前路颈椎椎间盘切除融合术(ACDF)是治疗颈椎病的金标准[1]。长期随访发现,ACDF术后相邻节段退行性变(ASDeg)和相邻节段疾病(ASDis)已成为ACDF术后相对严重的并发症而备受关注[2]。ASDis为具有临床症状的ASDeg[3]。有文献报道,ACDF术后相邻节段生物力学改变,从而导致ASDeg加速[4]。Zigler等[5]通过60个月的随访发现,2个节段行ACDF,术后ASDeg发生率高达54.7%,相邻节段再手术(ASR)发生率为11.6%。颈椎椎间盘置换术(CDA)因理论上可降低相邻节段代偿的活动度(ROM),延缓ASDeg的发生,而被用于治疗颈椎病。多项随机对照研究(RCT)也报道CDA较ACDF术后ASDeg的发生率更低[6-7]。然而,Hisey等[8]发现CDA和ACDF术后ASDis发生率差异没有统计学意义。因此,多项荟萃分析试图通过评估RCT分析CDA是否能够降低相邻节段相关并发症的发生率[9-11]。但是,众多荟萃分析因纳入的RCT数量较少,结论仍不能达成一致,而且多数荟萃分析只关注ASDis或ASR,忽略了ASDeg及相邻节段ROM的改变。综上,本研究通过纳入更多符合条件的RCT文献,对CDA和ACDF对相邻节段病变参数的影响进行详细的荟萃分析。
1 资料与方法 1.1 文献检索检索2018年6月前发表的CDA与ACDF的RCT文献,检索PubMed、Medline、EMbase和Cochrane图书馆数据库。英文搜索词选择“arthroplasty”“replacement”“arthrodesis”“kinematics”“mobility”“biomechanics”“range of motion”“biomechanical phenomena”“motion”“cervical vertebrae”“radiculopathy”“spinal cord diseases”“spondylosis”“adjacent segment”“adjacent level”“adjacent-level”“adjacent-segment”。纳入标准:①文献中包括相邻节段相应参数;②文献对ASDeg和ASDis有明确的定义。同时搜索纳入文献中的引用文献或者其他荟萃分析中符合条件的文献,排除重复研究。
1.2 数据提取、文献筛选及质量评价主要提取的数据包括作者信息、发表时间、病例数量、随访时间、相邻节段参数(ASDeg,ASDis,ASR,相邻节段ROM)。2名研究员对纳入文献独立分析筛选,进行质量评估和偏倚风险评估,使用Coehrane系统评价指南提供的偏倚风险评估量表[12],如存在争议,由第3名研究员介入裁决直到达成共识。kappa系数用来评估评定者间的可信度。偏倚风险评估量表包括随机序列的产生,分配隐藏,实施者和参与者盲法,结果评估的盲法,结果数据的完整性,选择性报告,基线指标相似性及其他偏倚。每项判断标准分为低度偏倚(+),高度偏倚(-),不清楚(?)。文献满足低度偏倚项≥4为低风险文献;文献满足低度偏倚项 < 4为高风险文献。
1.3 统计学处理采用RevMan 5.3软件对数据进行荟萃分析。首先对纳入的RCT文献进行临床异质性分析,若无异质性(I2 < 50%,P > 0.1),采用固定效应模型进行荟萃分析;若存在异质性(I2 > 50%,P < 0.1),采用随机效应模型进行荟萃分析;并进行亚组分析,根据随访时间是否超过24个月进行分组;采用敏感性分析研究单篇文献对整体结果的影响及高异质性的原因。比值比(OR)值和95%可信区间(95%CI)用于二分类变量;加权均数差(WMD)和95%CI用于连续性变量;以P < 0.05为差异有统计学意义;当一项荟萃分析中纳入研究数≥10项时,采用Stata 12.0软件分析得出的Bgger漏斗图评估发表偏倚。
2 结果 2.1 文献检索结果共检索出相关文献3 186篇,排除数据重复文献2 335篇;阅读文献题目及摘要排除729篇;进一步阅读全文,依据纳入、排除标准,排除文献69篇(非RCT 29篇,无相邻节段参数34篇,数据重复6篇);最终纳入文献33篇[2, 6, 8, 13-42],其中21篇随访时间 > 24个月,25篇为多中心研究;33篇文献中共有患者7 465例,4 209例采用CDA治疗,3 256例采用ACDF治疗。5篇文献存在纳入病例重复的情况,但因随访时间和相邻节段参数不同,也纳入研究。kappa系数为0.88,表示不同评估者之间一致性较高。大部分文献在以下方面为低度偏倚,结果数据的完整性,选择性报告和基线指标的相似性;在以下方面为高度险偏倚,随机序列的产生,分配隐藏,实施者和参与者盲法,结果评估的盲法。根据偏倚风险评估量表,28篇文献[2, 6, 8, 13-14, 16-18, 21-22, 24-36, 38-42]为低风险文献,5篇文献[15, 19-20, 23, 37]为高风险文献(表 1)。
CDA组ASR发生率明显低于ACDF组,差异有统计学意义[P < 0.000 01,OR=0.36,95%CI(0.27,0.48),图 1]。以随访时间进行亚组分析,随访时间≤24个月时,CDA组ASR发生率低于ACDF组,差异有统计学意义[P=0.03,OR=0.53,95%CI(0.30,0.93),图 1];随访时间 > 24个月,CDA组ASR发生率明显低于ACDF组,差异有统计学意义[P < 0.000 01,OR=0.31,95%CI(0.22,0.44),图 1]。以上结果说明,随着随访时间延长,相比ACDF组,CDA组降低ASR发生率的优势逐渐增加。
Davis等[34]对2个节段行CDA和ACDF治疗的患者进行比较,排除该文献后,随访时间≤24个月时2组ASR发生率差异无统计学意义[P=0.11,OR=0.61,95%CI(0.34,1.12),图 2];排除该文献后,随访时间 > 24个月时2组ASR发生率的结果没有改变。
ASDeg发生率,CDA组低于ACDF组,差异有统计学意义[P=0.001,OR=0.47,95%CI(0.29,0.74),图 3]。以随访时间进行亚组分析,随访时间≤24个月,2组ASDeg发生率差异无统计学意义[P=0.06,OR=0.46,95%CI(0.21,1.02),图 3];随访时间 > 24个月,CDA组ASDeg发生率明显低于ACDF组,差异有统计学意义[P=0.04,OR=0.48,95%CI(0.24,0.98),图 3]。
CDA组手术节段邻近上位节段ASDeg发生率高于下位节段,但差异无统计学意义[P=0.73,OR=1.11,95%CI(0.61,2.03),图 4];ACDF组手术节段邻近上位节段ASDeg发生率高于下位节段,但差异无统计学意义[P=0.13,OR=1.25,95%CI(0.93,1.68),图 5]。
CDA组ASDis发生率低于ACDF组,但差异无统计学意义[P=0.17,OR=0.72,95%CI(0.46,1.14),图 6]。排除混合节段的文献[24, 29],只对单节段进行分析后得出,CDA组ASDis发生率低于ACDF组,且差异仍无统计学意义[P=0.07,OR=0.56,95%CI(0.30,1.06),图 7]。
CDA组上位相邻节段ROM小于ACDF组,但差异无统计学意义[P=0.31,MD=-0.99,95%CI(-2.87,0.90),图 8];CDA组下位相邻节段ROM小于ACDF组,但差异无统计学意义[P=0.08,MD=-2.46,95%CI(-5.24,0.32),图 8]。
偏倚分析需纳入文献≥10篇,故只有ASR发生率的结果可以进行发表偏倚分析,漏斗图显示该荟萃分析发表偏倚不明显(图 9)。
敏感性分析是研究单篇文献对整体结果的影响及高异质性的原因分析。当Auerbach等[39]发表的文献排除后,2组上下相邻节段ROM的荟萃分析异质性明显下降,但最后整体结论基本没有变化。5篇高风险文献的敏感性分析结果显示均对荟萃分析结果及异质性无明显影响。
3 讨论ASDeg和ASDis为ACDF术后相对严重的并发症,ASDeg发生原因是相邻节段生物力学改变还是自然病程仍存在争议[43]。Hisey等[8]的RCT报道,ACDF和CDA随访中ASDis的发生率差异没有统计学意义。因此,有荟萃分析研究ACDF和CDA对相邻节段的影响,但是并没有形成统一的结论[9-11, 44]。
本研究结果显示,CDA组ASR发生率低于ACDF组。Gao等[45]的荟萃分析也显示CDA组具有更低的二次手术率,但其仅纳入6篇文献,且没有单独分析ASR。Zhu等[11]的荟萃分析结果与本研究一致,均证实CDA组具有更低的ASR发生率,但是该荟萃分析只纳入10篇文献。徐帅等[46]的研究也显示同样的结果,但该研究仅纳入5篇文献。本研究关于ASR的荟萃分析纳入了22篇RCT,并进行了随访时间亚组分析,得出随着随访时间延长,CDA组降低ASR发生率的优势较ACDF组增加,而且漏斗图显示没有明显发表偏倚。
文献检索发现,很少有荟萃分析研究ASDeg和相邻节段ROM。大部分荟萃分析只研究ASDis和ASR[9-11, 44-45, 47]。徐帅等[46]的研究显示,CDA组ASDeg发生率低于ACDF组,与本研究结果一致。但是本研究以24个月随访时间为节点进行亚组分析得出,随访≤24个月时CDA与ACDF组术后ASDeg发生率差异没有统计学意义,随着随访时间延长,CDA组较ACDF组有降低ASDeg发生率的优势,且差异有统计学意义。但是,该结果应被谨慎对待,因为纳入RCT的例数不多,且具有高异质性。
Verma等[44]和Yang[10]等分别通过荟萃分析报道CDA和ACDF术后ASDis发生率的差异没有统计学意义。而Luo等[47]和Zhu等[11]分别通过荟萃分析报道CDA组ASDis发生率低于ACDF组。本研究纳入8篇RCT进行荟萃分析后得出CDA组和ACDF组术后ASDis发生率差异没有统计学意义,该分析异质性低(I2=0%),敏感性分析也显示该结果具有较高的可靠性,且与徐帅等[46]的研究结果一致,但其仅纳入3篇文献。不同荟萃分析得出的结论存在争议的原因:①混淆了ASDis和ASDeg的概念,将ASDeg的数据纳入ASDis进行分析;②将前瞻性队列研究当成RCT进行分析;③纳入的RCT较少,导致偏倚的产生,特别是发表偏倚。
有文献报道ACDF术后相邻节段ROM增加,从而引发ASDeg,CDA通过减少相邻节段代偿ROM从而降低ASDeg发生率[4, 48-49]。然而本研究发现,CDA组和ACDF组上/下相邻节段ROM差异均无统计学意义。该研究结果提示,ASDeg可能不是相邻节段ROM增加所导致。但是该分析纳入的研究数量较少,而且随访时间较短,该结论应被谨慎对待。同时,应该有更多的研究分析是否因术后相邻节段应力增加等因素导致ASDeg。但是,理论上下位相邻节段的应力高于上位相邻节段,但本研究结果显示,2组手术节段上位相邻节段ASDeg发生率与下位相邻节段相比差异无明显统计学意义。因此,是否存在其他因素导致ASDeg的发生仍需进一步研究。
本研究的优势:①纳入33篇RCT文献进行相邻节段参数的比较,减少了发表偏倚,保证了结果的可靠性;②对ASDeg和相邻节段ROM进行了分析,同时分析了同一种术式上/下相邻节段ASDeg的发生率,以上数据在以往的荟萃分析中没有体现,以上参数对于分析ASDis和ASR发生的原因具有重要意义;③应用敏感性分析研究了异质性高的原因,保证结果的稳定性,而且进行了随访时间的亚组分析,并得出随访时间的变化导致相邻节段参数改变的趋势;④对以往发表的针对相邻节段的荟萃分析进行了详细比较。
本研究也存在不足之处,研究中测量软件、术者及人工椎间盘存在差异,可能导致部分结果存在高异质性,以及部分研究纳入RCT数量较少,均可能导致发表偏倚的产生,如相邻节段ROM和ASDeg发生率的结果。
综上所述,本研究结果显示,CDA相较于ACDF可降低ASDeg和ASR的发生率,而CDA和ACDF在ASDis发生率和相邻节段ROM方面差异无统计学意义。今后的研究中,更多的RCT应进一步纳入荟萃分析来确认结果的可靠性,减少发表偏倚的产生。
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