Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland.
Breast Center Zürich, Zurich, Switzerland.
Ann Surg Oncol. 2018 Sep;25(9):2632-2640. doi: 10.1245/s10434-018-6556-9. Epub 2018 Jun 8.
Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.
In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2].
TachoSil reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.
多项研究和一项荟萃分析表明，纤维蛋白胶贴剂可减少多种淋巴结清扫术后的淋巴引流。我们的目标是研究这些贴剂对乳腺癌腋窝清扫术后引流的影响。
在一项 III 期优效性试验中，我们将在瑞士 14 个地点进行保乳手术的患者随机分为接受和不接受三组大型 TachoSil 贴剂组。所有患者均插入腋窝引流管。评估结果的患者和研究者均对分组情况不知情。主要终点为总引流量。
2015 年 3 月至 2016 年 12 月，共随机分配了 142 名患者（TachoSil 组 72 例，对照组 70 例）。对照组的总引流量平均为 703ml[95%置信区间（CI）为 512-895ml]。使用 TachoSil 并未显著减少腋窝引流的总量[平均差异（MD）-110ml，95%CI-316 至 94，p=0.30]。与引流、发病率和生活质量相关的 8 个次要终点均未因使用 TachoSil 而得到改善。两组患者的平均每位患者总费用无显著差异[TachoSil 组为 34253 瑞士法郎（95%CI 32000-35880），对照组为 33365 瑞士法郎（95%CI 31771-34961），p=0.584]。在 TachoSil 组中，住院时间更长（MD 1 天，95%CI 0.3-1.7，p=0.009），疼痛改善更快，尽管后者差异无统计学意义[2 天（95%CI 1-4）vs. 5.5 天（95%CI 2-11）；p=0.2]。
TachoSil 并未显著或显著减少乳腺癌腋窝清扫术后的引流。
