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[Intensive Care Med在线发表]:维生素C和维生素B1联合治疗感染性休克:一项多中心、双盲随机对照试验
2020年08月21日 时讯速递, 进展交流 暂无评论

Original Published: 

Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled study

Sung Yeon Hwang, Seung Mok Ryoo, Jong Eun Park, et al

Intensive Care Med 2020

Purpose 目的

To evaluate the effects of early combination therapy with intravenous vitamin C and thiamine on recovery from organ failure in patients with septic shock.

评估静脉维生素C与维生素B1早期联合治疗对感染性休克患者器官衰竭恢复的影响。

Methods 方法

The ascorbic acid and thiamine effect in septic shock (ATESS) trial was a multi-centre, double-blind, randomized, controlled trial conducted in four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020. Patients were randomly assigned in a 1:1 ratio to either the treatment group [intravenous vitamin C (50 mg/kg, maximum single dose 3 g) and thiamine (200 mg) administration every 12 h for a total of 48 h] or the placebo group (identical volume of 0.9% saline with the same protocol). The primary outcome was Δ Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment–SOFA score after 72 h). Eighteen secondary outcomes were predefined, including shock reversal and 28-day mortality.

ATESS试验是一项多中心、双盲、随机对照试验,从2018年12月至2020年1月在4家医院的急诊科进行,入选感染性休克成人患者。入选患者按照1:1的比例随机分为治疗组[静脉维生素C 50 mg/kg,单剂最大剂量3 g及维生素B1 200 mg q12h,疗程48小时]或安慰剂[相同容量的0.9%生理盐水,治疗方案相同]。主要预后重点为ΔSOFA(入选时SOFA - 72小时后SOFA)。预先确定18项次要预后指标,包括休克逆转及28天病死率。

Results 结果

A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the placebo group. There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) − 1 to 5 vs. 3, IQR 0–4, respectively, p = 0.96]. Predefined secondary outcomes were also not significantly different between the groups.

共有111名患者入选,其中53名患者分至治疗组,58名分至安慰剂组。治疗组与安慰剂组间ΔSOFA没有显著差异[分别为3, IQR − 1 to 5 vs. 3, IQR 0 to 4, p = 0.96]。预先确定的次要预后指标在两组间也没有显著差异。

Conclusion 结论

In this study, vitamin C and thiamine administration in the early phase of septic shock did not improve organ function compared with placebo, despite improvements in vitamin C and thiamine levels.

此项研究中,与安慰剂相比,在感染性休克早期应用维生素C和维生素B1不能改善器官功能,尽管维生素C和维生素B1水平增加。

[评论]

我们都知道,ICU医生对于鸡尾酒疗法的热衷来自于Chest发表的一篇前后对照试验。该试验显示,对于感染性休克患者,鸡尾酒疗法(联合使用维生素C、维生素B1和糖皮质激素)伴随病死率显著降低(OR 0.13, 95%CI 0.04-0.48, p = 0.002)。

从循证医学的角度看,前后对照试验不能证实治疗与临床结局之间的因果关系,后者只能依靠随机对照临床试验证实。

本研究结果为阴性。但是,治疗组与安慰剂组分别有58%和50%的患者使用糖皮质激素治疗。所以,从严格意义上讲,这个研究并非验证传统鸡尾酒疗法的临床试验。

我们真的期待有关鸡尾酒疗法的RCT结果吗?

对于感染性休克这样一类异质性极大的临床综合征而言,是否真的需要根据基因型或表型区分不同的亚组,才能发现可能有益的治疗措施?

鉴于既往临床试验的失败,越来越多的研究者不再使用病死率作为主要预后终点。这是合理的改变,还是无奈之举?或者说,如果这样的改变只是为了得到阳性结果,那么这种阳性结果真的是临床试验应该追求的吗?

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