| 引用本文: | 赵嫔,翁稚颖.抗精神病药长效针剂治疗首发或早期精神分裂症疗效及安全性的Meta分析[J].中国现代应用药学,2025,42(7):125-132. |
| Zhao Pin,Weng Zhiying.Meta-analysis of The Efficacy And Safety of Long-acting Injectable Antipsychotics In The Treatment of First-episode or Early-stage Schizophrenia[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(7):125-132. |
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| 摘要: |
| 目的 系统评价抗精神病药长效针剂（long-acting injectable antipsychotic，LAI）治疗首发精神分裂症（first-episode schizophrenia，FES）或早期精神分裂症（early-phase schizophrenia，EPS）疗效及安全性。方法 系统检索中国知网、万方、维普（VIP）、SinoMed、PubMed、Embase、Cochrane Library、Clinical Trails数据库LAI治疗FES和EPS的RCT研究，检索时限为建库至2023年6月30日，根据纳排标准，由两名研究者独立筛选、提取文献资料并采用Cochrane系统评价员手册6.3.0评价纳入文献方法学质量；最后采用RevMan 5.4软件进行Meta分析。结果 最终共纳入6篇RCT研究，累计1987例患者。有效性Meta分析结果显示，与对照组相比，LAI在FES或EPS患者中可降低住院治疗率（RR=0.70，95%cl: 0.62~0.79，P＜0.00001），可降低阳性和阴性症状量表（Positive and Negative Syndrome Scale，PANSS）得分（MD=0.20，95%cl: 0.00~0.40，P=0.05）；在精神病恶化/复发率及临床总体印象——严重度量表（Clinical Global Impression-Severity，CGI-S）评分与对照组相比差异无统计学意义。安全性Meta分析结果显示，与对照组相比，LAI增加精神异常发生率的风险（RR=1.30，95%cl: 1.08~1.55，P=0.004）；在鼻咽炎发生率、体重增加发生率、中枢神经抑制发生率、心血管与内分泌系统反应发生率、锥体外系反应发生率与对照组相比差异无统计学意义。结论 在FES或EPS人群，LAI较常规口服抗精神病药（oral antipsychotics，OAP）可有效降低住院治疗率，改善精神病症状，安全性相当。 |
| 关键词: 抗精神病药 长效针剂 早期精神分裂症 首发精神分裂症 有效性及安全性 Meta分析 |
| DOI： |
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| 基金项目:云南省国际科技合作平台-滇美分子药物联合研究中心 |
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| Meta-analysis of The Efficacy And Safety of Long-acting Injectable Antipsychotics In The Treatment of First-episode or Early-stage Schizophrenia |
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Zhao Pin, Weng Zhiying
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School of Pharmacy, Kunming Medical University
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| Abstract: |
| ABSTRACT: OBJECTIVE The objective is to systematically assess the efficacy and safety of long-acting injectable antipsychotic (LAI) treatment for first-episode schizophrenia (FES) or early-phase schizophrenia (EPS).METHOD: RCT studies on LAI treatment for FES and EPS were retrieved from Chinese Academic Journals Full-text Database (CNKI), Wanfang Data, VIP Information, SinoMed, PubMed, Embase, Cochrane Library, and Clinical Trials databases. The search was performed until June 30, 2023. Two reviewers independently screened and extracted literature according to the inclusion criteria and evaluated the methodological quality of the included studies using the Cochrane Handbook for Systematic Reviews of Interventions 6.3.0. RevMan 5.4 software was used to conduct the meta-analysis.RESULTS: A total of 6 RCT studies involving 1987 patients were included. The meta-analysis of efficacy showed that compared with the control group, LAI reduced the hospitalization rate in FES or EPS patients (RR=0.70, 95% CI: 0.62-0.79, P<0.00001) and decreased the Positive and Negative Syndrome Scale (PANSS) scores (MD=0.20, 95% CI: 0.00-0.40, P=0.05). There was no statistically significant difference between LAI and the control group in terms of the rates of psychiatric deterioration/relapse and the Clinical Global Impression-Severity (CGI-S) scores. The meta-analysis of safety showed that compared with the control group, LAI increased the risk of psychiatric abnormality occurrence (RR=1.30, 95% CI: 1.08-1.55, P=0.004). There was no statistically significant difference between LAI and the control group in terms of the rates of rhinitis, weight gain, central nervous system inhibition, cardiovascular and endocrine system reactions, and extrapyramidal symptoms.CONCLUSION: LAI is more effective than OAP in FES or EPS patients in reducing hospitalization rate and improving psychiatric symptoms, with comparable safety. |
| Key words: antipsychotic drugs long-acting injectable early-phase schizophrenia first-episode schizophrenia efficacy and safety meta-analysis. |
