- 중증 알코올 관련 간염으로 입원한 환자들에서 시행된 무작위 이중맹검 임상시험
- 【아목시실린/클라불라네이트 + 프레드니솔론】은 【위약 + 프레드니솔론】과 비교하여 사망률을 낮추지 못함
- 2015.06.13일부터 2019.05.24일까지 프랑스와 벨기에 25개 센터에서 Maddrey function score ≥32과 Model for End-stage Liver Disease [MELD] score ≥21인 조직검사로 입증된 중증 알코올 관련 간염 환자를 180일 동안 추적 관찰함
- 284명 환자들 가운데 145명에게는 【아목시실린/클라불라네이트 + 프레드니솔론】을 투약하였고 147명에게는 【위약 + 프레드니솔론】을 투약함
- 1차 결과는 60일째 모든 원인 사망률, 2차 결과는 90일째, 180일째 모든 원인 사망률, 감염 발생률, 간신 증후군 발생률
- 【아목시실린/클라불라네이트 + 프레드니솔론】 그룹에서 60일째 사망률은 17.3%, 【위약 + 프레드니솔론】 그룹에서 사망률은 21.3%로 의미 있는 차이는 없었음 (hazard ratio, 0.77; 95% CI, 0.45-1.31).
- 60일째 감염률은 【아목시실린/클라불라네이트 + 프레드니솔론】 그룹에서 의미 있게 더 낮았으나 다른 나머지 3가지 2차 결과는 의미 있는 차이가 없었음
이 연구는 중증 알코올 관련 간염으로 입원한 환자에서 예방적 항생제 사용이 생존률을 개선시키지 않음을 시사.
Importance The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear.
Objective To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone.
Design, Setting, and Participants Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score ≥32 and Model for End-stage Liver Disease [MELD] score ≥21) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019.
Intervention Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147).
Main Outcome and Measures The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days.
Results Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [P = .33]; between-group difference, −4.7% [95% CI, −14.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, −11.8% [95% CI, −23.0% to −0.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; P = .02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group).
Conclusion and Relevance In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis.
Trial Registration ClinicalTrials.gov Identifier: NCT02281929
REF
1. JAMA. 2023;329(18):1558-1566. doi:10.1001/jama.2023.4902
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