骨水泥与非骨水泥型全膝关节假体置换效果的系统评价

Systematic review on non-cement prosthesis and bone cement prosthesis in total knee arthroplasty

背景:国外研究调查显示,在全膝关节置换中有95.2%采用骨水泥进行假体固定,但是也有专家学者认为使用骨水泥固定假体风险高。目的:应用Cochrane系统评价的方法评价膝关节置换中骨水泥型与非骨水泥型假体置换的效果差异。方法:检索Medline(1996年1月至2011年8月)、Embase(1980年1月至2011年8月)、Cochranelibrary(2011年8月)、中国生物医学文献数据库(CBM,1990年1月至2011年8月)及相关参考文献,收集骨水泥型和非骨水泥型假体全膝关节置换的随机对照试验,采用Cochrane的方法学评价文献质量,应用RevMan5.1.2进行Meta分析。比较骨水泥型和非骨水泥型假体在术后生存率、稳定性、相关并发症、翻修率、异位骨化的差异。并使用GRADEpro version3.2.2软件对纳入研究进行证据评级。结果与结论:纳入8个随机对照试验,共1381例患者,实验组(骨水泥组)676例,对照组(非骨水泥组)705例。4个研究比较了骨水泥组和非骨水泥组假体置换后≤5年组的膝关节生存率,两组差异有显著性意义,说明置换后≤5年骨水泥组生存率高。4个研究比较了置换后>5年组膝关节生存率,两组差异有显著性意义,说明置换后>5年组骨水泥假体组生存率高。3个研究在不同随访时间比较了置换后假体稳定性,结果显示两组间在假体稳定性上差异无显著性。4个研究在不同随访时间比较了置换后假体相关的并发症,两组间在假体相关并发症上比较差异无显著性意义。5个研究在不同随访时间比较了置换后翻修率,两组间在假体翻修率上差异无显著性意义。3个研究在不同随访时间比较了置换后假体异位骨化,两组间在置换后假体异位骨化上差异无显著性意义。两组置换后疗效均较术前明显提高,组间比较的Meta分析结果显示,不论是≤5年组还是>5年组,均是骨水泥型假体生存率均高于非骨水泥型假体生存率,两组在稳定性、相关并发症、翻修率、异位骨化等方面差异均无显著性意义(P>0.05)。

BACKGROUND： The foreign researches have shown that, the bone cement prosthesis replacement accounted for 95.2% during total knee arthroplasty, but some experts believe that the use of bone cement for prosthesis fixation has high risk. OBJECTIVE： To assess the effect difference of bone cement prosthesis and non-cement prosthesis replacement in total knee arthroplasty based on Cochrane system. METHODS： The Medline database （from January 1996 to August 2011 ）, Embase database （from January 1980 to August 2011 ）, Cochranelibrary （August 2011 ）, CBM database （from January 1990 to August 2011 ） and some other references were searched for the randomized controlled trials on bone cement prosthesis and non-cement prosthesis replacement in total knee arthroplasty. The quality of the included studies was assessed by Cochrane. RevMan 5.1.2 software was used for Meta-analysis. The differences of postoperative survival rate, stability, and related complications, revision rate and ectopic ossification of bone cement prosthesis and non-cement prosthesis were compared. CRADEpro version 3.2.2 software was used for evidence rating. RESULTS AND CONCLUSION： Totally 1 381 cases form eight randomized controlled trials were involved, The cases were divided into the experimental group （bone cement group） and the control group （non-cement group）, 676 cases in the experimental group and 705 cases in the control group. Four studies compared the knee survival rate in the less or equaled 5 years postoperative group, and the difference between two groups was significant, it illustrated that survival rate was higher in the bone cement group. Four studies compared knee survival rate in more than 5 years postoperative group, and the difference between two groups was significant, it illustrated that survival rate was higher in the non-cement group. Three studies compared the stability of postoperative prosthesis in different follow-up times in two groups and showed that there was no significant difference in the stability between two groups. Four studies compared the related complication of postoperative prosthesis in two groups in different follow-up times and showed that there was no significant difference in related complications between two groups. Five studies compared overhaul rates of postoperative prosthesis in two grups in different follow-up times and showed that there was no significant difference between two groups. Three studies compared ectopic ossification of postoperative prosthesis in two groups in different follow-up times and showed that there was no significant difference between two groups. The curative effect after operation in two groups was improved. The Meta-analysis results compared between the greater or less 5 years groups showed that survival rate of bone cement prosthesis was higher than that of non-cement prosthesis, and there was no significant difference in stability, related complications and overhaul rates, as well as ectopic ossification between two groups （P 〉 0.05）.