Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang, Lixin Xie

ABSTRACT

BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells. METHODS: This study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5 days starting within 24 h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28 days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial. DISCUSSION: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02937974 . Registered on 13 October 2016. Chinese clinical trial registry, ChiCTR-IPR-17011667. Registered on 15 June 2017. More... »

PAGES

136

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-019-3204-z

DOI

http://dx.doi.org/10.1186/s13063-019-3204-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112216369

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30777117


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Chinese PLA General Hospital", 
          "id": "https://www.grid.ac/institutes/grid.414252.4", 
          "name": [
            "Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, 100853, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Xie", 
        "givenName": "Sheling", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Chinese PLA General Hospital", 
          "id": "https://www.grid.ac/institutes/grid.414252.4", 
          "name": [
            "Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, 100853, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yan", 
        "givenName": "Peng", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Peking University", 
          "id": "https://www.grid.ac/institutes/grid.11135.37", 
          "name": [
            "Peking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, 100191, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yao", 
        "givenName": "Chen", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Peking University", 
          "id": "https://www.grid.ac/institutes/grid.11135.37", 
          "name": [
            "Peking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, 100191, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yan", 
        "givenName": "Xiaoyan", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Beijing Blue Balloons Technology Co., Ltd., 168 Beiyuan Road, Chaoyang District, 100191, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Huo", 
        "givenName": "Yuliang", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Tianjin University of Traditional Chinese Medicine", 
          "id": "https://www.grid.ac/institutes/grid.410648.f", 
          "name": [
            "Tianjin University of Traditional Chinese Medicine, 312 Anshan West Road, Nankai District, 300193, Tianjin, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Zhang", 
        "givenName": "Junhua", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Tianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, 301700, Tianjin, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Liu", 
        "givenName": "Si", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Tianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, 301700, Tianjin, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Feng", 
        "givenName": "Zhiqiao", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Beijing University of Chinese Medicine", 
          "id": "https://www.grid.ac/institutes/grid.24695.3c", 
          "name": [
            "Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, 5 Haiyuncang, Dongcheng District, 100700, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Shang", 
        "givenName": "Hongcai", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Chinese PLA General Hospital", 
          "id": "https://www.grid.ac/institutes/grid.414252.4", 
          "name": [
            "Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, 100853, Beijing, China"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Xie", 
        "givenName": "Lixin", 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1164/rccm.200612-1749oc", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000450293"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/pca.1284", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004981597"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa032736", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005827285"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0954-6111(03)80025-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009254108"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.rmed.2011.05.017", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009685916"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1378/chest.117.2_suppl.5s", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015111077"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1378/chest.117.2_suppl.5s", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015111077"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1164/rccm.200712-1869oc", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015778180"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11908-015-0496-3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1021826048", 
          "https://doi.org/10.1007/s11908-015-0496-3"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ctim.2016.09.009", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024254204"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/thoraxjnl-2011-201518", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024541525"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/thoraxjnl-2011-201518", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024541525"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1254/jphs.14055fp", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026318782"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1128/cmr.00051-05", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031355950"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmra0804752", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1032853282"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/5584_2015_178", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1033557093", 
          "https://doi.org/10.1007/5584_2015_178"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1183/09031936.00109906", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1036939816"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1038/sj.embor.7401166", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038183899"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1513/pats.200707-088et", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038729133"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/thx.2009.130260", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039302057"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/thx.2009.130260", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039302057"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3390/molecules200815319", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040497570"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3390/molecules200815319", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040497570"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1371/journal.pone.0111044", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040537187"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1378/chest.10-1393", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040697622"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1472-6882-14-239", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041834812", 
          "https://doi.org/10.1186/1472-6882-14-239"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/crj.12147", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044334820"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1365-2222.2008.03119.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044876832"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/resp.12780", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1048712766"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s13063-016-1282-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050681787", 
          "https://doi.org/10.1186/s13063-016-1282-8"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/qmh.0000000000000024", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052133584"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/qmh.0000000000000024", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052133584"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077134030", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077678062", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077863113", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1078030356", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1078139522", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1078778012", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3109/15412555.2015.1020151", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1079132183"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1164/rccm.201701-0218pp", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1079404015"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/14651858.cd004104.pub4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090658158"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1080/15412555.2017.1346069", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090901958"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10565-017-9405-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090990213", 
          "https://doi.org/10.1007/s10565-017-9405-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10565-017-9405-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090990213", 
          "https://doi.org/10.1007/s10565-017-9405-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10565-017-9405-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090990213", 
          "https://doi.org/10.1007/s10565-017-9405-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/bmjopen-2017-017099", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1091164149"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12890-017-0458-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1091206558", 
          "https://doi.org/10.1186/s12890-017-0458-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12890-017-0458-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1091206558", 
          "https://doi.org/10.1186/s12890-017-0458-7"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2019-12", 
    "datePublishedReg": "2019-12-01", 
    "description": "BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells.\nMETHODS: This study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5\u2009days starting within 24\u2009h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28\u2009days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial.\nDISCUSSION: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms.\nTRIAL REGISTRATION: ClinicalTrials.gov, NCT02937974 . Registered on 13 October 2016. Chinese clinical trial registry, ChiCTR-IPR-17011667. Registered on 15 June 2017.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/s13063-019-3204-z", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1297400", 
        "issn": [
          "1468-6708", 
          "1745-6215"
        ], 
        "name": "Trials", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "20"
      }
    ], 
    "name": "Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial", 
    "pagination": "136", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "74e65fde7af227a2faf0bce4f31eb22f463d1e43c13e8a05bc0185b3c2ab8a29"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30777117"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101263253"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s13063-019-3204-z"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1112216369"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s13063-019-3204-z", 
      "https://app.dimensions.ai/details/publication/pub.1112216369"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T10:38", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000349_0000000349/records_113676_00000005.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1186%2Fs13063-019-3204-z"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s13063-019-3204-z'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s13063-019-3204-z'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s13063-019-3204-z'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s13063-019-3204-z'


 

This table displays all metadata directly associated to this object as RDF triples.

257 TRIPLES      21 PREDICATES      69 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s13063-019-3204-z schema:about anzsrc-for:11
2 anzsrc-for:1103
3 schema:author N1588defea5714f70ab2a6c013881f08c
4 schema:citation sg:pub.10.1007/5584_2015_178
5 sg:pub.10.1007/s10565-017-9405-x
6 sg:pub.10.1007/s11908-015-0496-3
7 sg:pub.10.1186/1472-6882-14-239
8 sg:pub.10.1186/s12890-017-0458-7
9 sg:pub.10.1186/s13063-016-1282-8
10 https://app.dimensions.ai/details/publication/pub.1077134030
11 https://app.dimensions.ai/details/publication/pub.1077678062
12 https://app.dimensions.ai/details/publication/pub.1077863113
13 https://app.dimensions.ai/details/publication/pub.1078030356
14 https://app.dimensions.ai/details/publication/pub.1078139522
15 https://app.dimensions.ai/details/publication/pub.1078778012
16 https://doi.org/10.1002/14651858.cd004104.pub4
17 https://doi.org/10.1002/pca.1284
18 https://doi.org/10.1016/j.ctim.2016.09.009
19 https://doi.org/10.1016/j.rmed.2011.05.017
20 https://doi.org/10.1016/s0954-6111(03)80025-2
21 https://doi.org/10.1038/sj.embor.7401166
22 https://doi.org/10.1056/nejmoa032736
23 https://doi.org/10.1056/nejmra0804752
24 https://doi.org/10.1080/15412555.2017.1346069
25 https://doi.org/10.1097/qmh.0000000000000024
26 https://doi.org/10.1111/crj.12147
27 https://doi.org/10.1111/j.1365-2222.2008.03119.x
28 https://doi.org/10.1111/resp.12780
29 https://doi.org/10.1128/cmr.00051-05
30 https://doi.org/10.1136/bmjopen-2017-017099
31 https://doi.org/10.1136/thoraxjnl-2011-201518
32 https://doi.org/10.1136/thx.2009.130260
33 https://doi.org/10.1164/rccm.200612-1749oc
34 https://doi.org/10.1164/rccm.200712-1869oc
35 https://doi.org/10.1164/rccm.201701-0218pp
36 https://doi.org/10.1183/09031936.00109906
37 https://doi.org/10.1254/jphs.14055fp
38 https://doi.org/10.1371/journal.pone.0111044
39 https://doi.org/10.1378/chest.10-1393
40 https://doi.org/10.1378/chest.117.2_suppl.5s
41 https://doi.org/10.1513/pats.200707-088et
42 https://doi.org/10.3109/15412555.2015.1020151
43 https://doi.org/10.3390/molecules200815319
44 schema:datePublished 2019-12
45 schema:datePublishedReg 2019-12-01
46 schema:description BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells. METHODS: This study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5 days starting within 24 h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28 days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial. DISCUSSION: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02937974 . Registered on 13 October 2016. Chinese clinical trial registry, ChiCTR-IPR-17011667. Registered on 15 June 2017.
47 schema:genre research_article
48 schema:inLanguage en
49 schema:isAccessibleForFree true
50 schema:isPartOf N93724cb378b34cbfb118a3dd986d5590
51 Naec9134dcccd44adb4fb0b4b8116b45b
52 sg:journal.1297400
53 schema:name Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
54 schema:pagination 136
55 schema:productId N3861144ec6c34106bf7523d9467c4b84
56 N5866ea90fda64088805c23a408f34a9e
57 N93e3be8ae08a4adbbf50d42edfbcbda0
58 Nd0c9be6175f0457e8967c0c8dafc7cc3
59 Nd9cfd152a81745319696c611186505bb
60 schema:sameAs https://app.dimensions.ai/details/publication/pub.1112216369
61 https://doi.org/10.1186/s13063-019-3204-z
62 schema:sdDatePublished 2019-04-11T10:38
63 schema:sdLicense https://scigraph.springernature.com/explorer/license/
64 schema:sdPublisher N92cd2869d7604e33a3c368ea1101d041
65 schema:url https://link.springer.com/10.1186%2Fs13063-019-3204-z
66 sgo:license sg:explorer/license/
67 sgo:sdDataset articles
68 rdf:type schema:ScholarlyArticle
69 N0c4405c6aad34ae8ad3e564a7273f49d rdf:first N18d50a634dd84b4cbbb576ed2d48cccc
70 rdf:rest N133dfd5c0e4d442abb9f562b5a171897
71 N0c55e39d25204919893c44b6549fc7dc schema:affiliation https://www.grid.ac/institutes/grid.11135.37
72 schema:familyName Yan
73 schema:givenName Xiaoyan
74 rdf:type schema:Person
75 N133dfd5c0e4d442abb9f562b5a171897 rdf:first N0c55e39d25204919893c44b6549fc7dc
76 rdf:rest N3cd07802b0094b469b53db28f23a22f0
77 N1588defea5714f70ab2a6c013881f08c rdf:first N4440ba8b5cd9493ab65fc2ff17c0bef7
78 rdf:rest N5fc319dbafa5424eb7760b9ef310ac8e
79 N18b6969e601e46ec86c9a887e3d65ebe schema:affiliation https://www.grid.ac/institutes/grid.414252.4
80 schema:familyName Xie
81 schema:givenName Lixin
82 rdf:type schema:Person
83 N18d50a634dd84b4cbbb576ed2d48cccc schema:affiliation https://www.grid.ac/institutes/grid.11135.37
84 schema:familyName Yao
85 schema:givenName Chen
86 rdf:type schema:Person
87 N23630c5122224b7babee3a1ae80dce89 rdf:first N18b6969e601e46ec86c9a887e3d65ebe
88 rdf:rest rdf:nil
89 N3861144ec6c34106bf7523d9467c4b84 schema:name pubmed_id
90 schema:value 30777117
91 rdf:type schema:PropertyValue
92 N3cd07802b0094b469b53db28f23a22f0 rdf:first N82b158b5f58f41098f61f5965021ac19
93 rdf:rest Nd60e3c295b564d59ad987c8df497c9ec
94 N4440ba8b5cd9493ab65fc2ff17c0bef7 schema:affiliation https://www.grid.ac/institutes/grid.414252.4
95 schema:familyName Xie
96 schema:givenName Sheling
97 rdf:type schema:Person
98 N5866ea90fda64088805c23a408f34a9e schema:name nlm_unique_id
99 schema:value 101263253
100 rdf:type schema:PropertyValue
101 N5fc319dbafa5424eb7760b9ef310ac8e rdf:first Nd61b1fb015e544e48fa13bbb6029b103
102 rdf:rest N0c4405c6aad34ae8ad3e564a7273f49d
103 N66883868cff04c39bf8fae00171c91f3 schema:affiliation https://www.grid.ac/institutes/grid.410648.f
104 schema:familyName Zhang
105 schema:givenName Junhua
106 rdf:type schema:Person
107 N6edd15213c4a44b4a15d227e40ba1510 schema:name Tianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, 301700, Tianjin, China
108 rdf:type schema:Organization
109 N704633a384574bd890cc2a83de513732 rdf:first Nc108dc6cdfde49cb9e41905b9590201b
110 rdf:rest Nadc35301ca5e4021bbead50fd40afae6
111 N7f79e4b814d74572ad191e60872ba8b3 rdf:first N9e1ddf14f08e464cbeb9da3fafb1e174
112 rdf:rest N23630c5122224b7babee3a1ae80dce89
113 N82b158b5f58f41098f61f5965021ac19 schema:affiliation N9d782236a2a64c0ca78f060a7b320671
114 schema:familyName Huo
115 schema:givenName Yuliang
116 rdf:type schema:Person
117 N92cd2869d7604e33a3c368ea1101d041 schema:name Springer Nature - SN SciGraph project
118 rdf:type schema:Organization
119 N93724cb378b34cbfb118a3dd986d5590 schema:issueNumber 1
120 rdf:type schema:PublicationIssue
121 N937a7ac5eea84fb590c1adb8c6fd53ec schema:name Tianjin Chase Sun Pharmaceutical Co., Ltd., 20 Quanfa Road, Wuqing Development Area, 301700, Tianjin, China
122 rdf:type schema:Organization
123 N93e3be8ae08a4adbbf50d42edfbcbda0 schema:name readcube_id
124 schema:value 74e65fde7af227a2faf0bce4f31eb22f463d1e43c13e8a05bc0185b3c2ab8a29
125 rdf:type schema:PropertyValue
126 N9d782236a2a64c0ca78f060a7b320671 schema:name Beijing Blue Balloons Technology Co., Ltd., 168 Beiyuan Road, Chaoyang District, 100191, Beijing, China
127 rdf:type schema:Organization
128 N9e1ddf14f08e464cbeb9da3fafb1e174 schema:affiliation https://www.grid.ac/institutes/grid.24695.3c
129 schema:familyName Shang
130 schema:givenName Hongcai
131 rdf:type schema:Person
132 Nadc35301ca5e4021bbead50fd40afae6 rdf:first Nfef98c83d41c40ca8875f8a14f0aed90
133 rdf:rest N7f79e4b814d74572ad191e60872ba8b3
134 Naec9134dcccd44adb4fb0b4b8116b45b schema:volumeNumber 20
135 rdf:type schema:PublicationVolume
136 Nc108dc6cdfde49cb9e41905b9590201b schema:affiliation N6edd15213c4a44b4a15d227e40ba1510
137 schema:familyName Liu
138 schema:givenName Si
139 rdf:type schema:Person
140 Nd0c9be6175f0457e8967c0c8dafc7cc3 schema:name dimensions_id
141 schema:value pub.1112216369
142 rdf:type schema:PropertyValue
143 Nd60e3c295b564d59ad987c8df497c9ec rdf:first N66883868cff04c39bf8fae00171c91f3
144 rdf:rest N704633a384574bd890cc2a83de513732
145 Nd61b1fb015e544e48fa13bbb6029b103 schema:affiliation https://www.grid.ac/institutes/grid.414252.4
146 schema:familyName Yan
147 schema:givenName Peng
148 rdf:type schema:Person
149 Nd9cfd152a81745319696c611186505bb schema:name doi
150 schema:value 10.1186/s13063-019-3204-z
151 rdf:type schema:PropertyValue
152 Nfef98c83d41c40ca8875f8a14f0aed90 schema:affiliation N937a7ac5eea84fb590c1adb8c6fd53ec
153 schema:familyName Feng
154 schema:givenName Zhiqiao
155 rdf:type schema:Person
156 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
157 schema:name Medical and Health Sciences
158 rdf:type schema:DefinedTerm
159 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
160 schema:name Clinical Sciences
161 rdf:type schema:DefinedTerm
162 sg:journal.1297400 schema:issn 1468-6708
163 1745-6215
164 schema:name Trials
165 rdf:type schema:Periodical
166 sg:pub.10.1007/5584_2015_178 schema:sameAs https://app.dimensions.ai/details/publication/pub.1033557093
167 https://doi.org/10.1007/5584_2015_178
168 rdf:type schema:CreativeWork
169 sg:pub.10.1007/s10565-017-9405-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1090990213
170 https://doi.org/10.1007/s10565-017-9405-x
171 rdf:type schema:CreativeWork
172 sg:pub.10.1007/s11908-015-0496-3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1021826048
173 https://doi.org/10.1007/s11908-015-0496-3
174 rdf:type schema:CreativeWork
175 sg:pub.10.1186/1472-6882-14-239 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041834812
176 https://doi.org/10.1186/1472-6882-14-239
177 rdf:type schema:CreativeWork
178 sg:pub.10.1186/s12890-017-0458-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1091206558
179 https://doi.org/10.1186/s12890-017-0458-7
180 rdf:type schema:CreativeWork
181 sg:pub.10.1186/s13063-016-1282-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050681787
182 https://doi.org/10.1186/s13063-016-1282-8
183 rdf:type schema:CreativeWork
184 https://app.dimensions.ai/details/publication/pub.1077134030 schema:CreativeWork
185 https://app.dimensions.ai/details/publication/pub.1077678062 schema:CreativeWork
186 https://app.dimensions.ai/details/publication/pub.1077863113 schema:CreativeWork
187 https://app.dimensions.ai/details/publication/pub.1078030356 schema:CreativeWork
188 https://app.dimensions.ai/details/publication/pub.1078139522 schema:CreativeWork
189 https://app.dimensions.ai/details/publication/pub.1078778012 schema:CreativeWork
190 https://doi.org/10.1002/14651858.cd004104.pub4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1090658158
191 rdf:type schema:CreativeWork
192 https://doi.org/10.1002/pca.1284 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004981597
193 rdf:type schema:CreativeWork
194 https://doi.org/10.1016/j.ctim.2016.09.009 schema:sameAs https://app.dimensions.ai/details/publication/pub.1024254204
195 rdf:type schema:CreativeWork
196 https://doi.org/10.1016/j.rmed.2011.05.017 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009685916
197 rdf:type schema:CreativeWork
198 https://doi.org/10.1016/s0954-6111(03)80025-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009254108
199 rdf:type schema:CreativeWork
200 https://doi.org/10.1038/sj.embor.7401166 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038183899
201 rdf:type schema:CreativeWork
202 https://doi.org/10.1056/nejmoa032736 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005827285
203 rdf:type schema:CreativeWork
204 https://doi.org/10.1056/nejmra0804752 schema:sameAs https://app.dimensions.ai/details/publication/pub.1032853282
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1080/15412555.2017.1346069 schema:sameAs https://app.dimensions.ai/details/publication/pub.1090901958
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1097/qmh.0000000000000024 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052133584
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1111/crj.12147 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044334820
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1111/j.1365-2222.2008.03119.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1044876832
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1111/resp.12780 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048712766
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1128/cmr.00051-05 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031355950
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1136/bmjopen-2017-017099 schema:sameAs https://app.dimensions.ai/details/publication/pub.1091164149
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1136/thoraxjnl-2011-201518 schema:sameAs https://app.dimensions.ai/details/publication/pub.1024541525
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1136/thx.2009.130260 schema:sameAs https://app.dimensions.ai/details/publication/pub.1039302057
223 rdf:type schema:CreativeWork
224 https://doi.org/10.1164/rccm.200612-1749oc schema:sameAs https://app.dimensions.ai/details/publication/pub.1000450293
225 rdf:type schema:CreativeWork
226 https://doi.org/10.1164/rccm.200712-1869oc schema:sameAs https://app.dimensions.ai/details/publication/pub.1015778180
227 rdf:type schema:CreativeWork
228 https://doi.org/10.1164/rccm.201701-0218pp schema:sameAs https://app.dimensions.ai/details/publication/pub.1079404015
229 rdf:type schema:CreativeWork
230 https://doi.org/10.1183/09031936.00109906 schema:sameAs https://app.dimensions.ai/details/publication/pub.1036939816
231 rdf:type schema:CreativeWork
232 https://doi.org/10.1254/jphs.14055fp schema:sameAs https://app.dimensions.ai/details/publication/pub.1026318782
233 rdf:type schema:CreativeWork
234 https://doi.org/10.1371/journal.pone.0111044 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040537187
235 rdf:type schema:CreativeWork
236 https://doi.org/10.1378/chest.10-1393 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040697622
237 rdf:type schema:CreativeWork
238 https://doi.org/10.1378/chest.117.2_suppl.5s schema:sameAs https://app.dimensions.ai/details/publication/pub.1015111077
239 rdf:type schema:CreativeWork
240 https://doi.org/10.1513/pats.200707-088et schema:sameAs https://app.dimensions.ai/details/publication/pub.1038729133
241 rdf:type schema:CreativeWork
242 https://doi.org/10.3109/15412555.2015.1020151 schema:sameAs https://app.dimensions.ai/details/publication/pub.1079132183
243 rdf:type schema:CreativeWork
244 https://doi.org/10.3390/molecules200815319 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040497570
245 rdf:type schema:CreativeWork
246 https://www.grid.ac/institutes/grid.11135.37 schema:alternateName Peking University
247 schema:name Peking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, 100191, Beijing, China
248 rdf:type schema:Organization
249 https://www.grid.ac/institutes/grid.24695.3c schema:alternateName Beijing University of Chinese Medicine
250 schema:name Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, 5 Haiyuncang, Dongcheng District, 100700, Beijing, China
251 rdf:type schema:Organization
252 https://www.grid.ac/institutes/grid.410648.f schema:alternateName Tianjin University of Traditional Chinese Medicine
253 schema:name Tianjin University of Traditional Chinese Medicine, 312 Anshan West Road, Nankai District, 300193, Tianjin, China
254 rdf:type schema:Organization
255 https://www.grid.ac/institutes/grid.414252.4 schema:alternateName Chinese PLA General Hospital
256 schema:name Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, 100853, Beijing, China
257 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...