• Kunio Tarasawa, Kenji Fujimori, and Kiyohide Fushimi.
• Department of Health Administration and Policy, Tohoku University Graduate School of Medicine.
• Tohoku J. Exp. Med. 2020 Sep 1; 252 (1): 53-61.

AbstractThe anti-DIC biological agent, recombinant human soluble thrombomodulin (rhTM), is being used clinically for DIC treatment in Japan. Patients with acute cholangitis associated with DIC are severe and require improved treatment. In addition, although clinical efficacy of rhTM in patients with acute cholangitis and DIC is expected, its efficacy is controversial. Thus, it is useful to evaluate rhTM in patients with acute cholangitis with DIC. This study aimed to validate the hypothesis that rhTM use improves in-hospital mortality in patients with acute cholangitis with DIC. A propensity score-matching analysis using a nationwide administrative database, the Japanese Diagnosis Procedure Combination Inpatient Database from April 2012 to March 2018, was performed. This database includes administrative claims data for all inpatients discharged from more than 1,000 participating hospitals, covering 92% of all tertiary-care emergency hospitals in Japan. Eligible patients (n = 2,865) were categorized into the rhTM (n = 1,636) or control groups (n = 1,229). Propensity score-matching created a matched cohort of 910 pairs with and without rhTM. In-hospital mortality between the groups in the unmatched analysis showed no significant difference (rhTM vs. control; 10.8% vs. 12.2%; p = 0.227). However, in-hospital mortality between the groups in the propensity score-matched analysis showed a significant difference (rhTM vs. control; 9.5% vs. 12.9%; p = 0.021). These results demonstrated that the rhTM group had significantly lower in-hospital mortality for patients with acute cholangitis with DIC. We propose that rhTM should be used for the treatment of patients with acute cholangitis with DIC.

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