大剂量氨溴索治疗重症肺炎/呼吸综合窘迫症的循证评价

Evidence-based Evaluation of High-dose Ambroxol for Severe Pneumonia/Respiratory Distress

目的 系统性评价大剂量盐酸氨溴索在临床应用中治疗重症肺炎/呼吸窘迫综合症的有效性和安全性,为临床提供循证药学的参考。方法 计算机检索PubMed、EMbase、Medline、Cochrance Library、中国生物医学文献数据库(CBM)、维普(VIP)、中国知网(CNKI)和万方数据库。收集实验组(成人:1000 mg/d>日剂量>90 mg/d;婴儿:100 mg/kg>日剂量>30 mg/kg)与对照组(成人和婴儿日剂量均小于实验组最小值范围以下)治疗重症肺炎/呼吸综合窘迫症的安全性、有效性研究。检索时限从建库至2021年9月16日,纳入指标包括:白细胞介素(IL-6)、降钙素原(PCT)、氧合指数(PaO2/FiO2)。用EndNote软件进行文献筛查及管理,提取资料,并按照Jadad量表评价文献质量,采用RevMan5.3软件进行Meta分析,采用漏斗图进行偏倚分析。结果 共纳入10个RCTs,涉及952例患者,其中实验组480例,对照组472例,Jadad评分评价文献质量有3篇为4分,4篇为6分,3篇为1分,纳入的文献质量总体优良。Meta分析显示,实验组在降低IL-6 (MD=-0.38,95%CI:-0.44~-0.32,P<0.000 01)、PCT(MD=-0.47,95%CI:-0.79~-0.15,P=0.004)和升高PaO2/FiO2(MD=5.13,95%CI:2.57~7.68,P<0.0001)方面优于对照组。结论 大剂量氨溴索治疗重症肺炎/呼吸窘迫综合症可有效降低患者白细胞介素、降钙素原水平,提升其氧合指数,值得临床应用。

Objective To systematically evaluate the efficacy and safety of high-dose ambroxol hydrochloride in the treatment of severe pneumonia/respiratory distress syndrome in clinical application,and to provide evidence-based pharmacy reference for clinical practice.Methods PubMed,EMbase,Medline,Cochrance Library,CBM,VIP,CNKI and Wanfang database were searched by computer.The literature on the safety and effectiveness of the experimental group(adult:1000 mg/d>daily dose>90 mg/d;Infant:100 mg/kg>daily dose>30 mg/kg)and the control group(adult and infant daily dose were lower than the experimental group)in the treatment of severe pneumonia/respiratory distress syndrome was collected.The retrieval time limit was from the establishment of the database to September 16,2021.The included indicators included interleukin(IL-6),procalcitonin(PCT),oxygenation index(PaO2/FiO2).EndNote software was used for literature screening and management,data were extracted,and the quality of the literature was evaluated according to the jadad scale.RevMan5.3 software was used for Meta-analysis,and funnel plot was used for bias analysis.Results A total of 10 RCTs with 952 patients were included in this study,including 480 patients in the experimental group and 472 patients in the control group.After evaluation of literature quality using jadad score,3 articles scored 4 scores,4 articles scored 6 scores,and 3 articles scored 1 score.Therefore,the quality of the included literatures was generally good.Meta-analysis showed that the experimental group was superior to the control group in reducing IL-6(MD=-0.38,95%CI:-0.44 to-0.32,P<0.00001),PCT(MD=-0.47,95%CI:-0.79 to-0.15,P=0.004)and increasing PaO2/FiO2(MD=5.13,95%CI:2.57 to 7.68,P<0.0001).Conclusion For patients with severe pneumonia/respiratory distress syndrome,high-dose ambroxol can effectively reduce the levels of interleukin and procalcitonin,improve oxygenation index,which is worthy of clinical application.