Oguma Y, Sakuragawa N, Maki M, Hasegawa H, Nakagawa M
Department of Clinical Laboratory Medicine, Toyama Medical and Pharmaceutical University, Japan.
Semin Thromb Hemost. 1990 Oct;16 Suppl:34-40.
A multicenter cooperative study was carried out involving 47 nationwide institutions in Japan to assess the efficacy and safety of LMWH (FR-860) in DIC. Fifty-six cases were challenged by FR-860 injection principally for 5 days at doses of 75 U/kg/day in group I (n = 27) and 150 U/kg/day in group II, (n = 29). Scoring points were defined based on the severity of bleeding symptoms, organ failures, and abnormal coagulation-fibrinolytic tests. Therapeutic effects of FR-860 were evaluated objectively according to degrees of improvement of these scores. Six patients (10.7%) died of their underlying diseases or complications other than DIC. Hemorrhagic side effects occurred in 1 and 3 cases of groups I and II, respectively. Bleeding symptoms improved excellently or moderately in 45.5 and 31.6% of the cases in groups I and II, respectively. Concerning organ failures and coagulation-fibrinolytic tests, remarkable improvement was observed in 31.6 and 66.7% of the cases of the group I, whereas they remained 14.3% and 51.7% in group II. The overall usefulness of FR-860 was 66.7% in group I and 58.6% in group II. These results demonstrate that FR-860 is effective in DIC at a dose of 75 U/kg/day.
日本一项多中心合作研究在全国47家机构开展，以评估低分子肝素（FR - 860）治疗弥散性血管内凝血（DIC）的疗效和安全性。56例患者接受了FR - 860注射，主要疗程为5天，I组（n = 27）剂量为75 U/kg/天，II组（n = 29）剂量为150 U/kg/天。根据出血症状、器官功能衰竭及凝血 - 纤溶检查异常的严重程度定义评分点。根据这些评分的改善程度客观评估FR - 860的治疗效果。6例患者（10.7%）死于DIC以外的基础疾病或并发症。I组和II组分别有1例和3例出现出血副作用。I组和II组分别有45.5%和31.6%的病例出血症状显著或中度改善。关于器官功能衰竭和凝血 - 纤溶检查，I组分别有31.6%和66.7%的病例有显著改善，而II组分别为14.3%和51.7%。FR - 860在I组的总体有效率为66.7%，在II组为58.6%。这些结果表明，FR - 860以75 U/kg/天的剂量治疗DIC有效。
