国产奎硫平与氯氮平治疗慢性精神分裂症的随机对照研究

A randomized trial of clozaphine and domestic quetiapine for chronic schizophrenic patients

目的比较氯氮平与国产奎硫平(奎的平)治疗慢性精神分裂症的疗效及安全性.方法将83例慢性精神分裂症患者随机分为奎的平组(42例)和氯氮平(41例),两药治疗量均为200～600mg/d,疗程为12周.疗效指标包括阳性和阴性症状量表(PANSS)、简明精神病评定量表(BPRS);不良反应指标为治疗时出现的不良反应量表(TESS)及有关实验室检查.结果治疗结束时,两组PANSS和BPRS评分较入组时均有显著减低(P＜0.01);PANSS减分率:奎的平组为(63.4±24.7)%,氯氮平组为(64.7±23.1)%;临床总有效率:奎的平组为68.1%,氯氮平组为69.6%;两组疗效差异无显著性.奎的平组的不良反应较氯氮平少,其中活动减少、便秘、流涎、头晕、体位性低血压的发生率显著少于氯氮平组(P＜0.01或0.05).结论国产奎的平治疗慢性精神分裂症的疗效与氯氮平相似,某些不良反应较氯氮平轻而少;是一种相对安全、有效的抗精神病药,对慢性精神分裂症患者的康复及防止衰退均有积极的意义.

OBJECTIVE To compare the efficacy and safety of clozapine and quetiapine in treating chronic schizophrenic patients. METHODS Patients who met CCMD-3 criteria for chronic schizophrenia were randomly assigned into two group： quetiapine group （n =42） and clozapine group （n =41 ）. The range of the two experiment drugs was 200 -600mg/d, the treatment duration was 12 weeks. The PANSS, BPRS, TESS and related lab tests were employed for assessing the effectiveness and side effects. RESULTS At the end of treatments, the scores of PANSS and BPRS in both treatment groups decreased significantly compared with baseline （ P 〈 0.01 ）, and the decreasing rates on PANSS were （63.4 ±24.7）% in quetiapine group and （64.7 ± 23.1 ） % in clozapine group. Total clinical effective rates were 68.1% in quetiapine group and 69.6% in clozapine group, which was no significant difference between two groups. However, patients in quetiapine group reported much fewer side effects than those in clozapine group, especially in the items of reduced activities, constipation, sialorrhea, dizziness and low blood pressure on TESS （P 〈 0. 01 or P 〈 0. 05）. CONCLUSION Qutiapine has similar efficacy to clozapine , but has less side effects. Qutiapine is an effective antipsychotic drug with fewer side effects, and significant to rehabilitation and antideterioration of chronic schizophrenic patients.