Use of Tissue Plasminogen Activator in Abdominal Abscesses in Children-A Single-Center Randomized Control Trial.

Craig R Gibson, Afsaneh Amirabadi, Simal Goman, Nicholas C Armstrong, Jacob C Langer, Joao G Amaral, Michael J Temple, Dimitri Parra, Philip R John, Bairbre L Connolly
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Abstract

Purpose: To establish the efficacy of once-per-day intracavitary tissue plasminogen activator (tPA) in the treatment of pediatric intra-abdominal abscesses.

Methods: A single-center prospective, double-blinded, randomized controlled trial of the use of intracavitary tPA in abdominal abscesses in children. Patients were randomized to either tPA-treatment or saline-treatment groups. Primary outcome was drainage catheter dwell (hours). Secondary outcomes were length of hospital stay, times to discharge, clinical and sonographic resolution, and adverse events (AEs).

Results: Twenty-eight children were randomized to either group (n = 14 each). Demographics between groups were not significantly different (age P = .28; weight P = .40; gender P = .44). There were significantly more abscesses in the tPA-treated group (P = .03). Abscesses were secondary to perforated appendicitis (n = 25) or postappendectomy (n = 3). Thirty-four abscesses were drained, 4 aspirated, 3 neither drained/aspirated. There was no significant difference in number of drains (P = .14), drain size (P = .19), primary outcome (P = .077), or secondary outcomes found. No procedural or intervention drug-related AEs occurred. No patient in the saline-treated group required to be switched/treated with tPA.

Conclusion: No significant difference in the length of catheter dwell time, procedure time to discharge, or time to resolution was found. Intracavitary tPA was not associated with morbidity or mortality. The results neither support nor negate routine use of tPA in the drainage of intra-abdominal abscess in children. It is possible that a multicentre study with a larger number of patients may answer this question more definitively.

组织型纤溶酶原激活剂在儿童腹部脓肿中的应用——一项单中心随机对照试验。
目的:观察每天1次腔内组织型纤溶酶原激活剂(tPA)治疗小儿腹内脓肿的疗效。方法:采用单中心前瞻性、双盲、随机对照试验,观察腔内tPA治疗儿童腹部脓肿的疗效。患者被随机分为tpa治疗组和盐治疗组。主要观察指标为置管时间(小时)。次要结局是住院时间、出院时间、临床和超声缓解以及不良事件(ae)。结果:28例患儿随机分为两组(n = 14)。组间人口统计学差异无统计学意义(年龄P = 0.28;权重P = 0.40;性别P = .44)。tpa治疗组脓肿发生率显著高于对照组(P = .03)。脓肿继发于穿孔性阑尾炎(n = 25)或阑尾切除术后(n = 3)。34例脓肿引流,4例抽吸,3例未引流/抽吸。引流管数量(P = 0.14)、引流管大小(P = 0.19)、主要结局(P = 0.077)和次要结局均无显著差异。未发生程序性或干预性药物相关不良事件。在盐水治疗组中,没有患者需要切换tPA治疗。结论:两组患者留置导管时间、出院时间、出院时间均无显著差异。腔内tPA与发病率和死亡率无关。结果既不支持也不否定tPA在儿童腹腔脓肿引流术中的常规应用。有可能多中心的大量患者研究可以更明确地回答这个问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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