盐酸哌罗匹隆治疗女性精神分裂症对照研究

A control study of perospirone hydrochloride in the treatment of female schizophrenia

目的探讨盐酸哌罗匹隆治疗女性精神分裂症的临床疗效和安全性。方法将60例女性精神分裂症患者随机分为两组，每组30例，研究组口服盐酸哌罗匹隆治疗，对照组口服利培酮治疗，观察8周。于治疗前及治疗第2周、4周、6周、8周末采用阳性与阴性症状量表评定临床疗效，副反应量表评定不良反应。结果治疗后两组阳性与阴性症状量表总分及各因子分均较治疗前有显著下降（P〈0.01），同期两组评分比较差异均无显著性（P〉0.05）。治疗8周末，研究组显效率80．0％、总有效率93．3％，对照组分别为86．7％、90．0％，两组比较差异无显著性（χ^2=0．48、0．22，P〉0．05）。两组不良反应均轻微，研究组不良反应发生率为30．0％，对照组为36．7％，两组比较差异无显著性（χ^2=0．30，P〉0．05），但研究组内分泌方面改变（月经改变、泌乳、体质量增加等）发生率显著低于对照组（P〈0.05）。结论盐酸哌罗匹隆治疗女性精神分裂症疗效显著且与利培酮相当，安全性更高，依从性更好。

Objective To explore the efficacy and safety of perospirone hydrochloride in the treatment of female schizophrenia. Methods Sixty female schizophrenics were randomly assigned to two groups of 30 patients each, research group took orally perospirone hydrochloride and control group did risperidone for 8 weeks. Efficaeies were assessed with the Positive and Negative Syndrome Scale （PANSS） at baseline and at the end of the 2^nd, 4^th, 6^th and 8^th week and adverse reactions with the Treatment Emergent Symptom Scale （TESS）. Results After treatment the total and each factor scores of both groups lowered more significantly compared with pretreatment （P〈0.01）, there were no significant group differences in scores （P〈0.05）. At the end of the 8^th week, obvious and total effective rate were respectively 80. 0% and 93.3% in research and 86.7% and 90.0% in control group, which showed no significant differences （χ^2= 0.48, 0.22, P〉0.05）. Adverse reactions of both groups were mild, incidences of adverse reactions respectively 30.0% in research and 36.7% in control group which showed no significant differences （χ^2= 0.30, P〉0.05）, but incidences of endocrine changes （menstrual changes, lactation, increased body weight etc. ） were significantly lower in the former than in the latter （P〈0.05）. Conclusion Perospirone hydrochloride has an evident effect equivalent to risperidone, higher safety and better compliance in the treatment of female schizophrenia.