阿立哌唑和利培酮治疗首发精神分裂症的对照研究

目的:以利培酮为对照,探讨阿立哌唑治疗首发精神分裂症疗效和不良反应。方法:将符合CCMD-3精神分裂症诊断标准的60例患者随机分为阿立哌唑组和利培酮组进行治疗,分别在治疗0、2、4、8周末评定PANSS和TESS量表,在0、4、8周末检查心、脑电图和肝、肾功能。在0、8周末检查血催乳素和空腹血糖。结果:利培酮组锥体外系不良反应和内分泌改变的发生均明显高于阿立哌唑组。结论:阿立哌唑对首发精神分裂症患者的疗效与利培酮相当,不良反应较小。     

阿立哌唑在治疗抗精神病药物所致糖尿病13例的安全性研究

目的：评估阿立哌唑在抗精神病药物所致的糖尿病精神分裂症治疗中的风险。方法：将抗精神病药物所致的糖尿病27例精神分裂症患者随机分为两组,阿立哌唑＋降糖药物组、氟哌啶醇＋降糖药物组,治疗观察期均为12个月。两组患者均在入组治疗前进行1～2月的药物调整,调整后血糖（OGTT、FBG）仍异常者,并且符合1990年中国糖尿病学会诊断标准者。入组后每月末测定空腹血糖、身高、体重、腰围、计算体质量指数（BM I）并进行比较。结果：阿立哌唑＋降糖药物组和氟哌啶醇＋降糖药物组患者治疗后的空腹血糖、体质量、腰围、体重均低于治疗前（P〈0.05）,阿立哌唑组空腹血糖、体质量、腰围、体重各项减分率明显大于氟哌啶醇组,降糖药物平均剂量也低于氟哌啶醇组,没有出现因血糖升高而终止治疗者,阿立哌唑组的生活质量和依从性优于氟哌啶醇组。结论：阿立哌唑＋降糖药物与氟哌啶醇＋降糖药物均能有效减轻抗精神药物所致糖尿病病情,阿立哌唑＋降糖药物的疗效优于氟哌啶醇＋降糖药物组。氟哌啶醇＋降糖药物仍不失有效的治疗方法,但在这部分患者治疗中有出现血糖升高现象,需要对血糖严格监测和及时调整治疗方案。     

Effects of novel antipsychotics,amisulpiride and aripiprazole,on maternal behavior in rats

Rationale Rat maternal behavior, which entails complex motivational and social factors, is disrupted by the currently available typical and atypical antipsychotics. It is thought that this disruption reflects a side effect of antipsychotics, modeling the neuroleptic-induced negative or deficit state. Amisulpiride and aripiprazole are new atypical antipsychotics with mechanisms of action distinct from the current typical and atypical antipsychotics. The effects of these drugs on maternal behavior have not been explored. Objective In the present study, we systematically examined the behavioral effects of amisulpiride and aripiprazole on maternal behavior in postpartum female rats. Methods Various components of maternal behavior (pup retrieval, pup licking, nest building and pup nursing) were examined repeatedly over a period of 24 h after a single injection of three doses of amisulpiride (10, 30, and 100 mg/kg s.c.) and aripiprazole (3, 10, and 30 mg/kg). Results Amisulpiride at the lower doses (10 and 30 mg/kg) enhanced pup licking, and only at the highest dose disrupted the active components of maternal behavior such as pup retrieval and nest building. Its effect was delayed in onset and prolonged as compared to other antipsychotics. Aripiprazole, even at the highest dose (30 mg/kg) did not impair pup retrieval or pup licking. However, it did disrupt nest building and led to enhanced pup nursing. Conclusions The unique effects of these two drugs may be due to their unique actions at the mesolimbic dopamine synapses. The sparing of the major components of maternal behavior by aripiprazole may be related to its partial agonist effects, whereas the enhancement of pup licking by amisulpiride may be related to its dose-dependent preferential effect on the presynaptic autoreceptors. The potential clinical implications of these findings are discussed.     

阿立哌唑与利培酮治疗精神分裂症对照研究

目的 探讨阿立哌唑对首发精神分裂症患者的临床疗效及安全性。方法 46例精神分裂症患者随机分为两组，分别给予阿立哌唑与利培酮，治疗8周，用阳性与阴性症状表（PANSS）和副反应量表（TESS）评定疗效和不良反应。结果 阿立哌唑组疗效与利培酮组疗效相当，阿立哌唑不良反应亦不多于利培酮。结论 阿立哌唑是一种安全有效的抗精神病药。     

Clinical Trials with a New Atypical Antipsychotic (Aripiprazole): Gender Specific Information Analysis

ABSTRACT

Introduction: In 1993, the Food and Drug Administration (FDA) published a guideline for the study and evaluation of gender-related differences in clinical trials. However, the extent of the implementation of these recommendations has not been systematically reviewed.

Objectives: To determine the proportion of women in clinical trials of Aripiprazole, a new atypical antipsychotic, and to analyze the resulting information on a gender-specific basis.

Method: A systematic review was conducted in Medline to identify randomized trials that compared this new antipsychotic drug with placebo or with typical or atypical antipsychotics in patients diagnosed with schizophrenia. The FDA Guideline was followed for the study and evaluation of gender-specific results of clinical trials.

Results: Despite the inclusion of female participants in the samples studied, the failure to conduct analyses stratified by sex prevented us from ascertaining the possible differences between men and women in the therapeutic response or in the adverse side effects of treatment with Aripiprazole.     

阿立哌唑对首发精神分裂症患者心电图的影响

目的 探讨阿立哌唑与氯氮平对首发精神分裂症患者心电图影响的差异.方法 将100例首发精神分裂症患者随机分为两组,每组50例,分别给予阿立哌唑和氯氮平治疗.于治疗前和治疗后第2、4、8周定期进行心电图检查,并对结果进行对比分析.结果 阿立哌唑和氯氮平对精神分裂症患者的心电图均有影响,但阿立哌唑组所致心电图改变发生率明显低于氯氮平组（P〈0.01）,异常程度轻,以ST-T改变和窦性心律失常为主.结论 阿立哌唑可引起心电图发生改变,但发生率低,心电图改变程度轻,安全性相对较大.     

阿立哌唑治疗晚发性分裂症的临床研究

目的 探讨阿立哌唑治疗晚发性分裂症的临床疗效和不良反应.方法 将符合CCMD-3诊断标准的72例首发未服药的晚发性分裂症患者随机分为两组,分别给予阿立哌唑和奋乃静治疗,疗程8周;采用简明精神病评定量表(BPRS)于治疗前后评定疗效,治疗中出现的不良反应量表(TESS)评定不良反应.结果 阿立哌唑与奋乃静疗效无显著性差异,阿立哌唑引致的锥体外系反应显著低于奋乃静.结论 阿立哌唑、奋乃静治疗晚发性分裂症的疗效相当,前者不良反应轻,安全性高.     

阿立哌唑与利培酮治疗精神分裂症的随机双盲多中心对照研究

目的 评价阿立哌唑治疗精神分裂症的疗效及安全性.方法 采用随机双盲多中心对照研究方法.240例精神分裂症患者随机分为:阿立哌唑组120例,剂量10～30 mg/d;利培酮组120例,剂量2～6 mg/d.疗程6周.以阳性和阴性症状量表(PANSS)总分变化和有效率为疗效指标.结果 治疗第6周末,阿立哌唑组PANSS总分从基线的85.12分降至52.26分,平均减分32.86分;利培酮组从基线的86.89分降至50.30分,平均减分36.58分;两组的差异无统计学意义(F=1.61,P=0.206).阿立哌唑组有效率为64.3%,利培酮组为68.9%,两组的差异没有统计学意义(X2=1.00,P=0.316).阿立哌唑组和利培酮组相关不良事件发生率分别为65.0%和73.3%.阿立哌唑组对体质量(F=4.535,P=0.034)和血清催乳素(F=33.576,P=0.000)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,不良反应相似;但阿立哌唑较少引起患者体质量增加,对血清催乳素水平无影响.     

阿立哌唑与利培酮治疗女性首发精神分裂症患者血浆催乳素水平的比较

目的：比较阿立哌唑与利培酮治疗女性首发精神分裂症患者的疗效和血浆催乳素水平。方法：选择接受阿立哌唑和利培酮治疗的女性首发精神分裂症患者各60例,于治疗前和治疗8周后分别评估患者PANSS量表,并检测患者血浆催乳素水平。结果：治疗8周后阿立哌唑与利培酮组相比,PANSS减分率差异无显著性（49．79±23．48vs．63．3±22．66,p〉0．05）。利培酮治疗组血浆催乳素水平变化值高于阿立哌唑治疗组（26．92±9．48vs．-25．25±8．07,P〈0．001）。利培酮治疗8周血浆催乳素水平增加与疾病严重程度、药物治疗剂量、疗效及体重变化等变量无显著相关,而与治疗前后血浆催乳素水平显著相关（r=0.41,r=0．79,p〈0．01）。结论：阿立哌唑治疗精神分裂症疗效与利培酮相当,但较少引起血浆催乳素水平变化。