利培酮和氯丙嗪治疗首发精神分裂症的1年随访

One Year Follow-up Study:Risperidone and Chlorpromazine for Patients with First-episode Schizophrenia

目的:比较氯丙嗪和利培酮长期治疗首发精神分裂症的疗效、不良反应及依从性。方法:采用自然性观察研究方法,结合全病程管理模式对研究对象进行随访观察。研究对象符合ICD-10精神分裂症或分裂样精神障碍研究用诊断标准.年龄16～60岁,阳性和阴性症状评定量表(positive and negative symptom scale,PANSS)总分≥60,首次发病或首次来诊,总病程≤5年。研究中主要用PANSS评估疗效:副反应量表(treatment emergent symptom scale,TESS)评估治疗的不良反应;根据持续用药时间评估依从性;以健康状况调查问卷(SF-36)评估生命质量。结果:将PANSS减分率≥50%作为治疗有效。利培酮组第2、3、6、8、12个月时有效率分别为40.5%、46.6%、57.3%、64.1%、62.6%,氯丙嗪组的有效率分别为29.1%、41.8%、50.9%、50.9%、56.4%,两组无显著差异。经Ridit分析,利培酮组发生震颤、便秘、流涎的不良反应少于氯丙嗪组,而发生兴备激越、情感忧郁、失眠、恶心呕吐腹泻、月经紊乱的不良反应多于氟丙嗪组。利培酮组持续治疗时间平均为9.5±3.8个月,氯丙嗪组为8.9±3.8个月,两组间无显著差异。利培酮组终点时躯体角色功能、躯体疼痛、总体健康、社会功能、情绪角色功能和心理健康等生命质量的6个因子分显著高于相应的基线分,而氯丙嗪组仅社会功能和情绪角色功能2个因子分显著高于相应的基线分。结论:利培酮与氯丙嗪治疗首发精神分裂症是同样有效的。但两组的不良反应发生情况有所不同。与氯丙嗪相比,利培酮更能在多方面改善患者的生命质量。

Objective：To compare the efficacy and safety of risperidone and chlorpromazine in treatment of first-episode schizo phrenia. Methods：It is a one year naturalistic study. One hundred and eighty-six patients with first episode of schizophrenia were included who met ICD-10 criteria for schizophrenia or schizophreniform disorder and received integrated treatment （risper idone or ehlorpromazine plus psychosocial education, family psycho education）. There were 131 patients included in the risperidone group and 55 included in the chlorpromazine group. Written informed consent was obtained from the patients or their legal guardians. Clinical status was assessed with the Positive and Negative Symptom Scale （PANSS）, the Treatment Emergent Symptom Scale （TESS） and the time to the discontinuation of treatment. The Short Form-36 （sf-36） was used to assess the quality of life. Results： Thirty - five percent in the rieperdone group partially completed follow-up assessments and 51%in the chlorpromazine group did, the difference of the rates between the two groups was significant. Response rate was defined as improvement in PANSS total score of ≥50%. The response rates at the end of 2, 3, 6, 8, 12 months in the risperidone group were 29. 1%, 41.8%, 50.9%, 50.9%, 56.4% and in the chlorpromazine group were 40.5%,46.6 %, 57. 3 %, 64.1%, 62.6 %, respectively. There was no significant difference of the response rate at any of the follow-up time between the two groups. The relapse rates were similar as 20. 2% in the risperidone group and 20. 6% in the comparing group. The time to the discontinuation of treatment for any cause was longer in the risperidone group than in the chlorpromazine group, However, the difference was not significant. Risperidone was associated with lower symptoms of tremor, constipation, sialorrhea （ P〈0.01 ） and also associated with more frequent reports of agitation, depression, insomnia, gastrointestinal disturbance, menstrual disorder （ P〈0.05）. There are significant improvements in 6 factors （role of physics, body pain, globe health, social function, role of emotion and mental health） of sf-36 in risperidone group and only 2 factors （social function, role of emotion） in the comparative group. Conclusion：The efficacy of risperidone is as same as that of chlorpromazine in the treatment of first-episode schizophrenia, yet the rates of some adverse events are different in the two groups and risperidone may enhance the quality of life from more aspects.