棕榈酸帕利哌酮注射液对比其他抗精神病药长效针剂治疗精神分裂症有效性和安全性的Meta分析

Efficacy and safety of paliperidone palmitate versus other long-acting injectable antipsychotic drugs in the treatment of schizophrenia:a meta-analysis

目的系统评价棕榈酸帕利哌酮注射液与其他抗精神病药长效针剂比较治疗精神分裂症的有效性和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、PsycINFO、CNKI、SinoMed、VIP、WanFang Data数据库,搜集关于棕榈酸帕利哌酮注射液对比其他抗精神病药长效针剂治疗精神分裂症的随机对照试验(RCT),检索时限均从建库至2023年4月30日。由2名研究者独立筛选、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行Meta分析。结果共纳入12个RCT,包括4368例患者。Meta分析结果显示,棕榈酸帕利哌酮注射液组与利培酮长效针剂组的临床有效率差异无统计学意义(P>0.05),与其他抗精神病药长效针剂组的阳性和阴性症状量表(PANSS)总体评分改变值差异也无统计学意义(P>0.05)。与其他抗精神病药长效针剂组相比,棕榈酸帕利哌酮注射液组总退出率[RR=1.14,95%CI(1.06,1.24),P<0.01]和肌注部位异常的不良反应发生率[RR=2.08,95%CI(1.03,4.22),P=0.04]均显著增加。结论当前证据表明,与其他抗精神病药长效针剂相比,棕榈酸帕利哌酮注射液治疗精神分裂症的有效性并无明显差异,但部分不良反应发生率稍有增加。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To assess the safety of paliperidone palmitate(PP)injection versus other antipsychotic drugs long-acting injections(LAIs)in the treatment of schizophrenia.Methods PubMed,Web of Science,Embase,Cochrane Library,PsycINFO,CNKI,SinoMed,VIP and WanFang Data databases were searched to collect randomized controlled trials(RCTs)on PP injection versus other antipsychotic drugs LAIs in the treatment of schizophrenia from the inception to April 30,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Meta-analysis was then performed using RevMan 5.2 software.Results A total of 12 RCTs involving 4368 patients were included.The results of Meta-analysis showed that there was no significant difference in clinical efficacy between PP injection treated group and risperidone LAIs treated group(P>0.05),no significant difference was found for positive and negative syndrome scale(PANSS)overall score changes between PP injection treated group and other antipsychotic drugs LAIs treated group(P>0.05).Compared with other antipsychotic LAIs treated groups,PP injection treated group had a significantly higher rate of total withdrawls(RR=1.14,95%CI 1.06 to 1.24,P<0.01)and the incidence of adverse reactions of abnormal injection site(RR=2.08,95%CI 1.03 to 4.22,P=0.04).Conclusion Current evidence indicates that PP injection didn’t show significant difference in efficacy outcomes,while may increase the incidence of some adverse reactions when compared with other antipsychotic drugs LAIs for schizophrenic.However,due to the limitations of the quantity and quality of the included studies,the above conclusions still need to be validated by more high-quality studies.