喹硫平的国产与进口制剂治疗精神分裂症对照研究

A control study of domestic vs. import Quetiapine in the treatment of schizophrenia

目的：比较国产与进口喹硫平治疗精神分裂症的临床疗效及安全性。方法：将60例精神分裂症患者随机分为两组各30例，研究组口服国产喹硫平治疗，对照组口服进口喹硫平治疗，观察8w。于治疗前及治疗1、8w末采用阳性与阴性症状量表评定临床疗效，不良反应量表评定不良反应。结果：治疗8w末，研究组显效率80．0％、总有效率96．7％；对照组分别为76．7％和100％，两组显效率、总有效率比较差异均无显著性（x^2=0．981、x^2=1．017，P〉0．05）。阳性与阴性症状量表评分，两组治疗第1w末起总分均较治疗前有显著性下降（P均〈0．01），治疗8w末，总分及各因子分均显著低于治疗前（P均〈0．01）。两组不良反应均轻微，主要为轻度头昏、低血压、食欲减退等。结论：国产喹硫平治疗精神分裂症的疗效、起效时间、安全性、依从性与进口喹硫平相当。

Objective：To compare the clinical efficacy and safety of domestic vs. import Quetiapine in schizophrenia. Methods ： Sixty schizophrenias were randomly divided into research （ n = 30 ） orally took domestic Quetiapine and control group （ n = 30 ） did import Quetiapine for 8 weeks. Clinical efficacies were assessed with the Positive and Negative Symptom Scale （PANSS） and adverse reactions with the Treatment Emergent Symptom Scale （TESS）at the ends of week 1 and 8, respectively. Results： At the end of week 8, excellence and total effective rates were 80.0% and 96.7% in the research and 76.7% and 100% in the control group respectively, which showed no significant difference（ P 〉 0.05 ）. Since the end of week 1, total scores of the PANSS of both groups lowered much more significantly （both P 〈 0.01 ） , total and each factor score were very significantly lower at the end of week 8 compared with pretreatment （ all P 〈 0.01 ）. Adverse reactions of both groups were mild and mainly mild dizziness, hypotension, and anorexia and so on. Conclusions： Domestic Quetiapine is significantly effective, takes effects quicker, has higher safety and better compliance, is equivalent to import Quetiapine and may be Clinically extended as first line atypical anti psychopath.