目的 系統(tǒng)評價免疫球蛋白輔助治療擴張型心肌?。―CM）的療效與安全性。方法 檢索中國期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、維普生物醫(yī)學數(shù)據(jù)庫（VIP）、萬方數(shù)據(jù)庫（Wanfang Deta）、PubMed、Embase、Cochrane Librery等數(shù)據(jù)庫，收集從建庫至2022年1月發(fā)表的免疫球蛋白治療DCM的臨床隨機對照試驗（RCTs）。由2名研究員獨立篩選文獻、提取數(shù)據(jù)及質(zhì)量評價后，采用RevMan 5.3和R 4.1.0軟件進行Meta分析。結果 共納入21篇RCTs，1 691例患者，其中試驗組（常規(guī)治療聯(lián)合免疫球蛋白）患者851例、對照組（常規(guī)治療）患者840例。Meta分析結果顯示：與對照組比較，試驗組患者的臨床療效更好［RR=1.35，95% CI（1.25，1.45），P＜0.000 01］，左心室射血分數(shù)顯著增加［MD=7.35，95% CI（6.13，8.57），P＜0.000 01］；顯著降低左心室舒張末期內(nèi)徑［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］及腦鈉肽水平［MD=- 474.79，95% CI（-609.29，-340.28），P＜0.000 01］。結論 免疫球蛋白輔助治療進一步改善DCM患者的臨床療效、左心室射血分數(shù)、左心室舒張末期內(nèi)徑、免疫球蛋白G及腦鈉肽水平。但是納入文獻數(shù)目和樣本量較少，該結論還需更多高質(zhì)量、多中心的RCTs來驗證。

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

河南省中醫(yī)管理局國家中醫(yī)臨床研究基地科研重點專項（2018JDZX008）；河南省中醫(yī)藥科學研究專項（2022ZY1044）