静脉注射丙种球蛋白无反应型川崎病药物治疗Meta分析

摘要：目的　分析评价静脉注射丙种球蛋白（IVIG）无反应型川崎病（KD）药物治疗的随机对照研究（RCT）。方法　依据纳入和排除标准，从医学电子数据库中选择相关RCT文献，应用Juni量表进行质量评价，Review Manager 4.2软件进行Meta分析。疗效判断指标为观察期内体温改善和超声心动图检测冠状动脉病变情况。结果用相对危险度（RR）或比值比（OR）及其95%可信区间（CI）表示，P < 0.05为差异有统计学意义。结果　共有3篇RCT入选，绘制漏斗图提示可能存在发表偏倚。3篇RCT Meta分析包括再次IVIG治疗组（159例）和糖皮质激素（GCS）治疗对照组（66例），研究显示，IVIG无反应型KD患儿在静脉应用首剂IVIG无反应后，再次IVIG治疗组在体温恢复方面优于GCS治疗对照组，两组差异有统计学意义（RR = 1.29，95% CI：1.10～1.52，P = 0.002）；但在冠状动脉瘤（CAA）发生率方面两者差异无统计学意义（OR = 0.91，95% CI：0.33～2.49，P = 0.85）。结论　目前已发表的RCT Meta分析结果显示，IVIG无反应型KD患儿在首剂IVIG治疗无反应后，再次应用IVIG治疗较GCS治疗能更有效地控制体温，但两者在CAA发生率方面差异无统计学意义。

A Meta-analysis of medication for intravenous immunoglobulin resistant Kawasaki disease.

Abstract：Objective　This study was aimed at evaluating present randomized controlled trials （RCT） regarding the drug therapy for intravenous immunoglobulin （IVIG） resistant Kawasaki disease （KD）. Methods　According to inclusion and exclusion criteria， articles were selected from medical electronic databases. RCT were then assessed based on the Juni assessment， and meta-analysis was completed by the Review Manager 4.2 software. Indications to evaluate effects were the change of body temperature and change of coronary artery situation detected by ultrasound-cardiogram. The results were stated as relative risk （RR） or odd ratio （OR）， with a 95% confidence interval （CI） and a P < 0.05 significant level. Results　In total， three RCT were selected. Funel plot analysis showed possible publication bias. Meta-analysis of the three RCT， including all 59 patients in the 2nd intravenous immunoglobulin treatment group and 66 patients in the glucocorticosteroid treatment control group， indicated that after their first doses of IVIG treatment， the temperatures of IVIG resistant KD patients who received 2nd IVIG treatment could be more effectively improved than those who received glucocorticosteroid treatment （RR = 1.29，95% CI：1.10～1.52，P = 0.002）； but there were no differences on the incidence of coronary artery aneurysm between two groups （OR = 0.91，95% CI：0.33～2.49，P = 0.85）. Conclusion　The Meta-analysis of currently published RCT demonstrates that the 2nd IVIG can more effectively improve the temperature than glucocorticosteroid in IVIG resistant KD patients； but there were no differences on the incidence of coronary artery aneurysm between two groups.