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一项评估单纯抗生素治疗急性单纯性阑尾炎的疗效和生活质量的随机临床试验:COMMA 试验结果。

A Randomized Clinical Trial Evaluating the Efficacy and Quality of Life of Antibiotic-only Treatment of Acute Uncomplicated Appendicitis: Results of the COMMA Trial.

机构信息

Department of Surgery, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.

Department of Microbiology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.

出版信息

Ann Surg. 2021 Aug 1;274(2):240-247. doi: 10.1097/SLA.0000000000004785.

Abstract

OBJECTIVE

Evaluate the efficacy and quality of life associated with conservative treatment of acute uncomplicated appendicitis.

SUMMARY BACKGROUND DATA

Conservative management with antibiotics only has emerged as a potential treatment option for acute uncomplicated appendicitis. However the reported failure rates are highly variable and there is a paucity of data in relation to quality of life.

METHODS

Symptomatic patients with radiological evidence of acute, uncomplicated appendicitis were randomized to either intravenous antibiotics only or undergo appendectomy.

RESULTS

One hundred eighty-six patients underwent randomization. In the antibiotic-only group, 23 patients (25.3%) experienced a recurrence within 1 year following randomization. There was a significantly better EQ-VAS quality of life score in the surgery group compared with the antibiotic-only group at 3 months (94.3 vs 91.0, P < 0.001) and 12 months postintervention (94.5 vs 90.4, P < 0.001). The EQ-5D-3L quality-of-life score was significantly higher in the surgery group indicating a better quality of life (0.976 vs 0.888, P < 0.001). The accumulated 12-month sickness days was 3.6 days shorter for the antibiotics only group (5.3 vs 8.9 days; P < 0.01). The mean length of stay in both groups was not significantly different (2.3 vs 2.8 days, P = 0.13). The mean total cost in the surgery group was significantly higher than antibiotics only group (€4,816 vs €3,077, P < 0.001).

CONCLUSIONS

Patients with acute, uncomplicated appendicitis treated with antibiotics only experience high recurrence rates and an inferior quality of life. Surgery should remain the mainstay of treatment for this commonly encountered acute surgical condition.

摘要

目的

评估单纯保守治疗急性单纯性阑尾炎的疗效和生活质量。

背景资料概要

仅用抗生素进行保守治疗已成为急性单纯性阑尾炎的一种潜在治疗选择。然而,报告的失败率差异很大,而且与生活质量相关的数据很少。

方法

对有放射学证据的急性单纯性阑尾炎症状患者进行随机分组,分别接受静脉内抗生素治疗或进行阑尾切除术。

结果

186 名患者进行了随机分组。在仅用抗生素组中,23 名患者(25.3%)在随机分组后 1 年内复发。在术后 3 个月(94.3 对 91.0,P < 0.001)和 12 个月时,手术组的 EQ-VAS 生活质量评分明显更高,与仅用抗生素组相比(94.5 对 90.4,P < 0.001)。手术组的 EQ-5D-3L 生活质量评分明显更高,表明生活质量更好(0.976 对 0.888,P < 0.001)。仅用抗生素组的 12 个月累计病假天数减少了 3.6 天(5.3 对 8.9 天;P < 0.01)。两组的平均住院时间无显著差异(2.3 对 2.8 天,P = 0.13)。手术组的平均总费用明显高于仅用抗生素组(€4816 对 €3077,P < 0.001)。

结论

接受单纯抗生素治疗的急性单纯性阑尾炎患者复发率高,生活质量差。手术仍然是治疗这种常见急性外科疾病的主要方法。

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