对于MDR-GN肺炎的新疆戴元山:一个随机对照试验
Zongchen Jiang1, Zimin Yan2, Qiong Li2
1China Academy of Chinese Medical Sciences, Dongcheng District, 16 Nanshizi Street, Beijing, 100864, China.
辛·戴·桑 (XJDS) 没有在多药耐药格拉姆阴性肺炎的死亡率方面表现出非劣势. 然而,XJDS显著改善了细菌清除和临床结果,表明其作为辅助疗法的潜力.
科学领域:
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
- 关键护理医学 关键护理医学
背景情况:
- 耐多药格拉姆阴性 (MDR-GN) 肺炎构成了严重的全球健康威胁,治疗选择有限.
- 传统中医 (TCM) 提供了潜在的多目标疗法,需要严格的科学验证.
研究的目的:
- 评估一种TCM配方的新疆天元圣 (XJDS) 的疗效和安全性,作为MDR-GN肺炎的替代或辅助疗法.
- 在一个随机,双盲,头对头的临床试验中,将XJDS与标准的宽谱抗生素进行比较.
主要方法:
- 一个多中心,随机,双盲,安慰剂对照试验,涉及224名已确认患有MDR-GN肺炎的成年患者.
- 患者接受了XJDS颗粒加抗生素安慰剂或XJDS安慰剂加活性抗生素 (imipenem/cilastatin或 cefoperazone/sulbactam) 持续7天.
- 主要终点包括28天全因死亡率和7天唾液细菌负载减少;次要终点包括临床肺感染评分 (CPIS) 和炎症标志物的变化.
主要成果:
- 与标准抗生素相比,XJDS在28天全因死亡率中没有达到非劣势的主要终点.
- 在第7天,XJDS显著降低了唾液细菌负载 (p < 0.001),并显著加快了CPIS和APACHE-II得分的改善 (p ≤ 0.001).
- 用XJDS治疗与促炎性细胞因子 (TNF-α,IL-1β) 的显着减弱有关,并显示了与标准抗生素相比的安全性.
结论:
- 虽然在这种严重的患者群体中死亡率并不优越,但XJDS显著提高了MDR-GN肺炎的微生物清除和临床恢复.
- 由于其免疫调节和抗菌作用,XJDS具有作为一种有价值的辅助疗法的潜力,用于管理关键的耐药性感染.
- 需要进一步的研究来阐明XJDS的精确机制,并优化其在治疗耐药细菌感染中的临床应用.
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