PDE4抑制剂治疗哮喘患者临床疗效及安全性的Meta分析
Meta-analysis of clinical efficacy and safety of PDE4 inhibitors in the treatment of asthma patients
蒋佳豫 1李海峰 2桂辉娜 1秦宏花 1佟晓娜2
作者信息
- 1. 大理大学药学院,云南大理 671000;云南省第三人民医院药剂科,云南昆明 650011
- 2. 云南省第三人民医院药剂科,云南昆明 650011
- 折叠
摘要
目的:系统评价PDE4抑制剂治疗哮喘患者的疗效及安全性,为该类药物的临床应用提供循证参考.方法:检索PubMed、Embase、Cochrane Library和知网等中英文数据库,检索时间均为建库至2023年8月.按照纳排标准筛选文献,进行方法学质量评价后提取相关资料,应用RevMan 5.4软件进行Meta分析,亚组分析研究不同治疗方案、对照组、剂量和疾病类型对临床疗效的影响.结果:纳入31项随机对照研究(randomized controlled trials,RCTs),共计9 121例患者.Meta分析结果提示,罗氟司特组可以显著提高临床有效率[OR=5.87,95%CI:(3.21,10.72)];改善第1秒用力呼气容积[MD=0.06,95%CI:(0.02,0.11)]、呼气流量峰值[MD=0.53,95%CI:(0.28,0.78)];降低白细胞介素17[MD=-6.34,95%CI:(-9.99,-2.70)]、肿瘤坏死因子α[MD=-0.14,95%CI:(-0.23,-0.05)],同时也增加了不良事件的风险如头痛[OR=3.66,95%CI:(2.26,5.93)]、腹泻[OR=4.57,95%CI:(2.24,9.35)]、呕吐[OR=5.61,95%CI:(2.96,10.63)].此外,研究在改善用力肺活量方面差异未见统计学意义(P>0.05).结论:罗氟司特可有效改善肺功能,具有抗炎、改善气道重塑作用,支气管哮喘患者可从罗氟司特治疗中获益.
Abstract
OBJECTIVE To systematically evaluate the efficacy and safety of phosphodiesterase 4(PDE4)inhibitors for asthma and provide evidence-based references for clinical application of this class of drugs.METHODS The Chinese and Eng-lish databases of PubMed,EMbase,Cochrane Library and China National Knowledge Infrastructure(CNKI)were searched from inceptions of database to August 2023.Literature was screened according to the inclusion and exclusion criteria.And the relevant data were extracted after methodological quality evaluations.Meta-analysis was performed with RevMan 5.4 software and sub-group analyses for examining the effects of different treatment regimens,control groups,doses and disease types on clinical out-comes.RESULTS Thirty-one randomised controlled trials(RCTs)were included with a total of 9 121 patients.Meta-analysis indicated that roflumilast group could significantly boost the clinical efficacy rate[OR=5.87,95%CI:(3.21,10.72)],enhance the volume of forceful expiration at the first second[MD=0.06,95%CI:(3.21,10.72)]and improve the volume of forceful expiration at the first second[MD=0.06,95%CI 0.06,95%CI:(0.02,0.11)]and peak expiratory flow[MD=0.53,95%CI:(0.28,0.78)].It also decreased the levels of interleukin 17[MD=-6.34,95%CI:(9.99,-2.70)],tumour necrosis factor alpha[MD=-0.14,95%CI:(-0.23,-0.05)]and also elevated the risks of such adverse events as headache[OR=3.66,95%CI:(2.26,5.93)],diarrhoea[OR=4.57,95%CI:(2.24,9.35)]and vomiting[OR=5.61,95%CI:(2.96,10.63)].In addition,no statistically significant difference existed in improvement of exertion spirometry(P>0.05).CONCLUSION Roflu-milast is expected to be a novel anti-inflammatory drug for treating asthma.
关键词
PDE4抑制剂/哮喘/Meta分析Key words
PDE4 inhibitor/asthma/Meta-analysis引用本文复制引用
基金项目
国家自然科学基金(81860017/H0109)
出版年
2024