sự suy giảm của sự gia tăng nồng độ IL-6 trong huyết thanh hơn so với các bệnh nhân trong nhóm dùng giả dược vào ngày 1 và vào các ngày 4, 5, 6, và 7. Các biến chứng Tỷ lệ bệnh nhân có ít nhất một tác dụng phụ nghiêm trọng tương tự trong cả hai nhóm bệnh nhân. | ACTIVATED PROTEIN C AND SEVERE SEPSIS greater attenuation of the increase in serum IL-6 concentrations than in the patients in the placebo group on day 1 and on days 4 5 6 and 7. Complications The percentage of patients who had at least one serious adverse event was similar in both patient groups. The incidence of serious bleeding was higher however in the activated protein C group than in the placebo group 3-5 vs. 2-0 P 0-06 . This difference in the incidence of serious bleeding was observed only during the infusion period after this time the incidence was similar in the two groups. Among the patients who received activated protein C the incidence of serious bleeding was similar for those who received activated protein C alone and in those who also received heparin. In both the activated protein C group and the placebo group serious bleeding occurred mainly in those patients with some predisposition to bleeding such as gastrointestinal ulceration an activated partial-thromboplastin time aPTT of more than 120 seconds a prolonged prothrombin time PT a platelet count which fell below 30 000 ml and remained at that level despite standard therapy traumatic injury of a blood vessel or traumatic injury of a highly vascular organ. There was a fatal intracranial haemorrhage in two patients in the activated protein C group during the infusion one on day 1 and one on day 4 and in one patient in the placebo group six days after the end of the infusion. After adjustment for the duration of survival blood transfusion requirements were similar in both groups. There were no other safety concerns associated with treatment with activated protein C on the basis of assessments of organ dysfunction vital signs biochemical data or haematological data. The incidence of thrombotic events was similar in the two groups. The incidence of new infections was around 25 in both groups of patients and neutralising antibodies to activated protein C were not detected in any patient. Discussion In
