Oguma Y, Sakuragawa N, Maki M, Nakagawa M, Hasegawa H
Department of Clinical Laboratory Medicine, Toyama Medical and Pharmaceutical University, Japan.
Thromb Res. 1990 Jul 1;59(1):37-49. doi: 10.1016/0049-3848(90)90269-i.
A multicenter cooperative study was carried out involving 47 nationwide institutes in Japan to assess the efficacy and safety of low molecular weight heparin (Fragmin) on DIC. Fifty-six DIC cases were challenged by Fragmin injection principally for 5 days with the doses of 75 U/kg/day in the I group (n = 27) and 150 U/kg/day in the II group (n = 29). Scoring points were defined based on the severity of bleeding symptoms, organ failures and abnormal coagulation-fibrinolytic examinations, and therapeutic effect of Fragmin was evaluated objectively according to the improvement degrees of these scores. Six cases (10.7%) died of the underlying diseases or complications other than DIC and hemorrhagic side effects occurred in 3.7 and 10.3% cases of the I and II groups, respectively. However, in bleeding symptoms, 45.5 and 31.6% cases of the I and II groups improved excellently or moderately. In organ failures and coagulation-fibrinolytic examinations, remarkable improvement was observed in 31.6 and 66.7% cases of the I group, while they remained 14.3 and 51.7% in the II group, respectively. The overall utility of Fragmin was 66.7% in the I group and 58.6% in the II group. These results demonstrate that Fragmin is effective on DIC with a dose of 75 U/kg/day.
日本开展了一项多中心合作研究，涉及全国47家机构，以评估低分子量肝素（速碧林）对弥散性血管内凝血（DIC）的疗效和安全性。56例DIC患者接受了速碧林注射，主要为期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、器官功能衰竭和凝血-纤溶检查异常的严重程度定义评分点，并根据这些评分的改善程度客观评估速碧林的治疗效果。6例（10.7%）死于DIC和出血性副作用以外的基础疾病或并发症，I组和II组分别有3.7%和10.3%的病例出现出血性副作用。然而，在出血症状方面，I组和II组分别有45.5%和31.6%的病例有显著或中度改善。在器官功能衰竭和凝血-纤溶检查方面，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%。I组速碧林的总体有效率为66.7%，II组为58.6%。这些结果表明，剂量为75 U/kg/天的速碧林对DIC有效。
