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复杂阑尾炎术后使用抗生素 2 天与 5 天的比较:一项随机非劣效试验的成本分析。

Two Days Versus Five Days of Postoperative Antibiotics for Complex Appendicitis: Cost Analysis of a Randomized, Noninferiority Trial.

机构信息

Departments of Surgery, Erasmus MC-University Medical Center, Rotterdam, The Netherlands.

Departments of Surgery, Zuyderland Medical Center, Heerlen/Sittard, The Netherlands.

出版信息

Ann Surg. 2024 May 1;279(5):885-890. doi: 10.1097/SLA.0000000000006089. Epub 2023 Sep 12.

DOI:10.1097/SLA.0000000000006089
PMID:37698025
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10997181/
Abstract

OBJECTIVE

To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored.

METHODS

This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019.

RESULTS

In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - €625 (95% CI: -€ 958 to -€ 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of €31,117 per additional infectious complication.

CONCLUSIONS

Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.

摘要

目的

在复杂阑尾炎抗生素使用后试验中比较术后抗生素使用 2 天与 5 天的成本。背景:最近的研究表明,限制抗生素的使用可显著减少住院时间,而不会危及患者安全。但其对社会成本的潜在影响尚未得到充分探索。

方法

这是一项实用的、开放性标签、多中心临床试验,其目的是为了非劣效性。年龄≥8 岁的复杂阑尾炎患者被随机分配接受阑尾切除术后 2 天或 5 天的静脉内抗生素治疗。患者纳入时间为 2017 年 6 月至 2021 年 6 月,在 15 家荷兰医院进行。最终随访时间为 2021 年 9 月 1 日。主要试验终点是 90 天内感染并发症和死亡率的复合终点。在本研究中,主要观察指标是总体社会成本(包括直接医疗成本和与生产力损失相关的成本)和成本效益。根据电子病历中的数据记录直接医疗成本,并通过术后 90 天的电话随访进行补充。此外,通过经过验证的生产力成本问卷在手术后 4 周获得生产力损失数据。成本估算基于 2019 年的价格。

结果

在“意向治疗”分析中,共评估了 1005 例患者:502 例患者被分配到 2 天组,503 例患者被分配到 5 天组。2 天组的总体社会成本平均差异为-€625(95%CI:-€958 至-€278),这有利于 2 天组。这种差异主要归因于住院时间的缩短。两组之间的生产力损失相似。将术后抗生素限制为 2 天可节省成本,每增加 1 例感染并发症,估计可节省€31117。

结论

与 5 天相比,复杂阑尾炎术后使用 2 天抗生素可显著降低成本,且具有统计学意义。这些发现适用于资源充足的卫生保健环境下的腹腔镜阑尾切除术。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/9a2277ccde12/sla-279-885-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/009c949fe236/sla-279-885-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/0f7bf32fc1a7/sla-279-885-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/9a2277ccde12/sla-279-885-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/009c949fe236/sla-279-885-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/0f7bf32fc1a7/sla-279-885-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9360/10997181/9a2277ccde12/sla-279-885-g003.jpg

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本文引用的文献

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Lancet. 2023 Feb 4;401(10374):366-376. doi: 10.1016/S0140-6736(22)02588-0. Epub 2023 Jan 17.
2
The burden of bacterial antimicrobial resistance in the WHO European region in 2019: a cross-country systematic analysis.2019 年世卫组织欧洲区域细菌对抗菌药物耐药性的负担:跨国系统分析。
Lancet Public Health. 2022 Nov;7(11):e897-e913. doi: 10.1016/S2468-2667(22)00225-0. Epub 2022 Oct 14.
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Antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis (APPAC III): randomized double-blind superiority trial.
抗生素与安慰剂治疗 CT 证实的成人单纯性急性阑尾炎(APPAC III):随机双盲优效性试验。
Br J Surg. 2022 May 16;109(6):503-509. doi: 10.1093/bjs/znac086.
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Multicenter cohort study on the presentation and treatment of acute appendicitis during the COVID-19 pandemic.多中心队列研究:COVID-19 大流行期间急性阑尾炎的表现和治疗。
Int J Colorectal Dis. 2022 May;37(5):1087-1095. doi: 10.1007/s00384-022-04137-3. Epub 2022 Apr 12.
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