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随机对照临床试验:抗生素治疗单纯性阑尾炎。

Randomized clinical trial of antibiotic therapy for uncomplicated appendicitis.

机构信息

Department of Surgery, Hallym University College of Medicine, 170beon-gil 22, Gwanpyeongro, Dong An-Gu, Anyang, 14068, South Korea.

出版信息

Br J Surg. 2017 Dec;104(13):1785-1790. doi: 10.1002/bjs.10660. Epub 2017 Sep 19.

Abstract

BACKGROUND

Uncomplicated appendicitis may resolve spontaneously or require treatment with antibiotics or appendicectomy. The aim of this randomized trial was to compare the outcome of a non-antibiotic management strategy with that of antibiotic therapy in uncomplicated appendicitis.

METHODS

Patients presenting to a university teaching hospital with CT-verified uncomplicated simple appendicitis (appendiceal diameter no larger than 11 mm and without any signs of perforation) were randomized to management with a no-antibiotic regimen with supportive care (intravenous fluids, analgesia and antipyretics as necessary) or a 4-day course of antibiotics with supportive care. The primary endpoint was rate of total treatment failure, defined as initial treatment failure within 1 month and recurrence of appendicitis during the follow-up period.

RESULTS

Some 245 patients were randomized within the trial, and followed up for a median of 19 months. The duration of hospital stay was shorter (mean 3·1 versus 3·7 days; P < 0·001) and the medical costs lower (€1181 versus 1348; P < 0·001) among those randomized to therapy without antibiotics. There was no difference in total treatment failure rate between the groups: 29 of 124 (23·4 per cent) in the no-antibiotic group and 25 of 121 (20·7 per cent) in the antibiotic group (P = 0·609). Eighteen patients (9 in each group) had initial treatment failure, 15 of whom underwent appendicectomy and three received additional antibiotics. Thirty-six patients (20 in the no-antibiotic group, 16 in the antibiotic group) experienced recurrence, of whom 30 underwent appendicectomy and six received further antibiotics.

CONCLUSION

Treatment failure rates in patients presenting with CT-confirmed uncomplicated appendicitis appeared similar among those receiving supportive care with either a no-antibiotic regimen or a 4-day course of antibiotics. Registration number: KCT0000124 ( http://cris.nih.go.kr).

摘要

背景

单纯性阑尾炎可能会自行缓解,也可能需要抗生素治疗或阑尾切除术。本随机试验的目的是比较非抗生素治疗策略与单纯性阑尾炎的抗生素治疗的结果。

方法

将在大学教学医院接受 CT 证实的单纯性简单阑尾炎(阑尾直径不超过 11mm 且无穿孔迹象)的患者随机分为接受无抗生素方案支持治疗(静脉补液、必要时镇痛和解热)或 4 天疗程抗生素联合支持治疗。主要终点是总治疗失败率,定义为 1 个月内初始治疗失败和随访期间阑尾炎复发。

结果

在试验中,共有 245 名患者被随机分组,中位随访时间为 19 个月。与接受抗生素治疗的患者相比,接受无抗生素治疗的患者住院时间更短(平均 3.1 天 vs. 3.7 天;P<0.001),医疗费用更低(€1181 比 €1348;P<0.001)。两组总治疗失败率无差异:无抗生素组 124 例中有 29 例(23.4%),抗生素组 121 例中有 25 例(20.7%)(P=0.609)。18 例患者(每组 9 例)初始治疗失败,其中 15 例接受阑尾切除术,3 例接受额外抗生素治疗。36 例患者(无抗生素组 20 例,抗生素组 16 例)出现复发,其中 30 例接受阑尾切除术,6 例接受进一步抗生素治疗。

结论

在接受 CT 证实的单纯性阑尾炎患者中,接受支持治疗的患者中,使用非抗生素方案或 4 天疗程抗生素的治疗失败率似乎相似。注册号:KCT0000124(http://cris.nih.go.kr)。

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