引用本文： 侯雅竹, 閆玲燕, 毛靜遠, 王賢良, 李玲, 鐘成梁, 劉瀚文, 趙志強. 6 分鐘步行試驗在慢性心力衰竭臨床評估中的應用價值. 中國循證醫學雜志, 2018, 18(9): 907-917. doi: 10.7507/1672-2531.201804092 復制
慢性心力衰竭（chronic heart failure，CHF）是各種心臟疾病的終末階段，是由于各種心臟結構和功能異常，使心室充盈或射血功能受損導致的一組復雜臨床綜合征，多數患者會出現呼吸困難、疲乏等典型癥狀[1]。在心衰患者心功能的評價中，除了 NYHA 心功能分級、左室射血分數（left ventricular ejection fraction，LVEF）、生活質量等指標的評估，還需要評價運動耐量相關指標。心肺運動試驗是評價運動耐量的金標準[2]，但其操作需要精密設備和專業技術人員，對于患者更是具有挑戰性的極量運動，其臨床使用尚未普及。6 分鐘步行試驗（6-minute walk test，6MWT）作為一種能反映運動耐量的評價指標，具有易于管理、耐受性好、可重復性強、簡單安全的優點，可作為心肺運動試驗的補充指標[3, 4]。2002 年，美國胸科協會制定了《6 分鐘步行試驗臨床應用指南》[3]，對 6MWT 做了詳細的論述，并規范了其在評價心肺疾病中的應用。近年，美國心臟病學會/美國心臟協會[5]和歐洲心臟學會[6]也分別在各自的心衰診斷和治療指南中將 6MWT 作為心功能評估的一項指標，認可其在 CHF 評估中的價值。本文擬系統評價 6MWT 在 CHF 臨床評估中的應用價值，明確 6MWT 在心衰患者臨床評價中與運動耐量及心功能等系列指標的一致性及影響 6MWT 改善水平的因素，為臨床應用提供參考。
1 資料與方法
1.1 納入與排除標準
1.1.1 研究類型
隨機對照試驗（randomized controlled trial，RCT），文種限中英文。
1.1.2 研究對象
確診 CHF 的患者，其種族、國籍、病程不限。
1.1.3 干預措施
有明確的 CHF 干預措施，其類型不限。
1.1.4 結局指標
必須包括 6 分鐘步行距離（6-minute walk distance，6MWD）。
1.1.5 排除標準
① 未明確指出 CHF 干預措施的研究；② 子研究或重復研究；③ 數據不全或無法提取數據的研究。
1.2 文獻檢索策略
計算機檢索 PubMed、EMbase、The Cochrane Library、CBM、VIP、WanFang Data 和 CNKI 數據庫，搜集以 6MWD 為 CHF 評價指標的 RCT，檢索時限均從建庫至 2017 年 8 月。英文檢索詞包括：heart failure、cardiac failure、chronic heart failure、6MWT、6 minute walk test、6MWD、6 minute walk distance 等；中文檢索詞包括：心衰、心力衰竭、心功能不全、6 分鐘步行試驗、六分鐘步行試驗、6 分鐘步行距離、六分鐘步行距離等。以 PubMed 為例，具體檢索策略見框 1。
1.3 文獻篩選和資料提取
由 2 名研究者獨立篩選文獻，采用 Excel 軟件提取、整理相關數據，如有分歧，則通過討論或與第三方協商解決。提取內容包括：① 基本信息：文獻名稱、作者、發表時間等；② 研究對象的基線特征和干預措施：病例數、年齡、心衰分級、用藥用量、隨訪時間、6MWD、在 6MWT 實施過程中是否使用鼓勵性語言和是否進行基線值的重復試驗；③ 其他指標：癥狀、生活質量改善情況、運動耐量（exercise test time，ETT）、LVEF、峰值耗氧量（peak oxygen consumption，pVO2）和全因死亡等；④ 偏倚風險評價的關鍵要素。
1.4 納入研究的偏倚風險評價
由 2 位研究者獨立評價納入研究的偏倚風險，并交叉核對結果。RCT 的偏倚風險評價采用 Cochrane 手冊 5.1.0 推薦的 RCT 偏倚風險評估工具，從隨機方法、分配隱藏、盲法、選擇性偏倚、意向性分析等方面進行評價。
1.5 統計分析
所有數據采用 SPSS 17.0 統計軟件進行統計。應用 Kappa 一致性檢驗對干預后 6MWD、癥狀、生活質量、ETT、LVEF、pVO2 較干預前有無差異進行統計分析。Kappa 值≥0.75，說明一致性程度相當滿意；0.4<Kappa 值<0.75，說明一致性程度基本滿意；Kappa 值≤0.4，說明一致性程度不夠理想[7]。先使用單因素 Logistic 回歸分析可能影響 6MWD 改善情況的因素，預先設定的影響因素包括：中心數、隨訪時間、基線 6MWD、納入病人數、納入病人中 NYHA 分級Ⅲ～Ⅳ級人數所占比例及干預措施。對單因素有統計學意義的變量進行相關分析，再采用多因素 Logistic 回歸分析影響 6MWD 改善情況的因素，其中 Logistic 回歸分析采用二元 Logistic 回歸，回歸方法選擇 Logistic 逐步回歸的前向逐步法，以 P<0.05 為差異有統計學意義。
2 結果
2.1 文獻篩選流程及結果
初檢共獲得中英文文獻 1 993 篇，經逐層篩選，最終納入 158 個 RCT[8-165]，包括 17 853 例患者，其中澳大利亞和新西蘭心衰協作研究組（Australia/New Zealand Heart Failure Research Collaborative Group，ANZ）不同研究的納入人群為同一組患者，故病例數只計算 1 次。文獻篩選流程及結果見圖 1。
2.2 納入研究的基本特征及偏倚風險評價結果
納入研究中患者年齡范圍為 50.0～80.5 歲，NYHA 心功能分級為Ⅰ～Ⅳ級，其中以Ⅱ～Ⅲ級為主（>50%）。干預措施主要包括心衰的“金三角”（包括血管緊張素轉化酶抑制劑/血管緊張素Ⅱ受體拮抗劑、β 受體阻滯劑、醛固酮受體拮抗劑）治療、心衰其他藥物治療、心臟輔助裝置、運動訓練、中醫藥治療及其他治療。納入研究多數采用正確的隨機序列產生及分配隱藏方法，實行合適的盲法，結果數據相對完整，無明顯選擇性報告偏倚。納入研究的詳細情況和偏倚風險評價結果可與通訊作者聯系獲取。
2.3 納入研究中的 6MWT 應用概況
納入研究中，治療組與對照組關于 6MWD 的兩兩比較共 196 次，其中 102 次（包含 85 個研究，占全部研究的 53.8%）6MWD 較對照組有顯著提高（P<0.05）。其中，西藥干預研究中 37.8%（17/45）有提高，心臟輔助裝置研究中有 52.3%（10/19），運動訓練的研究中有 71.4%（20/28），中醫藥研究中有 85.7%（6/7）。
2.4 6MWD 與相關指標改善的一致性
納入研究中，涉及 6MWD 與癥狀改善情況的比較 29 次，6MWD 與生活質量改善情況的比較 116 次，6MWD 與 ETT 改善情況的比較 41 次，6MWD 與 LVEF 改善情況的比較 87 次，6MWD 與 pVO2 改善情況的比較 37 次。其一致性分析 Kappa 值分別為 0.791、0.724、0.462、0.401、0.729，提示 6MWD 與癥狀的一致性相當滿意，與生活質量、ETT、LVEF、pVO2 的一致性基本滿意。
根據隨訪時間的長短分為 3 個組：① ≤3 月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO2 的一致性 Kappa 值分別為 1.000、0.734、0.561、0.369、0.553，提示 6MWD 與癥狀的一致性相當滿意，與生活質量、ETT、pVO2 的一致性基本滿意，與 LVEF 的一致性不夠理想。② 3～6 月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO2 的一致性 Kappa 值分別為 0.444、0.665、0.375、0.276、0.889，提示 6MWD 與 pVO2 的一致性相當滿意，與癥狀、生活質量、ETT 的一致性基本滿意，與 LVEF 的一致性不夠理想。③ >6 個月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO 2 的一致性 Kappa 值分別為 1.000、0.809、0.462、0.625、0.545，提示 6MWD 與癥狀、生活質量的一致性相當滿意，與 ETT、LVEF、pVO2 一致性基本滿意（表 1）。
依據對 CHF 的干預措施將納入的 RCT 大致分為心衰藥物治療“金三角”組、運動訓練組、心臟輔助裝置組，再次對 6MWD 與 LVEF 的一致性進行分析。① “金三角”組 6MWD 與癥狀、生活質量、ETT、LVEF 的一致性 Kappa 值分別為 0.372、0.216、–0.174、0.245，提示其一致性均不夠理想，此組中 6MWD 與 pVO2 的 Kappa 值由于數值較少無法計算。② 運動訓練組 6MWD 與癥狀、生活質量、ETT、LVEF 的一致性 Kappa 值分別為 1.000、0.627、0.441、1.000、0.530，提示 6MWD 與癥狀及 LVEF 的一致性相當滿意，與生活質量、ETT、pVO2 的一致性基本滿意。③ 心臟輔助裝置組 6MWD 與生活質量、ETT、LVEF 的一致性 Kappa 值分別為 0.746、0.250、0.441、0.824，提示 6MWD 與 pVO2 的一致性相當滿意，與生活質量、LVEF 的一致性基本滿意，與 ETT 的一致性不夠理想，此組中 6MWD 與癥狀的 Kappa 值由于數值較少無法計算（表 2）。
表1
不同隨訪時間 6MWD 與相關指標的一致性檢驗 Kappa 值
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表1
不同隨訪時間 6MWD 與相關指標的一致性檢驗 Kappa 值
| 隨訪時間 | 隨訪次數（次） | 癥狀 | 生活質量 | ETT | LVEF | pVO2 |
| ≤3 個月 | 80 | 1.000 | 0.734 | 0.561 | 0.369 | 0.553 |
| 3～6 個月 | 59 | 0.444 | 0.665 | 0.375 | 0.276 | 0.889 |
| >6 個月 | 35 | 1.000 | 0.809 | 0.462 | 0.625 | 0.545 |
| 合計 | 108 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
表2
不同干預措施 6MWD 與相關指標的一致性檢驗 Kappa 值
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表2
不同干預措施 6MWD 與相關指標的一致性檢驗 Kappa 值
| 干預措施 | 隨訪次數（次） | 癥狀 | 生活
質量 |
ETT | LVEF | pVO2 |
| “金三角”組 | 38 | 0.372 | 0.216 | –0.174 | 0.245 | ? |
| 運動訓練組 | 31 | 1.000 | 0.627 | 0.441 | 1.000 | 0.530 |
| 心臟輔助裝置組 | 21 | ? | 0.746 | 0.250 | 0.441 | 0.824 |
| 合計 | 180 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
| ?：無法計算。 | ||||||
2.5 6MWD 改善的相關因素分析
以治療后干預組較對照組 6MWD 是否改善為因變量，以中心數≥3 個（138 個研究提及了具體中心數）、隨訪時間>3 月（154 個研究提供了有效隨訪時間）、納入研究病人單組病人數≥30 人（157 個研究提供了納入病人數）、NYHA 分級Ⅲ～Ⅳ級患者比例≥50%（105 個研究能夠判斷該比例）、基線 6MWD≥300 m（144 個研究提供了治療組基線 6MWD）、6MWT 實施過程中鼓勵（33 個研究提及是否鼓勵）為自變量進行單因素 Logistic 回歸分析，結果提示中心數、隨訪時間、NYHA 分級Ⅲ～Ⅳ級患者比例、基線 6MWD 水平是 6MWD 改善的獨立影響因素（P 值均<0.05）（表 3）。
故將此 4 個因素再次納入多因素 Logistic 回歸分析，逐步 Logistic 回歸分析篩選出基線 6MWD［OR=2.91，95%CI（1.278，6.634），P=0.011］和 NYHA 分級Ⅲ～Ⅳ級患者比例［OR=2.59，95%CI（1.091，6.138），P=0.031］是影響 6MWD 改善的相關因素，提示基線 6MWD≤300 m 的患者 6MWD 改善的概率是>300m 的 2.91 倍，NYHA 分級Ⅲ～Ⅳ級患者比例≥50% 的患者 6MWD 改善的概率是<50% 的 2.59 倍（表 4）。
表3
6MWD 改善情況影響因素的單因素分析
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表3
6MWD 改善情況影響因素的單因素分析
| 自變量 | 隨訪次數（次） | B 值 | OR（95%CI） | P 值 |
| 中心數≥3 個 | 59 | 0.721 | 2.06（1.068，3.965） | 0.031 |
| 隨訪時間≤3 個月 | 96 | 0.774 | 2.17（1.180，3.981） | 0.013 |
| 單組病人數≥30 人 | 109 | 0.123 | 1.13（?） | 0.411 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 85 | 0.924 | 2.52（1.219，5.202） | 0.013 |
| 基線 6MWD≤300 m | 98 | 0.948 | 2.58（1.345，4.949） | 0.004 |
| 鼓勵 | 27 | 0.163 | 1.18（?） | 0.622 |
| ?：無數據。 | ||||
表4
6MWD 改善情況影響因素的多因素分析
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表4
6MWD 改善情況影響因素的多因素分析
| 自變量 | B 值 | OR（95%CI） | P 值 |
| 基線 6MWD≤300 m | 1.069 | 2.91（1.278，6.634） | 0.011 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 0.951 | 2.59（1.091，6.138） | 0.031 |
3 討論
從 12 分鐘運動到 6 分鐘步行[166-168]，從肺功能檢測到心肺功能檢測[6, 169-171]，歷經 40 余年，6MWT 作為心功能評估的一項指標，逐步被納入臨床指南，并廣泛應用于心衰臨床療效評價。本文系統回顧了以 6MWD 作為療效指標的心衰治療的 RCT，對 6MWD 與心功能及運動耐量等指標的一致性進行了分析，結果提示 6MWD 總體上與癥狀、生活質量、ETT、LVEF、pVO2 改善是一致的，6MWT 是心衰療效評價的可靠指標之一。按照隨訪時間進行亞組分析，結果顯示 6MWD 與 LVEF 的改善只在>6 個月組具有一致性，說明運動耐量的提高先于 LVEF 的改善[172]；按照干預措施進行亞組分析，結果顯示 6MWD 與心功能及運動耐量等指標在運動訓練組中一致性滿意度更高，考慮與該組患者接受了較為完善的藥物治療且進行了科學的康復方案有關，進一步證實了規范的心衰基礎藥物治療聯合康復訓練的科學性。心臟輔助裝置組中 6MWD 的改善與其他指標的一致性優于心衰藥物組，推測與心臟輔助裝置能較為快速改善心功能、提高運動耐量有關；而“金三角”藥物組指標間的一致性不理想，考慮與部分分析數據的缺失有關。
6MWD 與 6MWT 研究的中心數量、隨訪時間、患者數量及基本情況（如性別、體重、身高、年齡等）、心衰嚴重程度、6MWD 基線水平及操作流程等因素密切相關。本研究結合納入文獻情況，選用了 7 個常見的因素進行回歸分析，發現基線 6MWD［OR=2.91，95%CI（1.278，6.634），P=0.011］和 NYHA 分級Ⅲ～Ⅳ級患者比例［OR=2.59，95%CI（1.091，6.138），P=0.031］是影響 6MWD 改善的相關因素。此結果可為未來以 6MWD 為主要療效指標的臨床研究的設計提供參考依據。
本研究的局限性：本研究采用 Kappa 一致性檢驗評價包括 6MWD 在內的兩種指標的一致性，采用 Logistic 回歸分析基線資料、隨訪時間、6MWT 中的實施方法、干預措施等因素對 6MWD 影響的大小，符合這兩種統計方法的原理。然而，由于研究涉及的原始文獻數量較多、覆蓋年限較廣、干預措施繁雜、納入患者的基本資料不均齊、結局指標選取不一致，可能會對綜合評價結果產生影響。
綜上所述，6MWT 是 CHF 臨床評估的可靠方法之一，可以反映 CHF 患者在干預性評價中心肺功能、運動耐力及其他相關系統整體功能，簡便易行，是一種值得推廣的客觀評價方法。
慢性心力衰竭（chronic heart failure，CHF）是各種心臟疾病的終末階段，是由于各種心臟結構和功能異常，使心室充盈或射血功能受損導致的一組復雜臨床綜合征，多數患者會出現呼吸困難、疲乏等典型癥狀[1]。在心衰患者心功能的評價中，除了 NYHA 心功能分級、左室射血分數（left ventricular ejection fraction，LVEF）、生活質量等指標的評估，還需要評價運動耐量相關指標。心肺運動試驗是評價運動耐量的金標準[2]，但其操作需要精密設備和專業技術人員，對于患者更是具有挑戰性的極量運動，其臨床使用尚未普及。6 分鐘步行試驗（6-minute walk test，6MWT）作為一種能反映運動耐量的評價指標，具有易于管理、耐受性好、可重復性強、簡單安全的優點，可作為心肺運動試驗的補充指標[3, 4]。2002 年，美國胸科協會制定了《6 分鐘步行試驗臨床應用指南》[3]，對 6MWT 做了詳細的論述，并規范了其在評價心肺疾病中的應用。近年，美國心臟病學會/美國心臟協會[5]和歐洲心臟學會[6]也分別在各自的心衰診斷和治療指南中將 6MWT 作為心功能評估的一項指標，認可其在 CHF 評估中的價值。本文擬系統評價 6MWT 在 CHF 臨床評估中的應用價值，明確 6MWT 在心衰患者臨床評價中與運動耐量及心功能等系列指標的一致性及影響 6MWT 改善水平的因素，為臨床應用提供參考。
1 資料與方法
1.1 納入與排除標準
1.1.1 研究類型
隨機對照試驗（randomized controlled trial，RCT），文種限中英文。
1.1.2 研究對象
確診 CHF 的患者，其種族、國籍、病程不限。
1.1.3 干預措施
有明確的 CHF 干預措施，其類型不限。
1.1.4 結局指標
必須包括 6 分鐘步行距離（6-minute walk distance，6MWD）。
1.1.5 排除標準
① 未明確指出 CHF 干預措施的研究；② 子研究或重復研究；③ 數據不全或無法提取數據的研究。
1.2 文獻檢索策略
計算機檢索 PubMed、EMbase、The Cochrane Library、CBM、VIP、WanFang Data 和 CNKI 數據庫，搜集以 6MWD 為 CHF 評價指標的 RCT，檢索時限均從建庫至 2017 年 8 月。英文檢索詞包括：heart failure、cardiac failure、chronic heart failure、6MWT、6 minute walk test、6MWD、6 minute walk distance 等；中文檢索詞包括：心衰、心力衰竭、心功能不全、6 分鐘步行試驗、六分鐘步行試驗、6 分鐘步行距離、六分鐘步行距離等。以 PubMed 為例，具體檢索策略見框 1。
1.3 文獻篩選和資料提取
由 2 名研究者獨立篩選文獻，采用 Excel 軟件提取、整理相關數據，如有分歧，則通過討論或與第三方協商解決。提取內容包括：① 基本信息：文獻名稱、作者、發表時間等；② 研究對象的基線特征和干預措施：病例數、年齡、心衰分級、用藥用量、隨訪時間、6MWD、在 6MWT 實施過程中是否使用鼓勵性語言和是否進行基線值的重復試驗；③ 其他指標：癥狀、生活質量改善情況、運動耐量（exercise test time，ETT）、LVEF、峰值耗氧量（peak oxygen consumption，pVO2）和全因死亡等；④ 偏倚風險評價的關鍵要素。
1.4 納入研究的偏倚風險評價
由 2 位研究者獨立評價納入研究的偏倚風險，并交叉核對結果。RCT 的偏倚風險評價采用 Cochrane 手冊 5.1.0 推薦的 RCT 偏倚風險評估工具，從隨機方法、分配隱藏、盲法、選擇性偏倚、意向性分析等方面進行評價。
1.5 統計分析
所有數據采用 SPSS 17.0 統計軟件進行統計。應用 Kappa 一致性檢驗對干預后 6MWD、癥狀、生活質量、ETT、LVEF、pVO2 較干預前有無差異進行統計分析。Kappa 值≥0.75，說明一致性程度相當滿意；0.4<Kappa 值<0.75，說明一致性程度基本滿意；Kappa 值≤0.4，說明一致性程度不夠理想[7]。先使用單因素 Logistic 回歸分析可能影響 6MWD 改善情況的因素，預先設定的影響因素包括：中心數、隨訪時間、基線 6MWD、納入病人數、納入病人中 NYHA 分級Ⅲ～Ⅳ級人數所占比例及干預措施。對單因素有統計學意義的變量進行相關分析，再采用多因素 Logistic 回歸分析影響 6MWD 改善情況的因素，其中 Logistic 回歸分析采用二元 Logistic 回歸，回歸方法選擇 Logistic 逐步回歸的前向逐步法，以 P<0.05 為差異有統計學意義。
2 結果
2.1 文獻篩選流程及結果
初檢共獲得中英文文獻 1 993 篇，經逐層篩選，最終納入 158 個 RCT[8-165]，包括 17 853 例患者，其中澳大利亞和新西蘭心衰協作研究組（Australia/New Zealand Heart Failure Research Collaborative Group，ANZ）不同研究的納入人群為同一組患者，故病例數只計算 1 次。文獻篩選流程及結果見圖 1。
2.2 納入研究的基本特征及偏倚風險評價結果
納入研究中患者年齡范圍為 50.0～80.5 歲，NYHA 心功能分級為Ⅰ～Ⅳ級，其中以Ⅱ～Ⅲ級為主（>50%）。干預措施主要包括心衰的“金三角”（包括血管緊張素轉化酶抑制劑/血管緊張素Ⅱ受體拮抗劑、β 受體阻滯劑、醛固酮受體拮抗劑）治療、心衰其他藥物治療、心臟輔助裝置、運動訓練、中醫藥治療及其他治療。納入研究多數采用正確的隨機序列產生及分配隱藏方法，實行合適的盲法，結果數據相對完整，無明顯選擇性報告偏倚。納入研究的詳細情況和偏倚風險評價結果可與通訊作者聯系獲取。
2.3 納入研究中的 6MWT 應用概況
納入研究中，治療組與對照組關于 6MWD 的兩兩比較共 196 次，其中 102 次（包含 85 個研究，占全部研究的 53.8%）6MWD 較對照組有顯著提高（P<0.05）。其中，西藥干預研究中 37.8%（17/45）有提高，心臟輔助裝置研究中有 52.3%（10/19），運動訓練的研究中有 71.4%（20/28），中醫藥研究中有 85.7%（6/7）。
2.4 6MWD 與相關指標改善的一致性
納入研究中，涉及 6MWD 與癥狀改善情況的比較 29 次，6MWD 與生活質量改善情況的比較 116 次，6MWD 與 ETT 改善情況的比較 41 次，6MWD 與 LVEF 改善情況的比較 87 次，6MWD 與 pVO2 改善情況的比較 37 次。其一致性分析 Kappa 值分別為 0.791、0.724、0.462、0.401、0.729，提示 6MWD 與癥狀的一致性相當滿意，與生活質量、ETT、LVEF、pVO2 的一致性基本滿意。
根據隨訪時間的長短分為 3 個組：① ≤3 月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO2 的一致性 Kappa 值分別為 1.000、0.734、0.561、0.369、0.553，提示 6MWD 與癥狀的一致性相當滿意，與生活質量、ETT、pVO2 的一致性基本滿意，與 LVEF 的一致性不夠理想。② 3～6 月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO2 的一致性 Kappa 值分別為 0.444、0.665、0.375、0.276、0.889，提示 6MWD 與 pVO2 的一致性相當滿意，與癥狀、生活質量、ETT 的一致性基本滿意，與 LVEF 的一致性不夠理想。③ >6 個月組，6MWD 與癥狀、生活質量、ETT、LVEF、pVO 2 的一致性 Kappa 值分別為 1.000、0.809、0.462、0.625、0.545，提示 6MWD 與癥狀、生活質量的一致性相當滿意，與 ETT、LVEF、pVO2 一致性基本滿意（表 1）。
依據對 CHF 的干預措施將納入的 RCT 大致分為心衰藥物治療“金三角”組、運動訓練組、心臟輔助裝置組，再次對 6MWD 與 LVEF 的一致性進行分析。① “金三角”組 6MWD 與癥狀、生活質量、ETT、LVEF 的一致性 Kappa 值分別為 0.372、0.216、–0.174、0.245，提示其一致性均不夠理想，此組中 6MWD 與 pVO2 的 Kappa 值由于數值較少無法計算。② 運動訓練組 6MWD 與癥狀、生活質量、ETT、LVEF 的一致性 Kappa 值分別為 1.000、0.627、0.441、1.000、0.530，提示 6MWD 與癥狀及 LVEF 的一致性相當滿意，與生活質量、ETT、pVO2 的一致性基本滿意。③ 心臟輔助裝置組 6MWD 與生活質量、ETT、LVEF 的一致性 Kappa 值分別為 0.746、0.250、0.441、0.824，提示 6MWD 與 pVO2 的一致性相當滿意，與生活質量、LVEF 的一致性基本滿意，與 ETT 的一致性不夠理想，此組中 6MWD 與癥狀的 Kappa 值由于數值較少無法計算（表 2）。
表1
不同隨訪時間 6MWD 與相關指標的一致性檢驗 Kappa 值
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表1
不同隨訪時間 6MWD 與相關指標的一致性檢驗 Kappa 值
| 隨訪時間 | 隨訪次數（次） | 癥狀 | 生活質量 | ETT | LVEF | pVO2 |
| ≤3 個月 | 80 | 1.000 | 0.734 | 0.561 | 0.369 | 0.553 |
| 3～6 個月 | 59 | 0.444 | 0.665 | 0.375 | 0.276 | 0.889 |
| >6 個月 | 35 | 1.000 | 0.809 | 0.462 | 0.625 | 0.545 |
| 合計 | 108 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
表2
不同干預措施 6MWD 與相關指標的一致性檢驗 Kappa 值
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表2
不同干預措施 6MWD 與相關指標的一致性檢驗 Kappa 值
| 干預措施 | 隨訪次數（次） | 癥狀 | 生活
質量 |
ETT | LVEF | pVO2 |
| “金三角”組 | 38 | 0.372 | 0.216 | –0.174 | 0.245 | ? |
| 運動訓練組 | 31 | 1.000 | 0.627 | 0.441 | 1.000 | 0.530 |
| 心臟輔助裝置組 | 21 | ? | 0.746 | 0.250 | 0.441 | 0.824 |
| 合計 | 180 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
| ?：無法計算。 | ||||||
2.5 6MWD 改善的相關因素分析
以治療后干預組較對照組 6MWD 是否改善為因變量，以中心數≥3 個（138 個研究提及了具體中心數）、隨訪時間>3 月（154 個研究提供了有效隨訪時間）、納入研究病人單組病人數≥30 人（157 個研究提供了納入病人數）、NYHA 分級Ⅲ～Ⅳ級患者比例≥50%（105 個研究能夠判斷該比例）、基線 6MWD≥300 m（144 個研究提供了治療組基線 6MWD）、6MWT 實施過程中鼓勵（33 個研究提及是否鼓勵）為自變量進行單因素 Logistic 回歸分析，結果提示中心數、隨訪時間、NYHA 分級Ⅲ～Ⅳ級患者比例、基線 6MWD 水平是 6MWD 改善的獨立影響因素（P 值均<0.05）（表 3）。
故將此 4 個因素再次納入多因素 Logistic 回歸分析，逐步 Logistic 回歸分析篩選出基線 6MWD［OR=2.91，95%CI（1.278，6.634），P=0.011］和 NYHA 分級Ⅲ～Ⅳ級患者比例［OR=2.59，95%CI（1.091，6.138），P=0.031］是影響 6MWD 改善的相關因素，提示基線 6MWD≤300 m 的患者 6MWD 改善的概率是>300m 的 2.91 倍，NYHA 分級Ⅲ～Ⅳ級患者比例≥50% 的患者 6MWD 改善的概率是<50% 的 2.59 倍（表 4）。
表3
6MWD 改善情況影響因素的單因素分析
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表3
6MWD 改善情況影響因素的單因素分析
| 自變量 | 隨訪次數（次） | B 值 | OR（95%CI） | P 值 |
| 中心數≥3 個 | 59 | 0.721 | 2.06（1.068，3.965） | 0.031 |
| 隨訪時間≤3 個月 | 96 | 0.774 | 2.17（1.180，3.981） | 0.013 |
| 單組病人數≥30 人 | 109 | 0.123 | 1.13（?） | 0.411 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 85 | 0.924 | 2.52（1.219，5.202） | 0.013 |
| 基線 6MWD≤300 m | 98 | 0.948 | 2.58（1.345，4.949） | 0.004 |
| 鼓勵 | 27 | 0.163 | 1.18（?） | 0.622 |
| ?：無數據。 | ||||
表4
6MWD 改善情況影響因素的多因素分析
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表4
6MWD 改善情況影響因素的多因素分析
| 自變量 | B 值 | OR（95%CI） | P 值 |
| 基線 6MWD≤300 m | 1.069 | 2.91（1.278，6.634） | 0.011 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 0.951 | 2.59（1.091，6.138） | 0.031 |
3 討論
從 12 分鐘運動到 6 分鐘步行[166-168]，從肺功能檢測到心肺功能檢測[6, 169-171]，歷經 40 余年，6MWT 作為心功能評估的一項指標，逐步被納入臨床指南，并廣泛應用于心衰臨床療效評價。本文系統回顧了以 6MWD 作為療效指標的心衰治療的 RCT，對 6MWD 與心功能及運動耐量等指標的一致性進行了分析，結果提示 6MWD 總體上與癥狀、生活質量、ETT、LVEF、pVO2 改善是一致的，6MWT 是心衰療效評價的可靠指標之一。按照隨訪時間進行亞組分析，結果顯示 6MWD 與 LVEF 的改善只在>6 個月組具有一致性，說明運動耐量的提高先于 LVEF 的改善[172]；按照干預措施進行亞組分析，結果顯示 6MWD 與心功能及運動耐量等指標在運動訓練組中一致性滿意度更高，考慮與該組患者接受了較為完善的藥物治療且進行了科學的康復方案有關，進一步證實了規范的心衰基礎藥物治療聯合康復訓練的科學性。心臟輔助裝置組中 6MWD 的改善與其他指標的一致性優于心衰藥物組，推測與心臟輔助裝置能較為快速改善心功能、提高運動耐量有關；而“金三角”藥物組指標間的一致性不理想，考慮與部分分析數據的缺失有關。
6MWD 與 6MWT 研究的中心數量、隨訪時間、患者數量及基本情況（如性別、體重、身高、年齡等）、心衰嚴重程度、6MWD 基線水平及操作流程等因素密切相關。本研究結合納入文獻情況，選用了 7 個常見的因素進行回歸分析，發現基線 6MWD［OR=2.91，95%CI（1.278，6.634），P=0.011］和 NYHA 分級Ⅲ～Ⅳ級患者比例［OR=2.59，95%CI（1.091，6.138），P=0.031］是影響 6MWD 改善的相關因素。此結果可為未來以 6MWD 為主要療效指標的臨床研究的設計提供參考依據。
本研究的局限性：本研究采用 Kappa 一致性檢驗評價包括 6MWD 在內的兩種指標的一致性，采用 Logistic 回歸分析基線資料、隨訪時間、6MWT 中的實施方法、干預措施等因素對 6MWD 影響的大小，符合這兩種統計方法的原理。然而，由于研究涉及的原始文獻數量較多、覆蓋年限較廣、干預措施繁雜、納入患者的基本資料不均齊、結局指標選取不一致，可能會對綜合評價結果產生影響。
綜上所述，6MWT 是 CHF 臨床評估的可靠方法之一，可以反映 CHF 患者在干預性評價中心肺功能、運動耐力及其他相關系統整體功能，簡便易行，是一種值得推廣的客觀評價方法。
表1 不同隨訪時間 6MWD 與相關指標的一致性檢驗 Kappa 值
| 隨訪時間 | 隨訪次數（次） | 癥狀 | 生活質量 | ETT | LVEF | pVO2 |
| ≤3 個月 | 80 | 1.000 | 0.734 | 0.561 | 0.369 | 0.553 |
| 3～6 個月 | 59 | 0.444 | 0.665 | 0.375 | 0.276 | 0.889 |
| >6 個月 | 35 | 1.000 | 0.809 | 0.462 | 0.625 | 0.545 |
| 合計 | 108 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
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表2 不同干預措施 6MWD 與相關指標的一致性檢驗 Kappa 值
| 干預措施 | 隨訪次數（次） | 癥狀 | 生活
質量 |
ETT | LVEF | pVO2 |
| “金三角”組 | 38 | 0.372 | 0.216 | –0.174 | 0.245 | ? |
| 運動訓練組 | 31 | 1.000 | 0.627 | 0.441 | 1.000 | 0.530 |
| 心臟輔助裝置組 | 21 | ? | 0.746 | 0.250 | 0.441 | 0.824 |
| 合計 | 180 | 0.791 | 0.724 | 0.462 | 0.401 | 0.729 |
| ?：無法計算。 | ||||||
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表3 6MWD 改善情況影響因素的單因素分析
| 自變量 | 隨訪次數（次） | B 值 | OR（95%CI） | P 值 |
| 中心數≥3 個 | 59 | 0.721 | 2.06（1.068，3.965） | 0.031 |
| 隨訪時間≤3 個月 | 96 | 0.774 | 2.17（1.180，3.981） | 0.013 |
| 單組病人數≥30 人 | 109 | 0.123 | 1.13（?） | 0.411 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 85 | 0.924 | 2.52（1.219，5.202） | 0.013 |
| 基線 6MWD≤300 m | 98 | 0.948 | 2.58（1.345，4.949） | 0.004 |
| 鼓勵 | 27 | 0.163 | 1.18（?） | 0.622 |
| ?：無數據。 | ||||
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表4 6MWD 改善情況影響因素的多因素分析
| 自變量 | B 值 | OR（95%CI） | P 值 |
| 基線 6MWD≤300 m | 1.069 | 2.91（1.278，6.634） | 0.011 |
| NYHA 分級Ⅲ～Ⅳ級占比≥50% | 0.951 | 2.59（1.091，6.138） | 0.031 |
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