Bimekizumab治疗中/重度斑块状银屑病的疗效与安全性的系统评价 |
投稿时间:2022-03-21 修订日期:2022-09-01 点此下载全文 |
引用本文:魏恂,高珊.Bimekizumab治疗中/重度斑块状银屑病的疗效与安全性的系统评价[J].药学实践杂志,2023,41(7):449~454 |
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中文摘要:目的 探讨bimekizumab治疗中/重度斑块状银屑病的有效性和安全性。方法 检索自建库以来到2022年1月Cochrane Library、Pubmed、MEDLINE、EMBASE、Web of Science、CBM、知网、万方、维普数据库关于bimekizumab治疗银屑病的随机对照试验(RCT),并使用RevMan5.3软件进行系统评价。结果 共纳入5篇文献,6项研究,共有2308例中/重度银屑病患者。在有效性方面,与阳性药物相比,Bimekizumab组银屑病皮损面积和严重程度指数(PASI)改善大于90%(PASI 90),PASI 100的患者多于对照组,研究者总体评估评分(IGA)评分达到0或1的患者比例则无统计学差异(P=0.05)。与安慰剂组相比,Bimekizumab组达到PASI 90,PASI 100和IGA评分达到0或1的患者比例均多于安慰剂组。在安全性方面,Bimekizumab的总不良反应事件的发生率多于安慰剂(P=0.000 2),与阳性药物相当(P=0.06)。严重不良反应事件发生率,在呼吸道感染和鼻咽炎方面,Bimekizumab与安慰剂和阳性药物对比,无统计学差异(P>0.05)。但在导致口腔念珠菌感染方面,Bimekizumab的发生率高于安慰剂组(P=0.005),也高于阳性药物对照组(P<0.000 01)。结论 Bimekizumab可安全、有效地治疗中/重度斑块状银屑病,但临床使用过程中需要注意监测口腔念珠菌的感染。 |
中文关键词:Bimekizumab 银屑病 疗效 安全性 系统评价 |
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Efficacy and safety of bimekizumab in treatment of moderate/severe plaque psoriasis: a systematic review |
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Abstract:Objective To evaluate the efficacy and safety of bimekizumab in the treatment of moderate/severe plaque psoriasis. Methods Literatures from Cochrane Library, PubMed, Embase, CNKI, VIP databases from the establishment time to January of 2022 were retrieved. The Review manager 5.3 statistical software was used to systematical review. Results 5 publications, 6 RCTs met the inclusion criteria, which involved 2308 participants. In terms of efficacy, patients in the experimental group were more than positive medicine control group in PASI 90, PASI 100, no significantly statistical difference in IGA 0 or 1 cases (P=0.05). PASI 90, PASI 100 and IGA 0 or 1 cases of patients in the experimental group were higher than that of the placebo group . In the safety evaluation, the incidence of adverse reaction in experimental group was higher than the placebo group (P=0.000 2), which was the same as the positive medicine control group (P=0.06). The experimental group was no statistical difference compared with positive medicine control and the placebo group in the incidence of serious adverse events including upper respiratory tract infection and nasopharyngitis (P>0.05). But the rate of oral candidiasis in experimental group was higher than the positive medicine control group (P<0.000 01) and the placebo group (P=0.005). Conclusion bimekizumab could treat moderate/severe plaque psoriasis effectively and safely, and the oral candidiasis during the treatment should be noticed. |
keywords:Bimekizumab psoriasis efficacy safety systematic review |
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