無癥狀人群中體檢篩查的循證醫(yī)學(xué)證據(jù)
·經(jīng)驗與總結(jié)·
無癥狀人群中體檢篩查的循證醫(yī)學(xué)證據(jù)
周江華1,楊 穎1,鄒 川1,董碧蓉2
(1.成都市第五人民醫(yī)院老年科,四川 成都 611130; 2. 華西醫(yī)院老年醫(yī)學(xué)中心,四川 成都 610041)
【摘要】目的:檢索全球體檢項目證據(jù),開發(fā)基于循證醫(yī)學(xué)證據(jù)的體檢項目軟件。方法:計算機檢索美國國立指南庫(NGC)、Cochrane library(2017年第3期)、PubMed、Embase、CBM、CNKI、VIP和WanFang Data等數(shù)據(jù)庫。搜集所有健康體檢項目的高質(zhì)量證據(jù)。檢索時限均為2005年1月至2017年3月。由2名研究者獨立篩選文獻、提取資料。結(jié)果:共納入183篇文獻,包括23篇高質(zhì)量的RCT、82篇指南和78篇系統(tǒng)評價?;诂F(xiàn)有證據(jù),27項體檢項目在成人中進行篩查有臨床意義,5項體檢項目進行篩查無臨床意義(尿酸、CEA、CA19-9、PSA、骨盆檢查)。推薦當(dāng)前體檢項目增加腹主動脈超聲、乳腺鉬靶、結(jié)腸鏡、黑色素瘤和老年綜合評估進行篩查。結(jié)論:當(dāng)前體檢模式尚存在缺陷,基于循證醫(yī)學(xué)證據(jù)的體檢篩查模式迫切需要。
【關(guān)鍵詞】循證醫(yī)學(xué);體檢;篩查
我國面臨著慢性疾病巨大挑戰(zhàn)。2009年我國高血壓疾病患者已超過1.6億,冠心病新發(fā)病例以每年75萬的速度遞增。60歲以上老年人中,有2/3的時間處于帶病生存狀態(tài),部分失能和全失能老人已超過3650萬。研究預(yù)測到2030年,因老年人健康問題會抵消我國年人均GDP 7%的增幅。因此,醫(yī)療服務(wù)的根本出路在于“預(yù)防疾病”,早檢查、早預(yù)防、早發(fā)現(xiàn)、早治療,這是解決“看病難、看病貴”,降低醫(yī)療費用的有效途徑之一。
目前很多健康體檢機構(gòu)提供“套餐”式服務(wù),但內(nèi)容往往是根據(jù)價格不同來制定的,價格越高,體檢的項目越多。然而,很多因素在健康體檢中有著舉足輕重的意義,如年齡、居住環(huán)境、職業(yè)等。另外,老年人也因功能狀態(tài)、衰弱程度、預(yù)期壽命的不同,疾病篩查重點應(yīng)該與非老年成年人不同,不能簡單地沿用成人的疾病篩查方法。韓國、日本因胃癌發(fā)生率高,尤其分別強調(diào)在40~75歲[1]和50歲以上成年人[2]中使用胃鏡進行篩查。因此,建立成人健康體檢和疾病篩查方法的循證醫(yī)學(xué)證據(jù)庫,對疾病篩查的利弊進行分析和結(jié)果給予科學(xué)解釋,并提出適應(yīng)臨床的推薦意見尤為迫切和重要。本研究旨在查詢各項體檢項目的體檢證據(jù),以助于建立一套基于循證醫(yī)學(xué)證據(jù)的體檢模式。
1 資料與方法
1.1 納入與排除標(biāo)準(zhǔn)
1.1.1 研究類型 關(guān)于體檢項目篩查的臨床指南、專家共識、系統(tǒng)評價、Meta分析、大型隨機對照研究。文種限中文、英文。
1.1.2 研究對象 無癥狀的成人。
1.1.3 暴露因素 采用在無癥狀人群中進行體檢篩查。體檢篩查是以無癥狀人群為體檢對象,以疾病預(yù)防為目的,在醫(yī)療單位或體檢機構(gòu)進行的身體檢查。具體體檢項目參考成都市三甲醫(yī)院體檢中心開展的體檢項目、《四川省干部體檢項目推進內(nèi)容》、《衛(wèi)生部健康體檢項目目錄》、2014年《健康體檢基本項目專家共識》[3],體檢項目如表1。
表1健康體檢項目目錄
1.1.4 結(jié)局指標(biāo) 死亡率、敏感性、特異性、假陽性率。
1.1.5 排除標(biāo)準(zhǔn) (1)會議摘要;(2)研究人群為兒童或者孕婦;(3)重復(fù)發(fā)表的文獻;(4)同一試驗前期發(fā)表的研究。
1.2 文獻檢索策略 計算機檢索數(shù)據(jù)庫Uptodate、美國國立指南庫(NGC)、美國預(yù)防服務(wù)工作組、加拿大周期性檢查服務(wù)工作組、美國醫(yī)學(xué)會、世界衛(wèi)生組織、美國胸外科協(xié)會、美國疾病與預(yù)防控制中心、美國癌癥協(xié)會、美國糖尿病協(xié)會、美國甲狀腺協(xié)會、美國國家綜合癌癥網(wǎng)絡(luò)指南,英國國家臨床研究所、Cochrane library、PubMed、Embase、CBM、CNKI、VIP和WanFang Data等數(shù)據(jù)庫,搜集所有健康體檢項目的高質(zhì)量證據(jù)。檢索時限均為2005年1月至2017年3月。英文檢索詞包括 screen、screening、systematic review、meta-analysis、randomized controlled trial、guideline。中文檢索詞包括:普查、篩查、隨機對照、系統(tǒng)評價、Meta分析。
1.3 文獻篩選與資料提取 由2位研究者獨立進行文獻篩選和資料提取,并交叉核對,若遇分歧則通過討論解決或交由第三方協(xié)助裁定。采用自制的資料提取表提取資料,提取內(nèi)容主要包括:第一作者、發(fā)表年限、調(diào)查地區(qū)、樣本量大小、年齡、研究時間段、研究類型、隨訪時間和主要結(jié)局等。
1.4 納入研究質(zhì)量評價 本研究主要納入的研究類型為指南、系統(tǒng)綜述和隨機對照研究,未進行研究的質(zhì)量評價。
1.5 結(jié)果分析 本研究根據(jù)Uptodate、美國國立指南庫(NGC)、美國預(yù)防服務(wù)工作組、加拿大周期性檢查服務(wù)工作組、美國醫(yī)學(xué)會、世界衛(wèi)生組織、美國胸外科協(xié)會等指南結(jié)果對篩查項目做出最終篩查意見。當(dāng)指南篩查意見不一致時,本研究采用Uptodate的建議為本研究結(jié)論。
2 結(jié) 果
2.1 文獻檢索結(jié)果 初檢出相關(guān)文獻19 336篇,經(jīng)逐層篩選后,最終納入183篇英文文獻。
2.2 納入研究基本信息 本文共納入23篇高質(zhì)量的RCT[4-26]、82篇指南和78篇系統(tǒng)評價(見表2)。
表2體檢項目相關(guān)的二次研究和指南
注:指南有7篇重復(fù),指南總數(shù)為82篇。
腫瘤標(biāo)志物常用于臨床診斷,但現(xiàn)有的證據(jù)不支持使用腫瘤標(biāo)志物進行篩查[29-36],缺乏CA19-9、AFP和CEA篩查的高質(zhì)量隨機對照研究。2個歐洲隨機對照研究推薦瘤體分別3~5.4 cm、<5 cm腹主動脈瘤中,定期使用超聲篩查[10-11]。然而,不推薦使用彩超篩查心血管疾病、頸動脈狹窄和甲狀腺癌[37-40,45]。乳腺癌和宮頸癌是最常見的婦科腫瘤。美國癌癥協(xié)會和美國婦產(chǎn)科協(xié)會推薦40歲以上的女性每年進行1次鉬靶篩查[48];美國預(yù)防工作組推薦在 21歲開始可進行宮頸癌篩查,30歲以下的女性使用子宮頸抹片進行篩查,30歲以上的女性使用子宮頸抹片或聯(lián)合HPV進行篩查[51,50]。
2.3 體檢證據(jù)匯總 健康體檢項目共36項,包括23項必選體檢項目和13項備選項目。其中27項體檢項目有證據(jù)支持在成人中進行篩查,5項體檢項目無證據(jù)支持篩查有臨床意義,4項體檢項目未找到高質(zhì)量的臨床證據(jù)。根據(jù)當(dāng)前的體檢項目,現(xiàn)有證據(jù)推薦增補腹主動脈超聲、乳腺鉬靶、結(jié)腸鏡、黑色素瘤、老年綜合評估等體檢項目。詳見表3。
表3體檢項目篩查證據(jù)一覽表
3 討 論
3.1 健康體檢項目的臨床實際意義 絕大多數(shù)體檢項目在成年人中進行常規(guī)篩查有臨床證據(jù)支持,但證據(jù)之間存在矛盾。2011年發(fā)表的美國國立肺篩查試驗(the National Lung Screening Trail)研究證實,在長期吸煙的55~74歲高風(fēng)險人群中,通過每年1次胸部低劑量CT(LDCT)篩查,可使肺癌死亡率降低20%。在進一步檢索和評估后,美國預(yù)防服務(wù)工作組推薦對55~80歲的高風(fēng)險人群進行篩查,但如果戒煙超過15年,或有其他影響壽命的疾病,則不建議持續(xù)篩查[60]。美國癌癥協(xié)會推薦40歲以上的女性每年進行1次鉬靶篩查,但沒有明確篩查的終止年齡。然而美國婦產(chǎn)科協(xié)會推薦75歲以上老年人應(yīng)咨詢醫(yī)生,決定是否應(yīng)該進行鉬靶篩查[61,46]。
某些項目在體檢機構(gòu)中過度使用或被忽略。CEA、CA19-9等體檢項目可降低減少死亡率,但其敏感性低、假陽性率高可引起過度診斷,影響體檢者的心理狀態(tài)和生活質(zhì)量[9-12]。腹主動脈瘤是最常見的動脈瘤,其特征為無明顯臨床癥狀,易發(fā)生瘤體破裂,死亡率極高。使用超聲篩查能夠?qū)崿F(xiàn)早期診斷,降低瘤體破裂導(dǎo)致死亡的風(fēng)險[56]。
3.2 體檢模式的優(yōu)缺點 當(dāng)前體檢模式往往是“套餐”式,其可篩查部分疾病,但其假陽性率高,并極大影響體檢者心理,造成醫(yī)療資源過度浪費。馮雨來等[62]研究強調(diào)將價格套餐模式向風(fēng)險套餐模式轉(zhuǎn)變,但基于危險因素做出體檢項目的推薦很有可能導(dǎo)致某些重要體檢項目被忽略。因此,基于循證醫(yī)學(xué)證據(jù)的體檢篩查模式迫切需要。
3.3 本研究缺點和局限 本研究僅納入已經(jīng)發(fā)表的文獻,缺乏灰色文獻。本研究未對納入研究文獻進行質(zhì)量評價。
綜上所述,當(dāng)前體檢模式尚存在缺陷,迫切需要建立基于循證醫(yī)學(xué)證據(jù)的體檢篩查模式。
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【中圖分類號】R194.3
【文獻標(biāo)識碼】A
DOI:10.11851/j.issn.1673-1557.2018.04.009
優(yōu)先數(shù)字出版地址:http://kns.cnki.net/kcms/detail/51.1688.R.20180723.1555.058.html
通信作者:董碧蓉,birongdong@163.com
(收稿日期:2017-08-02)
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