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棕榈酸帕利哌酮注射液治疗老年精神分裂症的有效性及安全性分析
Analysis on efficacy and safety of paliperidone palmitate in the treatment of senile schizophrenia
【摘要】 目的:探讨棕榈酸帕利哌酮注射液治疗老年精神分裂症患者的疗效、耐受性、安全性及社会功能的恢复。方法:将天津市安定医院2014年8月—2016年3月老年科收治的80例老年精神分裂症患者随机分为研究组和对照组,每组40例患者。研究组用棕榈酸帕利哌酮注射液治疗,第1日注射75 mg,第8日注射75 mg,此后每隔1个月左右注射50~75 mg;对照组用利培酮片剂治疗,第1日口服0.5 mg,在2周内逐步增量至最佳给药剂量,最大给药剂量不超过2mg/d,疗程24周。治疗前及治疗后4、8、16和24周采用阳性和阴性症状量表(PANSS)、依从性评定量表(MARS)、副反应量表(TESS)来评估疗效及安全性,用个人和社会功能量表(PSP)来评估社会功能。结果:72例患者完成24周临床治疗,有8例患者脱落。(1)两组PANSS评分在治疗第4、8、16和24周时均低于基线水平,差异均有统计学意义(P均<0.01);两组间同一时点PANSS评分比较,差异均无统计学意义(P均>0.05)。(2)研究组MARS评分在治疗第4、8、16和24周均高于基线水平,差异均有统计学意义(P均<0.01);对照组MARS评分在治疗第4、8周均有显著统计学意义(P均<0.05);两组间除基线外同一时点MARS评分比较,差异均有统计学意义(P均<0.01)。(3)研究组同一治疗时点PSP评分均高于对照组,且差异均有统计学意义(P均<0.01);对照组PSP评分在治疗第4、8、16和24周均高于基线水平,差异有统计学意义(P均<0.05);两组间除基线外同一时点PSP评分均高于对照组,差异均有统计学意义(P均<0.05)。(4)两组患者均无严重不良反应发生,组间不良反应发生率比较差异无统计学意义(P均>0.05)。结论:老年精神分裂症患者采用棕榈酸帕利哌酮注射液治疗疗效与利培酮片剂相当,但服药依从性好,社会功能明显恢复,无明显不良反应。
【Abstract】 Objective: To analyze efficacy,tolerance,safety and social function of paliperidone palmitate long-acting injection( PP-LAI) in the treatment of senile schizophrenia. Methods: The clinical data of 80 elderly patients with schizophrenia admitted into Tianjin Anding Hospital during the period from August 2014 to March 2016 were selected,and the patients were randomly divided into the observation group and the control group,each group having 40 cases. The patients in the observation group were treated with PP-LAI treatment,while the patients in the control group were given risperidone treatment. Positive and negative symptom scale( PANSS),medication adherence report scale( MARS) and Treatment Emergent Symptom Scale( TESS) were assessed prior to and at the weeks 4,8,16 and 24 after the treatment to measure efficacy and safety. Personal and social performance scale( PSP) was used to assess social function. Results: 72 patients completed the clinical treatment at the end of week 24,and eight cases fell off.(1) PANSS scores for both groups measured at weeks 4,8,16 and 24 after the treatment were lower than the baseline levels,the difference having statistical significance( P < 0. 01),Comparison of PANSS scores at the same time points between the two groups showed no statistical differences( P > 0. 05).(2) MARS scores for the observation group measured at weeks 4,8,16 and 24 in the treatment were higher than baseline,the difference having statistical significance( P < 0. 01). MARS scores for the control group at weeks 4,8,16 and 24 in the treatment were higher than baseline,the difference having statistical significance( P < 0. 01). In addition,MARS scores measured at the same time points for the observation group were different from those for the control group,and the differences were statistically significant( P < 0. 01).(3) PSP scores for the observation group were higher than those for the control group,and the difference was statistically significant( P < 0. 01); and PSP scores measured at weeks 4,8,16 and 24 in the treatment for the control group were higher than baseline,the difference being statistically significant( P <0. 05). In addition,PSP scores measured at the same time points for the observation group were different from those for the control group,and the differences were statistically significant( P 均 < 0. 05).(4)Two groups of patients had no serious adverse reactions,the incidence of adverse reactions between observation group and control group had no statistical significance( P > 0. 05). Conclusion: PP-LAI and risperidone in the treatment of elderly patients with schizophrenia have the same effect,but PP-LAI has higher treatment compliance,more obvious recovery in social function,and lower incidence of adverse reactions.
【Key words】 paliperidone palmitate long-acting injection; elderly schizophrenia; efficacy; safety; social function;
- 【文献出处】 天津药学 ,Tianjin Pharmacy , 编辑部邮箱 ,2017年03期
- 【分类号】R749.3
- 【被引频次】4
- 【下载频次】89