弹性髓内钉与外固定支架治疗儿童股骨干骨折的Meta分析

Elasticstable intramedullary nails versus external fixation for femoral shaft fracture in children:A Meta-analysis

目的通过Meta分析系统评价弹性髓内钉与外固定支架治疗儿童股骨干骨折的疗效及并发症的发生情况。方法检索万方、维普、CNKI、中国生物医学文献数据库、EMbase、PubMed等数据库,收集包括运用弹性髓内钉(elastic stable intramedullary nailing,ESIN)与外固定支架(external fixation,EF)治疗儿童股骨干骨折的对照试验。提取数据,进行质量评价,并通过RevMan 5.3软件进行Meta分析,比较两组患儿在末次随访对疗效的满意情况、术后成角或旋转畸形、再骨折、感染、皮肤激惹、双下肢不等长、固定物失效、关节活动受限等并发症及相关时间指标(手术时间、住院时间、临床愈合时间、骨性愈合时间)的差异。结果共纳入17篇文献,包括732例股骨干骨折患儿;按照治疗方式的不同将患儿分为弹性髓内钉组(ESIN组)385例,外固定支架组(EF组)347例。Meta分析结果显示,对于儿童股骨干骨折,ESIN组与EF组在末次随访疗效满意情况[RR=0.98,95%CI(0.90,1.06),P=0.55]、术后双下肢不等长[RR=2.44,95%CI(0.88,6.71),P=0.09]、术后固定物失效[RR=2.38,95%CI(1.01,5.60),P=0.05]、术后关节活动受限[RR=2.12,95%CI(0.34,13.06),P=0.42]、手术时间[RR=0.15,95%CI(-1.08,1.38),P=0.82]等方面的差异无统计学意义。与EF组相比,ESIN组在术后皮肤激惹发生率方面明显增加[RR=0.17,95%CI(0.06,0.46),P=0.0006],差异具有统计学意义;在术后再骨折发生率[RR=3.31,95%CI(1.53,7.18),P=0.002]、术后感染发生率[RR=7.72,95%CI(4.12,14.44),P<0.00001]、术后成角或旋转畸形发生率[RR=3.01,95%CI(1.22,7.40),P=0.02]等方面明显减少,差异具有统计学意义;在住院时间[RR=1.18,95%CI(0.19,2.16),P=0.02]、临床愈合时间[RR=0.89,95%CI(0.45,1.33),P<0.0001]、骨性愈合时间[RR=0.89,95%CI(0.39,1.40),P=0.005]等方面明显缩短,差异具有统计学意义。结论ESIN治疗儿童股骨干骨折具有疗效可靠、住院时间短、骨折愈合快、并发症少等优点,对于不伴严重软组织损伤的患儿,可以考虑作为首选的治疗方法。以上结论需要更多大样本、双盲、高质量的随机对照研究加以论证。

Objective To evaluate the clinical efficacies and complications of elastic stable intramedullary nails (ESIN) versus external fixation (EF) for femoral shaft fracture in children.Methods The databases of Wanfang, VIP, CNKI, Chinese Biomedical Database, EMbase and PubMed were searched for comparative studies of ESIN versus EF for managing femoral shaft fracture in children. After extracting literature reports and quality evaluations, RevMan 5.3 software was ultilized for systematic review. The satisfaction degree of efficacy at the last follow-up, malunion, refracture, infection, skin irritation, leg length discrepancy, fixation failure, activity limitation of hip or knee joint and the relevant time parameters (e.g. operative duration, hospital stay, clinical healing time & bone healing time) were analyzed.Results A total of 17 literature reports were included for this meta-analysis.According to different treatment methods, they were divided into two groups of ESIN (n=385) and EF (n=347). No significant inter-group difference existed in the satisfaction degree of efficacy at the last follow-up [RR=0.98, 95%CI(0.90, 1.06), P=0.55], leg length discrepancy [RR=2.44, 95%CI(0.88, 6.71), P=0.09], fixation failure [RR=2.38, 95%CI(1.01, 5.60), P=0.05], activity limitation of hip/knee joint [RR=2.12, 95%CI(0.34, 13.06), P=0.42] and operative duration [RR=0.15, 95%CI(-1.08, 1.38), P=0.82]. Meta-analysis indicated that ESIN group was superior to EF group in the aspects of refracture [RR=3.31, 95%CI(1.53, 7.18), P=0.002], infection [RR=7.72, 95%CI(4.12, 14.44), P<0.00 001], malunion [RR=3.01, 95%CI(1.22, 7.40), P=0.02], hospital stay [RR=1.18, 95%CI(0.19, 2.16), P=0.02], clinical healing time [RR=0.89, 95%CI(0.45, 1.33), P<0.0 001] and bone healing time [RR=0.89, 95%CI(0.39, 1.40), P=0.005]. However, ESIN group was inferior to in skin irritation [RR=0.17, 95%CI(0.06, 0.46), P=0.0 006].Conclusions As compared with EF, the advantages of ESIN are reliable curative effect, shorter hospital stay, faster fracture healing and fewer complications. And ESIN is recommended for femoral shaft fracture without serious injury of soft tissue. Larger sample size, double-blind and high-quality randomized controlled trials are warranted for confirming that conclusion.