目的 分析国产帕利哌酮缓释片治疗稳定期精神分裂症的疗效与安全性。方法 采用随机数字表法将驻马店市第二人民医院2021年10月—2023年10月收治的108例稳定期精神分裂症患者分为对照组（服用原研帕利哌酮缓释片）与观察组（服用国产帕利哌酮缓释片）,每组各54例,以阳性与阴性症状量表（PANSS）评分变化为疗效衡量指标,以不良反应发生率及药物副反应量表（TESS）评分变化为安全性衡量指标。结果 治疗后,两组PANSS评分均比治疗前降低,组内不同时间点评分差异有统计学意义（t=22.147、4.513、3.431、21.369、3.927、3.601,P值分别为<0.001、<0.001、0.001、<0.001、<0.001、<0.001）,但组间不同时间点评分比较差异无统计学意义（t=0.281、0.043、0.150,P=0.779、0.966、0.881）;观察组不良反应发生率（14.81%）与对照组（12.96%）比较差异无统计学意义（χ²=0.090,P=0.765）;两组TESS评分接近,不良反应皆轻微（t=0.185,P=0.856）。结论 国产帕利哌酮缓释片治疗稳定期精神分裂症患者可促进症状改善,且不良反应轻微,疗效及安全性与原研制剂相当。

Objective To analyze the efficacy and safety of domestic paliperidone sustained-release tablets in the treatment of stable schizophrenia．Methods A total of 108 patients with stable schizophrenia admitted to Zhumadian Second People's Hospital from October 2021 to October 2023 were divided into control group（taking the original paliperidone sustained-release tablet）and observation group（taking domestic paliperidone sustained-release tablet）by random number table method,with 54 cases in each group．The change of Positive and Negative Symptom Scale（PANSS）was used as the efficacy measure,and the change of incidence of adverse reactions and Treatment Emergent Symptom Scale（TESS） score was used as the safety measure．Results After treatment,PANSS scores in both groups were lower than before treatment,and the differences in scores at different time points in the groups were statistically significant（t=22.147,4.513,3.431,21.369,3.927,3.601,the P values were<0.001,<0.001,0.001,<0.001,<0.001,<0.001,respectively）．However,there was no significant difference in scores at different time points between the groups（t=0.281,0.043,0.150,P=0.779,0.966,0.881）．There was no significant difference in the incidence of adverse reactions between observation group（14.81%）and control group（12.96%）（χ²=0.090,P=0.765）．TESS scores were similar between the two groups,and adverse reactions were mild（t=0.185,P=0.856）．Conclusions The domestic paliperidone sustained-release tablets can improve the symptoms of stable schizophrenia patients,and the side effects are slight,and the efficacy and safety are comparable to the original agent．

目的 针对精神分裂症患者接受喹硫平与帕利哌酮联合治疗对其代谢功能及血清因子的影响。方法 纳入2022年1月—2023年3月驻马店市第二人民医院收治的120例精神分裂症患者,根据住院号进行编号,并通过通过随机抽签方法分为两组,对照组60例应用单一喹硫平治疗,观察组60例应用喹硫平与帕利哌酮联合治疗,对比两组的治疗效果。结果 经治疗,观察组临床总疗效高于对照组（P<0.05）;该组各项代谢功能指标均与对照组比较差异无统计学意义（P>0.05）;该组各项血清因子测定该结果均高于对照组（P<0.05）;该组各项精神症状评分均低于对照组（P<0.05）;该组不良反应发生率与对照组比较差异无统计学意义（P>0.05）。结论 采用喹硫平与帕利哌酮联合的方式治疗精神分裂症患者,可以提升临床疗效,对患者各种精神症状及血清因子改善效果更好,虽然药物会对患者代谢功能产生一定的影响,但是联合用药与单独用药的影响情况无差异,未增加不良反应发生率,安全性良好。

Objective To evaluate the combination of quetiapine and paliperidone on metabolic function and serum factors in schizophrenia．Methods A total of 120 patients with schizophrenia admitted to Zhumadian Second People's Hospital from January 2022 to March 2023 were included,numbered according to the hospitalization number,and divided into two groups by random drawing method．Sixty patients in the control group were treated with quetiapine alone,and 60 patients in the observation group were treated with quetiapine combined with paliperidone,and the therapeutic effects of the two groups were compared．Results After treatment,the total clinical efficacy of the observation group was higher than that of the control group,P<0.05;the metabolic function indexes comparison were P> 0.05;the serum factor of observation group was higher,P<0.05;the scores of psychiatric symptoms in the group were all lower than the control group,P<0.05;the incidence of adverse reactions in the observation improve group was not different from the control group,P>0.05．Conclusions Using quetiapine and schizophrenia,can improve clinical curative effect,various mental symptoms and serum factors,although certain effect on patient metabolic function may occur,but did not significantly increase the incidence of adverse reactions,with high safety．