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胸腺肽α1预防慢性阻塞性肺疾病稳定期急性加重的有效性及安全性Meta分析OACSTPCD

Efficacy and Safety of Thymosin α1 in Preventing Acute Exacerbation in Patients with Stable Phase of Chronic Obstructive Pulmonary Disease:A Meta-Analysis

中文摘要英文摘要

目的 系统评价胸腺肽α1 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α1 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α1 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<0.000 01],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CD4[MD=6.66,95%CI(4.39,8.93),P<0.000 01],CD8[MD=-6.00,95%CI(-8.96,-3.04),P<0.000 1],CD4/CD8[MD=0.61,95%CI(0.39,0.84),P<0.000 01];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α1 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 α1 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 α1 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 α1 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<0.000 01],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 CD4[MD=6.66,95% CI(4.39,8.93),P<0.000 01],T lymphocyte subsets CD8[MD=-6.00,95% CI(-8.96,-3.04),P<0.000 01],and CD4/CD8[MD=0.61,95% CI(0.39,0.84),P<0.000 01].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 α1 has good efficacy and safety in preventing acute exacerbation of SPCOPD.

肖敏;姜怡雯;钟燕

四川大学华西医院,四川 成都 610041西藏自治区人民政府驻成都办事处医院,四川 成都 610041

药学

胸腺肽α1慢性阻塞性肺疾病稳定期急性加重有效性安全性Meta分析

thymosin α1sable phase of chronic obstructive pulmonary diseaseacute exacerbationefficacysafetyMeta-analysis

《中国药业》 2024 (013)

115-120 / 6

四川省成都市卫生健康委员会医学科研课题[2022349].

10.3969/j.issn.1006-4931.2024.13.028

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