XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial

被引：164

作者：

Song, Yuanlin ^{[1
]}

Yao, Chen ^{[2
]}

Yao, Yongming ^{[3
]}

Han, Hui ^{[4
]}

Zhao, Xiaodong ^{[5
]}

Yu, Kaijiang ^{[6
]}

Liu, Luyi ^{[7
]}

Xu, Ying ^{[8
]}

Liu, Zhongmin ^{[9
]}

Zhou, Qingshan ^{[10
]}

Wang, Ying ^{[11
]}

Ma, Zhuang ^{[12
]}

Zheng, Youguang ^{[13
]}

Wu, Dawei ^{[14
]}

Tang, Zhongzhi ^{[15
]}

Zhang, Minzhou ^{[16
]}

Pan, Shuming ^{[17
]}

Chai, Yanfen ^{[18
]}

Song, Yan ^{[19
]}

Zhang, Jian ^{[20
]}

Pan, Lei ^{[21
]}

Liu, Yi ^{[22
]}

Yu, He ^{[23
]}

Yu, Xuezhong ^{[24
]}

Zhang, Hong ^{[25
]}

Wang, Xiaoge ^{[26
]}

Du, Zhaohui ^{[27
]}

Wan, Xianyao ^{[28
]}

Tang, Yijun ^{[29
]}

Tian, Yingping ^{[30
]}

Zhu, Yimin ^{[31
]}

Wang, Hongliang ^{[6
]}

Yan, Xiaoyan ^{[32
]}

Liu, Zhi ^{[33
]}

Zhang, Boli ^{[34
]}

Zhong, Nanshan ^{[35
]}

Shang, Hongcai ^{[36
]}

Bai, Chunxue ^{[1
]}

机构：

[1] Fudan Univ, Zhongshan Hosp, Dept Resp Med, Shanghai, Peoples R China

[2] Peking Univ, Hosp 1, Dept Med Stat, Beijing, Peoples R China

[3] Chinese Peoples Liberat Army Gen Hosp, Inst Field Surg, Beijing, Peoples R China

[4] Chinese Peoples Liberat Army Gen Hosp, Dept Emergency Med, Beijing, Peoples R China

[5] Chinese Peoples Liberat Army Gen Hosp, Dept Emergency Med, Affiliated Hosp 1, Beijing, Peoples R China

[6] Harbin Med Univ, Dept Intens Care Unit, Affiliated Hosp 2, Harbin, Heilongjiang, Peoples R China

[7] Qingdao Univ, Yuhuangding Hosp, Dept Intens Care Unit, Yantai, Peoples R China

[8] First Peoples Hosp Yunnan Prov, Dept Emergency Med, Kunming, Yunnan, Peoples R China

[9] Jilin Univ, Dept Intens Care Unit, Hosp 1, Changchun, Jilin, Peoples R China

[10] Wuhan Univ, Renmin Hosp, Dept Intens Care Unit, Wuhan, Hubei, Peoples R China

[11] Peoples Liberat Army Gen Hosp Rocket Forces, Dept Resp Med, Beijing, Peoples R China

[12] Shenyang Mil Command, Peoples Liberat Army Gen Hosp, Dept Resp Med, Shenyang, Liaoning, Peoples R China

[13] Zhengzhou Univ, Luoyang Cent Hosp, Dept Resp Med, Luoyang, Peoples R China

[14] Shandong Univ, Qilu Hosp, Dept Intens Care Unit, Jinan, Shandong, Peoples R China

[15] Guangzhou Mil Command, Wuhan Gen Hosp, Dept Emergency Med, Wuhan, Hubei, Peoples R China

[16] Guangdong Prov Hosp Tradit Chinese Med, Dept Intens Care Unit, Guangzhou, Guangdong, Peoples R China

[17] Shanghai Jiao Tong Univ, Sch Med, Xin Hua Hosp, Dept Emergency Med, Shanghai, Peoples R China

[18] Tianjin Med Univ, Gen Hosp, Dept Emergency Med, Tianjin, Peoples R China

[19] Shenyang Med Coll, Cent Hosp, Dept Intens Care Unit, Shenyang, Liaoning, Peoples R China

[20] Fourth Mil Med Univ, Affiliated Hosp 1, Dept Resp Med, Xian, Shaanxi, Peoples R China

[21] Capital Med Univ, Beijing Shijitan Hosp, Dept Resp Med, Beijing, Peoples R China

[22] Peoples Liberat Army Air Force Gen Hosp, Dept Resp Med, Beijing, Peoples R China

[23] Sichuan Univ, West China Hosp, Dept Resp Med, Chengdu, Sichuan, Peoples R China

[24] Beijing Union Med Coll Hosp, Dept Emergency Med, Beijing, Peoples R China

[25] Anhui Med Univ, Affiliated Hosp 1, Dept Emergency Med, Hefei, Anhui, Peoples R China

[26] China Med Univ, Affiliated Hosp 4, Dept Resp Med, Shenyang, Liaoning, Peoples R China

[27] Wuhan Univ, Zhongnan Hosp, Dept Anesthesiol & Crit Care Med, Wuhan, Hubei, Peoples R China

[28] Dalian Med Univ, Affiliated Hosp 1, Dept Intens Care Unit, Dalian, Peoples R China

[29] Hubei Univ Med, Taihe Hosp, Dept Resp Med, Shiyan, Peoples R China

[30] Hebei Med Univ, Hosp 2, Dept Emergency Med, Shijiazhuang, Hebei, Peoples R China

[31] Hunan Prov Peoples Hosp, Dept Emergency, Changsha, Hunan, Peoples R China

[32] Peking Univ, Clin Res Inst, Dept Biostat, Beijing, Peoples R China

[33] Tianjin Univ Tradit Chinese Med, Evidence Based Med Ctr, Tianjin, Peoples R China

[34] China Acad Chinese Med Sci, Gen Off, Beijing, Peoples R China

[35] Guangzhou Med Univ, Affiliated Hosp 1, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China

[36] Beijing Univ Chinese Med, Dongzhimen Hosp, Key Lab Chinese Internal Med, Minist Educ & Beijing, Beijing, Peoples R China

来源：

CRITICAL CARE MEDICINE | 2019年 / 47卷 / 09期

基金：

中国国家自然科学基金;

关键词：

28-day mortality rate; pneumonia severity index; randomized controlled trial; severe community-acquired pneumonia; XueBiJing injection; INFECTIOUS-DISEASES-SOCIETY; REQUIRING HOSPITALIZATION; MANAGEMENT; GUIDELINES; THERAPY;

D O I：

10.1097/CCM.0000000000003842

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

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, 100mL, 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.

引用

页码：E735 / E743

页数：9

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