脓毒症治疗一直都是存在着挑战,从早期发现、识别,到启动治疗、阶段调整及评估预后,基于其异质性的存在,也基于不同医疗机构医疗水平的差异性,脓毒症的治疗效果一直都是差强人意。中医药治疗,尤其是中药制剂的治疗,在简便性方面不逊于传统意义的现代医学制剂治疗,突破了传统中药的汤药形式,解决了经口服用、经胃肠道吸收在部分患者身上的局限性问题。但是,对于中药制剂的静脉应用,其疗效及安全性方面,一直受到广泛关注,尤其是某些制剂的安全性存在欠缺的现实,让很部分人对中药制剂产生了抗拒。
作为医学领域的权威学术杂志之一,JAMA系列刊物Internal Medicine在今年5月发表了一篇由国人重症牛人邱海波教授团队主导的、多中心、随机对照试验结果,结果提示,对于脓毒症患者,静脉应用血必净(100ml、BID)5天,能够有效改善28d死亡率(7.3%)。本研究纳入的是18~75岁的、SOFA评分2~13分、入院启动血必净治疗不超过48小时的患者。primary outcome评估的是28d全因死亡率,key secondary outcomes包括ICU死亡率、院内死亡率、ICU和住院时长、28d内最长和最短ICU-free时间等。
JAMA系列发表的article文章原文摘要如下:
Importance Previous research has suggested that Xuebijing injection (XBJ), an herbal-based intravenous preparation, may reduce mortality among patients with sepsis.
Objective To determine the effect of XBJ vs placebo on 28-day mortality among patients with sepsis.
Design, Setting, and Participants The Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP) trial was a multicenter, randomized double-blind, placebo-controlled trial conducted in intensive care units at 45 sites and included 1817 randomized patients with sepsis (sepsis 3.0) present for less than 48 hours. Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled. The study was conducted from October 2017 to June 2019. The final date of follow-up was July 26, 2019. Data analysis was performed from January 2020 to August 2022.
Interventions The patients were randomized to receive either intravenous infusion of XBJ (100 mL, n = 911) or volume-matched saline placebo (n = 906) every 12 hours for 5 days.
Main Outcomes and Measures The primary outcome was 28-day mortality.
Results Among the 1817 patients who were randomized (mean [SD] age, 56.5 [13.5] years; 1199 [66.0%] men), 1760 (96.9%) completed the trial. In these patients, the 28-day mortality rate was significantly different between the placebo group and the XBJ group (230 of 882 patients [26.1%] vs 165 of 878 patients [18.8%], respectively; P < .001). The absolute risk difference was 7.3 (95% CI, 3.4-11.2) percentage points. The incidence of adverse events was 222 of 878 patients (25.3%) in the placebo group and 200 of 872 patients (22.9%) in the XBJ group.
Conclusions and Relevance In this randomized clinical trial among patients with sepsis, the administration of XBJ reduced 28-day mortality compared with placebo.
Trial Registration ClinicalTrials.gov Identifier: NCT03238742