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腹腔镜胆囊切除术与抗生素治疗对 75 岁以上急性胆囊炎患者的作用:随机临床试验和回顾性队列研究。

Laparoscopic cholecystectomy versus antibiotic therapy for acute cholecystitis in patients over 75 years: Randomized clinical trial and retrospective cohort study.

机构信息

Kuopio University Hospital Puijonlaaksontie 270210 Kuopio Finland.

Turku University Hospital, Turku, Finland.

出版信息

Scand J Surg. 2023 Dec;112(4):219-226. doi: 10.1177/14574969231178650. Epub 2023 Aug 12.

Abstract

BACKGROUND AND OBJECTIVE

The prevalence of acute cholecystitis among elderly patients is increasing. The aim of this study was to compare laparoscopic cholecystectomy (LC) to antibiotics in elderly patients with acute cholecystitis.

METHODS

A randomized multicenter clinical trial including patients over 75 years with acute calculous cholecystitis was conducted in four hospitals in Finland between January 2017 and December 2019. Patients were randomized to undergo LC or antibiotic therapy. Due to patient enrollment challenges, the trial was prematurely terminated in December 2019. To assess all eligible patients, we performed a retrospective cohort study including all patients over 75 years with acute cholecystitis during the study period. The primary outcome was morbidity. Predefined secondary outcomes included mortality, readmission rate, and length of hospital stay.

RESULTS

Among 42 randomized patients (LC n = 24, antibiotics n = 18, mean age 82 years, 43% women), the complication rate was 17% (n = 4/24) after cholecystectomy and 33% (n = 6/18, 5/6 patients underwent cholecystectomy due to antibiotic treatment failure) after antibiotics (p = 0.209). In the retrospective cohort (n = 630, mean age 83 years, 49% women), 37% (236/630) of the patients were treated with cholecystectomy and 63% (394/630) with antibiotics. Readmissions were less common after surgical treatment compared with antibiotics in both randomized and retrospective cohort patients (8% vs 44%, p < 0.001% and 11 vs 32%, p < 0.001, respectively). There was no 30-day mortality within the randomized trial. In the retrospective patient cohort, overall mortality was 6% (35/630).

CONCLUSIONS

LC may be superior to antibiotic therapy for acute cholecystitis in the selected group of elderly patients with acute cholecystitis.

摘要

背景与目的

老年患者急性胆囊炎的患病率正在增加。本研究旨在比较老年急性胆囊炎患者行腹腔镜胆囊切除术(LC)与抗生素治疗的效果。

方法

本研究为在芬兰四家医院开展的一项随机多中心临床试验,纳入 2017 年 1 月至 2019 年 12 月期间 75 岁以上的急性结石性胆囊炎患者。患者被随机分为 LC 组或抗生素治疗组。由于患者入组困难,该试验于 2019 年 12 月提前终止。为评估所有符合条件的患者,我们对研究期间所有 75 岁以上的急性胆囊炎患者进行了回顾性队列研究。主要结局为发病率。预先设定的次要结局包括死亡率、再入院率和住院时间。

结果

在 42 例随机分组患者(LC 组 24 例,抗生素组 18 例,平均年龄 82 岁,43%为女性)中,LC 组的并发症发生率为 17%(4/24),抗生素组为 33%(6/18,5/6 例因抗生素治疗失败而行胆囊切除术)(p=0.209)。在回顾性队列(n=630,平均年龄 83 岁,49%为女性)中,37%(236/630)的患者接受了胆囊切除术,63%(394/630)的患者接受了抗生素治疗。在随机和回顾性队列患者中,手术治疗的再入院率均低于抗生素治疗(分别为 8%比 44%,p<0.001%和 11%比 32%,p<0.001)。随机试验中无 30 天内死亡病例。在回顾性患者队列中,总死亡率为 6%(35/630)。

结论

对于急性胆囊炎的老年患者,LC 可能优于抗生素治疗。

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