本研究為前瞻性的多中心研究，選取2011年6月至2017年5月期間計(jì)劃行擇期結(jié)直腸癌手術(shù)的患者，隨機(jī)分為患者自控TEA組或嗎啡靜脈鎮(zhèn)痛(PCA)組。主要觀察指標(biāo)是術(shù)后5年無病生存情況。次要觀察指標(biāo)是術(shù)后疼痛、術(shù)后30天的并發(fā)癥(心血管、呼吸系統(tǒng)、感染性、手術(shù)相關(guān)和泌尿系統(tǒng)并發(fā)癥)、住院時(shí)間(LOS)和首次返回腫瘤治療(RIOT)時(shí)間。

結(jié)果

研究共納入了221例(110例TEA和111例PCA)患者，其中有180例(89例TEA和91例PCA)納入了最終數(shù)據(jù)分析。5年無病生存率TEA組為76%，PCA組為69%;未調(diào)整風(fēng)險(xiǎn)比(HR): 1.31(95%[CI]: 0.74-2.32)， P=0.35;調(diào)整后的HR: 1.19(95%[CI]:0.61-2.31)， P = 0.61。在開放和微創(chuàng)手術(shù)中，TEA組的患者在術(shù)后前24小時(shí)有更好的疼痛緩解效果，但之后沒有差異。兩組之間術(shù)后并發(fā)癥、LOS和RIOT無差異。

結(jié)論

在大腸癌手術(shù)患者的5年無病生存率方面，TEA和PCA組之間沒有顯著差異。除了在術(shù)后最初24小時(shí)內(nèi)減少術(shù)后疼痛外，TEA與靜脈注射嗎啡的PCA相比沒有其他差異。

原始文獻(xiàn)來源

Falk W, Magnuson A, Eintrei C,et,al.Comparison between epidural and intravenous analgesia effects on disease-free survival after colorectal cancer surgery: a randomised multicentre controlled trial[J].Br J Anaesth. 2021 Jul;127(1):65-74. doi: 10.1016/j.bja.2021.04.002.

Comparison between epidural and intravenous analgesia effects on disease-free survival after colorectal cancer surgery: a randomised multicentre controlled trial

Abstract

Background: Thoracic epidural analgesia (TEA) has been suggested to improve survival after curative surgery for colorectal cancer compared with systemic opioid analgesia. The evidence, exclusively based on retrospective studies, is contradictory.

Methods: In this prospective, multicentre study, patients scheduled for elective colorectal cancer surgery between June 2011 and May 2017 were randomised to TEA or patient-controlled i.v. analgesia (PCA) with morphine. The primary endpoint was disease-free survival at 5 yr after surgery. Secondary outcomes were postoperative pain, complications,

length of stay (LOS) at the hospital, and first return to intended oncologic therapy (RIOT).

Results: We enrolled 221 (110 TEA and 111 PCA) patients in the study, and 180 (89 TEA and 91 PCA) were included in the primary outcome. Disease-free survival at 5 yr was 76% in the TEA group and 69% in the PCA group; unadjusted hazard ratio (HR): 1.31 (95% confidence interval [CI]: 0.74-2.32), P=0.35; adjusted HR: 1.19 (95% CI: 0.61-2.31), P=0.61. Patients in the TEA group had significantly better pain relief during the first 24 h, but not thereafter, in open and minimally invasive

procedures. There were no differences in postoperative complications, LOS, or RIOT between the groups.

Conclusions: There was no significant difference between the TEA and PCA groups in disease-free survival at 5 yr in patients undergoing surgery for colorectal cancer. Other than a reduction in postoperative pain during the first 24h after surgery, no other differences were found between TEA compared with i.v. PCA with morphine.