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Objective:To assess the efficacy and safety of Chinese medicine injection (CMI) for treating acute lung injury/acute respiratory distress syndrome (ALI/ARDS).Methods:Randomized controlled trials (RCTs) were identified by searching 3 English databases and 4 Chinese databases from their inceptions until February 2019.The Cochrane Handbook was used to evaluate risk of bias in the included studies.Data analysis was conducted using RevMan 5.3.3 software.Results:A total of 19 eligible RCTs involving 1,334 participants was included in this systematic review and meta-analysis.The main meta-analysis showed that CMI combined with conventional therapy (CT) was more effective than CT alone in reducing the acute physiology and chronic health evaluation(APACHE) Ⅱ score[mean difference (MD):-1.74 points,95％ confidence interval (CI):-2.77 to-0.71,I2=0]and increasing the total effective rate[relative risk (RR):1.35,95％ CI:1.17 to 1.56,I2=37％].Compared with CT,CMI combined with CT showed improvements in the arterial partial pressure of oxygen (PaO2,MD:9.25 mm Hg,95％CI:0.87 to 17.63,I2=98％) and oxygenation index[arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2),MD:50.75 mm Hg,95％ CI:35.18 to 66.31,I2=94％].CMI plus CT was superior to CT in reducing the systemic inflammatory response syndrome (SIRS) score (MD:-0.84 points,95％ CI:-1.26 to-0.42,I2=65％),length of hospital stay (MD:-4.22 days,95％ CI:-6.49 to-1.95,I2=92％),and duration of mechanical ventilation(MD:-2.94 days,95％ CI:-4.68 to-1.21,I2=89％).Only 1 study reported adverse events.Conclusions:CMI as an adjuvant therapy showed great potential benefits for the treatment of ALI/ARDS.However,we could not make a definite conclusion due to low quality of included studies and uncertain security.Future studies should focus on improving research design,especially in blindness and placebo.The reporting of adverse events was also needed.