唑的不良反应小.结论:阿立哌唑治疗精神分裂症的疗效与利培酮相当,但不良反应较利培酮少.     

阿立哌唑与利培酮治疗精神分裂症的对照研究

目的评价阿立哌唑与利培酮治疗精神分裂症的疗效及安全性。方法阿立哌唑组50例,剂量范围10~30mg/d;利培酮组48例,剂量范围4~6mg/d,两组均以PANSS、CGI量表及TESS、RSESE量表评定观察6周。结果阿立哌唑组治疗精神分裂症与利培酮组相比总体疗效相当。阿立哌唑组PANSS-阴性因子项目减分在第4周末(t=1.89,P<0.05)及6周末(t=2.27,P<0.05)优于利培酮组。阿立哌唑组的药物不良反应小。结论阿立哌唑是有效且安全的非典型抗精神病药,对精神分裂症阴性阳性症状均有效。     

阿立哌唑与利培酮对女性精神分裂症患者催乳素水平及体质量的影响

目的：探讨阿立哌唑与利培酮对女性精神分裂症患者催乳素（PROL ）水平和体质量的影响及其与临床疗效的关系。方法选取120例女性精神分裂症患者,采用随机对照研究,随机分为阿立哌唑组60例,利培酮组60例,分别给予阿立哌唑和利培酮治疗6个月,在治疗前及治疗后1、3、6个月末采用阳性与阴性症状量表（PANSS）及治疗中出现的症状量表（T ESS ）对2组进行临床疗效和不良反应评定,采用贝克曼全自动微粒子化学发光分析仪进行血清催乳素水平测定。结果2组PANSS各项评分及临床有效率差异无统计学意义（P＞0.05）;阿立哌唑组在PROL水平改变及体质量增加方面优于利培酮组（ P＜0.05或0.01）,泌乳、月经紊乱及闭经明显少于利培酮组。结论阿立哌唑与利培酮两药治疗女性精神分裂症均有较好疗效,阿立哌唑对女性内分泌影响较小,更适合于女性患者临床应用。     

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.     

阿立哌唑与利培酮对血清催乳素及体质量的影响

目的:比较阿立哌唑与利培酮治疗女性首发精神分裂症的疗效及对血清催乳素(PRL)水平及体质量的影响. 方法:70例女性首发精神分裂症患者分为阿立哌唑组和利培酮组,每组35例.分别给予阿立哌唑和利培酮治疗8周.以阳性与阴性症状量表(PANSS)及治疗中出现的症状量表(TESS)评估疗效和不良反应,同时检测两组的血清PRL水平. 结果:两组间PANSS各项评分及临床有效率差异无显著性(P>0.05);阿立哌唑组在PRL水平改变及体质量增加方面优于利培酮组(P<0.05或P<0.01),泌乳、月经紊乱明显少于利培酮组. 结论:两药治疗女性精神分裂症均有较好疗效,以阿立哌唑对内分泌影响较小,更适合于女性患者.     

阿立哌唑治疗利培酮所致精神分裂症女性患者高催乳素血症的研究

目的 探讨阿立哌唑治疗利培酮所致女性患者高催乳素血症的疗效及安全性.方法 117例利培酮所致高催乳素血症的女性患者,随机分为治疗组(60例)和对照组(57例).维持原有利培酮治疗不变,治疗组加用阿立哌唑5 mg,对照组加用安慰剂治疗,疗程均为6周.于治疗第0,6周末检测催乳素,评定简明精神病量表(BPRS)、治疗中需处理的不良反应症状量表(TESS).结果 (1)治疗第6周末,治疗组催乳素[(26±6)μg/L]较基线[(112±40)μg/L]下降,差异有统计学意义(P=0.000);对照组催乳素[(99±44)μg/L]与基线[(104±34)μg/L]比较,差异无统计学意义(P=0.180).(2)治疗第6周末,治疗组催乳素下降率[(75±8)%]、正常率(82%),均高于对照组[分别为(5+30)%,4%];P均=0.000.(3)治疗第6周末,治疗组[(20.4±2.1)分]、对照组[(20.8±1.9)分]BPRS评分均较基线[分别为(21.1±1.8)分,(21.4±1.9)分]下降,P均=0.045;两组不良反应发生率相近(P=0.553).结论 阿立哌唑治疗利培酮所致精神分裂症女性患者的血高催乳症有效、安全.     

阿立哌唑与利培酮治疗精神分裂症对照研究

目的:比较阿立哌唑与利培酮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平分为两组。阿立哌唑剂量为10~30mg/d,利培酮为2~6mg/d。疗程8周。采用阳性与阴性症状量表(PANSS)评定疗效,采用副反应量表(TESS)评定不良反应。结果:阿立哌唑组有效率为66.7%,利培酮组为70·0%,两组差异无显著性。阿立哌唑组的不良反应较利培酮组少,其中震颤、静坐不能、肌强直等发生率显著少于利培酮组。结论:阿立哌唑与利培酮治疗精神分裂症的疗效相当,某些不良反应较利培酮组轻而少。     

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首发精神分裂症的临床疗效及安全性。方法:将首发精神分裂症患者100例随机分为阿立哌唑组与利培酮组,疗程8周。采用阳性与阴性症状量表(PANSS)及副反应量表(TESS)评定疗效与不良反应。结果:阿立哌唑组与利培酮组的有效率分别为84.1%和88.9%,两组间治疗前后PANSS评分差异均无显著性(P>0.05),而不良反应发生率阿立哌唑组显著低于利培酮组(P<0.05)。结论:阿立哌唑与利培酮对精神分裂症疗效相当,不良反应发生率低,是一种安全有效的抗精神病药物。     

Aripiprazole,an antipsychotic with a novel mechanism of action,and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder

BACKGROUND: Aripiprazole is a dopamine D2 receptor partial agonist with partial agonist activity at serotonin 5HT1A receptors and antagonist activity at 5HT2A receptors. This multicenter trial examined the efficacy, safety, and tolerability of aripiprazole in patients with acute exacerbation of schizophrenia or schizoaffective disorder. METHODS: In this 4-week double-blind study, 404 patients were randomized to 20 mg/d (n = 101) or 30 mg/d (n = 101) of aripiprazole, placebo (n = 103), or 6 mg/d of risperidone (n = 99). Efficacy assessments included Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression scores. Safety and tolerability evaluations included extrapyramidal symptoms and effects on weight, prolactin, and corrected QT (QTc) interval. RESULTS: Aripiprazole (20 and 30 mg/d) and risperidone (6 mg/d) were significantly better than placebo on all efficacy measures. Separation from placebo occurred at week 1 for PANSS total and positive scores with aripiprazole and risperidone and for PANSS negative scores with aripiprazole. There were no significant differences between aripiprazole and placebo in mean change from baseline in the extrapyramidal symptom rating scales. Mean prolactin levels decreased with aripiprazole but significantly increased 5-fold with risperidone. Mean change in QTc interval did not differ significantly from placebo with any active treatment group. Aripiprazole and risperidone groups showed a similar low incidence of clinically significant weight gain. CONCLUSIONS: Aripiprazole is effective, safe, and well tolerated for the positive and negative symptoms in schizophrenia and schizoaffective disorder. It is the first non-D2 receptor antagonist with clear antipsychotic effects and represents a novel treatment development for psychotic disorders.     

A randomized, double-blind, placebo-controlled, study of the efficacy and safety of aripiprazole 10, 15 or 20 mg/day for the treatment of patients with acute exacerbations of schizophrenia

This double-blind, multicenter study aimed to investigate the efficacy and safety of aripiprazole 10, 15 or 20 mg/day versus placebo. Patients requiring inpatient hospitalization for acute exacerbation of schizophrenia were randomized to once-daily aripiprazole 10, 15 or 20 mg/day or placebo for 6 weeks. The primary efficacy outcome was the mean change from baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total score (last observation carried forward). Patients with no improvement by Week 3 (Clinical Global Impression-Global Improvement score > or =4) could transfer to open-label aripiprazole 20mg/day. In total, 420 patients were randomized to placebo (n = 108); aripiprazole 10 mg/day (n = 106); 15 mg/day (n = 106); or 20 mg/day (n = 100). Of these, 142 patients (34%) completed 6 weeks of treatment, 131 (31%) discontinued to receive open-label aripiprazole, and 147 (35%) for other reasons. Aripiprazole 10, 15 and 20 mg/day each showed significantly greater improvements from baseline than placebo for all efficacy measures, including PANSS Total, Positive and Negative scores, and the CGI-Severity of Illness score. Significantly greater improvements in PANSS Total score versus placebo were achieved by Week 1 with 10 or 20 mg/day and Week 3 with 15 mg/day. All three doses were well tolerated. Overall, aripiprazole was not associated with clinically meaningful differences in extrapyramidal symptoms, prolactin or weight changes versus placebo. Aripiprazole 10 mg/day is effective and well tolerated for patients experiencing an acute exacerbation of schizophrenia.     

阿立哌唑与利培酮治疗精神分裂症对照研究

目的：比较阿立哌唑与利培酮对精神分裂症的疗效及安全性。方法：选取70例精神分裂症患者,随机分为阿立哌唑组36例,利培酮组34例,分别给予阿立哌唑和利培酮治疗,疗程8周。在治疗前及治疗1、2、4、6、8周末分别采用阳性与阴性症状量表（PANSS）、治疗中出现的症状量表（TESS）对两组进行评定。并于治疗前、中、后检查催乳素水平。结果：两组治疗后PANSS评分均有显著下降。阿立哌唑组的锥体外系不良反应、体质量增加及月经失调均较利培酮组少而轻,对催乳素水平没有影响。结论：2药对精神分裂症均有较好的疗效,起效快,不良反应小。     

阿立哌唑与利培酮治疗儿童青少年精神分裂症的对照研究

目的比较阿立哌唑与利培酮治疗儿童青少年精神分裂症的疗效和安全性。方法对120例儿童青少年精神分裂症的住院患者随机分为两组,分别用阿立哌唑与利培酮治疗8周。采用阳性、阴性症状量表(PAN-SS)、临床总体印象量表(CGI)评定疗效,用不良反应量表(TESS)评定不良反应。结果阿立哌唑治疗儿童青少年精神分裂症的疗效与利培酮相似,两组疗效无显著性差异,阿立哌唑组不良反应显著少于利培酮。结论阿立哌唑是一种安全有效、见效快、不良反应轻的治疗儿童青少年精神分裂症的药物。     

阿立哌唑、利培酮及氯丙嗪对精神分裂症疗效及认知功能的影响

目的探讨非经典抗精神病药阿立哌唑、利培酮及传统抗精神病药氯丙嗪治疗精神分裂症的疗效及对认知功能的影响。方法将148例符合CCMD-3诊断标准的精神分裂症病人随机分为阿立哌唑组（48例）、利培酮组（52例）和氯丙嗪组（48例），观察12周，分别于治疗前及治疗后4、8、12周采用阳性症状与阴性症状量表（PANSS）、不良反应量表（TESS）评定疗效和不良反应；治疗前及治疗后12周采用韦氏成人记忆测检（WMS）及威斯康星卡片分类测验（WCST）测定。结果与治疗前比较，三组治疗后12周PANSS总分及各因子分显著下降（P〈0．01），但三组之间无显著差异；利培酮、氯丙嗪组的不良反应发生率高于阿立哌唑组（P〈0．05），主要表现为肌强直、震颤等锥体外系等不良反应；阿立哌唑、利培酮组WMS和WCST评分均有显著改善，而氯丙嗪组治疗前后则无差异。结论阿立哌唑、利培酮及氯丙嗪治疗精神分裂症均有效，且疗效相当，阿立哌唑所致锥体外系不良反应较少，阿立哌唑、利培酮对认知功能有改善作用，而氯丙嗪则对认知功能无影响。     

阿立哌唑与利培酮治疗晚发精神分裂症对照研究

目的:比较阿立哌唑与利培酮治疗晚发精神分裂症患者的临床疗效和安全性。方法:对52例晚发精神分裂症住院患者随机分为两组,分别用阿立哌唑和利培酮治疗6周。采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)评定不良反应。结果:阿立哌唑与利培酮治疗晚发精神分裂症患者的临床疗效差异无显著性。两组不良反应少而轻。结论:阿立哌唑治疗晚发精神分裂症疗效好,起效快,不良反应少。     

阿立哌唑与利培酮治疗精神分裂症的对照研究

目的比较阿立哌唑与利培酮治疗精神分裂症患者的疗效、不良反应及生活质量的影响。方法将68例精神分裂症患者,随机分为阿立哌唑组（研究组）和利培酮组（对照组）,每组34例,分别给予阿立哌唑与利培酮治疗8周,采用阳性和阴性综合征量表（PANSS）评定疗效,治疗中需处理的不良反应症状量表（TESS）评定不良反应,以生活质量综合评定问卷（GQOLI-74）评定生活质量。结果两组治疗后第4、8周末PANSS量表总分及各因子分与治疗前比较均显著降低（P〈0．01）。两组不良反应均较轻微,研究组不良反应发生率61．8％,对照组不良反应发生率70．6％,两组不良反应总发生率差异无统计学意义（P〉0．05）。研究组不良反应主要为失眠,且多于对照组（P〈0．05）,对照组在口干、静坐不能、肌强直、体质量增加、泌乳、月经异常、血糖升高不良反应方面多于研究组（P〈0．05,P〈0．01）。治疗后第8周末与治疗前比较两组GQOLI-74总分、躯体健康、心理健康及社会功能均显著升高（P〈0．01）。结论阿立哌唑与利培酮治疗精神分裂症疗效相当,不良反应小,均可提高患者生活质量。     

Sarcosine or D-serine add-on treatment for acute exacerbation of schizophrenia: a randomized, double-blind, placebo-controlled study

CONTEXT: Agents that enhance N-methyl-D-aspartate (NMDA) function through the glycine modulatory site (D-serine, glycine, or D-cycloserine) or through glycine transporter 1 (sarcosine) improve the symptoms of patients with stable chronic schizophrenia. OBJECTIVE: To determine whether NMDA-glycine site agonists or glycine transporter-1 inhibitors have better efficacy and whether NMDA receptor-enhancing agents have beneficial effects for acute exacerbation of schizophrenia. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Inpatient units of 2 major medical centers in Taiwan.Patients Sixty-five schizophrenic inpatients with acute exacerbation. INTERVENTIONS: Six weeks of treatment with sarcosine (2 g/d), D-serine (2 g/d), or placebo and concomitant optimal risperidone therapy. MAIN OUTCOME MEASURES: Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) (20 and 17 items) total scores. RESULTS: The sarcosine group revealed more reductions in PANSS total scores than the placebo (P = .04) and D-serine (P<.001) groups. Sarcosine adjunctive treatment was also superior to placebo in reducing SANS-20 (P = .007) and SANS-17 (P = .003) scores and to D-serine in decreasing SANS-20 (P = .006) and SANS-17 (P = .002) scores. The PANSS-general, PANSS-cognitive, and PANSS-depressive symptoms scores and SANS-alogia and SANS-blunted affect scores improved significantly more in sarcosine-cotreated patients than in risperidone monotherapy patients (P< or =.02 for all). Sarcosine adjunctive therapy also surpassed D-serine in terms of PANSS-general, PANSS-positive, PANSS-negative, and PANSS-depressive symptoms scores (P< or =.04 for all). D-serine and risperidone cotreatment did not differ significantly from risperidone monotherapy in all efficacy domains. CONCLUSIONS: This first short-term treatment study on NMDA receptor-enhancing agents suggests that sarcosine, superior to D-serine, can benefit not only patients with long-term stable disease but also acutely ill persons with schizophrenia. This finding indicates that a glycine transporter 1 inhibitor may be more efficacious than NMDA-glycine site agonists for adjuvant treatment of schizophrenia, at least during the acute phase. Further studies are needed.     

Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, double-blind, multicenter trial

BACKGROUND: More head-to-head comparisons of antipsychotics are needed to discern the relative efficacy and safety profiles of these compounds. Thus, we compared ziprasidone and risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder. METHOD: Patients with DSM-III-R acute exacerbation of schizophrenia or schizoaffective disorder were randomly assigned to double-blind ziprasidone 40 to 80 mg b.i.d. (N = 149) or risperidone 3 to 5 mg b.i.d (N = 147) for 8 weeks. Primary efficacy measures included Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness scale (CGI-S) score; secondary measures included scores on the PANSS negative sub-scale, CGI-Improvement scale (CGI-I), and PANSS-derived Brief Psychiatric Rating Scale (BPRSd) total and core items. Safety assessments included movement disorder evaluations, laboratory tests, electrocardiography, vital signs, and body weight. Efficacy analyses employed a prospectively defined Evaluable Patients cohort. Treatment equivalence was conferred if the lower limit of the 95% confidence interval of the ziprasidone/risperidone ratio of least-squares mean change from baseline was > 0.60. Data were gathered from August 1995 to January 1997. RESULTS: Equivalence was demonstrated in PANSS total scores, CGI-S scores, PANSS negative subscale scores, BPRSd total and core item scores, and PANSS total and CGI-I responder rates. Both agents were well tolerated. Risperidone exhibited a significantly higher Movement Disorder Burden (MDB) score (p < .05) and higher incidences of prolactin elevation and clinically relevant weight gain. However, compared with current recommendations, study dosing may have been high for some risperidone-treated patients (mean dose = 7.4 mg/day) and low for some ziprasidone-treated patients (mean dose = 114.2 mg/day). CONCLUSION: Both agents equally improved psychotic symptoms, and both were generally well tolerated, with ziprasidone demonstrating a lower MDB score and less effect on prolactin and weight than risperidone.