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作 者:肖敏[1] 姜怡雯 钟燕 XIAO Min;JIANG Yiwen;ZHONG Yan(West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041;Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region,Chengdu,Sichuan,China 610041)
机构地区:[1]四川大学华西医院,四川成都610041 [2]西藏自治区人民政府驻成都办事处医院,四川成都610041
出 处:《中国药业》2024年第13期115-120,共6页China Pharmaceuticals
基 金:四川省成都市卫生健康委员会医学科研课题[2022349]。
摘 要:目的系统评价胸腺肽α_(1)预防慢性阻塞性肺疾病(COPD)稳定期(SPCOPD)急性加重的有效性及安全性。方法采用计算机检索PubMed,Embase,Medline,The Cochrane Library及中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方(WanFang)、维普(VIP)数据库中胸腺肽α_(1)治疗SPCOPD的随机对照试验(RCT),检索时限为自建库起至2022年12月。参考Cochrane 2.0风险偏倚评估工具对文献进行偏倚风险评估,采用RevMan 5.3软件进行Meta分析。结果最终纳入10项RCT,涉及811例患者。Meta分析结果显示,有效性方面,胸腺肽α_(1)可减少SPCOPD患者的急性加重次数[MD=-0.96,95%CI(-1.59,-0.32),P=0.003]和急性加重天数[MD=-9.14,95%CI(-11.71,-6.56),P<0.00001],改善第1秒用力呼气容积[MD=0.12,95%CI(0.00,0.24),P=0.04],调节T淋巴细胞亚群CD[4 MD=6.66,95%CI(4.39,8.93),P<0.00001],CD[8 MD=-6.00,95%CI(-8.96,-3.04),P<0.0001],CD_(4)/CD_(8)[MD=0.61,95%CI(0.39,0.84),P<0.00001];安全性方面,仅少数患者有轻度恶心、口干、咽部不适等不良反应,可自行缓解。结论胸腺肽α_(1)预防SPCOPD急性加重的有效性和安全性均良好。Objective To systematically assess the efficacy and safety of thymosin α_(1) in preventing acute exacerbation in patients with stable phase of chronic obstructive pulmonary disease(SPCOPD).Methods The randomized controlled trails(RCT)related to the efficacy of thymosin α_(1) in the treatment of patients with SPCOPD in the PubMed,Embase,Medline,The Cochrane Library,CBM,WanFang,CNKI and VIP databases were searched from their inception to December 2022.The Cochrane Risk Bias Assessment Tool 2.0 was used to assess the basis risk of the literature was evaluated.Meta-analysis was conducted by the RevMan 5.3 software.Results Ten RCTs involving 811 patients were included.In terms of efficacy,the Meta-analysis results showed that thymosin α_(1) reduced the number of acute exacerbations in SPCOPD patients[MD=-0.96,95%CI(-1.59,-0.32),P=0.003]and the days of acute exacerbation[MD=-9.14,95%CI(-11.71,-6.56),P<0.00001],improved forced expiratory volume in the first second(FEV1)[MD=0.12,95%CI(0.00,0.24),P=0.04],and regulated T lymphocyte subsets CD_(4)[MD=6.66,95%CI(4.39,8.93),P<0.00001],T lymphocyte subsets CD_(8)[MD=-6.00,95%CI(-8.96,-3.04),P<0.00001],andCD_(4)/CD_(8)[MD=0.61,95%CI(0.39,0.84),P<0.00001].In terms of safety,the Meta-analysis results showed that only a few patients had mild adverse reactions such as nausea,dry mouth,and pharyngeal discomfort,which could be self-relieved.Conclusion Thymosin α_(1) has good efficacy and safety in preventing acute exacerbation of SPCOPD.
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