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

Song, Yuanlin; Yao, Chen; Yao, Yongming; Han, Hui; Zhao, Xiaodong; Yu, Kaijiang; Liu, Luyi; Xü, Ying; Liu, Zhongmin; Zhou, Qingshan; Wang, Ying; Ma, Zhuang; Zheng, Youguang; Wu, Dawei; Tang, Zhongzhi; Zhang, Minzhou; Pan, Shuming; Chai, Yifeng; Song, Yan; Zhang, Jian; Pan, Lei; Liu, Yi; He, Yu; Yu, Xuezhong; Zhang, Hong; Wang, Xiaoge; Du, Zhenhong; Wan, Xianyao; Tang, Yijun; Tian, Yunyun; Zhu, Yimin; Wang, Hongliang; Yan, Xiaoyan; Li, Zhi; Zhang, Boli; Zhong, Nanshan; Shang, Hongcai; Bai, Chunxue

doi:10.1097/ccm.0000000000003842

Cited by 116 publications

(126 citation statements)

References 35 publications

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“…The recovery rate of SARS-CoV-2 infection is about 92.7% in China, and the mortality is 5.1% globally [6]. The virus is highly infectious, spreading rapidly in human-tohuman transmission, posing a dangerous threat to global public health [7,8].…”

Section: Introductionmentioning

confidence: 99%

Clinical characteristics and drug therapies in patients with the common-type coronavirus disease 2019 in Hunan, China

Huang

Deng

et al. 2020

Int J Clin Pharm

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Background Clinical characteristics of patients with the coronavirus disease 2019 (COVID-19) may present differently within and outside the epicenter of Wuhan, China. More clinical investigations are needed. Objective The study was aimed to describe the clinical characteristics, laboratory parameters, and therapeutic methods of COVID-19 patients in Hunan, China. Setting The First Hospital of Changsha, First People's Hospital of Huaihua, and the Central Hospital of Loudi, Hunan province, China. Methods This was a retrospective multi-center case-series analysis. Patients with confirmed COVID-19 diagnosis hospitalized at the study centers from January 17 to February 10, 2020, were included. The following data were obtained from electronic medical records: demographics, medical history, exposure history, underlying comorbidities, symptoms, signs, laboratory findings, computer tomography scans, and treatment measures. Main outcome measure Epidemiological, clinical, laboratory, and radiological characteristics and treatments. Results A total of 54 patients were included (51 had the common-type COVID-19, three had the severe-type), the median age was 41, and 52% of them were men. The median time from the first symptoms to hospital admission was seven days. Among patients with the common-type COVID-19, the median length of stay was nine days, and 21 days among patients with severe COVID-19. The most common symptoms at the onset of illness were fever (74.5%), cough (56.9%), and fatigue (43.1%) among patients in the common-type group. Fourteen patients (37.8%) had a reduced WBC count, 23 (62.2%) had reduced eosinophil ratio, and 21 (56.76%) had decreased eosinophil count. The most common patterns on chest-computed tomography were ground-glass opacity (52.2%) and patchy bilateral shadowing (73.9%). Pharmacotherapy included recombinant human interferon α2b, lopinavir/ritonavir, novaferon, antibiotics, systematic corticosteroids and traditional Chinese medicine prescription. The outcome of treatment indicated that in patients with the common-type COVID-19, interferon-α2b, but not novaferon, had some benefits, antibiotics treatment was not needed, and corticosteroids should be used cautiously. Conclusion As of February 10, 2020, the symptoms of COVID-19 patients in Hunan province were relatively mild comparing to patients in Wuhan, the epicenter. We observed some treatment benefits with interferon-α2b and corticosteroid therapies but not with novaferon and antibiotic treatment in our study population.

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Section: Introductionmentioning

confidence: 99%

Clinical characteristics and drug therapies in patients with the common-type coronavirus disease 2019 in Hunan, China

Huang

Deng

et al. 2020

Int J Clin Pharm

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“…The overall results of this large trial showed that XBJ is an effective and well-tolerated therapy for patients with severe CAP [14]. With high efficacy and good tolerability, XBJ compares favorably with the placebo.…”

Section: Discussionmentioning

confidence: 90%

“…Pharmacological studies have shown that XBJ has an antagonistic effect on endotoxin, and an inhibitory effect on the uncontrolled release of endogenous inflammatory mediators produced by endotoxin-stimulated monocytes/macrophages [11][12][13]. A recent well-done randomized study showed XBJ effective in patients with severe CAP [14]. Impressive benefit with this herbal-based medication was an 8.8% absolute reduction in mortality in patients who received XBJ.…”

Section: Introductionmentioning

confidence: 99%

Marked Reduction in 28-Day Mortality among Elderly Patients with Severe Community-Acquired Pneumonia: Post Hoc Analysis of XueBiJing Injection Randomized Controlled Trial

Liu¹,

Zhang²,

Li³

et al. 2020

Preprint

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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.

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“…For a long period of time in China, it was believed that XBJ could improve prognosis in severe lung infection [33] as well as 28-day mortality rate, Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II score, white blood cell (WBC) count, and temperature in sepsis patients without causing serious adverse events. A prospective, randomized controlled trial in 33 hospitals in China, published in September 2019, showed that XBJ can signi cantly improve the primary endpoint of pneumonia severity in patients with severe communityacquired pneumonia, as well as secondary endpoints such as mortality rate, mechanical-ventilation duration, and length of intensive-care unit (ICU) stay [34]. This study preliminarily demonstrated XBJ's "multiple component-multiple target-multiple pathway" effector characteristics, and our network topology analysis of potential effector targets identi ed some critical effector targets of the compound.…”

Section: Discussionmentioning

confidence: 99%

Examining the effector mechanisms of Xuebijing Injection on COVID-19 based on network pharmacology.

Zheng

Yan

et al. 2020

Preprint

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Objective: To examine the potential effector mechanisms of Xuebijing (XBJ) on coronavirus disease 2019 (COVID-19) based on network pharmacology.Methods: We searched Chinese and international papers to obtain the active ingredients of XBJ. Then, we compiled COVID-19 disease targets from the GeneCards gene database and via literature searches. Next, we used the SwissTargetPrediction database to predict XBJ’s effector targets and map them to the abovementioned COVID-19 disease targets in order to obtain potential therapeutic targets of XBJ. Cytoscape software version 3.7.0 was used to construct a “XBJ active-compound-potential-effector target” network and protein-protein interaction (PPI) network, and then to carry out network topology analysis of potential targets. We used the ClueGO and CluePedia plugins in Cytoscape to conduct gene ontology (GO) biological process (BP) analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) signaling pathway enrichment analysis of XBJ’s effector targets. Results: We obtained 144 potential COVID-19 effector targets of XBJ. Fourteen of these targets—glyceraldehyde 3-phosphate dehydrogenase (GAPDH), albumin (ALB), tumor necrosis factor (TNF), epidermal growth factor receptor (EGFR), mitogen-activated protein kinase 1 (MAPK1), Caspase-3 (CASP3), signal transducer and activator of transcription 3 (STAT3), MAPK8, prostaglandin-endoperoxide synthase 2 (PTGS2), JUN, interleukin-2 (IL-2), estrogen receptor 1 (ESR1), and MAPK14—had degree values >40 and therefore could be considered key targets. They participated in extracellular signal–regulated kinase 1 and 2 (ERK1, ERK2) cascade, the T-cell receptor signaling pathway, activation of MAPK activity, cellular response to lipopolysaccharide, and other inflammation- and immune-related BPs. XBJ exerted its therapeutic effects through the renin–angiotensin system (RAS), nuclear factor κ-light-chain-enhancer of activated B cells (NF-κB), MAPK, phosphatidylinositol-4, 5-bisphosphate 3-kinase (PI3K)–protein kinase B (Akt)–vascular endothelial growth factor (VEGF), toll-like receptor (TLR), TNF, and inflammatory-mediator regulation of transient receptor potential (TRP) signaling pathways to ultimately construct a “ingredient-target-pathway” effector network. Conclusion: The active ingredients of XBJ regulated different genes, acted on different pathways, and synergistically produced anti-inflammatory and immune-regulatory effects, which fully demonstrated the synergistic effects of different components on multiple targets and pathways. Our study demonstrated that existing studies on the pharmacological mechanisms of XBJ in the treatment of sepsis and severe pneumonia, could explain the effector mechanism of XBJ in COVID-19 treatment, and those provided a preliminary examination of the potential effector mechanism in this disease.

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

Abstract: Supplemental Digital Content is available in the text.

Cited by 116 publications

References 35 publications

Clinical characteristics and drug therapies in patients with the common-type coronavirus disease 2019 in Hunan, China

Clinical characteristics and drug therapies in patients with the common-type coronavirus disease 2019 in Hunan, China

Marked Reduction in 28-Day Mortality among Elderly Patients with Severe Community-Acquired Pneumonia: Post Hoc Analysis of XueBiJing Injection Randomized Controlled Trial

Examining the effector mechanisms of Xuebijing Injection on COVID-19 based on network pharmacology.

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