Wu Xiuwen, Ren Jianan, Gu Guosheng, Wang Gefei, Han Gang, Zhou Bo, Ren Huajian, Yao Min, Driver Vickie R, Li Jieshou
Department of Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, P.R. China.
Department of Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, P.R. China.
Surgery. 2014 Mar;155(3):434-41. doi: 10.1016/j.surg.2013.09.001. Epub 2013 Oct 29.
Glue sealing has become an alternative option for occlusion of enterocutaneous fistula (ECF) because of it minimal invasiveness and simplicity. This study aimed to determine efficacy and safety of autologous, platelet-rich fibrin glue (PRFG) in promoting closure of ECFs.
This was a nonrandomized cohort study, recruiting patients who had low-output ECFs (<200 mL/24 h). Beside standard of care, patients were assigned to either the PRFG or control group. Clinical efficacy and safety were determined prospectively. Moreover, a well-balanced subcohort was generated by propensity score (PS) matching. Unadjusted and adjusted Cox proportional hazard models were employed to determine hazard ratios (HRs) of ECF closure in both cohorts.
From January 2008 to January 2012, 145 patients were enrolled initially, with 70 in the control group and 75 in the PRFG-treated group. Compared with the control group, patients in the PRFG group had lesser median time of fistula closure (7 vs 23 days; P = .0010). In addition, PRFG healed more fistulas within the first 28 days (77% vs 57%; P = .0127). For all fistulas included, PRFG-treated fistulas were 3.13 (95% confidence interval [CI], 1.82-5.36) times more likely to achieve closure than those with the non-PRFG approach in the adjusted Cox model. In a PS-matched cohort with 28 paired fistulas, HRs were 3.41 (95% CI, 1.91-6.07) for all fistulas regardless of location. No adverse events related to glue applications were observed.
Autologous PRFG seems to be safe and effective in the treatment of low-output ECFs, and can lessen closure times and promote closure rates.
由于微创性和操作简便,胶水封堵已成为肠造口瘘(ECF)封堵的一种替代选择。本研究旨在确定自体富血小板纤维蛋白胶(PRFG)促进ECF闭合的有效性和安全性。
这是一项非随机队列研究,招募低流量ECF(<200 mL/24 h)患者。除标准治疗外,患者被分配到PRFG组或对照组。前瞻性地确定临床疗效和安全性。此外,通过倾向评分(PS)匹配生成一个均衡的亚队列。采用未调整和调整后的Cox比例风险模型确定两个队列中ECF闭合的风险比(HRs)。
2008年1月至2012年1月,最初纳入145例患者,其中对照组70例,PRFG治疗组75例。与对照组相比,PRFG组患者瘘口闭合的中位时间更短(7天对23天;P = 0.0010)。此外,PRFG在最初28天内愈合的瘘口更多(77%对57%;P = 0.0127)。在调整后的Cox模型中,对于所有纳入的瘘口,PRFG治疗的瘘口实现闭合的可能性是非PRFG方法治疗瘘口的3.13倍(95%置信区间[CI],1.82 - 5.36)。在一个有28对配对瘘口的PS匹配队列中,无论位置如何,所有瘘口的HRs为3.41(95%CI,1.91 - 6.07)。未观察到与胶水应用相关的不良事件。
自体PRFG在治疗低流量ECF方面似乎是安全有效的,并且可以缩短闭合时间并提高闭合率。