Low-dose intravenous + nebulized polymyxin B vs. intravenous polymyxin B in the treatment of severe patients with pan-resistant Gram-negative bacillus ventilator pneumonia: a multi-center case-control study
Low-dose intravenous plus inhaled versus intravenous polymyxin B for the treatment of extensive drug-resistant Gram-negative ventilator-associated pneumonia in the critical illnesses: a multi-center matched case–control study
Research design
Retrospective multi-center pairing (1:2) Observational Cohort study
Research population
2018.1-2020 .1 VAP patients with pan-resistant Gram-negative bacillus infection in 8 ICU in China
selected criteria
①18 years old≤age≤80 years old,
②Confirmed VAP,
③ Single pan-resistant Gram-negative bacillus infection (such as bronchial secretions or alveolar lavage and cultured XD R lung, baumann, aeruginosa, Escherichia coli ),
④At least 6 doses of polymyxin B
exclusion standard
①Age <18>80 years old,
②mixed bacteria infection,
③Cystic fibrosis,
④Lung transplantation,
group
46 was included in the IH+IV group, and 151 cases were included in the IV group, age, gender, septic shock , Apache After pairing after the II score and other factors, 44 cases were included in the IH+IV group, and 88 cases were included in the IV group
Main endpoint
VAP clinical cure rate
secondary endpoint
① favorable clinical outcome,
②microbial outcome,
③V AP mortality rate,
④ hospital all-cause mortality rate,
⑤ VAP-related mortality rate 28 days after initiation of polymyxin B treatment,
⑥ polymyxin B side reaction,
related definition
VAP defined as pneumonia that occurs 48 hours after tracheal intubation ventilator treatment. The diagnosis of pneumonia needs to meet at least two of the following: new lung infiltration shadow; body temperature 38°C Or 36°C; peripheral blood leukocyte count 12×10^9/L or 4×10^9/L; original respiratory symptoms worsen; etiological colony count: bronchial alveolar tank wash ≥ 10^4CFU/ml, intratracheal aspirate ≥ 10^6CFU/ml, non-invasive sputum sample ≥ 10^7CFU/ml.
favorable clinical outcome: clinical cure is defined as the disappearance of infection symptoms and signs, and clinical improvement is defined as the improvement of infection symptoms and signs compared with before the medication. Clinical failure: the symptoms and signs of infection persist, worsen or die, and re-infection: the same bacteria are infected again within 72 hours after the drug is stopped. Advantageous clinical outcomes include clinical cure and clinical improvement, and adverse outcomes include clinical failure and reinfection. Two physicians who were blind to the treatment plan evaluated the treatment outcome separately, and their opinions were reviewed by experts at the same time.
microbial outcomes include : ① Cleared, the target bacteria did not grow in the lower respiratory tract specimen, ② Continuous, the target bacteria continued to grow, accompanied by signs of infection ③ Set value, the target bacteria continued to grow without signs of infection, ④ Reinfection, and the same bacteria were cultured again after discontinuing the use of polymyxin B, accompanied by signs of infection.
VAP-related mortality rate is defined as death caused by worsening of pneumonia, respiratory failure, and septic shock.
Results
①VAP clinical cure rate: 43.2% in IH+IV group, 27.3% in IV group, p=0.066, no significant difference.
② Favorable clinical outcome: 77.3% in IH+IV group, 58.0% in IV group, p=0.029, with significant differences.
③Microbial clearance rate (p=0.132), all-cause mortality rate (p=0.63), and VAP-related mortality rate (p=0.62).
④ Single-factor analysis showed that low SOFA score, high daily dose of IV polymyxin B, combined with IH polymyxin B, and the absence of septic shock were factors that favorable clinical outcomes.
⑤Multifactor logistic regression analysis showed that combined with IH polymyxin B, absence of septic shock, and low SOFA score were independent influencing factors that favor clinical outcomes.
details of the results are shown in the table below:
Table 1 Demographic and clinical characteristics between the two groups
Table 2 Comparison of the main endpoints between the two groups after pairing
Table 3 Single-factor analysis of favorable clinical outcomes
Table 4 Multi-factor regression analysis of favorable clinical outcomes
References:
Liu J, Shao M, Xu Q.et al. Low-dose intravenous plus inhaled versus intravenous polymyxin B for the treatment of extensive drug-resistant Gram-negative ventilator-associated pneumonia in the critical illnesses: a multi-center matched case-control study. Ann Intensive Care. 2022 Aug 8;12(1):72. doi: 10.1186/s13613-022-01033-5. PMID: 35934730; PMCID: PMC9357592.
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