[关键词]
[摘要]
目的 系统评价免疫球蛋白治疗新生儿感染性肺炎的疗效、安全性,及对免疫功能的影响。方法 计算机检索PubMed、EMbase、The Cochrane Library、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和维普中文期刊全文数据库(VIP)和万方数据库,检索年限为从建库至2020年4月,搜集免疫球蛋白治疗新生儿感染性肺炎的临床随机对照试验(RCT),筛选文献后提取数据,采用Jadad量表进行文献质量评价,通过RevMan 5.3软件对临床有效率、临床体征改善时间、血气分析指标、炎性因子指标、免疫球蛋白水平、T淋巴细胞水平和不良反应发生率进行Meta-分析。结果 共纳入13项研究,1 185例患者。Meta-分析结果显示:试验组(免疫球蛋白)的临床有效率比对照组高[RR=1.19,95%CI(1.13,1.24),P<0.01];退热时间[MD=-1.45,95%CI(-1.58,-1.32)]、咳嗽咳喘消失时间[MD=-2.06,95%CI(-2.23,-1.89)]、肺部啰音消失时间[MD=-1.85,95%CI(-2.00,-1.69)]和住院时间[MD=-2.37,95%CI(-2.59,-2.16)]均显著小于对照组(P<0.01);氧气分压(PO2)提高[MD=2.31,95%CI(1.56,2.89)]、二氧化碳分压(PCO2)下降[MD=-1.49,95%CI(-2.01,-0.97)]和动脉血氧饱和度(SaO2)提高[MD=1.08,95%CI(0.46,1.70)]均显著优于对照组(P<0.01);降钙素原下降[SMD=-1.39,95%CI(-2.48,-0.31)]和C-反应蛋白下降[SMD=-1.85,95%CI(-2.87,-0.84)]均优于对照组(P<0.01);免疫球蛋白IgG水平升高[SMD=1.80,95%CI(1.39,2.20)]显著优于对照组(P<0.01);CD3+增加值[MD=2.13,95%CI(1.08,3.19)]、CD4+增加值[MD=3.97,95%CI(2.88,5.06),P<0.01]、CD8+增加值[MD=1.33,95%CI(0.25,2.90),P=0.01]和CD4+/CD8+增加值[MD=0.33,95%CI(0.03,0.63),P=0.03]均显著优于对照组;不良反应发生率与对照组相当[RR=1.16,95%CI(0.57,2.35),P=0.69]。结论 免疫球蛋白能迅速减轻新生儿感染性肺炎临床症状、显著改善血氧含量、炎性因子水平和免疫功能,且安全性较好。
[Key word]
[Abstract]
objective To evaluate the clinical efficacy and immune function of immunoglobulin (IVIG) in the treatment of neonatal infectious pneumonia. Methods The databases of PubMed, EMbase, The Cochrane Library, CNKI, VIP, CBM and Wanfang Data were searched for randomized controlled trials (RCTs) of immunoglobulin in the treatment of neonatal infectious pneumonia from database establishment to April of 2020. According to the inclusion and exclusion criteria, data were extracted and Jadad scale was used to evaluate the quality of literature. Meta-analysis was performed for clinical effective rate, improvement time of clinical signs, blood gas analysis index, inflammatory factor index, immunoglobulin level, T lymphocyte level and incidence of adverse reactions by using RevMan 5.3 statistical software. Results A total of 13 RCTs were included, involving 1 185 patients. Meta-analysis showed that the clinical effective rate of the experimental group (immunoglobulin group) was higher than that of the control group[RR=1.19, 95%CI (1.13, 1.24), P<0.01]; the fade time[MD=-1.45, 95%CI (-1.58, -1.32)], time of cough and asthma abatement[MD=-2.06, 95%CI (-2.23, -1.89)], time of lung rale abatement[MD=-1.85, 95%CI (-2.00, -1.69] and hospitalization[MD=-2.37, 95%CI (-2.59, -2.16)] were significantly shorter than those of the control group (P<0.01); PO2 increased[MD=2.31, 95%CI (1.56, 2.89)], PCO2 decreased[MD=-1.49, 95%CI (-2.01, -0.97)] and Increased SaO2[MD=1.08, 95%CI (0.46, 1.70)] were significantly better than those of the control group (P<0.01); PCT decreased[SMD=-1.39, 95%CI (-2.48, -0.31] and decreased CRP[SMD=-1.85, 95%CI (-2.87, -0.84)] were superior than those of the control group (P<0.01); IgG increased[SMD=1.80, 95%CI (1.39, 2.20), P<0.01] was significantly better than the control group; CD3+ increased[MD=2.13, 95%CI (1.08, 3.19), P<0.01], CD4+ increased[MD=3.97, 95%CI (2.88, 5.06), P<0.01], CD8+ increased[MD=1.33, 95%CI (0.25, 2.90), P=0.01] and CD4+/CD8+ increased[MD=0.33, 95%CI (0.03, 0.63), P=0.03] were significantly better than those of the control group. The incidence of adverse reactions was comparable to the control group[RR=1.16, 95%CI (0.57, 2.35), P=0.69]. Conclusion Evidence-based studies shows that immunoglobulin can quickly reduce the clinical symptoms of neonatal infectious pneumonia, significantly improve blood oxygen content, inflammatory factor levels and immune function, and has good safety.
[中图分类号]
R985;R979.5
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