Alejandria M M, Lansang M A, Dans L F, Mantaring J B
Clinical Epidemiology Unit, University of the Philippines Manila, College of Medicine, 547 P. Gil St., Ermita, Manila, Philippines, 1000.
Cochrane Database Syst Rev. 2000(2):CD001090. doi: 10.1002/14651858.CD001090.
Death from severe sepsis and septic shock is common, and researchers have explored whether antibodies to the endotoxins in some bacteria reduces mortality. This review summarises the effects of intravenous immunoglobulin (IVIG) in patients with bacterial sepsis or septic shock on mortality, bacteriological failure rates, and duration of stay in hospital.
We searched the Cochrane Controlled Trials Register, Medline 1966 to April 1999, EMBASE 1988 to February 1999; we contacted investigators active in the field for unpublished data.
Randomised trials comparing intravenous immunoglobulin (monoclonal or polyclonal) with placebo or no intervention, in patients with bacterial sepsis or septic shock.
Inclusion criteria, trial quality assessment, and data abstraction were done in duplicate. We conducted pre-specified subgroup analyses by type of immunoglobulin preparation.
Twenty-three out of 49 studies met our inclusion criteria. Overall mortality was reduced in patients who received polyclonal IVIG (n=413; RR=0.60; 95% CI 0.47 to 0.76). Mortality was not reduced among patients who received monoclonal antibodies such as anti-endotoxins (n=1,736 in 4 good-quality studies; RR=0.98; 95% CI 0.86 to 1.12) or anti-cytokines (n=4,318; RR=0.93; 95% CI 0.86 to 1.01). A few studies measured secondary outcomes (deaths from sepsis or length of hospitalisation) but no differences in the intervention and control groups were identified except among those who received polyclonal IVIG, where sepsis-related mortality was significantly reduced (n=161; RR=0.35; 95% CI 0.18 to 0.69).
REVIEWER'S CONCLUSIONS: In our opinion, polyclonal IVIG significantly reduces mortality and can be used as an adjuvant treatment for sepsis and septic shock. Adjunctive therapy with monoclonal IVIGs remains experimental.
严重脓毒症和脓毒性休克导致的死亡很常见，研究人员探讨了针对某些细菌内毒素的抗体是否能降低死亡率。本综述总结了静脉注射免疫球蛋白（IVIG）对细菌性脓毒症或脓毒性休克患者死亡率、细菌学失败率及住院时间的影响。
我们检索了Cochrane对照试验注册库、1966年至1999年4月的Medline、1988年至1999年2月的EMBASE；我们联系了该领域的活跃研究者以获取未发表的数据。
在细菌性脓毒症或脓毒性休克患者中，比较静脉注射免疫球蛋白（单克隆或多克隆）与安慰剂或不干预的随机试验。
纳入标准、试验质量评估和数据提取均重复进行。我们根据免疫球蛋白制剂类型进行了预先设定的亚组分析。
49项研究中有23项符合我们的纳入标准。接受多克隆IVIG的患者总体死亡率降低（n = 413；RR = 0.60；95%CI 0.47至0.76）。接受单克隆抗体如抗内毒素（4项高质量研究中的n = 1736；RR = 0.98；95%CI 0.86至1.12）或抗细胞因子（n = 4318；RR = 0.93；95%CI 0.86至1.01）的患者死亡率未降低。少数研究测量了次要结局（脓毒症死亡或住院时间），但除接受多克隆IVIG的患者外未发现干预组与对照组有差异，接受多克隆IVIG的患者中脓毒症相关死亡率显著降低（n = 161；RR = 0.35；95%CI 0.18至0.69）。
我们认为，多克隆IVIG可显著降低死亡率，可作为脓毒症和脓毒性休克的辅助治疗。单克隆IVIG的辅助治疗仍处于试验阶段。
