摘要
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.
Abstract
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.
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