Saline lavage alone prolongs drainage compared with intrapleural enzyme therapy in pleural infection: the SCOPE randomised controlled trial.

Methods

The SCOPE trial was a two-centre, prospective, randomised superiority study designed to determine whether saline lavage alone or combined with IET was superior to IET alone in adults with pleural infection.

SCOPE试验是一项两中心、前瞻性、随机优效性研究，旨在确定单独使用生理盐水灌洗或与IET联合使用是否比单独使用IET在成人胸膜感染患者中更优越。

Patients were randomised in a 1:1:1 ratio to saline lavage alone, saline lavage plus IET (urokinase and DNase) or IET alone.

患者按照1:1:1的比例随机分配到仅用生理盐水灌洗、生理盐水灌洗加IET（尿激酶和脱氧核糖核酸酶）或仅IET治疗组。

Patients and outcome assessors were blinded to the treatment allocation.

患者和结果评估者对治疗分配情况不知情。

The primary end-point was the duration of pleural drainage.

主要终点是胸腔引流持续的时间。

Secondary end-points included radiographic resolution, need for additional interventions, length of hospital stay, mortality and adverse events.

次要终点包括影像学分辨率、需要额外干预的需求、住院时间、死亡率和不良事件。

Results

89 patients were analysed in three groups (saline lavage, n=30; saline+IET, n=30; IET, n=29).

分析了89名患者，分为三组（生理盐水灌洗组，n=30；生理盐水+IET组，n=30；IET组，n=29）。

Baseline characteristics were broadly similar across the groups.

各组患者的基线特征大致相似。

The median (interquartile range) drainage duration was longer with saline lavage alone (4.0 (3.0-6.75) days) than with IET alone (3.0 (2.0-4.0) days; p=0.01) or saline lavage plus IET (3.0 (3.0-3.75) days; p=0.01).

单独使用生理盐水冲洗的引流持续时间中位数（四分位数间距）较长（4.0（3.0-6.75）天），与单独使用IET（3.0（2.0-4.0）天；p=0.01）或生理盐水冲洗加IET（3.0（3.0-3.75）天；p=0.01）相比。

No significant difference was observed between the two IET-containing regimens (p=0.24).

两种含IET的方案之间没有观察到显著差异（p=0.24）。

Secondary outcomes showed no clear advantage for saline lavage alone or in combination with IET.

次要结果表明，单独使用生理盐水冲洗或与IET联合使用并无明显优势。

Conclusions

In pleural infection, saline lavage alone results in a longer drainage duration than IET.

在胸膜感染中，单独使用生理盐水冲洗比IET有更长的引流时间。

In this small superiority trial, adding saline lavage to IET did not demonstrate a clinically meaningful advantage over IET alone.

在这项小规模的优势试验中，将生理盐水灌洗添加到IET中，并没有显示出比单独使用IET有临床意义上的优势。