Gorter Ramon R, van der Lee Johanna H, Cense Huibert A, Kneepkens C M Frank, Wijnen Marc H W A, In 't Hof Klaas H, Offringa Martin, Heij Hugo A
Paediatric Surgical Centre of Amsterdam, Emma Children's Hospital AMC & VU University Medical Centre, Amsterdam, The Netherlands; Department of Surgery, Red Cross Hospital, Beverwijk, The Netherlands.
Paediatric Clinical Research Office Division Woman and Child, Academic Medical Centre, Amsterdam, The Netherlands.
Surgery. 2015 May;157(5):916-23. doi: 10.1016/j.surg.2015.01.008. Epub 2015 Mar 16.
Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children. The aims of this study were to investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach.
In a multicenter, prospective cohort study patients aged 7-17 years with a radiologically confirmed simple appendicitis were eligible. Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48-72 hours. Clinical reevaluation every 6 hours, daily blood samples, and ultrasound follow-up after 48 hours was performed. In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days. At any time, in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed. Follow-up continued until 8 weeks after discharge. Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis.
Of 44 eligible patients, 25 participated (inclusion rate, 57%; 95% CI, 42%-70%). Delayed appendectomy was performed in 2, and the other 23 were without symptoms at the 8 weeks follow-up. Minor complications occurred in three patients. None of the patients suffered from an adverse event or a recurrent appendicitis.
Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children; the intervention seems to be safe.
急性阑尾炎的初始抗生素治疗已被证明在成人中是安全的；到目前为止，关于这种治疗方法在儿童中的安全性和有效性知之甚少。本研究的目的是探讨一项随机对照试验（RCT）评估初始抗生素治疗儿童急性单纯性阑尾炎的可行性，并评估这种方法的安全性。
在一项多中心前瞻性队列研究中，年龄在7至17岁、经放射学确诊为单纯性阑尾炎的患者符合条件。静脉注射抗生素（阿莫西林/克拉维酸250/25mg/kg，每日4次；最大剂量6000/600mg/d，庆大霉素7mg/kg，每日1次）持续48至72小时。每6小时进行一次临床重新评估，每天采集血样，并在48小时后进行超声随访。如果48小时后病情改善，则给予口服抗生素共7天。在任何时候，如果72小时后临床病情恶化或无改善，则可进行阑尾切除术。随访持续至出院后8周。不良事件定义为抗生素治疗的主要并发症，如过敏反应、阑尾穿孔和复发性阑尾炎。
44名符合条件的患者中，25名参与研究（纳入率为57%；95%CI，42%-70%）。2名患者进行了延迟阑尾切除术，其他23名患者在8周随访时无症状。3名患者出现轻微并发症。没有患者发生不良事件或复发性阑尾炎。
我们的研究表明，在儿童中比较初始抗生素治疗策略与紧急阑尾切除术的RCT是可行的；该干预措施似乎是安全的。
