Parecoxib sequential with imrecoxib for occurrence and remission of severe acute pancreatitis: a multicentre, double-blind, randomised, placebo-controlled trial.

We aimed to evaluate the efficacy of cyclooxygenase-2 inhibitors (COX-2-Is) on the treatment of SAP and its safety.

我们旨在评估环氧合酶-2抑制剂(COX-2-Is)在治疗SAP及其安全性方面的疗效。

Methods

In this multicentre, double-blind, randomised, placebo-controlled, investigator-initiated trial, 348 patients with acute pancreatitis aged 18-75 years, <1 week from onset of illness to admission, and Acute Physiology and Chronic Health Evaluation II Score ≥7 or modified Marshall Score ≥2, were randomly assigned (1:1) to the COX-2-Is group (parecoxib sequential with imrecoxib) or the placebo group.

在这项多中心、双盲、随机、安慰剂对照、研究者发起的试验中，348名年龄在18-75岁之间的急性胰腺炎患者，从发病到入院的时间小于1周，且急性生理和慢性健康评估II评分≥7或改良Marshall评分≥2，被随机分配（1:1）到COX-2抑制剂组（parecoxib与imrecoxib序贯使用）或安慰剂组。

SAP occurrence, duration of OF, local complications, clinical outcomes and serum inflammatory mediators were measured.

测量了严重急性胰腺炎的发生率、器官衰竭的持续时间、局部并发症、临床结果和血清炎症介质。

Results

Compared with the placebo group, SAP occurrence was reduced by 20.7% (77.6% vs 61.5%, p=0.001) and the persistent OF duration in SAP was shortened by 2 days (p<0.001) after COX-2-Is treatment.

与安慰剂组相比，接受COX-2抑制剂治疗后，严重不良事件(SAP)的发生率降低了20.7%（77.6%对比61.5%，p=0.001），且SAP中持续的器官功能障碍(OF)持续时间缩短了2天（p<0.001）

For patients enrolled within or after 48 hours from symptom onset, SAP occurrence was reduced by 23.8% (p=0.001) and 8.5% (p=0.202), and the persistent OF duration in SAP was shortened by 3 days (p=0.001) and 2 days (p=0.010) after COX-2-Is treatment, respectively.

对于症状发作后48小时内或之后入组的患者，接受COX-2抑制剂治疗后，SAP的发生率分别降低了23.8%（p=0.001）和8.5%（p=0.202），且SAP中持续的OF持续时间分别缩短了3天（p=0.001）和2天（p=0.010）

The occurrence of local complications in the COX-2-Is group was significantly lower than those in the placebo group, 33.7% vs 49.1%, p=0.004.

COX-2抑制剂组的局部并发症发生率显著低于安慰剂组，分别为33.7%和49.1%，p=0.004。

The serum levels of inflammatory mediators and 30-day mortality (from 8.6% to 3.4%) were significantly reduced after COX-2-Is treatment, p<0.05.

经过COX-2抑制剂治疗后，炎症介质的血清水平和30天死亡率（从8.6%降至3.4%）显著降低，p<0.05。

The incidenceof adverse events was similar between the two treatment groups.

两组治疗之间的不良事件发生率相似。

Conclusions

Parecoxib sequential with imrecoxib was effective and well tolerated in reducing the occurrence and duration of SAP and local complications through suppression of systemic inflammatory response, leading to decreased morbidity.

帕瑞昔布与依那昔布序贯使用在减少SAP和局部并发症的发生和持续时间方面是有效的，并且耐受性良好，通过抑制全身性炎症反应，导致发病率降低。