精神分裂症患者情感及社会功能状态与泰必利的干预效应 随机双盲对照

Emotion and social function of patients with schizophrenia and the interventional effect of tiapride: A double-blind randomized control study

目的:探讨泰必利对精神分裂症阴性症状的干预效应及其安全性,并与经典药物奎的平随机盲法比较。方法:选择2004-03/2005-03在惠州市第二人民医院精神科精神分裂症住院的患者60例,简明精神症状量表总分>30分,阴性症状量表总分>35分。①随机分为2组,泰必利组与奎的平组,每组30例,患者家属知情同意。②随机用药选择:由药房工作人员将泰必利和奎的平分别研成粉末装入Ⅰ号和Ⅱ号胶囊,剂型分为100mg和25mg。医患双方盲式用药。初始剂量25mg,早晚各1次,以后隔日增加50mg,每日剂量范围300～550mg。③效果评估:使用阴性症状量表评定用药前后疗效及阴性症状改善情况,使用副反应量表评价药物的安全性。分别于治疗前、用药后第2,4,8周末各评分一次。同时进行实验室检查,包括肝功能、心电图、肾功能、血糖、电解质、血常规、尿常规、血压、体质量等,在治疗前、治疗第4周末及第8周末治疗结束时各检查1次。④疗效评估标准:阴性症状量表减分率≥75%为症状消失,50%～74%为显著进步,25%～49%为好转,<25%为无效。减分率计算公式为(治疗前分-治疗后分)/治疗前分×100%。根据资料数据性质进行检验。实验过程为双盲。结果:60例患者全部完成实验,进入结果分析。①两组疗效评价:泰必利组症状消失4例,显效14例,进步6例,无效6例,显效率80%;奎的平组症状消失6例,显效15例,进步4例,无效5例,显效率83%,两组疗效接近(χ2=0.925,P>0.05)。②两组阴性症状量表评定结果:治疗前两组间无差异,说明两组患者严重程度一致,具有可比性。两组治疗前与治疗后总分值自身比较差异均具有极显著性意义(P<0.01),提示两药对精神分裂症阴性症状均有效,能明显地改善精神分裂症阴性症状。两组在治疗第4周末和第8周末情感平淡、思维贫乏、意志缺乏、兴趣/社交缺乏、注意障碍和总分比较差异均无统计学意义(P>0.05),说明两药在总的治疗阴性症状方面疗效相近。③两组副反应量表评定:奎的平组治疗后2,4,8周末行为毒性及心血管系统均显著大于泰必利组,差异显著。而神经系统和植物神经系统差异不显著(P>0.05)。但泰必利组有2例溢乳,而奎的平组无。结论:实验结束时间为2个月,结果说明泰必利对精神分裂的阴性症状患者治疗效果与奎的平相似,毒性和心血管副反应比奎的平小,是一种安全有效的非典型抗精神病药物。

AIM： To investigate the interventional effect of tiapride on the negative symptoms of schizophrenia and its safety, and compare with the typical medicine of quetiapine in a blind and randomized manner. METHODS： Sixty inpatients with schizophrenia in the Department of Psychiatry, Huizhou Second People＇s Hospital between March 2004 and March 2005 participated in the study, their total score of brief psychiatric rating scale 〉 30 points, and the total score of scale for the assessment of negative symptoms 〉 35 points. ① The patients were divided randomly into tiapride group （n=30） and quetiapine group （n=30）, they were involved in the study with the permission of their relatives. ② Random selection of medicine： tiapride and quetiapine were ground into powder and then put into capsule Ⅰ （100 rag） and capsule Ⅱ （25 mg） respectively, the medicine was given double-blindly for beth the physicians and patients. The initial dosage was 25 mg, taken once in the morning and evening respectively, and then 50 mg was added every other day, the daily dosage ranged 300 to 550 mg. ③ The curative effect and amelioration of negative symptoms before and after medication were evaluated with the scale for the assessment of negative symptoms respectively, and the safety of the medicines was evaluated with the treatment emergent symptom scale respectively. They were assessed before treatment and at the ends of the 2^nd, 4^th and 8^th weeks respectively, and they also received laboratory tests, including liver function, electrocardiogram, renal function, blood glucose, electrolure, blood routine, urine routine, blood pressure and body mass before treatment and at the ends of the 4^th and 8^th weeks. ④ evaluation standard of the curative effect： the decrease rate of score of the scale for the assessment of negative symptoms ≥ 75% was taken as disappearance of symptoms, 50% to 74% as significantly improvement, 25% to 49% as turned to better, 〉 25% as invalid. The calculative formula for the decreasing rate of score was （the score before treatment-the score after treatment）/the score before treatment ×100% .The data were tested according to the quality double-blindly. RESULTS：① Evaluation of the curative effects in beth groups： In the tiapride group, the disappearance of symptoms was observed in 4 cases, significant improvement in 14 cases, improvement in 6 cases and invalid in 6 cases, the rate of significant effect was 80%; In the quetiapine group, the disappearance of symptoms was observed in 6 cases, significant improvement in 15 cases, improvement in 4 cases and invalid in 5 cases, the rate of significant effect was 83%; The curative effects in the two groups were close （X^2=0.925, P 〉 0.05）. ② The results of the scale for the assessment of negative symptoms： There were insignificant differences between the two groups before treatment, indicating that the severity was concordant in the two groups, which were comparable. The total scores were very significantly different before and after treatment in both groups （P 〈 0.01）, it was indicated that both of the two medicine had effects on the negative symptoms of schizophrenia, could obviously ameliorate the negative symptoms of schizophrenia. There were insignificant differences in the scores of flat affect, poverty of thought, abulia, interest/social communication deficiencies and disturbance of attention and the total score between the two groups at the ends of the 4th and 8th weeks （P 〉 0.05）, it was suggested that the total curative effects of the two medicine on negative symptoms were close. ③ Evaluation of treatment emergent symptom scale： The scores of behavioral toxicity and cardiovascular system were all significantly higher in the quetiapine group than in the tiapride group at the ends of the 2nd, 4th and 8th groups after treatment, but the scores of nerve system and antagonistic system were not significantly different （P 〉 0.05）. Spillage of milk was observed in 2 cases in the tiapride group, but not observed in the quetiapine group. CONCLUSION： The study was completed after 2 months, the results indicate that tiapride has the similar curative effects as quetiapine on the negative symptoms of patients with schizophrenia, its toxicity and cardiovascular side effects are milder than those of quetiapine, so it is a kind of safe and effective atypical antipsychotic drug.