A CONTROLLED CLINICAL-TRIAL OF HIGH-DOSE METHYLPREDNISOLONE IN THE TREATMENT OF SEVERE SEPSIS AND SEPTIC SHOCK
A CONTROLLED CLINICAL-TRIAL OF HIGH-DOSE METHYLPREDNISOLONE IN THE TREATMENT OF SEVERE SEPSIS AND SEPTIC SHOCK
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DOI：
10.1056/nejm198709103171101
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发表时间：
1987-09-10
影响因子：
158.5
通讯作者：
BALK, RA
中科院分区：
文献类型：
--
作者：
BONE, RC;FISHER, CJ;BALK, RA
使用大剂量皮质类固醇治疗严重脓毒症和脓毒性休克仍存在争议。我们的研究设计为一项前瞻性、随机、双盲、安慰剂对照试验，研究大剂量甲泼尼龙琥珀酸钠治疗严重脓毒症和脓毒性休克。诊断基于临床怀疑感染加上发热或体温过低（直肠温度> 38.3 ℃）的存在。C [101 ° F]或<35.6 °。C [96 ° F]）、呼吸急促（> 20次呼吸/分钟）、心动过速（> 90次心跳/分钟），以及存在以下适应症或器官功能障碍之一：精神状态改变、低氧血症、乳酸水平升高或少尿。382例患者入组。在诊断后2小时内开始，分4次输注甲泼尼龙琥珀酸钠（30 mg/kg体重）或安慰剂。在休克预防、休克逆转或总死亡率方面没有发现显著差异。在入组时血清肌酐水平升高（> 2 mg/dl）的患者亚组中，接受甲泼尼龙治疗的患者14天死亡率显著增加（78例患者中有46例[59%]，而接受安慰剂治疗的患者58例中有17例[29%]; P < 0.01）。在接受甲基强的松龙治疗的患者中，与继发感染相关的死亡人数明显增加。我们的结论是，使用高剂量皮质类固醇治疗严重脓毒症和脓毒性休克没有任何益处。
The use of high-dose corticosteroids in the treatment of severe sepsis and septic shock remains controversial. Our study was designed as a prospective, randomized, double-blind, placebo-controlled trial of high-dose methylprednisolone sodium succinate for severe sepsis and septic shock. Diagnosis was based on the clinical suspicion of infection plus the presence of fever or hypothermia (rectal temperature > 38.3.degree. C [101.degree.F] or < 35.6.degree. C [96.degree.F]), tachypnea (> 20 breaths per minute), tachycardia (> 90 beats per minute), and the presence of one of the following indications or organ dysfunction: a change in mental status, hypoxemia, elevated lactate levels, or oliguria. Three hundred eighty-two patients were enrolled. Treatment.sbd.either methylprednisolone sodium succinate (30 mg per kilogram of body weight) or placebo .sbd.was given in four infusions, starting within two hours of diagnosis. No significant differences were found in the prevention of shock, the reversal of shock, or overall mortality. In the subgroup of patients with elevated serum creatnine levels (> 2 mg per deciliter) at enrollment, mortality at 14 days was significantly increased among those receiving methylprednisolone (46 of 78 [59 percent] vs 17 of 58 [29 percent] among those receiving placebo; P < 0.01). Among patients treated with methylprednisolone, significantly more deaths were related to secondary infection. We conclude that the use of high-dose corticosteroids provides no benefit in the treatment of severe sepsis and septic shock.