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观察与抗生素治疗单纯性憩室炎:个体患者数据荟萃分析。

Observational versus antibiotic treatment for uncomplicated diverticulitis: an individual-patient data meta-analysis.

机构信息

Department of Surgery, Academic Medical Centre, Amsterdam, the Netherlands.

Department of Surgery, and Centre for Clinical Research Uppsala University, Västmanlands Hospital, Västerås, Sweden.

出版信息

Br J Surg. 2020 Jul;107(8):1062-1069. doi: 10.1002/bjs.11465. Epub 2020 Feb 19.

Abstract

BACKGROUND

Two RCTs (AVOD and DIABOLO) demonstrated no difference in recovery or adverse outcomes when antibiotics for acute uncomplicated diverticulitis were omitted. Both trials showed non-significantly higher rates of complicated diverticulitis and surgery in the non-antibiotic groups. This meta-analysis of individual-patient data aimed to explore adverse outcomes and identify patients at risk who may benefit from antibiotic treatment.

METHODS

Individual-patient data from those with uncomplicated diverticulitis from two RCTs were pooled. Risk factors for adverse outcomes and the effect of observational management were assessed using logistic regression analyses. P < 0·025 was considered statistically significant owing to multiple testing adjustment.

RESULTS

In total, 545 patients in the observational group and 564 in the antibiotics group were included. No statistical differences were found in 1-year follow-up rates of ongoing diverticulitis (7·2 versus 5·0 per cent in observation versus antibiotics groups respectively; P = 0·062), recurrent diverticulitis (8·6 versus 9·6 per cent; P = 0·610), complicated diverticulitis (4·0 versus 2·1 per cent; P = 0·079) and sigmoid resection (5·0 versus 2·5 per cent; P = 0·214). An initial pain score greater than 7, white blood cell count exceeding 13·5 × 10 /l and previous diverticulitis at presentation were risk factors for adverse outcomes. Antibiotic treatment did not prevent adverse outcomes in patients at high risk of adverse events.

CONCLUSION

Observational management of acute uncomplicated diverticulitis is safe. Some statistical uncertainty remains, depending on the thresholds of clinical relevance, owing to small differences, but no subgroup that would benefit from antibiotic treatment was apparent.

摘要

背景

两项 RCT(AVOD 和 DIABOLO)表明,在急性单纯性憩室炎中省略抗生素时,在恢复或不良结局方面没有差异。两项试验均显示,非抗生素组中复杂憩室炎和手术的发生率非显著升高。本项针对个体患者数据的荟萃分析旨在探讨不良结局,并确定可能从抗生素治疗中获益的高危患者。

方法

汇总来自两项 RCT 的单纯性憩室炎患者的个体患者数据。使用逻辑回归分析评估不良结局的危险因素和观察性管理的效果。由于多重测试调整,P<0·025 被认为具有统计学意义。

结果

共有 545 例观察组成员和 564 例抗生素组成员纳入分析。在 1 年随访时,观察组中持续性憩室炎(分别为 7.2%和 5.0%)、复发性憩室炎(分别为 8.6%和 9.6%)、复杂憩室炎(分别为 4.0%和 2.1%)和乙状结肠切除术(分别为 5.0%和 2.5%)的发生率无统计学差异(P 值分别为 0·062、0·610、0·079 和 0·214)。初始疼痛评分大于 7、白细胞计数超过 13.5×10 /l 和就诊时存在既往憩室炎是不良结局的危险因素。对于高风险不良事件的患者,抗生素治疗并不能预防不良结局。

结论

急性单纯性憩室炎的观察性管理是安全的。由于差异较小,取决于临床相关性的阈值,仍存在一些统计上的不确定性,但没有明显的亚组显示从抗生素治疗中获益。

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