PDF(Pubmed)
Abstract：
Lurasidone is an atypical anti-psychotic approved by the US Food and Drug Administration. It is mainly used to treat schizophrenia in adults through its antagonistic action on dopamine and 5-hydroxytryptamine receptors. The present study systematically assessed the efficacy and safety of lurasidone in the treatment of schizophrenia. Clinical, double-blind, parallel, randomized controlled trials (RCTs) of lurasidone in the treatment of schizophrenia were retrieved from PubMed\\Medline, EBSCO, Embase, Cochrane Library, OVID, Web of Science and related clinical trial registration websites up to May 2023. A total of two investigators independently screened the included references and evaluated their quality. RevMan 5.3 software was used for meta-analysis of each measure outcome. The present systematic review was registered in PROSPERO (ID=CRD42018108178). A total of eight RCTs were included in the present study, including a total of 2,456 patients with schizophrenia. All eight references were randomized, double-blind and parallel control trials. All eight references were evaluated as high quality. The meta-analysis results demonstrated that there were no significant change in total Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression of Severity (CGI-S) score and Montgomery-Asberg Depression Rating Scale (MADRS) between the 40 mg lurasidone group and the placebo group (P>0.05). However, as the dosage increased, the 80, 120 and 160 mg lurasidone groups had significant changes in total PANSS score, CGI-S score and MADRS Compared with placebo (P<0.05), although changes in MADRS in the 120 mg lurasidone group were not statistically significant (P>0.05). In terms of safety, the changes in the incidence of agitation in the 40 mg lurasidone group (P<0.05), vomiting in the 80 mg group (P<0.05) and akathisia in the 160 mg group (P<0.05) were statistically significant and there were also statistically significant changes in the incidence of akathisia, nausea, somnolence and extrapyramidal disorder among the 40, 80 and 120 mg lurasidone groups (P<0.05); No statistically significant changes in the in the incidence of other adverse reactions (P>0.05). In conclusion, existing evidence suggests that the initial dose of lurasidone for schizophrenia can be adjusted to 80 mg. As the condition aggravates, the dose can be incrementally increased to 160 mg. A dose of 160 mg lurasidone is recommended as the most efficacious and safe dose for acute schizophrenia and the risk of occurrence of akathisia, nausea, somnolence and extrapyramidal disorder is still high when lurasidone is administered at a dose of 80-120 mg. The dose should be promptly adjusted or the drug should be withdrawn if the aforementioned adverse reactions worsen. Multi-center, high-quality and long-term clinical RCTs influenced by the included references are still necessary to support the aforementioned conclusions.
摘要：
Lurasidone是一种由美国食品和药物管理局批准的非典型抗精神病药物。它主要通过对多巴胺和5-羟色胺受体的拮抗作用来治疗成人精神分裂症。本研究系统评估了鲁拉西酮治疗精神分裂症的疗效和安全性。临床,双盲,平行,鲁拉西酮治疗精神分裂症的随机对照试验(RCT)从PubMed\\Medline,EBSCO,Embase,科克伦图书馆,OVID,截至2023年5月的WebofScience和相关临床试验注册网站。共有两名研究者独立筛选了纳入的参考文献并评估了其质量。使用RevMan5.3软件对每个测量结果进行荟萃分析。本系统评价在PROSPERO注册(ID=CRD42018108178)。本研究共纳入8项RCT，包括总共2456名精神分裂症患者。所有八篇参考文献都是随机的，双盲和平行对照试验。所有8个参考被评价为高质量。荟萃分析结果显示,总体阳性和阴性症状量表(PANSS)评分无显著变化,40mglurasidone组与安慰剂组之间的临床总体严重程度印象（CGI-S）评分和蒙哥马利-阿斯伯格抑郁量表（MADRS）（P>0.05）。然而,随着剂量的增加，80、120和160mg鲁拉西酮组PANSS总分有显著变化，CGI-S评分和MADRS与安慰剂组比较(P<0.05),尽管120mg鲁拉西酮组的MADRS变化无统计学意义（P>0.05）。在安全方面,40mg鲁拉西酮组躁动发生率的变化（P<0.05），80mg组呕吐(P<0.05)和160mg组静坐不能(P<0.05)比较差异有统计学意义,恶心,40、80、120mg卢拉西酮组嗜睡和锥体外系障碍(P<0.05);其他不良反应发生率无统计学差异(P>0.05)。总之,现有证据表明，lurasidone治疗精神分裂症的初始剂量可以调整为80毫克。随着病情加重,剂量可以逐渐增加到160mg。建议使用160mg鲁拉西酮作为急性精神分裂症和发生静坐不能的风险的最有效和安全的剂量。恶心,当鲁拉西酮以80-120mg的剂量给药时，嗜睡和锥体外系障碍仍然很高。如果上述不良反应恶化，应及时调整剂量或停药。多中心,受纳入参考文献影响的高质量和长期临床RCTs仍需支持上述结论.
