Adjunctive sepsis therapy with aminophylline(STAP):a randomized controlled trial  

作　　者：Ruifang Zhang Huan Liu Dongmei Dai Xianfei Ding Dong Wang Yan Wang Xuexiu Shi Shuguang Zhang Xiaoguang Duan Haixu Wang Yonggang Luo Shaohua Liu Bing Han Xiaojuan Zhang Yu Fang Jing Yang Wangbin Xu Tongwen Sun 

机构地区：[1]General ICU,The First Affiliated Hospital of Zhengzhou University,Henan Key Laboratory of Critical Care Medicine,Zhengzhou Key Laboratory of Sepsis,Henan Engineering Research Center for Critical Care Medicine,Zhengzhou,Henan 450052,China [2]Department of Intensive Care Unit,the First Affiliated Hospital of Kunming Medical University,Kunming,Yunnan 650032,China [3]Precision Medicine Monitoring Center,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan 450052,China

出　　处：《Chinese Medical Journal》2022年第23期2843-2850,共8页中华医学杂志（英文版）

基　　金：the United Fund of National Natural Science Foundation of China(No.U2004110);the National Natural Science Foundation of China(No.82172129);the Medical Science and Technology Tackling Plan Provincial and Ministerial Major Projects of Henan Province(No.SBGJ202101015).

摘　　要：Background:Sepsis is a serious disease caused by infection.Aminophylline has anti-asthma and anti-inflammatory effects.We aimed to explore the safety and effect of aminophylline in sepsis.Methods:We conducted a clinical randomized controlled trial involving 100 patients diagnosed with sepsis within 48 h after intensive care unit(ICU)admission in two sites.All patients were randomized in a 1:1 ratio to receive standard therapy with or without aminophylline.The primary clinical outcome was all-cause mortality at 28 days.Results:From September 27,2018 to February 12,2020,we screened 277 septic patients and eventually enrolled 100 patients,with 50 assigned to the aminophylline group and 50 to the usual-care group.At 28 days,7 of 50 patients(14.0%)in the aminophylline group had died,compared with 16 of 50(32.0%)in the usual-care group(P=0.032).Cox regression showed that the aminophylline group had a lower hazard of death(hazard ratio=0.312,95%confidence interval:0.129–0.753).Compared with the usual-care group,patients in the aminophylline group had a longer survival time(P=0.039 by the log-rank test).The effects of aminophylline on vasopressor dose,oxygenation index,and sequential organ failure assessment score were timedependent with treatment.There were no significant differences in total hospitalization days,ICU hospitalization days,and rates of serious adverse events(all P>0.05).No adverse events were observed in the trial.Conclusions:Aminophylline as an adjunct therapy could significantly reduce the risk of death and prolong the survival time of patients with sepsis.Trial registration:ChiCTR.org.cn,ChiCTR1800019173.

关 键 词：AMINOPHYLLINE MORTALITY Randomized controlled trial SEPSIS 

分 类 号：R459.7[医药卫生—急诊医学]