帕利哌酮缓释片和利培酮片治疗首发精神分裂症的疗效和安全性开放性观察对照研究

王崴等

[摘要] 目的 评价帕利哌酮缓释片和利培酮片治疗首发精神分裂症的疗效和安全性。方法 选取56例首发精神分裂症患者为观察对象，并将其分为研究组和对照组各28例。分别给予帕利哌酮缓释片和利培酮片剂治疗，并于治疗前和治疗后的第1、2、4和8周采用阳性与阴性症状量表（PANSS）评定疗效，副反应量表（TESS）评定不良反应。 结果 两组患者治疗后阳性和阴性症状量表总分及各因子分均较治疗前下降，差异有统计学意义（P<0.01）；研究组治疗2周末的PANSS总分及2、4、8周的PANSS阴性评分低于对照组，差异有统计学意义（P<0.01）；两组患者8周末临床治疗总有效率分别为78.6%和71.4%，差异无统计学意义（P>0.05）；两组患者不良反应发生率差异有统计学意义（P<0.05）。 结论 帕利哌酮缓释片对精神分裂症疾病治疗效果确定，尤其是在早期显效和改善阴性症状方面优于利培酮，且安全性更好。

[关键词] 帕利哌酮缓释片；利培酮；首发精神分裂症

[中图分类号] R749 [文献标识码] A [文章编号] 1674-0742（2014）06（b）-0016-03

[Abstract] Objective To evaluate the efficacy and safety of paliperidone extended-release tablets and risperidone tablets in the treatment of first-episode schizophrenia. Methods 56 cases of first-episode schizophrenia patients were selected as the subjects and divided into study group and the control group with 28 cases in each， and the two groups were given paliperidone extended-release tablets and risperidone tablets treatment， respectively. Positive and Negative Syndrome Scale （PANSS） was used to assess the efficacy before the treatment and at 1， 2， 4， 8 weeks after the treatment； Treatment Emergent Symptom Scale（TESS） was used to evaluate the adverse reactions. Results After treatment， the PANSS total scores and factor scores of both groups of patients were lower than those before treatment， the differences were statistically significant（P<0.01）；the PANSS total score 2 weeks after the treatment and the PANSS negative score 2，4，8 weeks after the treatment of the study group were lower than those of the control group， the differences were statistically significant（P<0.01）； the clinical total effective rate 8 weeks after the treatment of the two groups was 78.6%， 71.4%， respectively， the difference was not statistically significant（P>0.05）； the difference in incidence of adverse reactions between two groups was statistically significant（P<0.05）. Conclusion The effect of paliperidone extended-release tablets for the treatment of schizophrenia disease is definite， and it is better than risperidone especially in taking effect early and improving negative symptoms with better safety.

[Key words] Paliperidone extended-release tablets； Risperidone； First-episode schizophrenia

精神分裂症作为一种病程迁延、致残率较高及慢性化的精神疾病，给患者的正常生活及工作带来严重影响。目前临床上精神分裂症的治疗强调全病程治疗，其中药物治疗显得尤为重要，非典型性抗精神病药物通常作为首选[1]。帕利哌酮缓释片作为临床上一种新型非典型抗精神病药物，于2009年在我国上市，其主要成分为利培酮的活性代谢产物9—羟基利培酮。考虑到帕利哌酮缓释片与利培酮片化学结构上的相似性，该研究选取该院2012年8月—2013年6月住院的首发精神分裂症患者为研究对象，利用利培酮作为对照药物，评价帕利哌酮缓释片治疗首发精神分裂症的疗效和安全性，现报道如下。endprint