李曾编译 翁习生审校
(中国医学科学院北京协和医学院北京协和医院骨科,北京100730)
髋关节置换已是一项成功的外科技术,随着假体设计及外科技术的不断改进,加之近年来围手术期的处理越来越受到人们的重视,每年都有很多新的研究成果问世。为此,我们把最新发表在The Journal of Bone and Joint Surgery.American Volume(JBJS)上的“What’s New in Hip Replacement”文章择译出,从假体设计、手术技术、术后疗效及并发症等方面,对近一年髋关节置换领域的600余篇文献进行了回顾与总结。
多个研究关注了生物型短柄的临床效果与影像学结果。在一项证据等级为Ⅰ级的临床试验中,研究者在小于55岁的人群中比较了传统解剖型生物柄与超短型生物柄的临床效果。通过平均11.8年的随访[1],并没有发现两者手术疗效或固定效果存在统计学差异。另一项随机对照试验通过24个月的随访对比了标准生物柄与短生物柄的临床疗效,并未发现假体周围骨量减少或固定效果存在统计学差异[2]。
大直径关节假体通常用来增加术后关节活动范围,减少脱位风险。多个研究关注了在金属-高交联聚乙烯界面中,假体磨损率与股骨头大小或内衬厚度之间的关系。在一项随机对照试验中,研究者比较了36 mm与28 mm直径的金属头对聚乙烯界面的平均磨损率[3]。虽然在1年和3年的随访中两者磨损程度相当,但研究者认为较大直径的股骨头可以提供更好的长期稳定性。
组配型假体的引入使术者在髋关节置换手术中有了更多的选择,包括选择更加合适的颈长、偏心距及型号以最大限度地增加假体的机械稳定性。但另一方面,组配型假体也增加了界面之间的磨损与腐蚀的风险。Langton等[4]通过对比未使用和使用过的假体,研究金对金假体头颈结合部失败的原因。结果显示两者结合界面磨损差异显著,接触界面的粗糙程度与假体磨损度密切相关。总之,在制造过程中不同假体的差异对于假体磨损与腐蚀的影响可能要远比传统观念严重。
另一项研究探究了血清金属离子浓度作为监测双锥组件全髋置换患者中锥形组件腐蚀相关性假瘤指标的敏感性与特异性[5]。结果表明,当钴离子浓度为2.8 μg/L时,其敏感性及特异性分别为88%、32%;当钴铬比率为3.8时,敏感性及特异性分别为70%、50%。研究者认为,虽然金属离子浓度不能作为是否进行翻修手术唯一的参考指标,但钴离子浓度为2.8 μg/L、钴铬比率为3.8可以作为锥形组件腐蚀引起的局部组织不良反应评估的参考项目。临床症状不明显并不能排除局部组织不良反应的存在,无论是否有相关症状,钴离子浓度及钴铬比率的升高提示可能存在腐蚀相关性假瘤[5-7]。
近一年来,大量研究关注了全髋关节置换术后并发症,其中部分原因归结于医疗保险捆绑支付模式下审查力度的加大及报销程序的改变[8-17]。据Bozic等报道,在享有美国医疗保障的人群中,2008年至2010年中期翻修率较1998年至2002年下降了14%,但短期(1~3年)的翻修率并没有明显改变[18]。
现阶段临床工作中存在一系列术前评估方法,用来分析危险因素,预测围手术期并发症的发生。Lakomkin等[19]评价了髋关节翻修术中术前改良Charlson合并症指数(CCI)与手术疗效的关系。结果表明CCI越高,并发症发生风险与住院时间越长。围手术期输血会增加约14%的风险,患者术后出院回家疗养可降低约28%的风险,术者手术量与住院时间也是重要的危险因素。髋关节置换术后30天再入院的五大最常见的原因分别是脱位(5.9%)、深部感染(5.1%)、切口感染(4.8%)、假体周围骨折(4.4%)以及血肿(3.4%)。无论如何,风险分层理念以及更完善的术后并发症评估方法将是以后研究的重点。
假体周围感染是全髋关节置换术后严重的并发症,不仅可导致住院天数及费用的增加,而且治疗程序繁琐复杂,并有较高的致残率。一个多中心经济学分析指出,假体周围感染患者的费用是无感染患者的4倍,且再入院率增高[20]。针对此问题,需要更积极的术前干预及对糖尿病患者更完善的管理。
在美国,手术室的清洁是遵照关节协会制定的标准完成的。近期在一项研究中,三磷酸腺苷(ATP)生物荧光试剂盒被用于检测手术室表面细菌分布情况,包括无影灯手柄、电刀开关、无菌台等[21]。结果表明,细菌最多的地方包括手术台、止血带机器开关以及空调管道。此研究表明,生物荧光技术可以用来监测细菌分布情况,提示手术室中的卫生死角,加强手术环境的清洁管理以预防感染发生。
关节腔内注射是临床常见的治疗方法。有两项研究表明,在3个月内进行髋关节内注射操作的患者更容易在髋关节置换术后第一年发生假体周围感染,比平均感染率高0.5%~1.0%[22,23]。所以,在计划进行髋关节置换术的3个月内,不建议进行关节腔内注射治疗。
关于术前是否需要进行鼻腔拭子细菌筛查及清除,研究表明此种处理可以降低手术部位感染率,但单纯清理鼻腔细菌同样有效,成本更低[24,25]。实际上,除去细菌筛查的步骤也简化了相关流程。另外,在鼻腔细菌清除方案的选择上,聚维酮碘消毒和预防使用莫匹罗星效果相当,但前者成本更低[25]。
近期有研究试图寻找除一代头孢菌素之外,还有哪些抗生素可以预防假体周围感染[26,27]。Bosco等[28]发现,髋关节置换术后感染中30%为革兰阴性菌,故其认为应在全髋关节置换患者中应用针对革兰阴性菌的抗生素。术前联用庆大霉素与头孢唑林后,其感染率从1.2%降至0.6%。当然,此方法引起的负面作用也是不能忽视的,如抗生素毒性累积、住院费用增加、细菌耐药性的产生[27]。
术后抗凝与假体周围感染的关系一直是热点问题。在一项对639例髋膝关节置换患者的随访中,Brimmo等发现术后应用利伐沙班抗凝患者的手术部位深部感染率(2.5%)远高于对照组(0.2%)(P<0.015)[29]。因此,更安全的术后抗凝方案还有待研究。
近几十年来,利用阿司匹林预防深静脉血栓与肺栓塞的文献层出不穷。近期,有研究基于患者风险分层分析,支持阿司匹林预防深静脉血栓。对于低血栓风险患者,相对于积极的抗凝治疗,阿司匹林所致的出血风险更低[30-32]。然而,如何界定血栓风险的高低仍然存在争议[33]。一些研究者将血凝过快、转移瘤、肺栓塞病史、近期深静脉血栓史视为高风险因素。而另外一些研究者则认为,慢性阻塞性肺疾病、代谢综合征、肥胖是高危因素。因此,何种人群可以从积极的抗凝方案中获益,还需要进一步研究[34-36]。
通过对大型医院髋膝关节置换并发症发生率的分析发现,在美国,越来越多的患者选择前往大医院手术,而且医院规模越大,并发症的发生率越低[37]。因此,专门的关节置换中心可能是未来的发展趋势。
关节置换患者出院后返回家中还是前往康复中心也是一个值得关注的问题。一项研究发现,术后前往配备专业护理及康复设施的康复中心,其关节置换术后不良事件风险高于回家疗养的患者[9]。同样,也有研究得出类似结论[8]。因此关节置换患者出院时,条件允许的情况下,回家疗养是最好的选择。
Perfetti等对全髋关节置换术后12个月的患者进行了一个倾向评分匹配分析,发现曾行腰椎融合术的患者人工髋关节术后脱位的风险是对照组的7倍[38]。Bedard等报道了类似的情况,其医院脊柱融合术后患者脱位率为20%[39]。研究者认为这种现象发生的原因可能是脊柱骨盆的融合限制了从站立位到坐位时骨盆正常的生理后倾。因此,对有腰椎融合术病史的患者,术前应充分告知其髋关节置换术后功能可能受到影响。
肥胖是公认的引起围手术期并发症的危险因素[11-13,16,17,40-44],可增加假体无菌松动、早期翻修的风险,降低患者术后满意度[11,17,41]。另外,肥胖或糖尿病还会增加术后翻修率,导致患者术后费用的增长。一项研究预测,假如人群肥胖或糖尿病的现状不予以控制,假体周围感染的翻修率将从1993年的5%~7%增长至2027年的30%~40%[45]。所以,对于肥胖患者,术前应告知其更易发生并发症,且手术疗效可能受到影响。
在过去的几年中,长期使用阿片类药物的患者越来越多。这导致在髋关节置换中这类患者也相应增加。这些患者在术前通常长期服用多种阿片类药物,术后对此类药物的需求将会更大。已有研究表明,长期使用阿片类药物对患者髋关节置换术后疗效等存在负面影响[46]。所以,在预测患者手术风险及疗效时,对于阿片类药物依赖患者,需要慎重考虑。
髋关节置换直接前方入路受到了越来越多的关注,其支持者称其优于外侧或后侧入路,但这仍存在着很多争议。一些研究认为其有利于术后早期康复,且不增加术后并发症的发生率[47]。但也有一些研究认为直接前方入路增加了相关围手术期并发症。
与其他入路相比,直接前方入路的切口并发症风险更高。在一项纳入约700例患者的研究中,75例(11.5%)直接前方入路患者存在需要处理的切口并发症,13例(2%)需要再次手术,其中最重要的危险因素是肥胖与糖尿病,结果显示BMI<28 kg/m2有助于降低其风险[48]。
根据全美关节置换患者数据,Menendez等发现2002~2011年,髋关节置换住院患者脱位率从0.025%增长至0.15%[49]。而另一项研究表明,直接前方入路患者术后脱位率为0.92%(8/817),其中6例发生在术后3周以内,这种脱位风险在1个月后基本消失[50]。而另一项超过2100例患者参加的研究却发现,直接前方入路并不比后方入路脱位的风险高[51]。总之,现阶段并没有哪一种入路体现出绝对的优势,而最终的选择需要医师根据患者的具体情况而定。
Dunn等研究了骨科医师、麻醉医师、手术室管理人员每天都在争论的问题,即手术室的最佳温度[52]。除了身着手术衣在灼热的无影灯下工作的医师,大部分人希望提高手术室温度。虽然存在关于手术室温度与并发症的相关研究,但其中大部分并没有特别纳入骨科手术患者,所以手术室温度与骨科手术并发症之间尚未建立明确的关联。也有研究表明,较高的室温可能增加手术并发症的发生、降低手术效率、增加术者疲劳感及操作失误,但并没有研究能清晰地阐述其因果关系。笔者建议术前、术中控制室温在19℃左右,这样有利于患者安全及术后疗效。
髂腰肌肌腱与髋臼假体撞击导致的腹股沟疼痛并不常见,但处理却非常棘手。Chalmers等对比了髂腰肌松解术或髋臼翻修术与保守治疗的疗效差异。结果表明,对于髋臼假体突出<8 mm的患者,保守治疗可以缓解50%患者的相关症状,腰大肌肌腱松解术效果更好[53]。而对于更严重的髋臼假体突出,则需要髋臼翻修手术。
关节置换术后再入院一直是医保部门关注的焦点。Weinberg等评估了近1100名因关节炎行关节置换的患者,其中50例(5%)在术后30 d内,69例(6%)90 d内再次入院[54]。在90 d内再次入院的69例患者中,只有3例的情况是可以避免的,1例为术后脱位,另2例为内科原因。故笔者认为90 d内6%的再入院率可以作为相关研究的基线数据,而这需要更大样本量的研究验证。
髋关节置换术后,患者最关心的问题之一就是能否正常驾驶车辆。一个纳入了19项研究的meta分析认为,右髋关节置换术后平均2周患者可恢复正常驾驶[55]。虽然对于不同的患者应有不同的判断,但这给医师提供了一个参考标准。
综上所述,在过去的一年中,髋关节置换领域涌现了很多新进展。这600余篇髋关节置换领域的最新文献主要涉及新型假体的评估、并发症的预测及预防、手术疗效评价等几个方面。与既往研究相比,髋关节置换领域的研究重点正从假体本身向手术疗效与医疗质量的提高转变。但另一方面,在这600多篇文献中的大部分是回顾性研究,只有一小部分研究证据等级为Ⅰ级。这从一个侧面说明,对临床医师而言,在降低费用、增加周转、提高疗效的多重压力下,设计与完成高质量的临床研究是有挑战性的。
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