Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.
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DOI:
10.1016/j.annemergmed.2016.08.446
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发表时间:
2017-07
影响因子:
6.2
通讯作者:
Olive View–UCLA Appendicitis Study Group
Olive View–UCLA Appendicitis Study Group
中科院分区:
医学1区
文献类型:
--
作者:
Talan DA;Saltzman DJ;Mower WR;Krishnadasan A;Jude CM;Amii R;DeUgarte DA;Wu JX;Pathmarajah K;Morim A;Moran GJ;Olive View–UCLA Appendicitis Study Group

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随机试验表明,非手术治疗非手术治疗非复杂性阑尾炎首先使用抗生素是安全的。据我们所知,还没有试验评估门诊治疗,也没有进行美国随机试验。这项初步研究评估了美国一项多中心研究的可行性,该研究比较了抗生素优先(包括门诊治疗)和阑尾切除术。在美国一家医院,5岁或5岁以上的无并发症阑尾炎患者随机接受阑尾切除术或静脉注射埃他培南大于或等于48小时,以及口服头孢地尼和甲硝唑。抗生素稳定-13岁以上的首次治疗参与者可以在急诊科观察超过或等于6小时后出院,并进行第二天的随访。结果包括1个月的主要并发症发生率(主要)和住院时间、疼痛、残疾、生活质量和住院费用,以及抗生素首次阑尾切除率。在48名符合条件的患者中,30名(62.5%)同意,其中16名(53.3%)随机接受抗生素优先治疗,14名(46.7%)接受阑尾切除术。年龄中位数33岁(9~73岁),白细胞计数中位数15,000/μL(6,200~23,100/μL),阑尾CT中位直径10 mm(7~18 mm)。在15名接受抗生素治疗的成年人中,14人(93.3%)已出院,均已症状缓解。在1个月时,2名阑尾切除术参与者(14.3%;95%可信区间[CI]1.8%至42.8%)和1名抗生素第一参与者(6.3%;95%可信区间0.2%至30.2%)发生了主要并发症。首先服用抗生素的参与者的总住院时间比阑尾切除术参与者少,分别为16.2小时和42.1小时。首先接受抗生素治疗的参与者疼痛和残疾较少。在中位数12个月的随访中,15名首次使用抗生素的参与者中有2名(13.3%;95%可信区间为3.7%至37.9%)发生了阑尾炎,1名成功地使用了抗生素,1名接受了阑尾切除术。两组均未发生严重并发症。美国的一项多中心试验比较了抗生素优先和阑尾切除术,包括门诊治疗,评估疗效和安全性是可行的。
Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy. Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate. Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/μL (range 6,200 to 23,100/μL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.
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