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胸腺肽类药物辅助治疗重症肺炎有效性和安全性的系统综述与用药合理性讨论

A systematic review of the efficacy and safety of the immunomodulator thymic polypeptides as adjuvant treatment for severe pneumonia
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摘要 目的 评价胸腺肽类药物辅助治疗重症肺炎的有效性和安全性并探讨应用的合理性。方法 检索中国知网、万方数据、维普、Sinomed、Pubmed、Embase、Cochrane Library数据库自建库至2023年12月发表的胸腺肽类药物辅助治疗重症肺炎的随机对照试验(randomized controlled trial, RCT),经过严格的筛选后,使用Cochrane偏倚风险评估工具评估文献质量,使用Revman 5.4软件进行统计分析。结果 纳入28项RCT(2 228例患者)。结果显示胸腺肽组死亡率(RR=0.51, 95%CI:0.32~0.83,P=0.006)、有效率(RR=1.24, 95%CI:1.19~1.30,P<0.001)、重症监护室(intensive care unit, ICU)住院天数(MD=-3.03, 95%CI:-3.79~-2.26,P<0.001)、机械通气时间(MD=-61.34,95%CI:-65.55~-57.12,P<0.001)、血气分析指标、炎性指标均略优于对照组,在不良事件发生率方面差异无统计学意义(P>0.05)。亚组分析显示≥60岁的人群ICU住院天数缩短更多。证据质量普遍较低,部分指标存在较高异质性。结论 基于现有证据,胸腺肽类药物辅助治疗重症肺炎有一定优势,但当前的证据存在局限性,不足以支持其在国内广泛应用的合理性,未来需要开展更多高质量的RCT,并且对药物的安全性和经济学效益进行深入研究。 Objective To evaluate the effectiveness and safety for thymic polypeptides as adjunctive treatment of severe pneumonia and explore the rationality for application.Methods A systematic searching was conducted in six Chinese and English databases to identify randomized controlled trials on the use of thymic polypeptides for severe pneumonia.After screening,the included studies were subjected to quality assessment and data synthesis.Results A total of 28 randomized controlled trials involving 2228 participants were included.Results showed that the thymic polypeptide group had lower mortality rate(RR=0.51,95%CI:0.32-0.83,P=0.006),higher effectiveness rate(RR=1.24,95%CI:1.19-1.30,P<0.001),shorter ICU stay(MD=-3.03,95%CI:-3.79--2.26,P<0.001),shorter mechanical ventilation time(MD=-61.34,95%CI:-65.55--57.12,P<0.001),and better blood gas and inflammatory indicators compared to the control group,with no significant difference in adverse event rate(P>0.05).Subgroup analyses revealed a trend for reduced ICU stay for patients over 60.The quality of evidence was generally low,with high heterogeneity in some indicators.Conclusions Based on the available evidence,thymic polypeptides show certain advantages as adjuvant treatment for severe pneumonia.However,there are limitations in the current evidence that do not justify the widespread use of them in China,There is a need for more RCTs to be conducted in the future,along with in-depth research into the safety and economic benefits of these medications.
作者 蒋子昀 张阳阳 杨会林 周建国 李迅 JIANG Ziyun;ZHANG Yangyang;YANG Huilin;ZHOU Jianguo;LI Xun(Department of Management,Beijing University of Chinese Medicine,Beijing 100029,China;The Second Clinical Medicine College,Beijing University of Chinese medicine,Beijing 100078,China;Fangshan Hospital of Beijing University of Chinese Medicine,Beijing 102488,China;Beijing Econ Medical Technology Co,Beijing 100062,China;Center for Evidence Based Medicine,Beijing University of Chinese Medicine,Beijing 100029,China)
出处 《中华疾病控制杂志》 CAS CSCD 北大核心 2024年第5期596-606,共11页 Chinese Journal of Disease Control & Prevention
基金 国家重点研发计划“中医药现代化”重点专项(2022YFC3501400) 北京中医药大学基本科研业务费项目(2022-JYB-JBRW-013) 北京中医药大学校级教育课题(XJY22020)。
关键词 重症肺炎 胸腺肽 胸腺五肽 系统综述 免疫治疗 Severe pneumonia Thymosin Thymopentin Systematic review Immunomodulatory
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