李宣明,劉權(quán)興,張時(shí)文

(1 四川省大竹縣人民醫(yī)院骨科 635100；2 第三軍醫(yī)大學(xué)新橋醫(yī)院胸外科,重慶 400038)

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全膝關(guān)節(jié)置換術(shù)中髕骨置換對(duì)手術(shù)效果影響的Meta分析

李宣明1,劉權(quán)興2,張時(shí)文1

(1 四川省大竹縣人民醫(yī)院骨科 635100；2 第三軍醫(yī)大學(xué)新橋醫(yī)院胸外科,重慶 400038)

目的 評(píng)價(jià)髕骨置換與非髕骨置換對(duì)全膝關(guān)節(jié)置換術(shù)療效的影響，為臨床治療方案的選擇提供循證依據(jù)。方法 檢索Pubmed、Cochrane、Medline、Embase、中國(guó)期刊全文數(shù)據(jù)庫(kù)(CNKI)及萬(wàn)方等數(shù)據(jù)庫(kù)，收集有關(guān)全膝關(guān)節(jié)置換術(shù)時(shí)髕骨置換與否的隨機(jī)對(duì)照研究。按照納入、排除標(biāo)準(zhǔn)由兩名研究人員獨(dú)立進(jìn)行篩選并提取相關(guān)數(shù)據(jù)，以再次手術(shù)率、膝關(guān)節(jié)疼痛分?jǐn)?shù)以及膝關(guān)節(jié)評(píng)分作為測(cè)量指標(biāo)。采用RevMan 5.3軟件進(jìn)行Meta分析。結(jié)果 15篇文獻(xiàn)納入分析，共1 788例患者，其中髕骨置換組患者共871例，非髕骨置換組患者共917例。髕骨置換組患者的再次手術(shù)率明顯低于非髕骨置換組患者(RR=0.50，95%CI：0.33～0.76;P=0.001)，且膝關(guān)節(jié)功能也得到明顯改善(WMD=3.04，95%CI：0.41～5.67;P=0.02)。而兩種手術(shù)方式患者的前膝關(guān)節(jié)疼痛(WMD=0.96，95%CI：-0.85～2.76;P=0.30)、膝關(guān)節(jié)評(píng)分(RR=0.81，95%CI:0.50～1.32;P=0.41)差異無(wú)統(tǒng)計(jì)學(xué)意義。結(jié)論 全膝關(guān)節(jié)置換術(shù)時(shí)進(jìn)行髕骨置換可以降低再次手術(shù)的風(fēng)險(xiǎn)，改善術(shù)后膝關(guān)節(jié)功能，但不能改善術(shù)后膝關(guān)節(jié)疼痛分?jǐn)?shù)及膝關(guān)節(jié)評(píng)分指數(shù)。

全膝關(guān)節(jié)置換術(shù)；髕骨置換；再次手術(shù)率；Meta分析

全膝關(guān)節(jié)置換術(shù)(total knee arthroplasty，TKA)中是否進(jìn)行髕骨置換，目前仍然存在爭(zhēng)議。一部分外科醫(yī)生在手術(shù)時(shí)更傾向于進(jìn)行髕骨置換，因?yàn)槠淇梢詼p少二次髕骨修復(fù)和其他再次手術(shù)的概率，并且還可以減輕前膝關(guān)節(jié)疼痛。但另一部分外科醫(yī)生卻不推薦在TKA時(shí)進(jìn)行髕骨置換，以避免骨折、松動(dòng)、不穩(wěn)定以及膝蓋骨肌腱損傷的出現(xiàn)[1]。本研究對(duì)已有的隨機(jī)對(duì)照試驗(yàn)結(jié)果進(jìn)行Meta分析評(píng)價(jià)，探討TKA術(shù)中髕骨置換與否對(duì)TKA手術(shù)療效差異，為臨床醫(yī)生決策提供參考。

1 資料與方法

1.1 文獻(xiàn)檢索 使用計(jì)算機(jī)檢索Pubmed、Cochrane、Medline、Embase、中國(guó)期刊全文數(shù)據(jù)庫(kù)(CNKI)及萬(wàn)方等數(shù)據(jù)庫(kù)，檢索時(shí)間均為建庫(kù)至2014年5月30日。由兩名研究人員根據(jù)納入、排除標(biāo)準(zhǔn)獨(dú)立嚴(yán)格檢索篩選后確定納入文獻(xiàn)。對(duì)于重復(fù)發(fā)表的文獻(xiàn)，納入報(bào)道最早且報(bào)道最全面的那篇文獻(xiàn)。英文檢索詞：total knee arthroplasty、patellar resurfacing、randomized controlled trial。中文檢索詞：全膝關(guān)節(jié)置換術(shù)、髕骨置換、隨機(jī)對(duì)照研究。

1.2 方法

1.2.1 納入、排除標(biāo)準(zhǔn) 納入標(biāo)準(zhǔn)：(1)納入所有比較TKA中髕骨置換與非髕骨置換臨床療效的文獻(xiàn)；語(yǔ)種限定英文和中文；(2)研究對(duì)象為TKA術(shù)中髕骨置換與非髕骨置換的患者，不分年齡、性別和種族等；(3)比較指標(biāo)為TKA術(shù)中髕骨置換與非髕骨置換兩種方式的再次手術(shù)率、前膝關(guān)節(jié)疼痛分?jǐn)?shù)及膝蓋評(píng)分。排除標(biāo)準(zhǔn)：(1)只采取一種手術(shù)方法，且未作兩種方法比較的研究；(2)只有摘要而無(wú)法獲得全文信息的會(huì)議論文以及未發(fā)表的數(shù)據(jù)；(3)非隨機(jī)對(duì)照研究或研究對(duì)象區(qū)分種族的研究。為避免重復(fù)統(tǒng)計(jì)，對(duì)同批患者進(jìn)行研究的多次研究合并為1次。

1.2.2 文獻(xiàn)質(zhì)量評(píng)估及數(shù)據(jù)提取 按照Cochrane評(píng)價(jià)手冊(cè)的評(píng)估標(biāo)準(zhǔn)，由2名獨(dú)立的研究人員對(duì)文獻(xiàn)是否符合納入標(biāo)準(zhǔn)進(jìn)行評(píng)估并從每一篇文獻(xiàn)中提取相關(guān)數(shù)據(jù)，對(duì)文獻(xiàn)納入和提取數(shù)據(jù)有質(zhì)疑的由第3名研究人員介入并通過(guò)討論達(dá)成一致。提取的數(shù)據(jù)包括：文獻(xiàn)信息、任意原因?qū)е碌脑俅问中g(shù)、隨訪時(shí)間、TKA術(shù)后患者承受的前膝蓋疼痛級(jí)別以及相關(guān)膝蓋評(píng)分。

1.3 統(tǒng)計(jì)學(xué)處理 使用RevMan 5.2軟件對(duì)提取的數(shù)據(jù)進(jìn)行分析。對(duì)納入的研究進(jìn)行異質(zhì)性檢驗(yàn)，若P≥0.1，I2≤50%，認(rèn)為各研究間無(wú)統(tǒng)計(jì)學(xué)異質(zhì)性，則采用固定效應(yīng)模型；若P<0.1，I2≥50%，認(rèn)為各研究間存在統(tǒng)計(jì)學(xué)異質(zhì)性，則對(duì)其異質(zhì)性來(lái)源進(jìn)行分析，無(wú)法解決或無(wú)法判定異質(zhì)性來(lái)源時(shí)采用隨機(jī)效應(yīng)模型進(jìn)行分析，必要時(shí)采用敏感性分析判斷結(jié)果的穩(wěn)定性，無(wú)法合并的指標(biāo)采用描述性分析。以P<0.05為差異有統(tǒng)計(jì)學(xué)意義。

2 結(jié) 果

2.1 文獻(xiàn)檢索結(jié)果 初步檢索出文獻(xiàn)172篇，其中英文文獻(xiàn)159篇，中文文獻(xiàn)13篇，經(jīng)過(guò)閱讀文獻(xiàn)題目、摘要后得到文獻(xiàn)共35篇，進(jìn)一步滿足納入標(biāo)準(zhǔn)進(jìn)行評(píng)價(jià)后得到文獻(xiàn)共15篇，所有文獻(xiàn)均為隨機(jī)對(duì)照研究[2-16]。共納入髕骨置換患者871例，非髕骨置換患者917例，見(jiàn)表1。

2.2 Meta分析結(jié)果

2.2.1 再次手術(shù)率 14篇文獻(xiàn)報(bào)道了再次手術(shù)率，效應(yīng)指標(biāo)采用RR表示。P=0.60，I2=0%，無(wú)異質(zhì)性差異，采用固定效應(yīng)模型。結(jié)果顯示相比非髕骨置換，進(jìn)行髕骨置換能夠降低TKA術(shù)后的再次手術(shù)率(RR=0.50，95%CI：0.33～0.76;P=0.001)，見(jiàn)圖1。

2.2.2 術(shù)后前側(cè)膝關(guān)節(jié)疼痛分?jǐn)?shù) 10篇文獻(xiàn)報(bào)道了術(shù)后前膝關(guān)節(jié)疼痛的患者數(shù)，效應(yīng)指標(biāo)采用WMD表示，P=0.003，I2=51%，存在異質(zhì)性差異，采用隨機(jī)效應(yīng)模型。結(jié)果顯示TKA手術(shù)中是否進(jìn)行髕骨置換對(duì)術(shù)后前側(cè)膝關(guān)節(jié)疼痛的影響差異無(wú)統(tǒng)計(jì)學(xué)意義(WMD=0.96，95%CI：-0.85～2.76;P=0.30)，見(jiàn)圖2。

2.2.3 膝關(guān)節(jié)評(píng)分 11篇文獻(xiàn)報(bào)道了膝關(guān)節(jié)評(píng)分的數(shù)據(jù)，效應(yīng)指標(biāo)采用RR表示，P<0.0001，I2≤75%，存在異質(zhì)性差異，采用隨機(jī)效應(yīng)模型。結(jié)果顯示TKA手術(shù)中是否進(jìn)行髕骨置換對(duì)術(shù)后膝關(guān)節(jié)評(píng)分的影響差異無(wú)統(tǒng)計(jì)學(xué)意義(RR=0.81，95%CI：0.50～1.32;P=0.41)，見(jiàn)圖3。

表1 納入Meta分析的原始研究

2.2.4 膝關(guān)節(jié)功能分?jǐn)?shù) 8篇文獻(xiàn)均報(bào)道了膝關(guān)節(jié)功能分?jǐn)?shù)，效應(yīng)指標(biāo)采用WMD表示，P<0.0001，I2≤75%，無(wú)異質(zhì)性差異，采用固定效應(yīng)模型。結(jié)果顯示相比非髕骨置換，進(jìn)行髕骨置換能夠改善TKA術(shù)后的膝關(guān)節(jié)功能，差異有統(tǒng)計(jì)學(xué)意義(WMD=3.04，95%CI：0.41～5.67;P=0.02)，見(jiàn)圖4。

圖1 再次手術(shù)率的比較

圖2 術(shù)后前側(cè)膝關(guān)節(jié)疼痛分?jǐn)?shù)的比較

圖3 膝關(guān)節(jié)評(píng)分的比較

圖4 膝關(guān)節(jié)功能評(píng)分的比較

3 討 論

通過(guò)Meta分析對(duì)納入隨機(jī)對(duì)照研究中的1 788例患者數(shù)據(jù)進(jìn)行分析，結(jié)果顯示在TKA中同期行髕骨置換可以顯著降低TKA術(shù)后患者再次手術(shù)的概率(P=0.001)，并且能夠改善術(shù)后膝關(guān)節(jié)功能(P=0.02)；而相比非髕骨置換，其對(duì)TKA術(shù)后前側(cè)膝關(guān)節(jié)疼痛(P=0.30)及術(shù)后膝關(guān)節(jié)評(píng)分則無(wú)明顯改善(P=0.41)。

本研究發(fā)現(xiàn)TKA中同期行髕骨置換可以降低再次手術(shù)率，這一結(jié)論與Fu等[17]的研究結(jié)果類似，但是本研究并未對(duì)再次手術(shù)后的相關(guān)指標(biāo)進(jìn)行分析。而Fu等[17]的研究中提示，再次手術(shù)后76%的患者膝關(guān)節(jié)相關(guān)性疼痛可以得到減輕。

在進(jìn)行文獻(xiàn)檢索過(guò)程中筆者發(fā)現(xiàn)，對(duì)于TKA中是否同期行髕骨置換術(shù)尚無(wú)嚴(yán)格的隨機(jī)對(duì)照試驗(yàn)設(shè)計(jì)的證據(jù)。而目前不論是前瞻性的研究或是回顧性研究都無(wú)法得出一致的結(jié)論。比如，Pakos等[18]、Patel等[19]和Calvisi等[20]的研究均表明TKA同期行髕骨置換將會(huì)降低再次手術(shù)率和減少術(shù)后前膝疼痛的發(fā)生。然而Fu等[17]和He等[21]僅僅發(fā)現(xiàn)同期髕骨置換有利于降低再次手術(shù)率，而對(duì)減少術(shù)后前膝疼痛的發(fā)生并無(wú)明顯作用。有研究認(rèn)為兩組中再手術(shù)發(fā)生率的差異是因?yàn)轶x骨損傷程度在兩組中的不一致造成的。為此，Seo等[22]進(jìn)行了一項(xiàng)回顧性研究，結(jié)果表明髕骨損傷程度與術(shù)中是否進(jìn)行髕骨置換并無(wú)明顯相關(guān)性。關(guān)于全膝關(guān)節(jié)置換術(shù)的一些研究文獻(xiàn)[23-24]顯示術(shù)中軟組織尤其是韌帶的損傷程度對(duì)于是否選擇進(jìn)行髕骨置換尤為重要。Hwang 等[23]研究表明，如果軟組織能保持正常功能并且髕骨友好型假體的設(shè)計(jì)使用得當(dāng)，保留髕骨的髕骨成形術(shù)是可行的，甚至對(duì)于髕骨嚴(yán)重?fù)p傷的患者也能進(jìn)行髕骨保留?；谝陨戏治?，TKA術(shù)中是否同期行髕骨置換目前并無(wú)統(tǒng)一意見(jiàn)。本研究為針對(duì)這一問(wèn)題提供了一個(gè)有力證據(jù)。

綜上所述，TKA中同期行髕骨置換可以顯著降低再次手術(shù)率，并且改善術(shù)后膝關(guān)節(jié)的功能，然而術(shù)后前膝關(guān)節(jié)疼痛及術(shù)后膝關(guān)節(jié)評(píng)分則無(wú)明顯改善。這一結(jié)論尚需要嚴(yán)格的隨機(jī)對(duì)照試驗(yàn)來(lái)支持。

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A meta analysis of influence of patellar resurfacing on effect of total knee arthroplasty

LiXuanming1，LiuQuanxing2，ZhangShiwen1

(1.DepartmentofOsteology,DazhuCountyPeople′sHospital,Dazhu,Sichuan635100,China; 2.DepartmentofThoracicSurgery,XinqiaoHospital,ThirdMilitaryMedicalUniversity,Chongqing400038,China)

Objective To evaluate the influence of patellar resurfacing and non-patellar resurfacing on the effect of total knee arthroplasty to provide the evidence-based basis for selecting the clinical treatment scheme.Methods The clinical randomized controlled trials(RCT)on the whether having patellar replacement in total knee arthroplasty were retrieved from the databases of Pubmed,Cochrane,Medline,Embase,CNKI and WanFang data.The screening was independently performed by two researchers according to the including and excluding criterion.The related data were extracted.The reoperation rate,knee joint pain score and knee joint score served as the measurement criteria.The RevMan 5.2 software was adopted to conduct the meta analysis.Results Fifteen literatures were included to analyze,involving 1 788 patients,among them 871 cases were in the patellar resurfacing group and 917 case sin the non-patellar resurfacing group.The reoperation rate in the patellar resurfacing group was significantly lower than that in the non-patellar resurfacing group(RR=0.50，95%CI：0.33-0.76;P=0.001),moreover the knee joint function was significantly improved(WMD=3.04，95%CI：0.41-5.67;P=0.02).However,the anterior knee joint pain(WMD=0.96，95%CI：-0.85-2.76;P=0.30)and knee joint score(RR=0.81，95%CI：0.50-1.32;P=0.41)had no statistical difference between the two operation modes.Conclusion Conducting patellar resurfacing in total knee arthroplasty can reduce the reoperation risk and improves the postoperative knee joint function,but does not improve postoperative knee joint pain score and knee joint score

total knee arthroplasty;patellar resurfacing;reoperation rate;Meta-analysis

李宣明(1965-)，本科，副主任醫(yī)師，主要從事創(chuàng)傷關(guān)節(jié)矯形方面的研究。

?證醫(yī)學(xué)·

10.3969/j.issn.1671-8348.2016.33.024

R687.4

A

1671-8348(2016)33-4680-04

2016-03-22

2016-06-06)