Translational Research Program, Osaka Medical College, Osaka, Japan.
Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Thromb Haemost. 2021 Jan;121(1):36-45. doi: 10.1055/s-0040-1715840. Epub 2020 Sep 9.
The terminal stage of solid tumors sometimes induces disseminated intravascular coagulation (DIC); however, no useful therapeutic strategies have been established. This study investigated the relationship between mortality and recombinant human soluble thrombomodulin (rTM) therapy for patients with DIC associated with stage IV solid tumors using a large nationwide inpatient database.
Using the Japanese Diagnosis Procedure Combination Inpatient Database, patients with stage IV solid tumors who developed DIC were identified. Those who received rTM within 3 days of admission were included in the treatment group; the remaining were included in the control group. The primary outcome was the 28-day in-hospital mortality.
Of 25,299 eligible patients, 1 to 4 propensity score matching was used to select 1,979 rTM users and 7,916 nonusers. There was no significant difference in the 28-day mortality (control vs. rTM: 37.4% vs. 34.3%; hazard ratio, 0.95; 95% confidence interval [CI], 0.88-1.04) and critical bleeding rate (control vs. rTM: 3.7% vs. 3.8%; odds ratio, 1.04; 95% CI, 0.75-1.42) between groups. Subgroup analyses showed that the 28-day mortality rate among patients with colorectal and gynecological cancer was significantly lower in the rTM than in the control group ( for interaction 0.033 and 0.010, respectively).
Although we identified a possibly beneficial association between rTM administration and mortality in specific populations of patients with colorectal and gynecological cancer, no such association was found when considering the entire cohort of patients with DIC associated with stage IV solid tumors.
实体肿瘤的终末期有时会引发弥散性血管内凝血（DIC）；然而，尚未建立有效的治疗策略。本研究使用大型全国住院患者数据库，调查了与 IV 期实体肿瘤相关的 DIC 患者的死亡率与重组人可溶性血栓调节蛋白（rTM）治疗之间的关系。
使用日本诊断程序组合住院患者数据库，确定患有 DIC 的 IV 期实体肿瘤患者。在入院后 3 天内接受 rTM 的患者被纳入治疗组；其余患者被纳入对照组。主要结局是 28 天住院死亡率。
在 25299 名合格患者中，使用 1 至 4 个倾向评分匹配选择了 1979 名 rTM 使用者和 7916 名非使用者。两组 28 天死亡率（对照组 vs rTM：37.4% vs 34.3%；风险比，0.95；95%置信区间[CI]，0.88-1.04）和严重出血发生率（对照组 vs rTM：3.7% vs 3.8%；比值比，1.04；95%CI，0.75-1.42）均无显著差异。亚组分析显示，在结直肠癌和妇科癌症患者中，rTM 组的 28 天死亡率明显低于对照组（交互检验 P 值分别为 0.033 和 0.010）。
尽管我们发现 rTM 给药与特定人群的结直肠癌和妇科癌症患者的死亡率之间存在可能有益的关联，但在考虑与 IV 期实体肿瘤相关的 DIC 所有患者时，未发现这种关联。
