目的 评价棕榈酸帕利哌酮注射液(paliperidone palmitate long-acting injection, PP-LAI)治疗精神分裂症的有效性和安全性。方法 系统收集国内外公开发表的棕榈酸帕利哌酮注射液治疗精神分裂症的文献;按照Jadad评分系统对纳入文献进行质量评价;采用RevMan 5.2 软件进行数据分析, 得到合并的效应值及其95%的可信区间。结果 最终纳入12个临床随机对照试验, 共39个研究分析集(棕榈酸帕利哌酮注射液组和对照组)。棕榈酸帕利哌酮注射液组的有效率是安慰剂组的1.70倍(95％CI: 1.50~1.91, Z=8.55, P<0.01), 且不劣于利培酮长效针剂组(RR=1, 95%CI: 0.88~1.13)。同时, 棕榈酸帕利哌酮注射液的不良反应事件发生率与安慰剂组(RR=1.01, 95%CI: 0.97~1.05)和利培酮长效针剂组(RR=1.07, 95%CI: 0.98-1.16)类似, 具有良好的耐受性。结论 棕榈酸帕利哌酮在治疗精神分裂症的有效性和安全性方面都具有一定的优势。
Abstract
OBJECTIVE To evaluate the efficacy and safety of paliperidone palmitate long-acting injection(PP-LAI) in the treatment of schizophrenia. METHODS Published studies concerning PP-LAI for schizophrenia were searched systemically and assessed by Jadad items. RevMan 5.2 software was used for data analysis and for calculating effectiveness and their 95%CIs. RESULTS Twelve Clinical random control trials including 39 analytic sets were selected for Meta-analysis. The incidence of efficient cases in PP-LAI group was 1.7(95％CI: 1.50-1.91) times higher than that in placebo group(Z=8.55, P<0.01) and equaled to the rate in risperidone group(RR=1, 95%CI: 0.88-1.13). Compared with the control group of placebo(RR=1.01, 95%CI: 0.97-1.05) and risperidone(RR=1.07, 95%CI: 0.98-1.16), PP-LAI seemed to be well tolerated, with the same incidence of adverse events.CONCLUSION Paliperidone palmitate has certain efficacy and safety in the treatment of schizophrenia.
关键词
棕榈酸帕利哌酮 /
长效针剂 /
安慰剂 /
利培酮 /
有效性 /
安全性 /
Meta分析
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Key words
paliperidone palmitate /
long-acting injection /
placebo /
risperidone /
efficacy /
safety /
Meta-analysis
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中图分类号：
R95
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参考文献
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