Prevention of rebleeding after primary haemostasis using haemostatic powder in non-variceal upper gastrointestinal bleeding: a multicentre randomised controlled trial.

Rebleeding rates following endoscopic treatment can reach up to 25% within 72 hours in patients with high-risk lesions.

在高风险病变患者中，内镜治疗后72小时内再出血率可高达25%。

To evaluate the efficacy of a haemostatic powder (Nexpowder) in reducing rebleeding rates after conventional endoscopic treatment in patients with NVUGIB.

评估止血粉末（Nexpowder）在减少非静脉曲张性上消化道出血（NVUGIB）患者常规内镜治疗后再次出血率的有效性。

Methods

This was a prospective, multicentre, randomised controlled trialinvolving patients with acute NVUGIB from high-risk lesions who achieved initial endoscopic haemostasis.

这是一项前瞻性、多中心、随机对照试验，涉及急性非静脉曲张性上消化道出血（NVUGIB）患者，这些患者来自高风险病变，且已实现初步内镜止血。

Participants were randomised 1:1 to receive either the haemostatic powder or no further therapy (control group).

参与者按1:1的比例随机分配，接受止血粉剂或不接受进一步治疗（对照组）

The primary outcome was the rebleeding rate within 72 hours post-treatment.

主要结果是治疗后72小时内再出血率

Secondary outcomes included the 30-day rebleeding rate and the safety profile.

次要结果包括30天内再出血率和安全性概况。

Results

A total of 341 patients (72.1% male; mean age 64.8 years) were included, with 173 in the powder group and 168 in the control group.

共有341名患者（72.1%为男性；平均年龄64.8岁）被纳入研究，其中173名患者在粉末组，168名患者在对照组。

Baseline characteristics were similar between groups.

两组基线特征相似。

Ulcer bleeding was the predominant aetiology (n=317), with Forrest type I bleeding observed in two-thirds of cases.

溃疡出血是主要病因（n=317），其中三分之二的病例观察到Forrest I型出血。

The 72-hour rebleeding rate was significantly lower in the powder group (2.9%, 95% CI 0.9 to 6.6%) compared with the control group (11.3%, 95% CI 6.9 to 17.1%; p =0.005).

在粉末组中，72小时再出血率为2.9%（95%置信区间0.9%至6.6%），显著低于对照组的11.3%（95%置信区间6.9%至17.1%；p=0.005）。

A significant reduction was also observed in the 30-day cumulative rebleeding rate (7.0% vs 18.8%), with similar findings in the ulcer subgroup for the 3-day rebleeding rate (3.0% vs 12.0%; p =0.004).

30天累积再出血率也显示出显著降低（7.0%对比18.8%），溃疡亚组中3天再出血率同样发现类似结果（3.0%对比12.0%；p=0.004）。

No adverse events related to the powder application were reported.

未报告与粉末应用相关的不良事件。

Conclusions

The application of Nexpowder following endoscopic haemostasis significantly reduced both early (3 days) and late (30 days) rebleeding rates in patients with NVUGIB, particularly in cases of ulcer-related bleeding.

在内镜下止血后应用Nexpowder显著降低了非静脉曲张性上消化道出血（NVUGIB）患者的早期（3天）和晚期（30天）再出血率，特别是在溃疡相关出血的病例中。

trial_registration_number

NCT04124588.

NCT04124588。