Kobayashi H, Kawai S, Sakayori S, Kaneko M, Ito Y, Ujike Y, Kobayashi K, Imaizumi H, Hoshi S, Endo S
First Department of Internal Medicine, Kyorin University.
Kansenshogaku Zasshi. 1994 Jan;68(1):81-115. doi: 10.11150/kansenshogakuzasshi1970.68.81.
The efficacy, safety and usefulness of murine anti-endotoxin monoclonal IgM antibody "E5, an intravenous dose of 2 mg/kg" were evaluated in 88 patients with suspected Gram-negative sepsis from 37 institutes in Japan. Out of these, 74 patients were evaluable for the efficacy, 85 for safety and 75 for clinical usefulness. In assessing the efficacy, the patients were divided into 3 groups based on the plasma endotoxin levels (Endospecy with new PCA treatment of plasma): H group with a level of above 9.8 pg/ml and M group with a level of 3.0-9.8 pg/ml and L group with a level of below 3.0 pg/ml. 1. The efficacy rates as assessed following administration of E5 were 73.1% in the H group, 70.4% in the M group and 38.1% in the L group being higher in the groups with significantly high plasma endotoxin levels. 2. In both the H and M groups in whom plasma endotoxin levels were significantly high, the majority of the patients showed rapid reduction of the levels after administration of E5. 3. In all groups, improvement in body temperature, pulse rate, blood TNF-alpha and blood IL-6 was observed after treatment with E5. In the H and M groups with an endotoxin level of > or = 3.0 pg/ml, improvement in platelet count as well as in CRP was noted. The H group showed also improvement in WBC. 4. Improvement in the shock score was noted in all the groups but was more outstanding in the H and M groups in the early stage of treatment. 5. Side effects were seen in 5 (5.9%) of 85 patients and all thought to be allergic in symptoms such as rash, itching, fever and flare. 6. The reaction to the prick test performed before administration of E5 was negative in all these 5 patients. For 3 of the 5 patients, anti-E5 IgE antibody was measured. In all of them, the IgE levels were higher than those of healthy controls. Also, in 47.6% of patients, an elevation of anti-E5 IgG antibody was noted two weeks after the administration. 7. Clinical laboratory abnormalities were observed in 3 (3.5%) of 85 patients. They were an elevation of S-GOT.S-GPT and lowering of BUN, increased Al-p and decreased CH50, increased neutrophilia (%) and were all slight in the degree of the changes. 8. The clinical usefulness of E5 was evaluated for 75 patients.(ABSTRACT TRUNCATED AT 400 WORDS)
在日本37家机构的88例疑似革兰氏阴性菌败血症患者中，评估了鼠抗内毒素单克隆IgM抗体“E5，静脉注射剂量为2mg/kg”的疗效、安全性和实用性。其中，74例患者可评估疗效，85例可评估安全性，75例可评估临床实用性。在评估疗效时，根据血浆内毒素水平（采用新型血浆PCA处理的内毒素检测法）将患者分为3组：血浆内毒素水平高于9.8pg/ml的H组、血浆内毒素水平为3.0-9.8pg/ml的M组和血浆内毒素水平低于3.0pg/ml的L组。1. 给予E5后评估的有效率在H组为73.1%，M组为70.4%，L组为38.1%，血浆内毒素水平显著高的组有效率更高。2. 在血浆内毒素水平显著高的H组和M组中，大多数患者在给予E5后血浆内毒素水平迅速降低。3. 在所有组中，用E5治疗后观察到体温、脉搏率、血液肿瘤坏死因子-α和血液白细胞介素-6有所改善。在内毒素水平≥3.0pg/ml的H组和M组中，血小板计数以及C反应蛋白有所改善。H组白细胞也有所改善。4. 所有组的休克评分均有改善，但在治疗早期H组和M组更为显著。5. 85例患者中有5例（5.9%）出现副作用，所有副作用均被认为是皮疹、瘙痒、发热和潮红等过敏症状。6. 这5例患者在给予E5前进行的皮试反应均为阴性。对其中3例患者检测了抗E5 IgE抗体。所有患者的IgE水平均高于健康对照。此外，47.6%的患者在给药两周后抗E5 IgG抗体升高。7. 85例患者中有3例（3.5%）出现临床实验室异常。分别为血清谷草转氨酶、血清谷丙转氨酶升高，尿素氮降低，碱性磷酸酶升高，补体CH50降低，中性粒细胞增多（%），且所有变化程度均较轻。8. 对75例患者评估了E5的临床实用性。（摘要截选至400字）
