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帕利哌酮与阿立哌唑治疗青少年首发精神分裂症的临床对照研究
A controlled clinical study between paliperidone and aripiprazole in adolescents with first-episode schizophrenia
【摘要】 目的比较帕利哌酮与阿立哌唑治疗青少年首发精神分裂症的临床疗效及安全性。方法 68例青少年首发精神分裂症患者随机分为帕利哌酮组和阿立哌唑组,每组34例。帕利哌酮组起始剂量3 mg·d-1,剂量范围3~12 mg·d-1;阿立哌唑组起始剂量2.5 mg·d-1,剂量范围2.5~20 mg·d-1,治疗12周。于基线及2、4、8、12周末,采用阳性与阴性症状量表(PANSS)、个人和社会功能量表(PSP)评定疗效,采用副反应量表(TESS)评价不良反应。结果最终有63例纳入分析,其中帕利哌酮组32例,阿立哌唑组31例。帕利哌酮组治疗总显效率为72%,阿立哌唑组为68%,疗效无显著差异(P>0.05)。治疗12周末时两组PANSS总分、阳性症状分、阴性症状分和一般精神病理症状分均较治疗前有显著下降(P<0.05或P<0.01),组间比较无显著差异(P>0.05)。两组PANSS减分在治疗2周末比较有显著差异(P<0.01),其余时间点比较无显著差异(P>0.05)。两组PSP值均比治疗前显著增高(P<0.01),帕利哌酮组增高更明显,组间比较有显著差异(P<0.05)。两组不良反应发生率无显著差异(72%vs.70%,P>0.05)。结论帕利哌酮治疗青少年首发精神分裂症疗效与阿立哌唑相当,且起效快,安全性高。
【Abstract】 AIM To compare the clinical efficacy and safety of paliperidone and aripiprazole in treatment of the adolescent with first - episode schizophrenia.METHODS Sixty - eight adolescents with first - episode schizophrenia were randomly assigned into paliperidone group(n = 34) and aripiprazole group(n = 34) for the 12-week controlled trial.The initial dose of paliperidone and aripiprazole was 3 mg·d-1 and 2.5 mg·d-1 respectively,and the effective dose range was 3 - 12 mg·d-1 and 2.5 - 20 mg·d-1 respectively.The positive and negative symptom scale(PANSS) and personal and social functioning scale(PSP) were used to evaluate the clinical efficacy and social function,and the treatment emergent symptom scale(TESS) was used to assess the adverse reactions before the treatment or after 2,4,8 and 12 weeks treatment.RESULTS Totally 63 patients were included in the analysis,32 for the paliperidone group and 31 for the aripiprazole group.The total efficiency of the paliperidone group and aripiprazole group was 72%and 68%respectively with no significant difference(P>0.05).At the end of 12 weeks,the total PANSS scores,positive symptoms,negative symptoms and general psychopathology symptoms of the two groups were obviously decreased compared with those before the treatment(P<0.05 or P<0.01),and the two groups had no significant difference(P>0.05).There was significant difference in the PANSS reduction between the two groups at the end of two weeks treatment(P<0.01),the other time points showed no significant differences(P>0.05).The PSP values of the two groups were improved(P<0.01) after 12 weeks treatment,and the paliperidone group improved more significantly (P<0.05).There was no significant differences in adverse reactions between the two groups(72%vs.70%, P>0.05).CONCLUSION Paliperidone has the same efficacy as aripiprazole in the treatment of adolescents with first-episode schizophrenia,and has rapid effect and high safety.
【Key words】 paliperidone; aripiprazole; adolescent; schizophrenia; controlled clinical trials;
- 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2013年01期
- 【分类号】R749.3
- 【被引频次】7
- 【下载频次】154