Objective:

2

To assess the efficacy and safety of Chinese medicine injection (CMI) for treating acute lung injury/acute respiratory distress syndrome (ALI/ARDS).

Methods:

2

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:

2

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

I

2

=0] and increasing the total effective rate [relative risk (RR

): 1.35

95% CI: 1.17 to 1.56

I

2

=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

I

2

=98%) and oxygenation index [arterial partial pressure of oxygen (PaO

2

)/fraction of inspired oxygen (FiO

2

)

MD: 50.75 mm Hg

95% CI: 35.18 to 66.31

I

2

=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

I

2

=65%)

length of hospital stay (MD: –4.22 days

95% CI: –6.49 to –1.95

I

2

=92%)

and duration of mechanical ventilation (MD: –2.94 days

95% CI: –4.68 to –1.21

I

2

=89%). Only 1 study reported adverse events.

Conclusions:

2

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.