Background There were a few studies on the case mortality of severe community-acquired pneumonia (CAP) in elderly people. Improved outcomes with XueBiJing (XBJ) Injection versus placebo have been shown in overall trial populations. We investigated the efficacy and safety of XBJ versus 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 elder and nonelderly patients with XBJ, 100 ml, q12h, or a visually indistinguishable placebo for 5-7 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% verse 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 two groups. The overall incidence of adverse events was similar in both groups.
Conclusions XBJ was safe and effective for reduction in 28-day mortality among elderly patients with severe CAP. Additional trials involving elderly patients are needed to further confirm the present results.