Marked Reduction in 28-day Mortality Among Elderly Patients with Severe Community-acquired Pneumonia: Post Hoc Analysis of a Large Randomized Controlled Trial
Received 30 June 2020
Accepted for publication 6 October 2020
Published 9 November 2020 Volume 2020:15 Pages 2109—2115
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Zhi-Ying Wu
Yan Liu, 1,* Chi Zhang, 2,* Chengyu Li, 1 Chunxue Bai, 3 Hongcai Shang 1
1Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 2Institute for Brain Disorders, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 3Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Hongcai Shang
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, 5 Haiyuncang, Dongcheng District, Beijing 100700, People’s Republic of China
Background: 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).
Methods: 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.
Results: Among subjects ≥ 65 years (n=291), 23 (16.0%) XBJ recipients and 41 (27.9%) placebo recipients (P=0.014) died within 28 days. Among subjects < 65 years (n=360), XBJ still had lower mortality (XBJ 15.6% vs placebo 22.8%; P=0.082), without significantly statistical difference. Total duration of ICU stay and the time of mechanical ventilation were similar in both groups (P> 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.
Conclusion: 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.
Trial Registration: http://www.chictr.org.cn/index.aspx. ChiCTR-TRC-13003534.
Keywords: severe community-acquired pneumonia, randomized controlled trial, post hoc analysis, 28-day mortality rate, XueBiJing injection
Corrigendum for this paper has been published