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棕榈酸帕利哌酮与利培酮治疗急性精神分裂症的随机开放性对照研究 被引量:11

Efficacy of flexible dose of paliperidone palmitate in the treatment of acute schizophrenia:A randomized,open,placebo-controlled study
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摘要 目的:探讨棕榈酸帕利哌酮对急性精神分裂症症状的疗效、社会功能的改善以及安全性。方法:将60例急性精神分裂症患者随机分为研究组(30例,棕榈酸帕利哌酮治疗)和对照组(30例,利培酮治疗),于基线,治疗后第1,2,4及6周末分别评定阳性与阴性症状量表(positiveand negative eymptoms scales,PANSS)及个人和社会功能量表(personal and social performance scale,PSP);于基线、治疗后第6周末评定副反应量表(treatment emergent symptom scale,TESS)。对各量表评分进行组间及治疗后各访视点与基线的比较。结果:57例患者完成6周的临床治疗,3例脱落。两组在治疗1周末的PANSS的总分、阳性症状、一般精神病理分均较基线明显降低(P<0.01),且研究组的PANSS总分比对照组降低明显(P<0.05)。研究组在治疗2周末PANSS阴性症状因子分与基线相比出现降低(P<0.05),而对照组在治疗4周末PANSS阴性症状因子分与基线相比出现降低(P<0.05)。两组在治疗2周后各访视点的PANSS总分、各因子分无统计学差异(P>0.05)。两组在治疗6周末的有效率(治疗组64.2%,对照组56.7%)无统计学差异(P>0.05)。两组在治疗1周末的PSP评分均较基线升高(P<0.05),且研究组在治疗2周末的PSP评分均较基线出现明显升高(P<0.01),但在各访视点两组组间PSP评分比较无统计学差异(均P>0.05)。研究组的主要不良反应为注射部位疼痛、血清泌乳素升高、失眠、头晕等,而对照组的主要不良反应为肌张力障碍、血清泌乳素升高、静坐不能、失眠等,两组不良反应差异无统计学意义(P>0.05)。结论:棕榈酸帕利哌酮可有效改善急性精神分裂症患者的症状、社会功能,安全性好。 Objective:To compare the efficacy and safety of paliperidone palmitate and risperidone in the treatment of acute schizophrenia. Methods:A total of 60 acute schizophrenics were randomly divided into study group with paliperidone pahnitate and control group with risperidone for 6-week treatment. They were assessed and analyzed by positive and negative symptoms scales (PANSS) and personal and social performance scale (PSP) at baseline, the 1st weekend, 2nd weekend, 4th weekend and 6th weekend. They were assessed and analyzed by treatment emergent symptom scale (TESS) at baseline and the 6th weekend. Results:Fifty-seven patients comple- ted 6 weeks of treatment and three patients dropped out. On the 1 st weekend of treatment, the positive factor, gener- al psychopathology scores and total scores of PANSS in the two groups were all significantly lower than those atbaseline (P 〈 0.01 ), and the total scores of PANSS were significantly lower in the study group than those in the control group (P 〈 0.05). On the 2th weekend of treatment, the negative factor score of PANSS in the study group was significantly lower than that at baseline (P 〈 0.05). On the 4th weekend of treatment, the negative factor score of PANSS in the control group was significantly lower than that at baseline (P 〈 0.05 ). There was no statisti- cally significant difference in the factors and total scores of PANSS between the two groups after 2-week treatment. The effecacy rate was 64.2% in the study group, while the corresponding values was 56.7% in the control group ( P 〉 0.05 ). After 2-week treatment, the total scores of PSP in the two groups were all significantly lower than those at baseline (P 〈0.01 ), and the total scores of PSP were not statistically different between the two groups (P 〉 0.05). Conclusion. Paliperidone palmitate is effective to improve the social functions and psychiatric symptoms of acute schizophrenia with high safety.
出处 《中国新药杂志》 CAS CSCD 北大核心 2013年第10期1190-1195,共6页 Chinese Journal of New Drugs
关键词 棕榈酸帕利哌酮 急性精神分裂症 社会功能 paliperidone palmitate acute schizophrenia social function
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参考文献17

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