摘要
背景:越来越多的青壮年患者在接受全髋关节置换术(total hip arthroplasty,THA)中使用羟基磷灰石(hydroxyapatite,HA)涂层股骨柄假体,评价HA涂层多孔股骨柄假体的相关临床对照研究的报道并不完全一致,且样本量较少,存在一定局限性。目的:通过Meta分析评价THA使用HA涂层股骨柄假体的有效性及安全性。方法:计算机检索数据库Medline(1966年至2012年2月)、PubMed(1966年至2012年2月)、Embase(1966年至2012年2月)、Cochrane图书馆(2011年第4期)、中国生物医学光盘数据库(1978年至2012年2月)、中国生物医学文献数据库(1978年至2012年2月)和维普中文科技期刊数据库(1978年至2012年2月),收集THA使用HA涂层股骨柄假体和多孔股骨柄假体的临床随机对照试验,提取数据进行分析,采用统计软件RevMan5.1进行Meta分析。结果:共纳入10个随机对照研究,其中试验组480例,对照组478例。Meta分析结果显示,与对照组相比,接受HA涂层股骨柄假体的患者THA术后Harris评分无统计学差异(均数差=1.49,95%置信区间[-2.32,5.31],P=0.44),周围透光线的发生率无统计学差异(优势比=1.06,95%置信区间[0.76,1.48],P=0.74),点焊现象发生率无统计学差异(优势比=1.09,95%置信区间[0.74,1.62],P=0.66)。结论:HA喷涂于股骨柄假体多孔表面,对于初次THA无临床益处。限于纳入文献的数量和质量,Meta分析结果尚有待于更多高质量大样本随机对照试验以予证实。
Background: With the development of total hip arthroplasty (THA), porous-coated femoral prosthesis with hydroxyapatite (HA) was applied more younger patients during THA. But randomized clinical trials showed the different results of its effi- cacy and safety. Objective: The aim of this study is to assess the efficacy and safety of porous-coated femoral prosthesis with hydroxyapatite in primary uncemented THA by Meta-andysis. Methods: Studies were identified by computer from the Cochrane Central Register of Controlled Trials(Issue 4, 2011). MEDLINE (1966 to February 2012), EMBASE (1966 to February 2012), CBM(1978 to February 2012) and VIP (1978 to February 2012). Relevant journals or conference proceedings were also searched manually. The authors only enrolled ran- domized controUed trials (RCTs). Mean difference (MD) of Harris hip score, odds ratio (OR) of endosteal bone ingrowth and radioactive lines in hydroxyapatite coated group versus control group were calculated across. Results: Ten RCTs met the criteria for Meta analysis. The use of porous-coated femoral prosthes with hydroxyapatite did not improve Harris hip score (MD=1.49, 95%CI [-2.32, 5.31], P=0.44). Radiologically, both groups showed equal presence of endosteal bone ingrowth (OR=l.09, 95%CI [0.74, 1.62], /=-0.66). Radioactive lines (OR=1.06, 95%CI [0.76, 1.48], P=- 0.74) on the surface of the prosthesis.Conclusions: This Meta-analysis demonstrates neither clinical nor radiologic benefits on the application of a hydroxyapatite coating femoral prosthesis in uncemented primary total hip arthroplasty. More and stronger evidence will be needed for supporting the outcomes.
出处
《中国骨与关节外科》
2012年第3期207-211,共5页
Chinese Journal of Bone and Joint Surgery
基金
天津市卫生局科技基金(No.2011kz117)