{"title":"大剂量非镇静性抗组胺药治疗慢性自发性荨麻疹的疗效和安全性:随机临床试验的系统回顾和荟萃分析。","authors":"Xianjun Xiao, Peiwen Xue, Yunzhou Shi, Junpeng Yao, Wei Cao, Leixiao Zhang, Zihao Zou, Siyuan Zhou, Chuan Wang, Mingling Chen, Rongjiang Jin, Ying Li, Qianhua Zheng","doi":"10.1186/s40360-023-00665-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Standard doses of second-generation H<sub>1</sub>-antihistamines (sgAHs) as first-line treatment are not always effective in treating chronic spontaneous urticaria (CSU), and hence an increase in the dose of sgAHs is recommended. However, literature evaluating the efficacy and safety of this treatment remains inconclusive, highlighting the need for a systematic review and meta-analysis. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of high-dose sgAHs compared with standard-dose sgAHs in treating CSU.</p><p><strong>Methods: </strong>A systematic literature search of double-blind, randomized controlled trials (RCT) utilizing multiple doses of sgAHs was performed by searching the electronic databases Medline, Embase, PsycInfo, Cochrane databases, and Web of Science. Bibliographies were also manually searched. The Cochrane Risk of Bias Tool for assessing risk of bias was used to assess the quality of randomized controlled trials (RCTs). Two reviewers screened studies, extracted data, and evaluated the risk of bias independently. The response rate, the number of adverse events, somnolence, and withdrawal due to adverse events were extracted from each article. The data were combined and analyzed to quantify the safety and efficacy of the treatment. RevMan (V5.3) software was used for data synthesis.</p><p><strong>Results: </strong>A total of 13 studies were identified, seven of which met the eligibility criteria for the meta-analysis. Our pooled meta-analyses showed that high-dose sgAHs was associated with a significantly higher response rate than standard-dose (RR 1.13, 95% CI 1.02 to 1.26; P = 0.02). Conversely, high doses of sgAHs were associated with significantly higher somnolence rates than standard dose (RD 0.05, 95% CI 0.01 to 0.09; P = 0.02). There was no significant difference in adverse events or withdrawal due to adverse events between standard- and high-dose treatments.</p><p><strong>Conclusions: </strong>Our analyses showed that a high dose of sgAHs (up to two times the standard dose) might be more effective than a standard dose in CSU treatment. High-dose and standard-dose sgAHs showed similar adverse events, except for somnolence, where incidence was found to be dose-dependent in some studies. However, given the limited number of studies, our meta-analysis results should be interpreted with caution.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2023-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10080829/pdf/","citationCount":"0","resultStr":"{\"title\":\"The efficacy and safety of high-dose nonsedating antihistamines in chronic spontaneous urticaria: a systematic review and meta-analysis of randomized clinical trials.\",\"authors\":\"Xianjun Xiao, Peiwen Xue, Yunzhou Shi, Junpeng Yao, Wei Cao, Leixiao Zhang, Zihao Zou, Siyuan Zhou, Chuan Wang, Mingling Chen, Rongjiang Jin, Ying Li, Qianhua Zheng\",\"doi\":\"10.1186/s40360-023-00665-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Standard doses of second-generation H<sub>1</sub>-antihistamines (sgAHs) as first-line treatment are not always effective in treating chronic spontaneous urticaria (CSU), and hence an increase in the dose of sgAHs is recommended. However, literature evaluating the efficacy and safety of this treatment remains inconclusive, highlighting the need for a systematic review and meta-analysis. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of high-dose sgAHs compared with standard-dose sgAHs in treating CSU.</p><p><strong>Methods: </strong>A systematic literature search of double-blind, randomized controlled trials (RCT) utilizing multiple doses of sgAHs was performed by searching the electronic databases Medline, Embase, PsycInfo, Cochrane databases, and Web of Science. Bibliographies were also manually searched. The Cochrane Risk of Bias Tool for assessing risk of bias was used to assess the quality of randomized controlled trials (RCTs). Two reviewers screened studies, extracted data, and evaluated the risk of bias independently. The response rate, the number of adverse events, somnolence, and withdrawal due to adverse events were extracted from each article. The data were combined and analyzed to quantify the safety and efficacy of the treatment. RevMan (V5.3) software was used for data synthesis.</p><p><strong>Results: </strong>A total of 13 studies were identified, seven of which met the eligibility criteria for the meta-analysis. Our pooled meta-analyses showed that high-dose sgAHs was associated with a significantly higher response rate than standard-dose (RR 1.13, 95% CI 1.02 to 1.26; P = 0.02). Conversely, high doses of sgAHs were associated with significantly higher somnolence rates than standard dose (RD 0.05, 95% CI 0.01 to 0.09; P = 0.02). There was no significant difference in adverse events or withdrawal due to adverse events between standard- and high-dose treatments.</p><p><strong>Conclusions: </strong>Our analyses showed that a high dose of sgAHs (up to two times the standard dose) might be more effective than a standard dose in CSU treatment. High-dose and standard-dose sgAHs showed similar adverse events, except for somnolence, where incidence was found to be dose-dependent in some studies. 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引用次数: 0
摘要
背景:标准剂量的第二代h1 -抗组胺药(sgAHs)作为一线治疗并不总是对慢性自发性荨麻疹(CSU)有效,因此建议增加sgAHs的剂量。然而,评估这种治疗的有效性和安全性的文献仍然没有定论,强调需要进行系统回顾和荟萃分析。本系统综述和荟萃分析的目的是评价高剂量sgAHs与标准剂量sgAHs治疗CSU的疗效和安全性。方法:通过检索Medline、Embase、PsycInfo、Cochrane数据库和Web of Science等电子数据库,对使用多剂量sgAHs的双盲随机对照试验(RCT)进行系统文献检索。书目也要手工检索。使用Cochrane偏倚风险评估工具评估随机对照试验(rct)的质量。两位审稿人筛选研究、提取数据并独立评估偏倚风险。从每篇文章中提取反应率、不良事件数量、嗜睡和不良事件引起的停药。这些数据被合并和分析,以量化治疗的安全性和有效性。采用RevMan (V5.3)软件进行数据合成。结果:共纳入13项研究,其中7项符合meta分析的资格标准。我们的汇总荟萃分析显示,高剂量sgAHs的应答率显著高于标准剂量(RR 1.13, 95% CI 1.02 ~ 1.26;p = 0.02)。相反,高剂量的sgAHs与显著高于标准剂量的嗜睡率相关(RD 0.05, 95% CI 0.01 ~ 0.09;p = 0.02)。标准剂量和高剂量治疗在不良事件或因不良事件而停药方面没有显著差异。结论:我们的分析表明,高剂量的sgAHs(高达标准剂量的两倍)可能比标准剂量的CSU治疗更有效。高剂量和标准剂量的sgAHs表现出类似的不良事件,除了嗜睡,在一些研究中发现嗜睡的发生率与剂量有关。然而,考虑到研究数量有限,我们的荟萃分析结果应该谨慎解读。
The efficacy and safety of high-dose nonsedating antihistamines in chronic spontaneous urticaria: a systematic review and meta-analysis of randomized clinical trials.
Background: Standard doses of second-generation H1-antihistamines (sgAHs) as first-line treatment are not always effective in treating chronic spontaneous urticaria (CSU), and hence an increase in the dose of sgAHs is recommended. However, literature evaluating the efficacy and safety of this treatment remains inconclusive, highlighting the need for a systematic review and meta-analysis. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of high-dose sgAHs compared with standard-dose sgAHs in treating CSU.
Methods: A systematic literature search of double-blind, randomized controlled trials (RCT) utilizing multiple doses of sgAHs was performed by searching the electronic databases Medline, Embase, PsycInfo, Cochrane databases, and Web of Science. Bibliographies were also manually searched. The Cochrane Risk of Bias Tool for assessing risk of bias was used to assess the quality of randomized controlled trials (RCTs). Two reviewers screened studies, extracted data, and evaluated the risk of bias independently. The response rate, the number of adverse events, somnolence, and withdrawal due to adverse events were extracted from each article. The data were combined and analyzed to quantify the safety and efficacy of the treatment. RevMan (V5.3) software was used for data synthesis.
Results: A total of 13 studies were identified, seven of which met the eligibility criteria for the meta-analysis. Our pooled meta-analyses showed that high-dose sgAHs was associated with a significantly higher response rate than standard-dose (RR 1.13, 95% CI 1.02 to 1.26; P = 0.02). Conversely, high doses of sgAHs were associated with significantly higher somnolence rates than standard dose (RD 0.05, 95% CI 0.01 to 0.09; P = 0.02). There was no significant difference in adverse events or withdrawal due to adverse events between standard- and high-dose treatments.
Conclusions: Our analyses showed that a high dose of sgAHs (up to two times the standard dose) might be more effective than a standard dose in CSU treatment. High-dose and standard-dose sgAHs showed similar adverse events, except for somnolence, where incidence was found to be dose-dependent in some studies. However, given the limited number of studies, our meta-analysis results should be interpreted with caution.
期刊介绍:
BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.