目的 系统评价免疫球蛋白辅助治疗扩张型心肌病（DCM）的疗效与安全性。方法 检索中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普生物医学数据库（VIP）、万方数据库（Wanfang Deta）、PubMed、Embase、Cochrane Librery等数据库，收集从建库至2022年1月发表的免疫球蛋白治疗DCM的临床随机对照试验（RCTs）。由2名研究员独立筛选文献、提取数据及质量评价后，采用RevMan 5.3和R 4.1.0软件进行Meta分析。结果 共纳入21篇RCTs，1 691例患者，其中试验组（常规治疗联合免疫球蛋白）患者851例、对照组（常规治疗）患者840例。Meta分析结果显示：与对照组比较，试验组患者的临床疗效更好［RR=1.35，95% CI（1.25，1.45），P＜0.000 01］，左心室射血分数显著增加［MD=7.35，95% CI（6.13，8.57），P＜0.000 01］；显著降低左心室舒张末期内径［MD=-6.23，95% CI（-7.41，-5.05），P＜0.000 01］、免疫球蛋白G水平［MD=- 1.37，95% CI（- 1.96，- 0.78），P＜0.000 01］及脑钠肽水平［MD=- 474.79，95% CI（-609.29，-340.28），P＜0.000 01］。结论 免疫球蛋白辅助治疗进一步改善DCM患者的临床疗效、左心室射血分数、左心室舒张末期内径、免疫球蛋白G及脑钠肽水平。但是纳入文献数目和样本量较少，该结论还需更多高质量、多中心的RCTs来验证。

Objective Systematic evaluation of efficacy and safety on immunoglobulin adjuvant therapy for dilated cardiomyopathy. Methods Data were electronically searched from CNKI, CBM, VIP, Wanfang Deta, Cochrane Library, PubMed, and Embase to collet randomized controlled trails (RCTs) on immunoglobulin in adjuvant therapy of patients with dilated cardiomyopathy. The searching time was from the establishment time of the databases to January 2022. After independent literature screening, data extraction and evaluation of the bias risk of included studies by two evaluators, RevMan 5.3 and R 4.1.0 software was used for Metaanalysis.Results A total of 21 RCTs involving 1 691 patients were included. There were 851 patients in experimental group (treated with conventional methods combined with immunoglobulin), and 840 patients in the control group (treated with conventional methods). The results of Meta-analysis showed that the clinical efficacy of the experimental group was better than that of the control group[RR=1.35, 95%CI (1.25,1.45), P < 0.000 01], left ventricular ejection fraction increased significantly[MD=7.35, 95%CI (6.13, 8.57), P < 0.000 01], left ventricular end diastolic diameter decreased significantly[MD=-6.23, 95%CI (-7.41, -5.05), P < 0.000 01], IgG levels decreased significantly[MD=-1.37, 95%CI (-1.96, -0.78), P < 0.000 01] and the level of brain natriuretic peptide decreased significantly[MD=-474.79, 95%CI (-609.29, -340.28), P < 0.000 01]. Conclusion Immunoglobulin adjuvant therapy progress improves the clinical efficacy, left ventricular ejection fraction, left ventricular end diastolic diameter, IgG and brain natriuretic peptide levels in patients with dilated cardiomyopathy. However, the number of included literatures and sample size were small at present, and the conclusions of this study were needed more high-quality, multi-center RCTs in the future.

R969.3;R782

河南省中医管理局国家中医临床研究基地科研重点专项（2018JDZX008）；河南省中医药科学研究专项（2022ZY1044）