陳金忠 黃建婷 楊埜 李野 韓超 劉佳 謝克恭 唐毓金
【摘要】?目的?系統(tǒng)地比較直接前入路(DAA)與前外側(cè)入路(ALA)在人工全髖關(guān)節(jié)置換術(shù)的臨床療效。
方法?計(jì)算機(jī)檢索PubMed、Embase、Cochrane、知網(wǎng)、萬(wàn)方、維普等數(shù)據(jù)庫(kù)(自建庫(kù)以來(lái)到2019年7月)關(guān)于DAA與ALA髖關(guān)節(jié)置換術(shù)后臨床療效對(duì)照研究文獻(xiàn),按照納入與排除標(biāo)準(zhǔn)進(jìn)行篩選文獻(xiàn)提取數(shù)據(jù),并對(duì)文獻(xiàn)質(zhì)量進(jìn)行評(píng)估。采用Review manager 5.2進(jìn)行Meta分析,比較DAA與ALA臨床療效的差異,主要分析指標(biāo)包括并發(fā)癥(股外側(cè)神經(jīng)損傷、周圍骨折)、影像學(xué)表現(xiàn)(前傾角、髖臼杯外展角)、術(shù)后髖關(guān)節(jié)功能Harris評(píng)分,次要指標(biāo)為術(shù)中出血量、手術(shù)時(shí)間、住院時(shí)間。
結(jié)果?共有8篇文獻(xiàn)、730例患者納入研究。研究結(jié)果顯示兩組患者周圍骨折[RR=2.02,95%CI(0.45~9.10),P=0.36]、前傾角[WMD=2.22,95%CI(-0.06~4.51),P=0.06]、髖臼杯外展角[WMD=0.66,95%CI(-0.38~1.71),P=0.21]、術(shù)后髖關(guān)節(jié)Harris評(píng)分[WMD=0.47,95%CI(-2.71~3.66),P=0.77]、手術(shù)時(shí)間[WMD=-0.44,95%CI(-1.14~0.26),P=0.22]、手術(shù)切口[WMD=-1.18,95%CI(-2.89~0.51),P=0.17]等方面差異無(wú)統(tǒng)計(jì)學(xué)意義;DAA入路股外側(cè)神經(jīng)損傷發(fā)生率高于ALA入路[RR=3.79,95%CI(1.43~10.01),P=0.007],但術(shù)中出血量少于ALA入路[WMD=-75.15,95%CI(-107.30~-43.00),P<0.001],患者住院時(shí)間短于ALA入路[WMD=-2.30,95%CI(-4.24~-0.36),P=0.02]。
結(jié)論?兩種入路在影像學(xué)表現(xiàn)、術(shù)后髖關(guān)節(jié)功能Harris評(píng)分、手術(shù)時(shí)間、術(shù)口長(zhǎng)度等方面無(wú)顯著差異,但DAA入路術(shù)中出血量少,住院時(shí)間短,兩者在并發(fā)癥方面DAA入路股外側(cè)神經(jīng)損傷發(fā)生率高,但周圍骨折發(fā)生率兩者均較低,差異不明顯。納入研究異質(zhì)性較大,結(jié)果需要更高質(zhì)量對(duì)照研究進(jìn)一步驗(yàn)證。
【關(guān)鍵詞】?髖關(guān)節(jié)置換術(shù);直接前入路;前外側(cè)入路;Meta分析
中圖分類號(hào):R687.4?文獻(xiàn)標(biāo)志碼:A?DOI:10.3969/j.issn.1003-1383.2019.10.003
Meta-analysis of clinical efficacy of direct anterior approach and anterolateral approach after total hip arthroplasty
CHEN Jinzhong,HUANG Jianting,YANG Ye,LI Ye,HAN Chao,LIU Jia,XIE Kegong,TANG Yujin
(Department of Spinal Joint Osteopathy,Youjiang Medical University for Nationalities,Baise 533000,China)
【Abstract】?Objective?To systematically compare the clinical outcomes of direct anterior approach(DAA) and anterior lateral approach(ALA) in total hip arthroplasty.
Methods?Controlled research literatures on the clinical effects of DAA and ALA hip arthroplasty were searched from PubMed,Embase,Cochrane,CNKI,Wanfang,Weipu and other databases(since the establishment of the databases until July,2019).According to inclusion and exclusion criteria,the literatures were screened and extracted,and the quality of them were evaluated.Meta-analysis was conducted by Review Manager 5.2,and the difference of clinical efficacy between DAA and ALA was compared.The main analysis indexes were complications(lateral femoral nerve injury and peripheral fracture),imaging findings(anterior dip angle,acetabular cup abduction angle) andpostoperative Hip function Harris score.Secondary analysis indexes were intraoperative blood loss,operation time and hospital stay.
Results?A total of 8 articles and 730 patients were included in the study.The results of the study showed that there were no statistically significant differences in peripheral fractures[RR=2.02,95%CI(0.45~9.10),P=0.36],anteversion angles[WMD=2.22,95%CI(-0.06~4.51),P=0.06],hip cup abduction angles[WMD=0.66,95%CI(-0.38~1.71),P=0.21],postoperative hip joint Harris scores[WMD=0.47,95%CI(-2.71~3.66),P=0.77],operation time [WMD=-0.44,95%CI(-1.14~0.26),P=0.22],and surgical incisions[WMD=-1.18,95%CI(-2.89~0.51),P=0.17]between the two groups.The incidence of lateral nerve injury in the DAA approach was higher than that in the ALA approach[RR=3.79,95%CI(1.43~10.01),P=0.007],but the intraoperative blood loss was less than that in the ALA approach[WMD=-75.15,95%CI(-107.30~-43.00),P<0.001],patient hospitalization time was shorter than that in the ALA approach [WMD=-2.30,95%CI(-4.24~-0.36),P=0.02].
Conclusion?There are no significant differences between the two approaches in imaging findings,postoperative hip function Harris score,operation time and the length of the operation opening.However,the DAA approach has less bleeding and shorter hospital stay.The incidence of lateral nerve injury in the DAA approach is high,but the incidence of peripheral fractures in both approaches is low,difference is not significant.The heterogeneity of the inclusion study is large,and the results need to be further verified by higher quality control studies.
【Key words】?total hip arthroplasty;direct anterior approach;anterior lateral approach;Meta analysis
髖關(guān)節(jié)置換術(shù)(Total hip arthroplasty,THA)是現(xiàn)代醫(yī)學(xué)最成功的骨科手術(shù)之一,應(yīng)用于臨床已有百年歷史。THA入路有直接前入路(Direct anterior approach,DAA)、外側(cè)入路[前外側(cè)入路(Anterior lateral approach,ALA)、直接外側(cè)入路、后外側(cè)入路]、后路入路。但目前THA最有效的手術(shù)方法仍存在爭(zhēng)議。2010年從全球整形外科登記處提取的數(shù)據(jù)表明,55%和33%的THA分別采用后路入路和ALA進(jìn)行[1]。自2013年以來(lái),10%的骨科關(guān)節(jié)成形外科醫(yī)生認(rèn)為DAA入路是他們的首選方法[2]。DAA與ALA是THA中常用的微創(chuàng)入路,在一些臨床隊(duì)列研究中發(fā)現(xiàn)具有更低的脫位風(fēng)險(xiǎn)、早期步態(tài)改善及疼痛少等優(yōu)勢(shì)[3]。但在一項(xiàng)關(guān)于THA入路的網(wǎng)狀Meta分析發(fā)現(xiàn),DAA與ALA能有效提高視覺(jué)模擬評(píng)分(VAS)及Harris評(píng)分,但從并發(fā)癥來(lái)分析,后路發(fā)生率最低,其次是外側(cè),最差的是前入路[4]。既往文獻(xiàn)中有較多關(guān)于THA不同入路臨床療效的研究,關(guān)于DAA與ALA比較的文獻(xiàn)數(shù)量較少。最近有一篇關(guān)于DAA與ALA的薈萃分析[5],納入9篇文獻(xiàn),但比較的指標(biāo)是步態(tài)分析,納入的標(biāo)準(zhǔn)存在將外側(cè)入路籠統(tǒng)歸于前外側(cè)入路。本Meta分析嚴(yán)格按納入與排除標(biāo)準(zhǔn)篩選文獻(xiàn),結(jié)合國(guó)內(nèi)外文獻(xiàn),通過(guò)分析并發(fā)癥(股外側(cè)神經(jīng)損傷、周圍骨折)、影像學(xué)表現(xiàn)(前傾角、髖臼杯外展角)、髖關(guān)節(jié)功能Harris評(píng)分、手術(shù)時(shí)間、術(shù)口長(zhǎng)度、術(shù)中出血量、住院時(shí)間,系統(tǒng)地比較DAA與ALA臨床療效。
1?資料與方法
1.1?文獻(xiàn)檢索
計(jì)算機(jī)檢索PubMed、Embase、Cochrane、知網(wǎng)、萬(wàn)方、維普等數(shù)據(jù)庫(kù),手工檢索已發(fā)表關(guān)于DAA與ALA在人工髖關(guān)節(jié)置換術(shù)臨床療效比較的文獻(xiàn),限定文獻(xiàn)種類為英文或中文,使用的中文關(guān)鍵詞:髖關(guān)節(jié)置換術(shù)、關(guān)節(jié)成形術(shù)、直接前入路、前入路、前外側(cè)入路。英文關(guān)鍵詞:Hip replacement,Total hip arthroplasty,Direct anterior approach(DAA),Anterior lateral approach(ALA)。
1.2?納入及排除標(biāo)準(zhǔn)
納入標(biāo)準(zhǔn):①研究設(shè)計(jì)為隊(duì)列研究(隨機(jī)對(duì)照或回顧性研究);②研究人群為成人且因髖關(guān)節(jié)病變(原發(fā)性骨性關(guān)節(jié)炎或缺血性壞死)需行THA患者;③干預(yù):DAA或ALA全髖關(guān)節(jié)置換術(shù);④可以有效提取觀察指標(biāo)。排除標(biāo)準(zhǔn):①非中英文全文;②書(shū)信、摘要、綜述、Meta分析、會(huì)議論文、個(gè)案報(bào)道及重復(fù)發(fā)表的文獻(xiàn);③雙切口;④無(wú)法提取觀察指標(biāo)。
1.3?文獻(xiàn)質(zhì)量評(píng)估
采用改良JADAD評(píng)分表對(duì)每篇文章進(jìn)行質(zhì)量評(píng)估,主要基于隨機(jī)系列、隨機(jī)化隱藏、盲法及隨訪期間撤退與退出進(jìn)行評(píng)分(1~3分視為低質(zhì)量,4~7分視為高質(zhì)量)。
1.4?統(tǒng)計(jì)學(xué)方法
運(yùn)用RevMan 5.2軟件對(duì)提取的數(shù)據(jù)進(jìn)行Meta分析。對(duì)于計(jì)量資料以加權(quán)均數(shù)差(weighted mean difference,WMD)和95%可信區(qū)間(confidence interval,CI)為效應(yīng)指標(biāo)進(jìn)行分析,而計(jì)數(shù)資料則以相對(duì)危險(xiǎn)度(risk ratio,RR)及其95%CI為效應(yīng)指標(biāo)。檢驗(yàn)水準(zhǔn):α=0.05,雙側(cè)檢驗(yàn)。在合并研究時(shí)異質(zhì)性檢驗(yàn)采用I2檢驗(yàn),當(dāng)研究無(wú)統(tǒng)計(jì)學(xué)異質(zhì)性時(shí)(P>0.05,I2≤50%),采用固定效應(yīng)模型進(jìn)行分析。若出現(xiàn)統(tǒng)計(jì)學(xué)異質(zhì)性時(shí)(P≤0.05,I2>50%),采用隨機(jī)效應(yīng)模型,并盡可能找出異質(zhì)性來(lái)源,敏感性分析處理判斷Meta結(jié)果的穩(wěn)健性。Meta分析結(jié)果以森林圖展示。缺少標(biāo)準(zhǔn)差數(shù)據(jù),只描述均值、極值、樣本量的文獻(xiàn),采用Hozo[6]計(jì)算標(biāo)準(zhǔn)差并納入本次研究。
2?結(jié)果
2.1?文獻(xiàn)檢索結(jié)果
按照納入及排除標(biāo)準(zhǔn)進(jìn)行文獻(xiàn)篩選,提取資料內(nèi)容:第一作者姓名、發(fā)表年份、地域、術(shù)后髖關(guān)節(jié)功能Harris評(píng)分(6周、6個(gè)月)、并發(fā)癥(股外側(cè)神經(jīng)損傷、周圍骨折)、影像學(xué)表現(xiàn)(前傾角、髖臼杯外展角)、術(shù)中出血量、手術(shù)時(shí)間、住院時(shí)間。納入本次分析的文獻(xiàn)有8篇,共計(jì)730例患者。具體文獻(xiàn)篩選流程見(jiàn)圖1,具體納入資料見(jiàn)表1。
2.2?Meta分析結(jié)果
2.2.1?股外側(cè)神經(jīng)損傷
共有6篇文獻(xiàn)、569例納入研究,各研究之間無(wú)顯著異質(zhì)性(P=0.41,I2=1%),采用固定效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用RR,DAA入路股外側(cè)損傷發(fā)生率高,差異有統(tǒng)計(jì)學(xué)意義[RR=3.79,95%CI(1.43~10.01),P=0.007]。見(jiàn)圖2。
2.2.2?周圍骨折
共有3篇文獻(xiàn)、407例納入研究,各研究之間無(wú)顯著異質(zhì)性(P=0.78,I2=0),采用固定效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用RR,結(jié)果顯示兩種手術(shù)入路出現(xiàn)周圍假體骨折發(fā)生率相當(dāng),差異無(wú)統(tǒng)計(jì)學(xué)意義[RR=2.02,95%CI(0.45~9.10),P=0.36]。見(jiàn)圖3。
2.2.3?前傾角
術(shù)后采用標(biāo)準(zhǔn)髖關(guān)節(jié)正位片作為評(píng)估依據(jù),共有4篇文獻(xiàn)493例納入研究,各研究之間存在異質(zhì)性(P<0.001,I2=90%),采用隨機(jī)效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,兩種入路術(shù)后測(cè)量的前傾角差異無(wú)統(tǒng)計(jì)學(xué)意義 [WMD=2.22,95%CI(-0.06~4.51),P=0.06]。見(jiàn)圖4。
2.2.4?髖臼杯外展角
術(shù)后采用標(biāo)準(zhǔn)髖關(guān)節(jié)正位片作為評(píng)估依據(jù),正常范圍為30°~50°,共有3篇文獻(xiàn)、433例納入研究,研究之間無(wú)異質(zhì)性(P=0.27,I2=24%),采用固定效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示兩種入路并不影響髖臼外展角,差異無(wú)統(tǒng)計(jì)學(xué)意義[WMD=0.66,95%CI(-0.38~1.71),P=0.21]。見(jiàn)圖5。
2.2.5?術(shù)后Harris評(píng)分
共有3篇文獻(xiàn)242例患者納入研究,各研究間無(wú)顯著異質(zhì)性(P=0.18,I2=42%),采用固定效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,術(shù)后6個(gè)月髖關(guān)節(jié)Harris評(píng)分在兩種手術(shù)入路中差異無(wú)統(tǒng)計(jì)學(xué)意義[WMD=0.47,95%CI(-2.71~3.66),P=0.77]。見(jiàn)圖6。
2.2.6?手術(shù)時(shí)間
共有6篇文獻(xiàn)387例納入研究,各研究間存在顯著異質(zhì)性(P<0.001,I2=90%),采用隨機(jī)效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,兩種手術(shù)方式手術(shù)時(shí)間差異無(wú)統(tǒng)計(jì)學(xué)意義[WMD=-0.44,95%CI(-1.14~0.26),P=0.22]。見(jiàn)圖7。
2.2.7?術(shù)中出血量
共有5篇文獻(xiàn)228例納入研究,各研究之間存在異質(zhì)性(P<0.001,I2=67%),采用隨機(jī)效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,與ALA相比,DAA術(shù)中出血量較少 [WMD=-75.15,95%CI(-107.30~-43.00),P<0.001]。見(jiàn)圖8。
2.2.8?切口長(zhǎng)度
共有5篇文獻(xiàn)354例納入研究,各研究間存在顯著異質(zhì)性(P<0.001,I2=95%),采用隨機(jī)效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,兩種手術(shù)方式的手術(shù)切口長(zhǎng)度相當(dāng),差異無(wú)統(tǒng)計(jì)學(xué)意義[WMD=-1.18,95%CI(-2.86~0.51),P=0.17]。見(jiàn)圖9。
2.2.9?住院時(shí)間
共有3篇文獻(xiàn)244例患者納入研究,各研究間存在顯著異質(zhì)性(P<0.001,I2=90%),采用隨機(jī)效應(yīng)模型,效應(yīng)量合并分析指標(biāo)選用WMD。結(jié)果顯示,經(jīng)DAA入路行THA的患者住院時(shí)間較ALA入路的患者短,差異有統(tǒng)計(jì)學(xué)意義[WMD=-2.30,95%CI(-4.24~-0.36),P=0.02]。見(jiàn)圖10。
2.3?發(fā)表偏倚
由于手術(shù)時(shí)間納入研究的文獻(xiàn)是所有二分類變量中最多的,所以用該指標(biāo)的漏斗圖分析發(fā)表偏倚,結(jié)果表明該研究的發(fā)表偏倚較明顯。見(jiàn)圖11。
3?討論
現(xiàn)代THA的發(fā)展始于20世紀(jì)50年代,是改善髖關(guān)節(jié)功能最可靠的手術(shù)干預(yù)措施之一。2010年的一項(xiàng)流行調(diào)查研究表明,美國(guó)每年接受近332 000例THA,預(yù)計(jì)在未來(lái)的幾十年,數(shù)量還會(huì)不斷增長(zhǎng)[15]。THA可以采用多種手術(shù)入路進(jìn)行,有后路、直接外側(cè)入路、DAA、ALA以及雙切口入路。1917年,史密斯-彼得森首次描述DAA入路,1949年首次用于THA[16~17]。ALA入路也稱Watson Jones方法,由Watson Jones[18]在1936年描述,與DAA入路為常用的微創(chuàng)方法。與后入路或直接外側(cè)相比,DAA入路與ALA入路是經(jīng)肌間隙暴露髖關(guān)節(jié),最大限度減少肌肉損傷,有效減少術(shù)中出血量及術(shù)后疼痛,早期恢復(fù)功能鍛煉[19~20]。目前關(guān)于DAA與ALA的隊(duì)列研究較少,近幾年研究得出的結(jié)果部分是相互矛盾的,最近一篇DAA與ALA的Meta分析比較了兩者術(shù)后步態(tài)的差異性,得出的結(jié)論是無(wú)論何種手術(shù)方式,患者術(shù)后的步態(tài)均有改善,兩者之間無(wú)顯著差異,但并沒(méi)有涉及其他方面的分析[5]。
術(shù)后髖關(guān)節(jié)功能的改善程度與并發(fā)癥發(fā)生率(周圍骨折、脫位、股外側(cè)神經(jīng)損傷)往往是患者與醫(yī)生最為關(guān)注的問(wèn)題,而術(shù)中周圍假體骨折以及假體安放錯(cuò)誤往往是毀滅性的。股外側(cè)神經(jīng)損傷可導(dǎo)致患者局部皮膚感覺(jué)障礙,本次研究結(jié)果顯示DAA入路發(fā)生率顯著高于ALA入路,由于DAA入路的特殊性,在向髖關(guān)節(jié)的遠(yuǎn)端延伸分離時(shí),股四頭肌群前外側(cè)部分的神經(jīng)血管損傷發(fā)生率顯然高于其他入路[21]。雖然本次研究發(fā)現(xiàn)兩者在周圍骨折方面并無(wú)明顯差異,但由于樣本量少,異質(zhì)性大,能夠解釋的范圍較小。該研究結(jié)果顯示兩種入路術(shù)后Harris髖關(guān)節(jié)功能評(píng)分并無(wú)明顯差異。但許多學(xué)者發(fā)現(xiàn)DAA入路手術(shù)在手術(shù)后的前六周,Harris髖關(guān)節(jié)評(píng)分均高于前外側(cè)、直接外側(cè)等其他入路,但隨著患者功能鍛煉逐漸加強(qiáng)后,在術(shù)后的3個(gè)月、6個(gè)月Harris髖關(guān)節(jié)評(píng)分并無(wú)明顯差異,其原因可能與外展肌的分離和再附著在術(shù)后6周ALA較DAA恢復(fù)慢相關(guān)[5,22]。因此,DAA入路對(duì)于功能恢復(fù)的優(yōu)勢(shì)可能僅限于早期以及輕微的活動(dòng),就算兩種方法的THA術(shù)后步態(tài)異常仍然存在,但這可能是由于其他因素引起,如術(shù)前步態(tài)適應(yīng)[23]。髖臼組件定位對(duì)THA術(shù)后髖關(guān)節(jié)穩(wěn)定性有重要影響,髖臼外展角和前傾角的術(shù)后影像學(xué)測(cè)量是評(píng)估髖臼組件朝向常用方法。Lewinnek等[24]定義髖臼杯和前傾角在30°~50°和5°~25°為安全區(qū),該安全區(qū)將THA術(shù)后不穩(wěn)定降至最低,本次研究結(jié)果提示兩種手術(shù)入路可能都不影響假體的安放,更多取決于術(shù)者的經(jīng)驗(yàn)。手術(shù)時(shí)間主要取決于術(shù)者對(duì)手術(shù)步驟及解剖的熟練程度。雖然本次研究提示兩者手術(shù)時(shí)間差異并無(wú)統(tǒng)計(jì)學(xué)意義,但在很多研究中已經(jīng)描述了DAA法的陡峭學(xué)習(xí)曲線,與后入路或直接外側(cè)入路相比手術(shù)時(shí)間顯著增加,并且易發(fā)生其他手術(shù)入路不常見(jiàn)的并發(fā)癥,例如假體周圍骨折、股外側(cè)神經(jīng)損傷,這可能與學(xué)習(xí)曲線有關(guān),也可能與暴露不足有關(guān)[25~26]。通過(guò)使用現(xiàn)代麻醉技術(shù)、術(shù)中止血技術(shù)和術(shù)中常規(guī)使用一些止血藥,無(wú)論何種手術(shù)方法,都應(yīng)該有最小的失血量。該研究發(fā)現(xiàn)在術(shù)中出血量方面的差異有統(tǒng)計(jì)學(xué)意義,這可能與手術(shù)者的熟練程度及組織分離程度相關(guān)。正如Rodriguez等[27]報(bào)道的那樣,與直接外側(cè)入路相比,DAA減少了術(shù)中失血,其中切口越長(zhǎng),軟組織分離越多,出血量可能越多,并且可能伴隨外展肌的損傷。住院時(shí)間受許多因素的影響,由于出院所需的康復(fù)方案的性質(zhì)各不相同,外科醫(yī)生的決定、患者的期望值、患者經(jīng)濟(jì)能力、床位壓力都可能影響到患者住院時(shí)間,雖然在整個(gè)研究中住院時(shí)間的差異有統(tǒng)計(jì)學(xué)意義,但并不足以說(shuō)明DAA更有利于縮短患者住院時(shí)間。
本次研究納入文獻(xiàn)較少,各個(gè)研究存在的異質(zhì)性較大,徐亦鵬等[7]研究中DAA采用的是Bikini入路,可能增加各個(gè)研究之間的異質(zhì)性,另外各個(gè)研究之間體重指數(shù)差異較大也可能增加異質(zhì)性。考慮到這次Meta分析的局限性,需要更多高質(zhì)量的隨機(jī)對(duì)照研究來(lái)進(jìn)一步確定DAA與ALA的臨床療效。
參?考?文?獻(xiàn)
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(收稿日期:2019-08-13?修回日期:2019-09-07)