国内外不同大头金属-金属髋关节假体用于全髋关节假体置换:中国人群1年随访比较

Import and domestic metal-metal hip prostheses for total hip replacement: 1 year follow-up of Chinese populations

目的:比较进口和国内的金属-金属髋关节假体在髋关节置换治疗中临床应用的安全性和远期疗效。方法:以"人工髋关节,金属大头髋,人工髋关节置换"为中文关键词;"Hipreplacement,Bulkmetalhip"为英文关键词。采用计算机检索1969-01/2009-12相关文章。纳入与有关生物材料与组织工程血管相关的文章;排除重复研究或Meta分析类文章。以14篇文献为主重点进行了讨论。临床验证选择广西壮族自治区人民医院和广西医科大学第四附属医院关节外科收治的行大头金属-金属全髋关节置换的患者63例(71髋),按患者选用的置换物分为两组:A组采用爱康(A.K)公司生产的第4代大头金属-金属髋关节假体;B组使用美国Depuy公司生产的第4代大头金属-金属髋关节假体。比较2组随访1年时髋关节Harris评分,髋关节活动范围,X射线假体周围透亮带,双下肢不等长及置换后并发症等指标。结果:人工髋关节根据假体的股骨头、髋臼材料可分为4种:金属-聚乙烯、陶瓷-聚乙烯、陶瓷-陶瓷、金属-金属;其中后者还依据有无金属柄分为金属大头髋和金属表面置换两种。临床验证结果:A组随访15～28个月;B组随访13～26个月。两组患者置换1年时,A体组Harris髋关节评分65～98分,平均89分;B组71～99分,平均92分,两组相比,差异无显著性意义(P>0.05)。髋关节活动范围B组为37°,A组为35°,两组相比,差异无显著性意义(P>0.05)。双下肢不等长差值B组平均5.1mm(2～11mm),A组为6.8mm(5～14mm),两组相比,差异无显著性意义(P>0.05)。两组均有≤1mm假体周围透亮带发生(A组4例,B组1例);B组有1例脱位。结论:进口和国内的大头金属-金属髋关节假体在治疗髋关节疾病中应用安全有效,短期疗效相似。

OBJECTIVE： To compare the clinical safety and long-term effect between import and domestic metal-to-metal hip prosthesis in hip replacement. METHODS： A computer-based online search was performed for related articles published between January 1969 and December 2009, with key words ＂hip replacement, bulk metal hip＂ in English. Articles related with biomaterials and tissue-engineered vessels were included. Repetitive studies or Meta analysis were excluded. A total of 14 articles were discussed. A total of 63 patients （71 hips） undergoing bulk metal total hip replacement in Department of Joint Surgery, Fourth Hospital of Guangxi Medical University were divided into two groups. Group A was treated with the fourth generation bulk metal hip prosthesis （A.K.）, and group B was treated with the fourth generation bulk metal hip prosthesis （Depuy, USA）. Harris scores for hip joint, range of motion, X-ray radiolucent zone, leg length discrepancy and complications during 1 year follow up were compared. RESULTS： Artificial hip joint was divided into 4 types according to femoral and acetabular materials： metal-polyethylene, ceramics-polyethylene, ceramics-ceramics, metal-metal. And the metal-metal prosthesis included bulk metal hip and metal surface replacement. Clinical results showed that group A was followed up for 15-28 months and group B for 13-26 months. At 1 year following replacement, Harris scores were 89 （range 65-98） in group A, and 92 （71-99） in group B （P 0.05）. Range of motion was 37° in group B and 35° in group A （P 0.05）. Keg length discrepancy was 5.1 mm （2-1 1 mm） in group B and 6.8 mm （5-14 mm） in group A （P 0.05）. X-ray radiolucent zone （≤1 mm） was observed in two groups （4 cases in group A and 1 in group B）. In addition, 1 case of group B developed dislocation. CONCLUSION： Import and domestic bulk metal hip prostheses are safe and effective in treating hip joint diseases and exhibit similar short-term effect.