Coloproctology Unit Clinical Management Unit of General and Gastrointestinal Surgery Division Seville, Biomedical Research Institute (BIS), University Hospital Virgen del Rocio / CSIC University of Seville, Avenida Manuel Siurot s/n, 41013, Seville, Spain.
Int J Colorectal Dis. 2019 Jun;34(6):1113-1119. doi: 10.1007/s00384-019-03290-6. Epub 2019 Apr 29.
To compare the clinical outcome of autologous platelet-rich growth factor (PRP) with commercial fibrin glue in the management of high cryptogenic fistulae-in-ano.
The study was conducted at a single center between July 2012 and July 2015 and performed as a phase III, randomized, double-blind comparison of autologously prepared PRP versus fibrin glue for cryptoglandular anal fistulae without active sepsis. Patients were assessed with clinical and endosonographic follow-up. Patients were followed up at 1 week and then at 3, 6, and 12 postoperative months. The primary outcome measure was the fistula healing rate (complete, partial, and non-healing) with secondary outcome measures assessing fistula recurrence, continence status, quality of life, and visual analog pain scores.
Of the 56 enrolled patients, 32 were PRP-treated and 24 were fibrin-treated. The groups were well matched for fistula type with an improved overall healing rate for PRP-treated over fibrin-treated cases (71% vs. 58.3%, respectively; P = 0.608); a complete healing rate of 48.4% vs. 41.7%, respectively; and a partial healing rate of 22.6% vs. 16.7%, respectively. The median pain scores of PRP-treated patients were lower at the first visit with a greater initial pain decrease early during follow-up. Improvements in pain reduction impacted the quality of life measures (P = 0.035). All adverse events were minor and no patient experienced a negative impact on continence.
Treatment of complex cryptoglandular anal fistula with autologous PRP is as effective as fibrin glue with less cost and no adverse effect on continence.
比较自体富血小板生长因子（PRP）与商业纤维蛋白胶在治疗高隐源性肛瘘中的临床疗效。
该研究于 2012 年 7 月至 2015 年 7 月在一家中心进行，是一项 III 期、随机、双盲的自体 PRP 与纤维蛋白胶治疗无活动性脓毒症的隐源性肛腺肛瘘的对比研究。患者接受临床和内镜随访评估。患者在术后 1 周及 3、6、12 个月进行随访。主要疗效指标为瘘管愈合率（完全、部分和未愈合），次要疗效指标包括瘘管复发、控便情况、生活质量和视觉模拟疼痛评分。
56 例纳入患者中，32 例接受 PRP 治疗，24 例接受纤维蛋白治疗。两组患者的瘘管类型匹配良好，PRP 治疗组的总体愈合率高于纤维蛋白治疗组（分别为 71%和 58.3%；P=0.608）；完全愈合率分别为 48.4%和 41.7%；部分愈合率分别为 22.6%和 16.7%。PRP 治疗组患者的首次就诊时疼痛评分较低，随访早期疼痛明显减轻。疼痛缓解的改善对生活质量指标有影响（P=0.035）。所有不良事件均较轻，无患者出现控便功能受损。
与纤维蛋白胶相比，自体 PRP 治疗复杂隐源性肛腺肛瘘的效果相当，且成本更低，对控便功能无不良影响。
