甲强龙在儿童体外循环辅助下心脏手术中应用价值的系统评价和Meta分析

摘要

目的：评估儿童体外循环辅助下心脏手术围术期应用甲强龙的价值。方法纳入体外循环辅助下行心脏手术年龄﹤16岁的患儿、英文RCT、试验组预防性应用甲强龙、对照组为安慰剂或空白对照的文献。检索PubMed、Embase、Medline和 Cochrane图书馆数据库，以PubMed为例，检索式：methylprednisolone AND cardiopulmonary bypass OR CPB。检索时间均为建库至2016年5月13日。主要结局指标为术后出院时病死率，并根据甲强龙给药方式（术前静脉给药和术中膜肺给药）行分层分析。采用Cochrane协作网推荐的偏倚风险评估工具评价文献质量。结果系统检索后6篇文献中的486例体外循环辅助下心脏手术患儿进入本文分析，其中甲强龙组253例，对照组233例。5篇文献描述了随机序列产生方法，2篇文献采用了分配隐藏，6篇文献均采用了盲法并描述了脱落或失访，5篇文献未选择性报告研究结果，其他偏倚来源均为不确定。2篇静脉给药的文献术后病死率为9.6%（13／135），甲强龙组与对照组术后病死率[1.5%（2／67）vs 8.1%（11／68）]，差异有统计学意义（固定效应模型，RR =0.22，95%CI：0.06~0.83，P=0.03）。次要结局指标中体外循环（CPB ）时间（固定效应模型，MD=-10.67，95% CI：-17.82~-3.53，P=0.003）和术前静脉给药亚组ICU住院时间（固定效应模型，MD=-0.72，95%CI：-1.33~-0.12，P=0.02）与对照组比较差异均有统计学意义。术中膜肺给药亚组ICU住院时间以及甲强龙组机械通气时间和阻断时间与对照组比较差异均无统计学意义。结论在有限证据下，儿童体外循环辅助下心脏手术围术期预防性静脉使用甲强龙可降低术后病死率，术前静脉给药可以缩短CPB时间和ICU住院时间。%Objective To evaluate the effects of perioperative administration of methylprednisolone in pediatric patients undergoing cardiac surgery together with cardiopulmonary bypass. Methods Randomized controlled trials published in English language involving pediatric patients aged under 16 years undergoing cardiac surgery together with cardiopulmonary bypass,which prophylactic perioperative methylprednisolone administrated during cardiac surgery was compared with placebo or blank control were included. The PubMed,Embase,Medline,and the Cochrane Library were searched systematically up to May 2016. The search strategy was"methylprednisolone" AND "cardiopulmonary bypass" OR "CPB". The primary outcome to evaluate the efficacy of methylprednisolone in pediatric cardiac surgery with cardiopulmonary bypass was all-cause in-hospital mortality. The meta-analysis was performed by RevMan 5. 3 software. A subgroup analysis about delivery method was made between intravenous administration before surgery( subgroup A)and CPB circuit in CPB prime( subgroup B). Results Six RCTs with 486 patients were included into this meta-analysis,including 253 patients with methylprednisolone and 233 patients with placebo or blank control. Five RCTs reported the information of random sequence generation,2 RCTs reported adequate information about allocation concealment. All of the included RCTs reported blinding of outcome assessment and described off or lost,5 RCTs didnˊt report selective results,other bias were uncertain. Compared with placebo patients,methylprednisolone administration was associated with significant reduction of postoperative mortality(RR=0. 22,95% CI:0. 06 to 0. 83,P = 0. 03). The results of meta-analysis showed that the CPB time was decreased in experimental groups(MD= -10. 67,95% CI:-17. 82 to -3. 53,P=0. 003),and similar trend was found in subgroup A,the MD(95%CI)was -0. 72(95%CI:-1. 33 to -0. 12,P=0. 02). There was no relation with decreased cross- clamp time,mechanical ventilation time and length of ICU stay in subgroup B. Conclusion Under the limited evidence,the delivery method of intravenous administration before surgery may be better than CPB circuit in CPB prime to decrease ICU stay and CPB time.