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脓毒症治疗:中药制剂血必净带来新的启发?     
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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。

杂志同时还发表了一篇评述文章,Xuebijing Injection for the Treatment of SepsisWhat Would a Path to FDA Approval Look Like?( doi:10.1001/jamainternmed.2023.0788),评议了血必净可否获得FDA批准。文章对研究中的几个问题,一方面是血必净是中药制剂(herbal preparation)而非药物(drug),其实也是对中药制剂与化学提取物之间的差异进行了考究;另一方面,研究也是一个单一疗效研究;最后,还提出该研究是非美国国内的研究、而是仅在中国国内进行的研究。

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

转自【良山夜谈公众号

  0    已被阅读了639次  楼主 2023-06-07 13:17:11
回复列表
梁小新
131F
梁新婵Lv106 
血必净带来的新启发值得学习哦,非常不错哦!
  0     2023-08-19 19:16:50  回复
刘金明
129F
随风飘飘Lv794 
血必净具有拮抗内毒素,抑制炎症因子,抑制炎症风暴的发生,保护内皮细胞,保护内脏功能,缩短患者住院时间,降低死亡率,针对脓毒症患者,效果显著,不良反应少见。
  0     2023-08-19 13:18:56  回复
原芳
128F
@Lv186 
emotion血必净治疗效果明显
  0     2023-08-19 06:37:09  回复
Sky
127F
(^_^)Lv1741 
emotion血必净治疗效果好
  0     2023-08-16 15:45:25  回复
若怀
126F
若怀Lv54 
从临床可以监测的炎症指标以及临床症状改签情况来看,血必净确实对脓毒症患者有一定效果,但临床检测指标缺乏特异性,希望可以将超快速检测发展为床旁诊疗常规。基于OMICS的技术,将重点从传统的生物标志物转移到全基因组血液基因表达谱,更有助于深入了解血必净治疗脓毒症的作用靶点,并为更好的开发更多中药合剂服务于临床提供参考数据,让广大患者受益。
  0     2023-08-15 12:01:00  回复
张建华
125F
张建华Lv1972 
脓毒症在临床中发热的病人很常见,但是治疗必须建立在诊断的基础上,病人全身状态差恢复困难,血必净在这方面有独树一帜的优势
  0     2023-08-08 17:10:50  回复
晓妍
124F
赏虹姿Lv132 
血必净抗炎的效果显著,很好
  0     2023-08-08 05:59:36  回复
金灶沐9527
123F
血必净具有清除内毒素,增强免疫力的作用,能抑制炎症因子,改善凝血功能。保护内皮细胞,保护内脏功能,大大减少了住院时间,降低浓毒症患者的死亡率。
  0     2023-08-07 06:57:46  回复
陈杰明
122F
陈医生Lv356 
在脓毒症治疗中,血必净树立了中医药领域的典范。在新冠治疗中,也起到非常重要的作用。
  0     2023-08-05 06:42:01  回复
梓祺
121F
陈连辉Lv152 
脓毒症是永恒的话题,除了常规抗感染,血必净的治疗是不错的选择。
  0     2023-08-04 21:23:28  回复

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