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

Open Observation and Control Study of the Efficacy and Safety of Paliperidone Extended-release Tablets and Risperidone Tablets in the Treatment of First-episode Schizophrenia

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。

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 ad-verse 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.