Efficacy of recombinant human soluble thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis: A systematic review and meta-analysis.

Idiopathic pulmonary fibrosis (IPF) is a chronic fibrosing lung disease of unknown etiology. Recombinant human soluble thrombomodulin (rhTM) is used for the management of acute exacerbation (AE) of IPF. The present review aimed to summarize the evidence and perform a meta-analysis of the efficacy and safety of rhTM in the management of AE-IPF. An electronic search of titles and abstracts published until 31st August 2019 was performed in the PubMed, Biomed Central, Scopus and Embase databases. Studies comparing rhTM-treated and control subjects with AE-IPF and assessing mortality and adverse events were included. Six studies met the inclusion criteria. A total of 145 patients received rhTM, while 146 patients served as controls. The meta-analysis indicated that rhTM resulted in a reduction in 28-day [odds ratio (OR), 0.25; 95% CI, 0.08-0.77; P=0.02; I=0%] and 90-day mortality (OR, 0.29; 95% CI, 0.17-0.49; P<0.00001; I=0%) compared with the controls. Adverse events were pooled and no difference was determined between rhTM and control groups (OR, 1.07; 95% CI, 0.45-2.51; P=0.88; I=0%). It was indicated that administration of rhTM may reduce the short-term mortality in patients with AE-IPF; however, the quality of evidence was not high. The drug appears to be safe without any enhanced risk of adverse events, although high-quality randomized controlled trials with a large sample size are required to further support its use in the treatment of IPF.