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脓肿切开引流术联合或不联合超声检查的随机对照试验。

Abscess Incision and Drainage With or Without Ultrasonography: A Randomized Controlled Trial.

机构信息

Department of Emergency Medicine, UMass Memorial Medical Center, Worcester, MA.

Department of Emergency Medicine, UMass Memorial Medical Center, Worcester, MA.

出版信息

Ann Emerg Med. 2019 Jan;73(1):1-7. doi: 10.1016/j.annemergmed.2018.05.014. Epub 2018 Aug 17.

Abstract

STUDY OBJECTIVE

We hypothesize that clinical failure rates will be lower in patients treated with point-of-care ultrasonography and incision and drainage compared with those who undergo incision and drainage after physical examination alone.

METHODS

We performed a prospective randomized clinical trial of patients presenting with a soft tissue abscess at a large, academic emergency department. Patients presenting with an uncomplicated soft tissue abscess requiring incision and drainage were eligible for enrollment and randomized to treatment with or without point-of-care ultrasonography. The diagnosis of an abscess was by physical examination, bedside ultrasonography, or both. Patients randomized to the point-of-care ultrasonography group had an incision and drainage performed with bedside ultrasonographic imaging of the abscess. Patients randomized to the non-point-of-care ultrasonography group had an incision and drainage performed with physical examination alone. Comparison between groups was by comparing means with 95% confidence intervals. The primary outcome was failure of therapy at 10 days, defined as a repeated incision and drainage, following a per-protocol analysis. Multivariate analysis was performed to control for study variables. Our study was designed to detect a clinically important difference between groups, which we defined as a 13% difference.

RESULTS

A total of 125 patients were enrolled, 63 randomized to the point-of-care ultrasonography group and 62 to physical examination alone. After loss to follow-up and misallocation, 54 patients in the ultrasonography group and 53 in the physical examination alone group were analyzed. The overall failure rate for all patients enrolled in the study was 10.3%. Patients who were evaluated with ultrasonography were less likely to fail therapy and have repeated incision and drainage, with a difference between groups of 13.3% (95% confidence interval 0.0% to 19.4%). Abscess locations were predominantly torso (21%), buttocks (21%), lower extremity (18%), and axilla or groin (16%). There was no difference in baseline characteristics between groups relative to abscess size, duration of symptoms before presentation, percentage with cellulitis, and treatment with antibiotics.

CONCLUSION

Patients with soft tissue abscesses who were undergoing incision and drainage with point-of-care ultrasonography demonstrated less clinical failure compared with those treated without point-of-care ultrasonography.

摘要

研究目的

我们假设,在接受即时超声引导下切开引流术的患者中,临床失败率会低于仅接受体格检查后切开引流术的患者。

方法

我们对一家大型学术急救部门就诊的软组织脓肿患者进行了前瞻性随机临床试验。符合纳入标准且需要切开引流术治疗的单纯软组织脓肿患者可参与本研究,并随机分为接受即时超声检查与不接受即时超声检查两组。脓肿的诊断依据是体格检查、床边超声或两者。被随机分配至即时超声组的患者,在床边超声检查引导下进行脓肿切开引流术。被随机分配至非即时超声组的患者仅接受体格检查后行脓肿切开引流术。通过比较两组间的均值及其 95%置信区间来进行组间比较。主要结局是 10 天后的治疗失败率,其定义为符合方案分析后行重复切开引流术。采用多变量分析来控制研究变量。我们的研究旨在检测两组间的临床重要差异,我们将其定义为 13%的差异。

结果

共有 125 例患者入组,其中 63 例随机分配至即时超声组,62 例随机分配至仅接受体格检查组。经失访和错配后,超声组有 54 例患者和仅接受体格检查组有 53 例患者纳入分析。所有入组患者的总体治疗失败率为 10.3%。接受超声检查的患者发生治疗失败和需要重复切开引流术的可能性较小,两组间差异为 13.3%(95%置信区间 0.0%至 19.4%)。脓肿部位主要位于躯干(21%)、臀部(21%)、下肢(18%)和腋窝或腹股沟(16%)。两组间脓肿大小、就诊前症状持续时间、蜂窝织炎发生率和抗生素治疗等基线特征无差异。

结论

与未接受即时超声检查的患者相比,接受即时超声引导下切开引流术的软组织脓肿患者的临床失败率较低。

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