Prolonged thromboprophylaxis with Low Molecular Weight heparin for abdominal or pelvic surgery
Background Major abdominal and pelvic surgery carries a high risk of venous thromboembolism (VTE). The efficacy of thromboprophylaxis with low-molecular weight heparin (LMWH) administered during the in-hospital period is well documented, but the optimal duration of thromboprophylaxis after surgery remains controversial. Some studies suggest that patients undergoing major abdominal surgery benefit from prolongation of the thromboprophylaxis to 1 month after surgery. No systematic review on prolonged thromboprophylaxis after major abdominal or pelvic surgery has been published. Objectives Objectives To evaluate the efficacy and safety of prolonged thromboprophylaxis with LMWH for at least 1 month after abdominal or pelvic surgery with thromboprophylaxis administered during the in-hospital period only in preventing late VTE. Search methods Search methods Electronic searches were performed January 2008 in the Medline, Embase, Lilacs, and the Cochrane Central Register of Controlled Trials. Abstract books from major congresses addressing thromboembolism were hand searched, as were reference lists from studies of relevance. Selection criteria Selection criteria We assessed both randomised and non-randomised controlled clinical trials comparing prolonged thromboprophylaxis with any anti-thrombotic agent with placebo and/or thromboprophylaxis during the admission period only. The patient population in the trials were patients undergoing abdominal or pelvic surgery. The outcome measures included VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE)) as assessed by objective means (ascending bilateral venography, ultrasonography, pulmonary ventilation/perfusion scintigraphy, spiral CT scan or autopsy). Studies exclusively reporting on clinical diagnosis of VTE, without objective confirmation were excluded. Data collection and analysis Data collection and analysis The identification of studies and data extraction were performed by the authors. Outcomes were VTE (DVT or PE) assessed by objective means. Safety outcome were defined as bleeding complications and mortality within 3 months after surgery. Main results Main results The search exclusively detected trials evaluating prolonged thromboprophylaxis with LMWH as compared to control or placebo. 133 studies were found in the searches, of which only 4 were found eligible for inclusion, and 129 were excluded. The incidence of overall VTE after major abdominal or pelvic surgery was 14.3% (95% confidence interval 11.2% - 17.8%) in the control group as compared to 6.1% (95% CI 4.0% - 8.7%) in the patients receiving out-of-hospital LMWH. This difference was statistically significant, Peto Odds Ratio 0.41 (95% CI 0.26 -0.63), P < 0.0005. Prolonged thromboprophylaxis with LMWH was also associated with a statistically significant reduction of even the incidence of symptomatic VTE from 1.7% (95% CI 0.8% - 3.4%) in the control group to 0.2 % (95% CI 0.0% - 1.2%) in patients receiving prolonged thromboprophylaxis, Peto Odds ratio 0.22 (95% CI 0.06 -0.80), P = 0.02. The respective incidence of bleeding in the control and LMWH group were 3.7% (95% CI 2.4% -5.5%) and 4.1% (95% CI 2.7% - 6.0%), Peto Odds ratio 1.11 (95% CI 0.62 - 1.97), P = 0.73. There was no significant heterogeneity detected as regards to outcome parameters reported in the included trials. Authors' conclusions Authors' conclusions Prolonged thromboprophylaxis with LMWH significantly reduces the risk of VTE compared to thromboprophylaxis during hospital admittance only, without increasing bleeding complications after major abdominal or pelvic surgery. 背景 胃腸或骨盆手術低分子量的肝素的長期的血栓預防主要腹部和盆腔手術具有高風險的靜脈血栓栓塞(VTE).對低分子量肝素(LMWH)thromboprophylaxis的療效與管理,在住院期間是有據可查的，但是手術後對thromboprophylaxis的最佳時間仍存在爭議。一些研究表明，患者接受重大腹部手術,血栓預防的受益延長至手術後1個月。沒有系統的審查在腹部或骨盆手術後的長期的血栓預防被出版. 目標 目標 評估用低分子量肝素長期的血栓預防治療的有效性和安全性,在腹部或骨盆手術後至少1個月後,在住院期間防止晚期靜脈血栓栓塞症. 搜尋策略 搜尋策略 電子搜查2008年1月完成在了MEDLINE，EMBASE， Lilacs，和Cochrane Central Register 的對照試驗.從主要討論血栓代表大會,摘要本書.從研究的相關性,手工搜查參考文獻。 選擇標準 選擇標準 我們的評估隨機和非隨機對照臨床試驗比較長期的血栓預防與任何抗血栓劑與安慰劑和/或thromboprophylaxis，只有在入院期間。接受試驗的患者是腹部或骨盆手術的患者。結果措施包括:深部靜脈栓塞(DVT)或肺栓塞(PE)為客觀的評估方法(ascending bilateral venography, ultrasonography, pulmonary ventilation/perfusion scintigraphy, spiral CT scan or autopsy)。深部靜脈栓塞的臨床診斷的專門研究報告,沒有客觀的證據被排除在外. 資料收集與分析 資料收集與分析 作者確立研究提出數據和執行.成果是用客觀的方法評估深部靜脈栓塞.安全結果以出血合併症和術後三個月內的死亡率為定義. 主要結論 主要結論 完全檢測搜索試驗評估長期的血栓預防及低分子量肝素或安慰劑的比較,控制.在搜查中133個研究發現,其中只有4個有資格列入，129個被排除在外.主要腹部或骨盆手術後的整體深部靜脈栓塞控制組發生率 14.3% (95% 可信區間11.2% −17.8%)比較患者接受院外低分子量肝素發生率6.1% (95% CI 4.0% −8.7%).這種差異有統計學意義, Peto比值比為0.41(95％CI為0.26 −0.63)，P<0.0005.長期的血栓預防與低分子量肝素也是有關的,當患者接受長期的血栓預防,顯著的減少了症狀性深部靜脈栓塞的發生率在控制組從1.7% (95% CI 0.8% −3.4%)到0.2 %.出血的個別發生率在控制組和低分子量肝素組是3.7%(95% CI 2.4% −5.5%)和4.1% (95% CI 2.7% −6.0%), Peto Odds ratio 1.11 (95% CI 0.62 −1.97), P = 0.73.在試驗中,無顯著異質性檢測被視為結果參數報告. 作者結論 作者結論 長期的血栓預防與低分子量肝素顯著的減少了深部靜脈栓塞的危險,比起血栓預防只在住院期間,在主要腹部或骨盆手術後沒有增加出血的合併症. 翻譯人 翻譯人 本摘要由國泰綜合醫院張世昌翻譯。此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。 總結 總結 低分子量肝素的延長管理,降低了腹部或骨盆手術後下肢的血塊數量:患者接受重大腹部手術有相當大的危險性,發展下肢靜脈血塊.這些血塊可能在肺部脫落發展,造成猝死.下肢的血塊可能使靜脈功能受損導致長期腿部腫脹或潰瘍.為了避免這些合併症,在手術後第一周經常提供保護性藥品.但是在手術後一個月,患者可能有血塊發展的危險.這個審查表明預防至少在手術後一個月能管理這個現象.