EvidenceAlerts

Song Y, Yao C, Yao Y, et al. XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial. Crit Care Med. 2019 Jun 3. doi: 10.1097/CCM.0000000000003842. (Original study)
Abstract

OBJECTIVES: To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia.

DESIGN: Prospective, randomized, controlled study.

SETTING: Thirty-three hospitals in China.

PATIENTS: A total of 710 adults 18-75 years old with severe community-acquired pneumonia.

INTERVENTIONS: Participants in the XueBiJing group received XueBiJing, 100 mL, q12 hours, and the control group received a visually indistinguishable placebo.

MEASUREMENTS AND MAIN RESULTS: The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]).

CONCLUSIONS: In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.


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Ratings
Discipline Area Score
Infectious Disease 6 / 7
Intensivist/Critical Care 6 / 7
Respirology/Pulmonology 6 / 7
Hospital Doctor/Hospitalists 5 / 7
Internal Medicine 5 / 7
Comments from MORE raters

Infectious Disease rater

This large multicenter Chinese study looks at the impact on various outcomes of an herbal derived treatment in pneumonia. There was measurable impact on improvements in pneumonia parameters as well as total 28-day mortality and two measures of hospital morbidity. The intervention is probably unknown to most Western clinicians. At face value, the addition of this herbal product improved outcomes and, if you look at mortality, the number needed to treat was about 11. However, for the first two weeks after treatment initiation, there was no mortality benefit, which began to appear in the second two weeks. Odd. The impact on the pneumonia severity index is odd since it is usually meant to address incoming mortality risk in US institutions. It is difficult to draw definitive conclusions from this study.

Infectious Disease rater

Interesting paper because it brings up the potential implementation of immune modulation strategies for severe infections.

Internal Medicine rater

The trial seems to be well done, but the primary endpoint of improvement in the index isn't really very compelling. Further study and better characterization of the test product are needed before this is adopted into practice outside of China.

Internal Medicine rater

The benefit is that it provides a new adjunctive intervention to improve morbidity and mortality associated with severe pneumonia. The limitations are that the important adverse effects of the intervention were not listed, the patient population had low prevalence of comorbidities, and most were on ventilator treatment.

Respirology/Pulmonology rater

This is an interesting study. I'm not sure how this information will be received by those outside of China, but the study is thought provoking.

Respirology/Pulmonology rater

Nice RCT supporting the use of XueBiJing in severe community-acquired pneumonia. While this supports the previous smaller studies and showed reduced time in the ICU and hospital, the therapy will be available only in China (approved by the Chinese FDA) and not in the US, Canada, or West Europe. This may impact the decision about whether this research data is worthy of selecting for our readership.
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