Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Institute for Brain Disorders, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Clin Interv Aging. 2020 Nov 9;15:2109-2115. doi: 10.2147/CIA.S268140. eCollection 2020.
There were few studies on the case mortality of severe community-acquired pneumonia (CAP) in elderly people. Improved outcomes with XueBiJing (XBJ) injection vs placebo have been shown in overall trial populations. We investigated the efficacy and safety of XBJ vs placebo in subjects with severe CAP stratified by age (<65 and ≥65 years).
This post hoc analysis of a large randomized trial compared data from elderly and nonelderly patients with XBJ, 100 mL, q 12 h, or a visually indistinguishable placebo for five-to-seven days.
Among subjects ≥65 years (n=291), 23 (16.0%) XBJ recipients and 41 (27.9%) placebo recipients (=0.014) died within 28 days. Among subjects <65 years (n=360), XBJ still had lower mortality (XBJ 15.6% vs placebo 22.8%; =0.082), without significantly statistical difference. Total duration of ICU stay and the time of mechanical ventilation were similar in both groups (>0.05). XBJ also had a favorable safety profile, with no clinically relevant differences between the two groups. The overall incidence of adverse events was similar in both groups.
XBJ was safe and effective for reduction in 28-day mortality among elderly patients with severe CAP. Additional confirmatory trials involving elderly patients are needed to further confirm the present results.
http://www.chictr.org.cn/index.aspx. ChiCTR-TRC-13003534.
老年人重症社区获得性肺炎（CAP）的病死率研究较少。血必净注射液（XBJ）与安慰剂相比，在总体试验人群中显示出更好的疗效。我们调查了 XBJ 与安慰剂在按年龄分层（<65 岁和≥65 岁）的重症 CAP 患者中的疗效和安全性。
这是一项大型随机试验的事后分析，比较了老年和非老年患者接受 XBJ（100ml，每 12 小时一次）或外观上无法区分的安慰剂治疗 5-7 天的数据。
在≥65 岁的患者中（n=291），23 名（16.0%）接受 XBJ 治疗的患者和 41 名（27.9%）接受安慰剂治疗的患者在 28 天内死亡（=0.014）。在<65 岁的患者中（n=360），XBJ 组的死亡率仍较低（XBJ 组 15.6% vs 安慰剂组 22.8%；=0.082），但无统计学差异。两组患者的 ICU 总住院时间和机械通气时间相似（>0.05）。XBJ 还具有良好的安全性，两组之间无临床相关差异。两组的不良事件总发生率相似。
XBJ 可降低重症 CAP 老年患者 28 天病死率，安全有效。需要进行更多涉及老年患者的验证性试验来进一步证实目前的结果。
