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XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia

A Randomized Controlled Trial

Song, Yuanlin MD1; Yao, Chen MD2; Yao, Yongming MD3; Han, Hui MD4; Zhao, Xiaodong MD5; Yu, Kaijiang MD6; Liu, Luyi MD7; Xu, Ying MD8; Liu, Zhongmin MD9; Zhou, Qingshan MD10; Wang, Ying MD11; Ma, Zhuang MD12; Zheng, Youguang MD13; Wu, Dawei MD14; Tang, Zhongzhi MD15; Zhang, Minzhou MD16; Pan, Shuming MD17; Chai, Yanfen MD18; Song, Yan MD19; Zhang, Jian MD20; Pan, Lei MD21; Liu, Yi MD22; Yu, He MD23; Yu, Xuezhong MD24; Zhang, Hong MD25; Wang, Xiaoge MD26; Du, Zhaohui MD27; Wan, Xianyao MD28; Tang, Yijun MD29; Tian, Yingping MD30; Zhu, Yimin MD31; Wang, Hongliang MD6; Yan, Xiaoyan PhD32; Liu, Zhi PhD33; Zhang, Boli MD34; Zhong, Nanshan MD35; Shang, Hongcai MD36; Bai, Chunxue MD1

doi: 10.1097/CCM.0000000000003842
Online Clinical Investigation: PDF Only
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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.

1Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

2Department of Medical Statistics, Peking University First Hospital, Beijing, China.

3Institute of Field Surgery, Chinese People’s Liberation Army General Hospital, Beijing, China.

4Department of Emergency Medicine, Chinese People’s Liberation Army General Hospital, Beijing, China.

5Department of Emergency Medicine, First Affiliated Hospital of Chinese People’s Liberation Army General Hospital, Beijing, China.

6Department of Intensive Care Unit, Second Affiliated Hospital of Harbin Medical University, Harbin, China.

7Department of Intensive Care Unit, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, China.

8Department of Emergency Medicine, First People’s Hospital of Yunnan Province, Kunming, China.

9Department of Intensive Care Unit, The First Hospital of Jilin University, Changchun, China.

10Department of Intensive Care Unit, Renmin Hospital of Wuhan University, Wuhan, China.

11Department of Respiratory Medicine, People’s Liberation Army General Hospital of Rocket Forces, Beijing, China.

12Department of Respiratory Medicine, People’s Liberation Army General Hospital of Shenyang Military Command, Shenyang, China.

13Department of Respiratory Medicine, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, China.

14Department of Intensive Care Unit, Qilu Hospital of Shandong University, Jinan, China.

15Department of Emergency Medicine, Wuhan General Hospital of Guangzhou Military Command, Wuhan, China.

16Department of Intensive Care Unit, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.

17Department of Emergency Medicine, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.

18Department of Emergency Medicine, Tianjin Medical University General Hospital, Tianjin, China.

19Department of Intensive Care Unit, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China.

20Department of Respiratory Medicine, The First Affiliated Hospital of The Fourth Military Medical University, Xi'an, China.

21Department of Respiratory Medicine, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.

22Department of Respiratory Medicine, People’s Liberation Army Air Force General Hospital, Beijing, China.

23Department of Respiratory Medicine, West China Hospital of Sichuan University, Sichuan, China.

24Department of Emergency Medicine, Beijing Union Medical College Hospital, Beijing, China.

25Department of Emergency Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, China.

26Department of Respiratory Medicine, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.

27Department of Anesthesiology and Critical Care Medicine, Zhongnan Hospital, Wuhan University, Wuhan, China.

28Department of Intensive Care Unit, First Affiliated Hospital of Dalian Medical University, Dalian, China.

29Department of Respiratory Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, China.

30Department of Emergency Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, China.

31Department of Emergency, Hunan Provincial People’s Hospital, Hunan, China.

32Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China.

33Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

34General Office, China Academy of Chinese Medical Sciences, Beijing, China.

35State Key Laboratory of Respiratory Diseases, first Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.

36Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported, in part, by a Tianjin Science and Technology committee grant (14ZXLJSY00230) and National Natural Science Foundation of China (81630001,81490533).

Drs. X. Yu and Zhi Liu disclosed work for hire. Dr. B. Zhang disclosed government work. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Clinical Trial Registration: http://www.chictr.org.cn/index.aspx. Unique identifier: ChiCTR-TRC-13003534.

For information regarding this article, E-mail: bai.chunxue@zs-hospital.sh.cn; shanghongcai@126.com

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