PDF(Pubmed)
Abstract：
Sepsis is an overwhelming reaction to infection that comes with high morbidity and mortality. It requires urgent interventions in order to improve outcomes. Intravenous immunoglobulins (IVIG) are considered as potential therapy in sepsis patients. Results of trials on IVIG as adjunctive therapy for sepsis have been conflicting due to the variability in population characteristics, country geography and drug dosage form in different studies.
A systematic article search was performed for eligible studies published up to January, 31, 2023, through the PubMed, Embase, Cochrane Library and Chinese National Knowledge Infrastructure database. The included articles were screened by using rigorous inclusion and exclusion criteria. Subgroup analyses were conducted according to different IVIG types, ages and economic regions. All analyses were conducted using Review Manager 5.4. Quality of studies and risk of bias were evaluated.
In total, 31 randomized controlled trials were included with a sample size of 6,276 participants. IVIG could reduce the mortality (RR 0.86, 95% CI: 0.77-0.95, p = 0.005), the hospital stay (MD - 4.46, 95% CI: - 6.35 to - 2.57, p = 0.00001), and the APACHE II scores (MD - 1.65, 95% CI: - 2.89 to - 0.63, p = 0.001). Additionally, the results showed that IgM-enriched IVIG was effective in treating sepsis (RR 0.55, 95% CI: 0.40 - 0.76; p = 0.0003), while standard IVIG failed to be effective (RR 0.91, 95% CI: 0.81-1.02, p = 0.10). And the effect of IVIG in reducing neonatal mortality was inconclusive (RR 0.93, 95% CI: 0.81-1.05, p = 0.24), but it played a large role in reducing sepsis mortality in adults (RR 0.70, 95% CI: 0.57-0.86, p = 0.0006). Besides, from the subgroup of different economic regions, it indicated that IVIG was effective for sepsis in high-income (RR 0.89, 95% CI: 0.79-0.99, p = 0.03) and middle-income countries (RR 0.49, 95% CI: 0.28-0.84, p = 0.01), while no benefit was demonstrated in low-income countries (RR 0.56, 95% CI: 0.27-1.14, p = 0.11).
There is sufficient evidence to support that IVIG reduces sepsis mortality. IgM-enriched IVIG is effective in both adult and neonatal sepsis, while standard IVIG is only effective in adult sepsis. IVIG for sepsis has shown efficacy in high- and middle-income countries, but is still debatable in low-income countries. More RCTs are needed in the future to confirm the true clinical potential of IVIG for sepsis in low-income countries.
A systematic article search was performed for eligible studies published up to January, 31, 2023, through the PubMed, Embase, Cochrane Library and Chinese National Knowledge Infrastructure database. The included articles were screened by using rigorous inclusion and exclusion criteria. Subgroup analyses were conducted according to different IVIG types, ages and economic regions. All analyses were conducted using Review Manager 5.4. Quality of studies and risk of bias were evaluated.
In total, 31 randomized controlled trials were included with a sample size of 6,276 participants. IVIG could reduce the mortality (RR 0.86, 95% CI: 0.77-0.95, p = 0.005), the hospital stay (MD - 4.46, 95% CI: - 6.35 to - 2.57, p = 0.00001), and the APACHE II scores (MD - 1.65, 95% CI: - 2.89 to - 0.63, p = 0.001). Additionally, the results showed that IgM-enriched IVIG was effective in treating sepsis (RR 0.55, 95% CI: 0.40 - 0.76; p = 0.0003), while standard IVIG failed to be effective (RR 0.91, 95% CI: 0.81-1.02, p = 0.10). And the effect of IVIG in reducing neonatal mortality was inconclusive (RR 0.93, 95% CI: 0.81-1.05, p = 0.24), but it played a large role in reducing sepsis mortality in adults (RR 0.70, 95% CI: 0.57-0.86, p = 0.0006). Besides, from the subgroup of different economic regions, it indicated that IVIG was effective for sepsis in high-income (RR 0.89, 95% CI: 0.79-0.99, p = 0.03) and middle-income countries (RR 0.49, 95% CI: 0.28-0.84, p = 0.01), while no benefit was demonstrated in low-income countries (RR 0.56, 95% CI: 0.27-1.14, p = 0.11).
There is sufficient evidence to support that IVIG reduces sepsis mortality. IgM-enriched IVIG is effective in both adult and neonatal sepsis, while standard IVIG is only effective in adult sepsis. IVIG for sepsis has shown efficacy in high- and middle-income countries, but is still debatable in low-income countries. More RCTs are needed in the future to confirm the true clinical potential of IVIG for sepsis in low-income countries.
摘要：
背景：脓毒症是对感染的压倒性反应，伴随着高发病率和死亡率。它需要紧急干预，以改善结果。静脉免疫球蛋白（IVIG）被认为是脓毒症患者的潜在治疗方法。由于人群特征的变异性，IVIG作为脓毒症辅助治疗的试验结果相互矛盾。不同研究中的国家地理和药物剂型。
方法：对截至1月发表的合格研究进行了系统的文章搜索，2023年31日，通过PubMed，Embase,Cochrane图书馆和中国国家知识基础设施数据库。纳入的文章采用严格的纳入和排除标准进行筛选。根据不同的IVIG类型进行亚组分析，年龄和经济区域。所有分析均使用ReviewManager5.4进行。评估研究质量和偏倚风险。
结果：总计，纳入了31项随机对照试验，样本量为6,276名参与者。IVIG可以降低死亡率（RR0.86，95%CI：0.77-0.95，p=0.005），住院时间（MD-4.46，95%CI：-6.35至-2.57，p=0.00001），和APACHEII评分（MD-1.65，95%CI：-2.89至-0.63，p=0.001）。此外,结果表明，富含IgM的IVIG可有效治疗脓毒症（RR0.55，95％CI：0.40-0.76；p=0.0003），而标准IVIG无效（RR0.91，95%CI：0.81-1.02，p=0.10）。IVIG降低新生儿死亡率的效果尚无定论（RR0.93，95％CI：0.81-1.05，p=0.24），但它在降低成人脓毒症死亡率方面发挥了重要作用(RR0.70,95%CI:0.57-0.86,p=0.0006).此外,来自不同经济区域的分组，它表明IVIG对高收入国家（RR0.89，95％CI：0.79-0.99，p=0.03）和中等收入国家（RR0.49，95％CI：0.28-0.84，p=0.01）的败血症有效，而低收入国家则无获益(RR0.56,95%CI:0.27-1.14,p=0.11).
结论：有足够的证据支持IVIG降低脓毒症死亡率。富含IgM的IVIG对成人和新生儿败血症均有效，而标准IVIG仅对成人败血症有效。IVIG治疗脓毒症在高收入和中等收入国家已经显示出疗效，但在低收入国家仍有争议。未来需要更多的随机对照试验来确认在低收入国家IVIG治疗脓毒症的真正临床潜力。
方法：对截至1月发表的合格研究进行了系统的文章搜索，2023年31日，通过PubMed，Embase,Cochrane图书馆和中国国家知识基础设施数据库。纳入的文章采用严格的纳入和排除标准进行筛选。根据不同的IVIG类型进行亚组分析，年龄和经济区域。所有分析均使用ReviewManager5.4进行。评估研究质量和偏倚风险。
结果：总计，纳入了31项随机对照试验，样本量为6,276名参与者。IVIG可以降低死亡率（RR0.86，95%CI：0.77-0.95，p=0.005），住院时间（MD-4.46，95%CI：-6.35至-2.57，p=0.00001），和APACHEII评分（MD-1.65，95%CI：-2.89至-0.63，p=0.001）。此外,结果表明，富含IgM的IVIG可有效治疗脓毒症（RR0.55，95％CI：0.40-0.76；p=0.0003），而标准IVIG无效（RR0.91，95%CI：0.81-1.02，p=0.10）。IVIG降低新生儿死亡率的效果尚无定论（RR0.93，95％CI：0.81-1.05，p=0.24），但它在降低成人脓毒症死亡率方面发挥了重要作用(RR0.70,95%CI:0.57-0.86,p=0.0006).此外,来自不同经济区域的分组，它表明IVIG对高收入国家（RR0.89，95％CI：0.79-0.99，p=0.03）和中等收入国家（RR0.49，95％CI：0.28-0.84，p=0.01）的败血症有效，而低收入国家则无获益(RR0.56,95%CI:0.27-1.14,p=0.11).
结论：有足够的证据支持IVIG降低脓毒症死亡率。富含IgM的IVIG对成人和新生儿败血症均有效，而标准IVIG仅对成人败血症有效。IVIG治疗脓毒症在高收入和中等收入国家已经显示出疗效，但在低收入国家仍有争议。未来需要更多的随机对照试验来确认在低收入国家IVIG治疗脓毒症的真正临床潜力。
